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Symptom Checklist-90-R | The SCL-90-R [Subjects’ responses ranged from 0 (not at all) to 4 (very strongly). Cronbach’s | PMC10104919 |
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EORTC QLQ-C30 and EORTC QLQ-BR23 | The EORTC QLQ-C30 [ | PMC10104919 |
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Statistical analyses | Statistical analyses were performed using Statistical Package for the Social Sciences software (SPSS, version 26). A total of 124 subjects (69.67%) answered the entire questionnaire without omissions. Subscales with two or more missing values were not included in the calculation. This procedure resulted in 177 complete questionnaires (98.2%).To compare the two groups (FRIPOS group and TAU group) analyzed at the same time of administration, multiple independent-samples | PMC10104919 |
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Sample | psychiatric, SD, cognitive impairment, breast cancer | DISEASE, BREAST CANCER | Women who had been diagnosed with operable breast cancer were included in the study (ICD-10-CM Diagnosis Code C50.919) [110]. The exclusion criteria for the study were (a) cognitive impairment and/or psychiatric comorbidity and/or a physical condition related to the disease that, in the opinion of the treating physicians or the administrator, could lead to invalid data when completing the questionnaires; (b) poor knowledge of the Italian language; and (c) an assumed life expectancy of less than 6 months at the time of initial diagnosis.A total of 270 women were recruited for this study, of whom 182 gave informed consent to participate and provided data 3 times (participation rate 60%): 103 belong to the FRIPOS group and 79 to the control group (TAU). The mean age of the sample is 57.88 years (SD = 11.55) and ranges from 25 to 87 years. Table Sociodemographic characteristics of the participants | PMC10104919 |
Results | PMC10104919 |
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Discussion | nonverbal behaviors, dyspnea, fatigue, breast cancer, cancer | REGRESSION, CANCER, BREAST CANCER | The integrated approach proposed in the FRIPOS project seems to be an adequate response to the claims that appear in the literature related to the concept of holistic management [Indeed, the inclusion of the psycho-oncologist in the treatment has brought significant benefits or at least a state of stability in many areas (in contrast to what happened in the group TAU), especially in relation to several aspects highlighted in the literature: the development of symptomatic manifestations related to psychopathology as a result of or during the journey against cancer and the indices of psychological functioning, especially at the emotional level [In addition, the results show the effectiveness of the integrated intervention in terms of quality-of-life scales, especially in terms of fatigue, dyspnea, and sleep disturbances. This result can be taken as an indication of the importance of assessing not only the level of distress, but a more comprehensive picture of the person (including the assessment of unmet needs), taking into account in particular nonverbal behaviors as part of a holistic approach that can be of greater use for interventions in breast cancer patients. One of the advantages of the FRIPOS personalized approach is that it can be adapted to the specific needs of the patient. The psycho-oncologist throughout the oncological path can therefore implement psychological support on the basis of the particular psychological functioning of the person. In line with the literature [In nine of ten regression models for psychological symptomatology (all except the somatization subscale), membership in the FRIPOS group together with the quality-of-life subscales significantly contributed to the prediction of the mean score of the respective subscale at T2. These results suggest that the FRIPOS program was effective, confirming the hypothesis and joining the ranks of studies demonstrating the importance of integrated approaches [Further studies on the cost-effectiveness of an integrated approach are needed, especially for health systems such as the Italian one, which faces an increasing demand for integrated psycho-oncology services but also dwindling financial resources, especially for psychosocial care.Despite methodological limitations such as the relatively small sample size, the use of self-reports, and a possible implicit influence of the greater participation in the FRIPOS group (in which the women who completed all three surveys were more numerous), this study may provide important general insights for the clinical setting, including various health situations in which the presence of a parallel psychological support network in conjunction with medical interventions could significantly affect the quality of life and psychophysiological balance of those involved in the treatment process. Another limitation is that due to the pioneering and exploratory nature of this project, there is not yet a manualization of the integrative interventions. For this reason, the intervention was planned using information from the scientific literature on actual difficulties reported by cancer patients (especially breast cancer patients), but no measures were taken to ensure consistency of treatment. This problem needs to be addressed in the future. Potential psychological variables that would be useful to examine in future research involve perceived support by family and partner and specific personality traits. | PMC10104919 |
Acknowledgements | OME, PRIAMO | ONCOLOGY, BREAST | We thank the patients who participated in the study and dedicated time and resources at a particularly sensitive moment in their lives. We also thank the professionals who made the development and implementation of the Fil-Rouge project possible: Psychological Service of the Clinical Institute of S. Anna Brescia, San Donato Group; Scientific Committee of the PRIAMO Association; Service of Minimally Invasive Diagnosis and Intervention in Breast Care of the Clinical Institute of S. Anna Brescia, San Donato Group; Service of Breast Diagnosis and Minimally Invasive Intervention of the Clinical Institute of San Rocco OME, San Donato Group; Service of Breast Radiology; U.O. General Surgery of S. Anna Clinical Institute Brescia, San Donato Group; Pathological Anatomy Service of S. Anna Clinical Institute Brescia, San Donato Group; Department of Medical Oncology of S. Anna Clinical Institute Brescia, San Donato Group; Department of Oncology and Oncology Day Hospital of S. Anna Clinical Institute Brescia, San Donato Group; Department of Radiotherapy and Clinical Oncology of S. Anna Clinical Institute Brescia, San Donato Group; Secretariat of the Breast Unit of S. Anna Clinical Institute Brescia, San Donato Group; and Analytical Laboratory of S. Anna Clinical Institute Brescia, San Donato Group. | PMC10104919 |
Author contribution | Conceptualization, C.C., D.L. and F.P.; methodology, D.L., G.F., F.P., A.Be., A.Bu., V.G., N.R.; formal analysis, C.C. and A.D.B.; data curation, C.C., E.D.; writing-original draft preparation, C.C.; writing, C.C., A.D.B., E.D., G.D.F., G.G.; supervision, D.L., F.V., G.D.F., G.G.; project administration, D.L., G.F., F.P., A.Be., A.Bu., V.G., N.R.; funding acquisition, D.L. All authors have read and agreed to the published version of the manuscript. | PMC10104919 |
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Funding | Open access funding provided by Università degli Studi di Torino within the CRUI-CARE Agreement. This research was funded by Associazione Priamo, viale Piave, 101—25123 Brescia; | PMC10104919 |
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Data availability | The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy reasons. | PMC10104919 |
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Declarations | PMC10104919 |
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Ethics approval | The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the S. Anna Clinical Institute in Brescia (Prot. Number: 1.0; 06/06/2016). | PMC10104919 |
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Informed consent | Informed consent was obtained from all subjects involved in the study. | PMC10104919 |
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Competing interests | The authors declare no competing interests. | PMC10104919 |
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References | PMC10104919 |
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Background | Cesarean section is becoming increasingly common. Well-managed postoperative analgesia improves patient comfort while encouraging early ambulation and breastfeeding. The analgesic efficacy of transversalis facial plane block (TFPB) vs. anterior quadratus lumborum block (QLB) was compared in this study. | PMC10362577 |
