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Amendments from Version 2 | EVENT, SECONDARY | [version 3; peer review: 2 approved]No competing interests were disclosed.
Abstract
Background
Childbirth is a life-transforming intense event to a woman and her family. Even though a variety of non-pharmacological techniques are readily available to alleviate the distress of women in labour, the majority of women are unaware of its benefits. The objective of the study was to explore the impact of a simple non-pharmacological technique i.e., antepartum breathing exercises on maternal outcomes of labour among primigravid women.
Methods
A single centre prospective, single-blinded, randomized controlled trial was conducted at the antenatal outpatient clinic of a secondary healthcare institution. Eligible primigravid women were randomized into intervention and standard care groups. Both groups received standard obstetrical care. In addition, the intervention group were taught antepartum breathing exercises and were advised to practise daily and also during the active stage of labour. The primary outcome of the trial was the maternal outcome of labour measured in terms of onset of labour, nature of delivery, duration of labour, and need for augmentation of labour. Data was collected using World Health Organization (WHO) partograph, structured observational record on the outcome of labour.
Results
A total of 98 (70%) primigravid women who practised antepartum breathing exercises had spontaneous onset of labour. The odds of spontaneous onset of labour after randomization in the intervention group was 2.192 times more when compared to standard care at a (95% confidence interval 1.31–3.36,
Conclusion
Antepartum breathing exercises during labour can facilitate spontaneous vaginal birth, shorten the duration of labour, and reduce the need for operative interference.Introductory review has been reworded in context with use of interventions during labour and mentioned use of childbirth education to empower women during labour process. | PMC10359740 |
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Introduction | pain | EVENT | The health and well-being of mother and child during pregnancy and childbirth are public health concerns because both of them have special needs, which cannot be catered to by general health services.
Childbirth is a life-transforming intense event to a woman and her family.
A systematic review on childbirth education reports that childbirth preparation helps in building self-esteem, self-confidence and control, but weakly validates impact on reducing interventions during labour.
A variety of non-pharmacological techniques such as relaxation, breathing techniques, positioning/movement, massage, hydrotherapy, hot/cold therapy, music, guided imagery, acupressure, and aromatherapy are available to women in labour. Women are encouraged to employ any of these techniques, as they are non-invasive and appear to be safe for mother and baby.Breathing is one of the simple, cost-effective non-pharmacological techniques, which connects the mind and the body, combination of controlled breathing and conscious relaxation are power-packed tools for labour.
A clinical trial conducted on pregnant women to assess the efficacy of supervised antenatal yoga program, which included breathing patterns on perceived maternal labour pain and birth outcomes reported that women experienced lower pain intensity, required decreased need for labour induction, showed lower rates of caesarean deliveries and experienced a shorter duration of second as well as the third stage of labour.
The Cochrane Systematic Review on the effectiveness of the non-pharmacological intervention on pain management for labour, reports relaxation, massage acupuncture, and hydrotherapy helped in the management of labour with few side effects; however, more exploration is needed to establish the efficacy of these techniques.
In response to the need to establish a strong evidence base for non-pharmacological intervention, we undertook a randomized controlled trial to test the hypothesis that women who participated in an antepartum breathing exercise program, in addition to usual antenatal care, would experience the spontaneous onset of true labour, spontaneous vaginal birth, shorter duration of labour, and lesser demand for augmentation of labour than antenatal women who receive standard antenatal care alone. | PMC10359740 |
Methods | PMC10359740 |
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Study design | The antepartum breathing exercise program was based on the Lamaze method, with the Lamaze breathing component for use during pregnancy and childbirth. Antenatal women were recruited to a two-arm study consisting of an intervention group, who received training of the antepartum breathing exercise program in addition to usual care, and a standard care group, who received standard care alone. The study was a single-blinded and prospective randomized controlled trial (RCT). This trial was developed based on the extension of the CONSORT statement for reporting RCT.