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Methods | pain | We analyzed the data of 49 pregnant women (gestation, ≥ 37weeks; age, 18–45years) scheduled for elective cesarean delivery (CD) under general anesthesia. They were randomly divided into TFPB and anterior QLB groups. All blocks were administered bilaterally with 25mL of 0.25% bupivacaine under ultrasound guidance prior to extubation. Postoperative morphine consumption and numerical rating scale (NRS) pain scores (static and dynamic [during coughing]) were recorded at 1, 3, 6, 9, 12, 18, and 24h. | PMC10362577 |
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Results | There was no difference in postoperative morphine consumption between the groups at the third, sixth, and ninth hours, but the anterior QLB group consumed less morphine at the 12th, 18th, and 24th hours. Except for the first hour, resting and dynamic NRS scores were comparable between the groups. The first-hour resting and dynamic NRS scores were lower in the TFPB group (resting NRS, anterior QLB group, median [interquartile range], 2 [2–3] vs. TFPB group, 2 [0–2], | PMC10362577 |
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Conclusions | pain | In patients undergoing CD, anterior QLB decreased morphine consumption in the late period (9–24h) compared to TFPB, while pain scores were similar between both groups. The reduction in morphine consumption was statistically significant, but not clinically significant. | PMC10362577 |
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Keywords | PMC10362577 |
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Introduction | Since the introduction of ultrasound technology in anesthesia practice, interfacial plane blocks have become a part of postoperative analgesia management for many surgical procedures, including cesarean delivery (CD) [The anterior QLB, described by Børglum et al. [ | PMC10362577 |
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Methods | PMC10362577 |
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Study protocol | RECRUITMENT | This was a single-center, prospective, randomized (1:1) controlled, double-blind, parallel group study. The study was approved by the local ethics committee (OMU-KAEK 2021/379) and Ministry of Health (2021-AKD-764205) and registered on ClinicalTrials.gov prior to the initial patient recruitment with registration number NCT05408403. The manuscript was written in accordance with the CONSORT guidelines. | PMC10362577 |
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Participants | renal, cardiac, hepatic disease | OBESE | The study was conducted at a training hospital between June and October 2022. Written informed consent was obtained from all participants for the interventions before including the study. The study included patients aged 18–45 years, with an American Society of Anesthesiologists (ASA) score of II and gestational age of ≥ 37weeks, scheduled for elective cesarean section via a Pfannenstiel incision under general anesthesia. Patients with severe renal, cardiac, hepatic disease; those requiring spinal anesthesia; obese patients (> 100kg, BMI > 35kg/m | PMC10362577 |
Randomization and blinding | The patients were divided into two groups of 25 patients each. The sealed envelope technique was used for randomization. All patients were assigned a randomization ID. This ID was used during postoperative follow-up. An experienced anesthesiologist who would not be involved in the patient's intraoperative or postoperative care and would only perform the block procedure opened the sealed envelope 1h before the surgery to learn which group the patient would be assigned to. Intraoperative and postoperative follow-up examinations were performed by two different physicians who were blinded to the patient group. | PMC10362577 |
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Anesthesia management | All patients were administered general anesthesia according to our clinic's standard CD protocol. No premedication was administered to the patients. In addition, all the patients were started on intravenous infusion of Ringer’s lactate solution (5–7mL/kg/h). After ASA-recommended standard monitoring (non-invasive blood pressure monitoring, electrocardiography, and peripheral oxygen saturation), anesthesia was induced with propofol (2.5mg/kg) and rocuronium (0.6mg/kg), followed by tracheal intubation. After the umbilical cord was clamped, remifentanil was administered at 0.25mcg/kg/min as an analgesic. Sevoflurane and O | PMC10362577 |
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Interventions | All ultrasound-guided fascial plane blocks were performed before extubation at the end of surgery, in accordance with the rules of asepsis/antisepsis. In both blocks, a low-frequency convex transducer (2–5MHz, LOGIQ V1, GE Healthcare, USA) and block needles (21 G, 100mm, SonoPlex STIM Pajunk, Germany) were used. As a local anesthetic agent, 25mL of 0.25% bupivacaine (Marcaine®, Astra Zeneca, US) was used bilaterally. | PMC10362577 |
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Anterior QLB | CREST, DECUBITUS | While the patient was in the lateral decubitus position, the transducer was first placed between the iliac crest and subcostal margin. The abdominal muscles, latissimus dorsi muscle, erector spinae muscle, psoas muscle, transverse process of the 4th lumbar vertebra, and vertebral corpus were visualized by sonography (Fig. | PMC10362577 |
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Postoperative management | NRS, pain | All patients received 1g of IV paracetamol 30min before surgery and another 1g every 8 h in the hospital. A numeric rating scale (NRS) was used to measure the pain level. Patients were informed about the NRS scoring system (0 points, indicating no pain; 10 points, indicating the worst pain imaginable) during the preoperative period, and if their NRS score at rest was greater than 3, they were informed that they could request painkillers from the patient-controlled analgesia device (PCA). Patients were monitored in the post-anesthesia care unit after extubation. Both groups of patients received an IV-PCA (Bodyguard 575 pain manager, UK) device containing 0.5–1mg/mL of morphine. The PCA settings were adjusted to 1-mg morphine bolus, 8-min lock time, and 24mg 4h limit time. | PMC10362577 |
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Outcomes | postoperative pain, nausea, toxicity, nausea and vomiting, vomiting, pain, organ damage, hematoma | SECONDARY, RESPIRATORY DEPRESSION, HEMATOMA | The primary outcome of this study was the amount of opioid consumption in the first 24h after surgery; postoperative pain scores and the time of first opioid demand were the secondary outcomes. Morphine consumption was measured at 3, 6, 9, 12, 18, and 24h, and static and dynamic pain scores were measured at 1, 3, 6, 9, 12, 18, and 24h postoperatively.A five-stage verbal descriptive scale (0 = absent, 1 = mild nausea, 2 = moderate nausea, 3 = vomiting once, and 4 = vomiting more than once) was used to score the intensity of nausea and vomiting. Ondansetron (4mg IV) was administered to patients with a score of ≥ 3. Reports of nausea and vomiting as well as technical and drug-related issues (respiratory depression, local anesthetic toxicity, hematoma, and organ damage) were recorded. | PMC10362577 |
Sample size | The mean 24-h cumulative morphine consumption in the pilot study, which included ten patients, was 6.08 ± 2.17mg in the anterior QLB group and 8.50 ± 2.55mg in the TFPB group. Therefore, with 95% confidence (1 − α), 95% test power (1 − β), and effect size d = 1.032, the sample size calculation determined that a minimum of 22 patients in each group should be included in the study. Given the risk of data loss, each group was designed with 25 patients, for a total of 50 patients. | PMC10362577 |
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Statistical analysis | Statistical analyses were performed using IBM SPSS V23.0 (IBM, New York, USA). Normality was tested using the Shapiro–Wilk test. The mean ± standard deviation and median were used to express the continuous variables (25th–75 | PMC10362577 |
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Results | hemorrhage | SEVERE PRE-ECLAMPSIA, HEMORRHAGE | Sixty patients scheduled for elective cesarean section were screened for participation in the study. Ten patients were excluded from the study due to the following reasons: five patients were diagnosed with severe pre-eclampsia, and an additional five patients declined to participate. Therefore, 50 patients were included in the study. One patient with TFPB was excluded from the study because of massive obstetric hemorrhage. Figure Flow diagram showing the distribution of patient data. Abbreviations: TFPB, transversalis fascia plane block; QLB, quadratus lumborum blockDescriptive characteristics and first analgesic demand of patientsContinuous variables are presented as mean ± standard deviation and categorical variables are presented as counts (percentages)In the third, sixth, and ninth postoperative hours, there was no statistically significant difference between the groups in terms of morphine consumption (anterior QLB [median]; 1, 3, 5.5 vs. TFPB; 2, 5, 7 mg, respectively); however, at other time points, the anterior QLB group had statistically lower morphine consumption than the TFPB group (anterior QLB [median]; 7, 7.5, 7.5 vs. TFPB; 9, 10, 10 mg, respectively) (Table Cumulative morphine consumption in 24 h (mg), postoperativelyContinuous variables are presented as median (interquartile range). Statistically significant differences are highlighted in boldCumulative postoperative morphine consumption of groups at different time-points (mg)The resting and dynamic NRS scores were similar between the groups at all time points except for the first hour. The first-hour resting and dynamic NRS scores were lower in the TFPB group (resting NRS, anterior QLB group, 2 [2–3] vs. TFPB group, 2 [0–2], Static and dynamic NRS scores of patientsContinuous variables are presented as median (interquartile range). Statistically significant differences are highlighted in bold | PMC10362577 |
Discussion | visceral pain, thoracolumbar, somatic pain, inguinal hernia, pain | COMPLICATIONS, UTERUS | In the present study, on the patients who underwent CD under general anesthesia, the total opioid demand in the first 24h was reduced in the anterior QLB group compared to that the TFPB group, but there was no difference in the early (0–9h) opioid requirements. The patients' postoperative resting and dynamic NRS ratings were similar, except for the first hour ratings.There are two components of CD pain. The first is somatic pain from the skin incision, and the second is visceral pain from the exteriorization and straining of the uterus. The anterior branches of the T10–L1 (particularly T12–L1) spinal nerves should be blocked for somatic pain, and the superior/inferior hypogastric plexus branches should be inhibited for visceral pain [TFPB selectively blocks the anterior branches of the T12 and L1 spinal nerves as well as the subcostal, ilioinguinal-iliohypogastric nerves. These nerves carry purely somatic innervations [In the present study, we predicted that anterior QLB would provide visceral analgesia in addition to somatic blockade and would have a better analgesic effect than TFPB, which only provides somatic analgesia. However, contrary to this prediction, the findings of this study revealed that the analgesic activities of both the blocks were comparable. The QL muscle runs in the craniomedial to the caudo-lateral direction as it progresses from the 12th rib to the ilium. The thoracolumbar fascia, latissimus dorsi muscle, lateral raphe, lumbar interfascial triangle, QL, and investing fascia form the lateral part of the paraspinal muscles below L2, while only the transversalis fascia forms the lateral part above L2. This anatomical difference has been reported to allow easy spread of local anesthetics to the posterior of the endothoracic fascia on the transversalis fascia and reach the lower thoracic paravertebral space through anterior QL injections, which are administered at levels higher than the L2 level [A single study comparing these two blocks in lower abdominal surgery for inguinal hernia repair under general anesthesia was found in the literature; the postoperative analgesic activities of both blocks were comparable in this study [In our study, the pain levels were comparable at all measurement times (except for the first hour), and the cumulative morphine requirement was lower in the first 9 h (5.5
[3–8] mg vs. 7 [6–8] mg). We observed that these two blocks had comparable efficacy in the early postoperative hours, when post-surgical pain peaked. The anterior QLB appears to be superior in terms of opioid requirement in the long run (9–24h). However, this difference was small. In the anterior QLB group, the median opioid requirement in the 15h was 2 (IQR, 1–3) mg, and in the TFPB group, it was 3 (IQR, 3–4) mg. Recently, statistical and clinical significance debate has been raised when comparing opioid requirements in studies on fascial plane blocks [Quadriceps weakness, one of the most serious complications of these two blocks, has been reported after anterior QLB and TFPB [CD is usually performed under neuraxial anesthesia in our clinic. Intrathecal morphine for postoperative analgesia is an effective and cost-effective method of analgesia [Our study had the following limitations: first, dermatome examination could not be performed and there was no control group; second, block performance times, including time taken to position, were not recorded, patient ambulation and quadriceps strength were not evaluated. | PMC10362577 |
Conclusion | In the present study, the analgesic effects of the anterior QLB and TFPB blocks were found to be similar in the first 9h in patients undergoing CD under general anesthesia. However, there was a benefit to QLB in terms of reducing morphine consumption in the late period (9–24h), which was not clinically significant, but statistically significant. Both techniques improve the quality of the postoperative analgesia regimen when used in conjunction with multimodal analgesia in patients undergoing CD under general anesthesia. | PMC10362577 |
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Acknowledgements | None | PMC10362577 |
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Authors’ contributions | NoneSB, ST, EK, CK: Study conception, design, data collection and write the manuscript. HA, CG: Data collection, CK, ST: Analysis and interpretation of results, data collection. BD, NS, EK: Data collection. HA, CG, BD, NS: Study design, supervised the work, performed the analysis, contributed data and analysis tools. All authors read and approved the final version of the manuscript. | PMC10362577 |
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Funding | None. | PMC10362577 |
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Availability of data and materials | The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. | PMC10362577 |
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Declarations | PMC10362577 |
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Ethics approval and consent to participate | This study was approved by the ethics committee of Ondokuz Mayis University Clinical Research Ethics Committee, approval no: 2021/379. Informed consent was obtained from all subjects and/or their legal guardian(s). The Declaration of Helsinki was adhered to in this study. All methods were performed in accordance with the relevant guidelines and regulations. | PMC10362577 |
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Consent for publication | Not applicable. | PMC10362577 |
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Competing interests | The authors declare no competing interests. | PMC10362577 |
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References | PMC10362577 |
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Background | long-term illness, Tele-yoga | Yoga is a mind-body exercise that has demonstrated its feasibility and safety even for individuals with severe long-term illness. Engaging in yoga has the potential to yield positive effects on both physical and mental well-being. Tele-yoga is a novel approach to rehabilitation in which participants practice group yoga with a live-streamed yoga instructor digitally via a tablet. This is especially beneficial for individuals who may find it difficult to leave their homes to participate in an exercise session. As part of our ongoing evaluation of the tele-yoga intervention in individuals with long-term illness, we have undertaken an exploration of participants’ expectations regarding yoga in general and tele-yoga specifically. Understanding these expectations is crucial, as they can significantly impact their satisfaction with treatment and care and influence overall intervention outcomes. | PMC10534282 |
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Objective | long-term illness | This study aims to explore the expectations of tele-yoga among individuals with long-term illness before starting a tele-yoga intervention. | PMC10534282 |
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Methods | The study employed an inductive qualitative design and is part of a process evaluation within an ongoing randomized controlled trial. A total of 89 participants were interviewed before the start of the tele-yoga intervention. The interview guide encompassed questions about their general perceptions of yoga and the specific expectations they held for the upcoming tele-yoga sessions. The interviews were transcribed and analyzed using inductive qualitative content analysis. | PMC10534282 |
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Results | anger, pains, aches, anxiety | Participants expressed their expectations for tele-yoga, focusing on the anticipated improvements in physical function and overall health. These expectations included hopes for reduced respiratory issues; relief from discomfort, aches, and pains; as well as increased physical flexibility, coordination, and overall well-being. Besides, they expected to achieve improved psychological well-being and performance; to acquire strategies to manage stress, anger, and anxiety; and to have their motivational drive strengthened and influence other activities. Participants described tele-yoga as a new and exciting technical solution that would facilitate the delivery of yoga. A few participants remained a little hesitant toward the use of technology, with some expectations based on previous experiences. When asked about expectations, some had no idea about what to expect. Participants also had varying perspectives on yoga, with some finding it mysterious and difficult to understand. Participants expressed thoughts that they found the idea of tele-yoga taking place in groups exciting and enjoyable. They also had expectations that being part of a group would provide opportunities for mutual inspiration and encouragement among the group members. | PMC10534282 |
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Conclusions | Expectations before an intervention can provide valuable insights into understanding the factors influencing adherence to tele-yoga and its outcomes. Our findings provide a wide range of expectations for tele-yoga, spanning both physical and mental aspects. Moreover, the technology’s potential to facilitate yoga delivery and the supportive nature of digital group interactions were evident from the results. | PMC10534282 |
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Trial Registration | ClinicalTrials.gov NCT03703609; https://clinicaltrials.gov/ct2/show/NCT03703609 | PMC10534282 |
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Introduction | PMC10534282 |
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Background | illness, fatigue, pain, long-term illness, unformed, shortness of breath | Long-term illness is common and leads to limitations in daily life and to a decreased health-related quality of life in all dimensions among those affected [Medical yoga is a therapeutic form of Kundalini yoga led by a certified yoga instructor that uses different standardized yoga programs with a combination of physical postures, breathing exercises, and relaxation/meditation specifically targeting individuals with long-term illness [People with long-term illnesses are often homebound and limited by fatigue, pain, and shortness of breath, which may be barriers to participation in center-based rehabilitation training [Our research team is currently conducting a randomized controlled trial to evaluate the effects of tele-yoga in individuals with long-term illness. The design and pilot results of the randomized controlled trial have been previously published [Before engaging in digital rehabilitation, such as tele-yoga, the participants harbor expectations and perceptions about their upcoming experience. These expectations may sometimes be unformed and remain unexpressed. Expectations can stem from both cognitive and emotional aspects and are influenced by a person’s past experiences, knowledge, belief, hopes, needs, and external factors (eg, media, family, or friends) [Expectations have been found to significantly impact satisfaction with treatment and care, and they also influence the outcomes of an intervention [ | PMC10534282 |
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Aim | long-term illness | The objective of this study was to explore the expectations of individuals with long-term illness regarding a tele-yoga intervention before the actual initiation of the program. | PMC10534282 |
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Methods | PMC10534282 |
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Design and Sample | long-term illness, impaired cognitive | The study utilized a qualitative design with an inductive approach and was conducted as part of a process evaluation within a randomized controlled trial evaluating the effects of tele-yoga (ClinicalTrials.gov Identifier: NCT03703609). This study used a single-blind methodology where the evaluator and analyst were blinded, and it followed a parallel 2-arm randomized controlled study format. The participants were allocated in a 1:1 ratio to either the intervention group, which received tele-yoga, or the control group. A total of 200 individuals with long-term illness were recruited so far in the randomised controlled trial from 4 hospitals in southern Sweden and subsequently randomized into 2 groups. The first group (n=100) participated in a tele-yoga intervention conducted at home over a period of 3 months. The second group (n=100) served as the control group and received individual exercise advice during the same timeframe. The participants were recruited from those who had been admitted to the departments of cardiology or intensive care in the past 3-36 months, with a minimum length of stay of 48 hours during their hospitalization. To meet the training requirements, the participants were included in the study when they were stable in their medical condition and aged over 18 years. Exclusion criteria were short life expectancy (<6 months), impaired cognitive ability, lack of ability to fill in forms, and inability to complete the tele-yoga intervention. In this qualitative study, we consecutively invited the 100 patients randomized to the intervention group at baseline before starting the tele-yoga intervention to participate in an interview. | PMC10534282 |
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Data Collection | We constructed a semistructured interview guide comprising a total of 10 questions (see | PMC10534282 |
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Data Analysis | PMC10534282 |
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Overview | The interviews were tape-recorded and transcribed verbatim. Qualitative content analysis with an inductive approach was performed using the structure described by Elo and Kyngäs [ | PMC10534282 |
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Preparation Phase | Initially, the first 2 authors (TH and ML) independently read 20 transcribed interviews and identified units of analysis in the text that described different expectations of tele-yoga.A meaningful unit comprised sentences and could encompass multiple meanings. Subsequently, the entire research team engaged in discussions to share their impressions of the text as a whole and the meaningful units identified. | PMC10534282 |
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Organizing Phase | In the next step, the first 2 authors (TH and ML) independently coded 5 randomly selected interviews, discussed their coding, and established a mutual agreement for the open coding. Following this agreement, they proceeded to analyze the remaining interviews. In the open coding process, notes and headings were written in the text while reading the interviews. The meaningful units were read and reread, and in the margins, as many headings as necessary were written to describe all aspects of the content. Discrepancies in coding were discussed until a consensus was reached. Meaningful units were then grouped under the respective headings. Each meaningful unit could be assigned to more than 1 code, and these codes were then organized and sorted on a coding sheet for further analysis. The codes were used to freely generate categories, which in turn were sorted and merged into fewer, more overarching categories. The first author maintained a log, in which the headings and ideas about relationships between categories were documented.Throughout the analysis, the interviews were read repeatedly to gain an overall understanding of the full picture, and there was a constant comparison between the parts of the analysis and the raw data from the completed interviews.During the abstraction phase, the structure and content of the categories and subcategories were discussed among all the authors. | PMC10534282 |
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Ethical Consideration | The study was conducted in accordance with the ethical guidelines designed for studies of human research according to the World Medical Association Declaration of Helsinki [ | PMC10534282 |
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Results | PMC10534282 |
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Emerging Categories and Subcategories | During the interviews, we specifically inquired about the participants’ expectations regarding both the exercise format of the intervention (ie, medical yoga) and the delivery mode (ie, the technology to deliver the yoga; in this case, tele-yoga). Most participants had no prior experience with yoga or telerehabilitation. However, most participants described several diverse expectations about tele-yoga. Some participants, however, found it difficult to have expectations, because they either did not believe in yoga or had no idea what to expect.The analysis of the interviews resulted in the formulation of 3 categories and 10 subcategories (Categories and subcategories. | PMC10534282 |
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Expectations That Tele-Yoga Can Improve Physical Function and Health | PMC10534282 |
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Category Overview | breathing, reduced pain, pain | This category encompasses the expectations of tele-yoga regarding the potential physical benefits that participants anticipated in yoga practice. The study participants were seeking ways to manage their symptoms, as they often felt a lack of control over their condition. They believed that tele-yoga could enhance their physical function and overall health.The participants held various expectations regarding the improvement of physical function through tele-yoga. They envisioned benefits such as enhanced breathing, reduced pain, and improved flexibility and balance. Many of them experienced stiffness and frequent pain, and they believed that yoga could positively impact their daily life by addressing these issues. | PMC10534282 |
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Decrease in Respiratory Problems
| respiratory problems, breathlessness, long-term illness, breathing difficulties, COPD, shortness of breath | COPD | Many participants described breathing difficulties, such as shortness of breath and breathlessness, as a result of their long-term illness. These symptoms significantly impacted their daily lives and overall well-being. The participants believed that tele-yoga would have a positive impact on their breathing and help reduce their respiratory problems in daily life. They hoped to learn techniques to better control their breathing and improve their overall respiratory function. They also described experiencing nocturnal respiratory problems that led to stress and expressed a desire to find techniques to manage these issues during the night. Although they did not often have a clear understanding of the specific breathing techniques in yoga, they perceived that it would be an important aspect of the tele-yoga sessions.Since I have COPD, I sometimes have...Like last Sunday, I felt so bad, I couldn’t go from downstairs to upstairs without resting on the stairs halfway. I could have such difficulty breathing and get really short of breath and it is known that in yoga, you learn to breath. | PMC10534282 |
Relief From Discomfort, Aches, and Pain
| pains, aches, pain | The participants had expectations that tele-yoga training would provide relief from long-term pain and reduce aches and pains. They perceived tele-yoga as an alternative to painkillers, preferring to work with their body’s natural resources instead of solely relying on pharmacological solutions. Although they did not expect to be completely pain free, they hoped that tele-yoga could empower them to better manage and gain more control over their aches and pains. They perceived that the mind-body connection in yoga would help them overcome the influence of pain on their lives. Many described their pain as being difficult to manage and stated that stress aggravated the pain. They believed that tele-yoga could reduce stress and tension in the body and thus have a pain-relieving effect....to be completely pain-free, I know I will never be because I have such broken nerves eh...in my back. I know it will never be...//...I will be able to have a pain like...I couldn’t say that I accept it, but it must be there, it must be there on my terms. I am the one who decides how this pain should be allowed to act in my body, not the other way around. At the moment, it decides over me... and it’s very hard. Physically, but above all mentally. Because I couldn’t be the person I want to be, I fear I couldn’t be the father, for example, that I want to be to my children. | PMC10534282 |
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Increased Physical Flexibility, Appearance, and Coordination
| Stiffness and inflexibility, reduced mobility | BENDING | Several participants had an expectation that tele-yoga would improve their body function and make them more active. Many had experienced reduced mobility and increased stiffness, and they believed that tele-yoga could address these issues by enhancing their flexibility and mobility. They anticipated that yoga postures would lead to a more flexible and supple body, enabling them to experience positive effects in various aspects of their lives. Stretching the body was perceived to be difficult, but effective, as it could lead to increased flexibility and mobility. For some participants, yoga seemed difficult to perform as it had physical challenges. This was especially the case when the yoga sessions required them to sit in complicated positions and the exercises involved bending and performing difficult body movements. Some expressed concerns about their ability to perform tele-yoga properly, especially if they lacked agility or flexibility.Stiffness and inflexibility were also highlighted as areas of concern for performing yoga, as some had difficulty sitting on the floor. However, participants found the format of the tele-yoga intervention, performed on a chair, feasible.Then I thought yoga, of course I’ve been a little afraid of it, because I’m stiff as an old goat and then I thought that it’s good anyway, to soften the body. Then, it can be fun to see if this can inspire me to get started, to run and exercise again. | PMC10534282 |
Expectations That Tele-Yoga Can Affect Psychological Well-Being and Performance | PMC10534282 |
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Category Overview | anger, anxiety | This category focused on the psychological aspects of tele-yoga, with participants expressing expectations of improved psychological well-being. They had both positive and negative thoughts about the spiritual dimensions of yoga. The participants expected that tele-yoga would help reduce stress and negative emotions such as anger, fear, anxiety, and passiveness through relaxation techniques. Additionally, they believed that tele-yoga would serve as a motivational driver for engaging in other forms of exercise and activities. | PMC10534282 |
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Embracing an Intangible, Mystic, and Spiritual Dimension of Life | Participants had varying perspectives on yoga, with some finding it mysterious and difficult to understand due to its roots in ancient Eastern religion and history. Some participants were more skeptical and judgmental, while some were more curious and open-minded about the practice.....initially it came across as a bit fuzzy, I think, I have to say. But it’s an old oriental history, so it’s certainly useful to keep doing. Then we’ll see how it develops, we don’t know. I have no idea.Some participants found the concept of yoga itself to be vague and unclear, struggling to fully comprehend all its aspects and the tele-yoga intervention. Some participants formed their expectations of yoga based on the experiences shared by their relatives and friends.I’ve never tried it myself (yoga)... My wife does yoga but not me....I also want to try it.Yes, it’s probably because of not having done any yoga personally, so you think it’s hocus-pocus, but it might work great on me, I have no idea. I think it’s worth a try anyway. | PMC10534282 |
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Strategies to Manage Stress, Negative Emotions, and Anxiety | calmness, anger, anxiety | Participants had expectations that tele-yoga would offer them relaxation and provide a sense of peace and tranquility in their daily life.They also had expectations that tele-yoga would help reduce stress levels and improve stress management, leading to increased feelings of calmness and relaxation. They anticipated that tele-yoga could assist in reducing anger, regulating negative emotions, and enhancing their ability to cope with life’s challenges in a more positive and composed manner. During overwhelming moments, they hoped that tele-yoga could guide them back to a more balanced and relaxed state. By alleviating stress, they believed that it could also enhance their focus, inner peace, self-assurance, and overall well-being.So partly I could be the kind of person who could be stressed inside and maybe not look so stressed on the outside. But inside I could stress myself out about things and I think maybe I could get some help with that. Calm down.Participants expressed expectations that tele-yoga could potentially alleviate anxiety through the relaxation and improved breathing techniques learned during the intervention. They also anticipated that tele-yoga might lead to improved sleep patterns, often associated with reduced stress and the relaxation benefits they believed it would offer. Additionally, they held expectations that tele-yoga could improve memory capacity. Furthermore, participants looked forward to experiencing an overall sense of well-being, positivity, and increased happiness through their participation in tele-yoga. | PMC10534282 |
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Influence on Motivational Drive
| long-term illness | Participants anticipated that tele-yoga would have a positive impact on their overall physical activity levels.I was not expecting to be part of that group but otherwise I had thought that it was something that would give me a kick in the butt to get started and move a little more again, it has been quite bad with that.Some exercised regularly or were active in other ways, but thought that tele-yoga could offer them a different perspective on exercise. However, many participants did not exercise at all, but expected that tele-yoga could help motivate them to start exercising and help them to improve their physical fitness and lose weight. While their long-term illness had, in many cases, made them sedentary and inactive, some had problems moving and did not have any motivation to exercise.Yes...it sounded interesting and might push me a little more...give me motivation to exercise more. Because that’s what is missing sometimes...the motivation. | PMC10534282 |
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Expectations That the Technology Can Facilitate the Delivery of Yoga
| PMC10534282 |
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Category Overview | This category encompasses participants’ expectations regarding the implementation of tele-yoga using technology. They expressed their thoughts about practicing yoga remotely in a group setting, as well as the time commitment required for the tele-yoga intervention during the study. | PMC10534282 |
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Technology Can Simplify Participation | Many participants were of the belief that the technology would facilitate participation in tele-yoga sessions from home and decrease traveling. They anticipated that performing tele-yoga would be comfortable and easy to follow from home.I think it will be great not to have to go anywhere but to be at home in the environment where you are comfortable.Many participants recognized the flexibility that the technology offered, enabling them to participate in tele-yoga from various locations such as the workplace, summer house, or during travel. Several participants worked and some specifically mentioned planning to engage in yoga sessions from their workplace. They also appreciated how the technology simplified participation in tele-yoga and facilitated communication with both other participants and instructors.Some were concerned about potential disruptions while participating in tele-yoga from home or work. They acknowledged that finding a suitable, quiet space to perform tele-yoga without disturbances or background noise was essential for a satisfactory experience. | PMC10534282 |
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Feasibility and User-Friendliness of the Technology | Participants’ expectations regarding the technology were influenced by their previous experiences with computers, tablets, smartphones, and other mobile devices. In general, most participants were familiar with the technology, described the use of technology as exciting, and did not consider it to be a problem. Even those who were not accustomed to using technology expressed their eagerness to use it and indicated that it was interesting to learn something new.Some participants expressed concerns about using technology and shared negative perceptions and expectations. They mentioned feeling insecure and facing difficulties when using technology that they were not accustomed to. Besides, some had a strong need for control and therefore always found it difficult to manage new technology, as it was associated with a fear of making mistakes.Some participants made more neutral statements, assuming that the technology would not be a problem but acknowledging that they would not know for sure until they had used it. Others mentioned that they had not given much thought about the technology aspect at all.Despite some participants expressing a lack of confidence in the technology, they expected that they would gradually learn to use it. They understood that the technology was new and might require some effort to understand, but they were generally confident that they would learn to use it step by step. Additionally, some participants appreciated the convenience of a tablet, as it is easy to carry and use.That it’s pretty simple, it feels like, it’s pretty good, I think since I have a tablet. Because it’s a larger screen than a phone and not as clumsy as a computer. I think it’s a good tool. Easy to bring with you if you happen to be somewhere else and so on. It feels good. | PMC10534282 |
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Performing Tele-Yoga in a Cyberspace Group | DISEASE | During the tele-yoga sessions, participants engaged in group meetings, and their expectations regarding group participation were explored. Some participants expressed disinterest or had negative thoughts about being part of a group. They mentioned being like a “lone wolf” or shared past negative experiences with group activities. Furthermore, some were concerned that creating a sense of group belonging might be challenging in an online setting compared with face-to-face interactions. It became evident that physical social togetherness was valued in the group, and there were concerns that this aspect might be lost during online sessions.So, I think it’s fun to do things in a group. So, it’s the social interaction in everything...I’ll miss that now.As the group sessions had not started yet, some participants had envisioned how tele-yoga and digital sessions would appear on their tablet screens. They wondered whether they would be able to see other participants or if only the yoga instructor would be visible. There were questions about whether it would truly feel like a group experience when meeting online and seeing each other only through the tablet screen. Some participants were not aware that they could communicate with other participants since the sessions involved videoconference meetings. On the other hand, some participants had not focused on the group aspect at all, being primarily concerned with their tele-yoga practice, making the group element seem less significant to them.Most participants expressed positive expectations regarding the group. Participants expressed thoughts that they found the idea of tele-yoga taking place in groups exciting and fun. They also had expectations that being part of the group would provide opportunities for mutual inspiration and encouragement among the members. Some participants drew from their previous experiences in other types of group activities and acknowledged the benefits of being part of a group, such as receiving support to succeed in an activity. In addition, the opportunity to work with others and share thoughts and reflections on both the yoga and the disease was perceived as positive. Additionally, some participants had positive experiences with other types of group activities, such as online games. | PMC10534282 |
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Elaborations of Time Spent on Yoga | The participants were asked if they expected that the time allocated for the tele-yoga was reasonable and how much time they planned to spend doing yoga. The participants mostly answered that they would follow the allotted time and that it seemed appropriate, but some also felt that they might set aside more time, especially if tele-yoga had a clear effect after the sessions.To begin with, it’s these two times, Tuesdays and Fridays, and we have to start with that. This is how you feel, if you think this makes sense, so you might spend more time, I don’t really know.By contrast, others were more insecure, stating that they had difficulty specifying the specific time, as they were not sure how much time it would take.However, a few stated more specifically how much time they planned to spend and gave suggestions varying from half an hour per day to 2 hours maximum.Some participants expressed concerns about the time commitment required for tele-yoga, wondering whether they could dedicate such a significant amount of time to the practice. They questioned whether investing time in yoga would be worthwhile if they did not experience the desired benefits. On the other hand, some participants appreciated having scheduled sessions for tele-yoga, as it provided structure and a sense of accountability. | PMC10534282 |
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Discussion | PMC10534282 |
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Principal Findings | weight loss | This study aimed to investigate the expectations of participants before a tele-yoga intervention, where the participants were expected to engage in both group and individual yoga training using technology. The main findings of the study revealed that several of the expectations regarding tele-yoga were normative expectations [Expectations that tele-yoga would result in significant weight loss, dramatic improvement in agility, and increased engagement in all other physical activities can, to some extent, be categorized as more ideal expectations, which include desires, visions, and hopes for what might happen [According to Thompson and Suñol [Some participants faced challenges in expressing their expectations regarding the tele-yoga intervention. Those who indicated being more hesitant and adopting a wait-and-see approach had what Thompson and Suñol [High expectations have been associated with improved adherence to an intervention and positive outcomes, which correlates positively with symptom changes [Additionally, it became apparent that participants who were motivated to improve their physical and mental well-being displayed a more positive attitude toward yoga than those who participated for other reasons (eg, contributing to research and being able to help others or other external factors, such as their relatives wanting them to participate in the study). Some of our participants also encountered challenges in expressing their expectations. These participants lacked a clear understanding of yoga and were uncertain about what to expect from the intervention, leading to more negative or neutral expectations. Previous studies have indicated that a lack of self-motivation, vague exercise identity, and lower previous physical activity levels may reduce expectations [Another study indicated that group yoga motivated their participants to become more active [Expectations play a crucial role in shaping individuals’ satisfaction with outcomes. In various fields, studies have shown that patients with high preoperative expectations face a higher risk of long-term dissatisfaction if those expectations are not met [The COVID-19 pandemic posed challenges with rehabilitation, necessitating the need for remote rehabilitation [ | PMC10534282 |
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Methodological Strength and Limitations | verbal and nonverbal communication, unformed | The consecutive selection is a strength as it ensures the inclusion of a representative sample of study participants. The substantial number of participants (N=89) has provided us with rich and representative data on expectations. As the question of expectations can be relatively broad, a larger sample is preferable. Regarding the scope of the interviews, some interviews were short, especially for the participants with mainly unformed expectations. Overall, the amount of data was sufficient and manageable, while not being too extensive.All data were collected through interviews. The interviewers had no care relationship with the participants nor had ever met them before the interview, which created a sense of equality in power dynamics and facilitated open unbiased conversations. The interviews were primarily conducted via telephone, which meant body language, facial expressions, and reactions could not be captured. This limitation could have resulted in the interviewer missing opportunities to seek clarification for discrepancies between verbal and nonverbal communication. However, certain forms of response bias are reduced by the fact that the interviewer does not influence the participants through physical presence [To ensure trustworthiness, analyst triangulation was applied, with the researchers independently coding and categorizing data, and each step of the analysis process was discussed until consensus about the interpretation was achieved. A strength of the study is that the participants differed in age, gender, and other sociodemographic variables (eg, previous training experience), which provided a rich variety of information. All data in the interviews relevant to the aim have been included in the analysis. The data were very rich and sufficient to explore a broad range of expectations for tele-yoga. | PMC10534282 |
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Conclusions | This study explored participants’ expectations before starting a tele-yoga intervention. By studying the expectations of the participants in the intervention, we can further understand what influences them to participate and how expectations can affect adherence to the tele-yoga intervention as well as the outcomes. Several expectations for tele-yoga emerged, including various aspects of improved physical function and health, along with increased mental well-being and performance. There was also an expectation that the technology could facilitate the delivery of yoga. This facilitates the understanding of what influences and motivates participants to participate in an intervention study focusing on digitally delivered yoga.The study was supported by the Swedish Research Council for Medicine and Health – VR (grant number 2018-02719), the Swedish Research Council for Health, Working Life and Welfare – FORTE (grant number 2018-00650), the Swedish Heart-Lung Foundation (grant number 20170766), and FORSS (grant number 941180).Conflicts of Interest: None declared.Interview guide. | PMC10534282 |
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Data Availability | Data are stored according to the electronic data management plan at the Department of Health, Medicine and Caring Sciences at Linköping University. | PMC10534282 |
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Background | The increased complexity of residents and increased needs for care in long-term care (LTC) have not been met with increased staffing. There remains a need to improve the quality of care for residents. Care aides, providers of the bulk of direct care, are well placed to contribute to quality improvement efforts but are often excluded from so doing. This study examined the effect of a facilitation intervention enabling care aides to lead quality improvement efforts and improve the use of evidence-informed best practices. The eventual goal was to improve both the quality of care for older residents in LTC homes and the engagement and empowerment of care aides in leading quality improvement efforts. | PMC10054219 |
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Methods | SECONDARY | Intervention teams participated in a year-long facilitative intervention which supported care aide-led teams to test changes in care provision to residents using a combination of networking and QI education meetings, and quality advisor and senior leader support.This was a controlled trial with random selection of intervention clinical care units matched 1:1 post hoc with control units. The primary outcome, between group change in conceptual research use (CRU), was supplemented by secondary staff- and resident-level outcome measures. A power calculation based upon pilot data effect sizes resulted in a sample size of 25 intervention sites. | PMC10054219 |
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Results | resident-adjusted pain, pain | SECONDARY | The final sample included 32 intervention care units matched to 32 units in the control group. In an adjusted model, there was no statistically significant difference between intervention and control units for CRU or in secondary staff outcomes. Compared to baseline, resident-adjusted pain scores were statistically significantly reduced (less pain) in the intervention group ( | PMC10054219 |
Conclusions | The Safer Care for Older Persons in (residential) Environments (SCOPE) intervention resulted in a smaller change in its primary outcome than initially expected resulting in a study underpowered to detect a difference. These findings should inform sample size calculations of future studies of this nature if using similar outcome measures. This study highlights the problem with measures drawn from current LTC databases to capture change in this population. Importantly, findings from the trial’s concurrent process evaluation provide important insights into interpretation of main trial data, highlight the need for such evaluations of complex trials, and suggest the need to consider more broadly what constitutes “success” in complex interventions. | PMC10054219 |
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Trial registration | PMC10054219 |
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Keywords |
Given the complexity of care environments and the influence of contextual factors in implementation, pragmatic trials are needed; however, attention to study design and measurement is crucial as is assessment of implementation of complex interventions in the long-term care environment.This study, highlights the ways in which a negative trial may still be “successful” despite the absence of anticipated change in the primary outcome, underscoring the need to further explore what constitutes success in complex trials.Engagement and empowerment of care aides in leading quality improvement teams can result in tangible improvements in care provided to older adults in LTC. | PMC10054219 |
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Introduction | bladder and bowel incontinence, Dementia | As a greater proportion of our population survives into late life, the number of people living with chronic and co-existing medical conditions and cognitive impairment has increased [Dementia is one of the most distressing and burdensome health problems encountered by the LTC home workforce [Over recent decades, national and international reports have highlighted concerns about the quality of LTC provided to residents [The vast majority of direct care to residents in LTC homes, including personal care such as bathing, dressing, assistance with mobility and activities of daily living, and increasingly managing bladder and bowel incontinence, wound care and assessment of vital signs, is provided by care aides (also known as personal support workers, nursing aides, nursing assistants) [This study examined the effectiveness of the SCOPE (Safer Care for Older Persons in (residential) Environments) intervention. SCOPE is a facilitation and quality improvement intervention which aimed to empower and enable care aides to lead quality improvement (QI) efforts and to improve the quality of care for older residents in LTC homes. We examined whether SCOPE resulted in increased use of best practices in care and improved care aide’s quality of work life. The intervention stemmed from a proof of principle study with care aide led teams [ | PMC10054219 |
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Intervention | one-and-a-half, pain | The SCOPE intervention is based on a modified Institute for Healthcare Improvement (IHI) Breakthrough Collaborative Series model designed around successful collaborative learning approaches for quality improvement [A “Getting Started Kit”: Teams and Sponsors (unit and facility managers) received baseline performance data on their selected clinical area, one of three—reducing pain, maintaining mobility, reducing responsive behaviours, selected by care aides as the most pressing problem within their LTC home in a Delphi process [Four face-to-face “Learning Congresses” (LCs) brought together team members and sponsors from each region for one to one-and-a-half days every three months for networking and short plenary sessions and activities on the improvement model, measurement in PDSA cycles, team dynamics and function, engagement of colleagues in implementing ideas, and overcoming barriers to spread. The final congress was a celebration meeting, allowing teams to showcase their achievements and share experiences. Learning congresses were delivered primarily by the regional Quality Advisors and the Quality Coordinator.Three “action periods” (improvement activity with ongoing coaching from Quality Advisors and the Quality Coordinator between LCs) when teams made small tests of change using Plan-Do-Study-Act (PDSA) cycles to improve care delivery in their selected clinical area and conducted small-scale measurement to gauge improvement. Teams used the IHI model for improvement comprising elements of successful process improvement: specific and measurable improvement aims, measures of improvement tracked over time, changes resulting in the desired improvement, and a series of testing “cycles” during which unit teams learned how to apply their ideas across their care unit. Teams implemented their change ideas with increasing numbers of residents on the unit during this time. PDSA cycles continued to adapt, adopt, or abandon change ideas throughout these action periods.Participation in several facilitation activities to support QI during the action periods. Teams participated in a minimum of monthly teleconferences and a site visit facilitated by the regional Quality Advisors. Teams were supported in adoption and use of best practices, idea generation, measurement tools, analysis of results, and implementation challenges, with the degree of support tailored to the needs of each team.A program of in-person learning sessions and online discussions on leadership, focused on “supporting and enabling change” for sponsors, delivered by the Quality Co-ordinator.The SCOPE intervention | PMC10054219 |
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Theoretical framing | The study was theoretically informed by the Facilitation has been described both as a single intervention and as part of a multifaceted intervention [ | PMC10054219 |
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Methods | SCOPE was a pragmatic controlled trial with each randomly selected LTC home identifying a care unit to participate in the intervention. Care aides and residents of these units (clustered within the units) formed the units of analysis. Control (usual care) units in non-intervention LTC homes were matched to intervention units post hoc (see below). | PMC10054219 |
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Setting | This study was part of a larger research program examining modifiable contextual factors that influence implementation and improvement efforts in LTC homes in British Columbia, Alberta, and Manitoba, the Translating Research in Elder Care (TREC) program. TREC is a longitudinal research program comprised of many studies (including SCOPE). Its overall aim is to improve the quality of care and quality of life for LTC home residents and quality of work life for the staff who care for them [ | PMC10054219 |
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Outcomes and measures | SCOPE was situated between two routinely occurring waves of TREC data collection and used variables from these sources for its quantitative outcome measurement. The primary outcome measure for this study aimed at improving use of best practices for resident care was between group change in | PMC10054219 |
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Sample size and power calculation | The primary outcome measure was change in Conceptual Research Use (CRU), from baseline to post intervention, compared between intervention and control (usual care) units. Initial modeling was based on unit aggregate expected change in the primary outcome, dictating a sample size of 34 units to be matched to usual care units, but was replaced by a care aide level analytical model, deviating from the original published trial protocol (NCT03426072). Thus, for an effect size of | PMC10054219 |
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Sampling | dementia | FRASER | To be eligible to participate, LTC homes had to (a) be a part of the TREC cohort in Alberta and British Columbia; (b) have units comprising general nursing care for older adults, rather than those co-managed with acute care; (c) have the majority of residents over the age of 65; (d) have more than 35 beds in total; (e) be geographically located within 100km of either Edmonton: Edmonton Health Zone (EH) or Calgary: Calgary Health Zone (CH) in Alberta (AB), or Kelowna: Interior Health (IH), or New Westminster: Fraser Health (FH) in British Columbia (BC); (f) use the Resident Assessment Instrument-Minimum Data Set 2-0 (RAI-MDS) to gather resident level care indicators; and (g) have 8 or more care aide responses to the baseline trial data collection survey.Eligible LTC homes were stratified by region (EH, CH, IH, FH), owner operator model (for profit, not for profit), and size (small: <80 beds, medium: eight-120 beds, large: >120 beds), and randomly selected for participation. Based upon feedback from decision-makers and LTC home administrators, it was decided that randomization to intervention or control at the outset would not be feasible because of the likelihood of bias favouring refusal to participate as an inactive “control” site. Thus, Because of the limited number of eligible LTC homes in the cohort, homes which declined to participate were returned to the main TREC cohort to act as usual care (control) comparators. After removing ineligible units (those who did not participate in both the baseline and follow up data collections and those with fewer than eight care aide responses to the TREC care aide survey) to ensure stability of measures at either the baseline or follow up data collections, we randomly matched a control unit to each intervention unit, based on the unit type: general long-term care versus dementia care unit, number of beds on unit, facility size category (small: <80 beds, medium: eight-120 beds, large: >120 beds), ownership model (for-profit, not-for-profit), and region.Directors of care in charge of each selected home were invited to participate, provided with information about the study, and included if they consented to participate. Homes were provided with $3000 as partial compensation for the time and resources required to participate. Following discussion of trial requirements, Directors of Care were given the task of identifying one care unit within their home to participate in the intervention and to identify staff as members of their SCOPE team. | PMC10054219 |
Participants | SCOPE teams comprised four to seven members, at least two of which were care aides. Each team was either led by a care aide or co-led by two care aides. Other team members consisted of unit-based care aides and/or professional staff (e.g | PMC10054219 |
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Analysis | ® | REGRESSION | SAS® 9.4 (SAS Institute Inc., Cary, NC, USA) was used for all statistical analyses. Using descriptive statistics, baseline characteristics of LTC homes, care units, care aides, and residents were compared between study arms. To assess intervention effectiveness, mixed effects regression models were used [ | PMC10054219 |
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