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Ethical considerations | Ethical clearance was obtained from the Institutional Ethics Committee of Kasturba Hospital, Manipal (IEC 212/2012) and the trial was registered under The Clinical Trials Registry - India (CTRI). The registration number for this trial was CTRI/2016/02/006621, registered on 05.02.2016 (Available at URL
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Participants | eclampsia, malpresentation | RECRUITMENT, PRETERM LABOUR, ECLAMPSIA, PLACENTA PREVIA, MEDICAL COMPLICATION, OBSTETRIC COMPLICATION | Women attending the antenatal clinic were eligible to participate in the study from 36 weeks of gestation. They were provided with a subject information sheet. Those women who were willing, interested, and eligible to participate, signed individual consent forms. Women were eligible to enter the trial if they had a singleton pregnancy with a cephalic presentation, had low risk (no pre-existing medical complications or existing obstetric complications), and were first-time childbearing women (primigravida). Women were excluded from entering the trial if they had pre-identified risk factors like eclampsia, preterm labour, placenta previa, multiple gestation, malpresentation and malposition or had been previously randomized to the trial. Recruitment was undertaken at one tertiary health care hospital in Udupi, Karnataka. All eligible antenatal women were approached in the antenatal clinic individually and were randomized to the study. | PMC10359740 |
Randomization | We used block randomization to randomize participants into the groups. Randomization was done in a 1:1 allocation ratio to ensure equal numbers in each group. Further allocation of participants to the intervention and standard care groups was done by an outpatient nurse with the help of a sequentially numbered opaque sealed envelope (SNOSE). The randomization of the study is illustrated in the reporting guidelines [ref
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Intervention | CONTRACTIONS | Five breathing patterns were introduced namely- cleansing breathing for relaxation, slow-paced breathing, modified-paced breathing and patterned-paced breathing. These patterns were used during and following contractions. Gentle pushing, and breath-hold during pushing were instructed during the second stage of labour which encouraged descent of the baby (
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Images of Lambze breathing patterns. |
An educational video explaining five patterns of breathing exercises was shown and their benefits were taught to women enrolled in the intervention group during the first appointment. These breathing patterns were demonstrated by the investigator to the women on a one-to-one basis. Women were asked to repeat these breathing patterns immediately after teaching and were advised to practice them twice daily for 15 minutes. Instructions were given to continue during the active phase of the first stage of labour under the supervision of labour room nurses.
Women in the intervention group continued practising breathing exercises and compliance was monitored with help of a daily log along with the daily fetal movement count (Sadovsky method, as advised by obstetrician). This daily log was followed-up by the investigator during weekly antenatal visits. Occasionally the investigator checked for compliance through phone calls and enquired if they had any difficulties.
Monitoring during labour was done at the active phase of labour by the observers (nurses in the labour room), who were oriented on breathing exercises.
Likewise, the women randomized to the standard care group received health talk on antepartum care and services according to local health care provision. They were also monitored during the active phase of labour by the observers in the labour room. | PMC10359740 |
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Validity, reliability and rigour | birth injuries | Maternal and neonatal outcomes were measured using structured observational records on outcomes of labour. The tool consisted of 25 items that observed outcomes, which were the outcome of labour, nature of delivery, duration of labour, rate of episiotomy, augmentation of labour, gestational age at birth, birth injuries, and APGAR score at birth. The tool shows an accepted validity with an inter-rater reliability of one. Observational checklist on the performance of antepartum breathing patterns during the active phase of labour had 24 items; was reliable with an inter-rater reliability of .92, and .89 for test-retest reliability. | PMC10359740 |
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Sample size and power | RECRUITMENT | The sample size calculation was based on two independent means derived from the pilot study. The trial was designed to demonstrate minimum detectable differences in the duration of labour between two groups as one hour and anticipate an attrition rate of 10% since outcomes were measured until 40 weeks of gestation. This required a total sample size of 140 primigravid women in each arm of the trial for 80% power at a significance level of p<.05. Recruitment continued until at least 140 women had been enrolled, and from those randomized to the intervention group, 138 completed the study and two were excluded due to elective Lower Segment Caesarean Section (LSCS) or non-reactive Non Stress Test (NST). A low dropout rate (<7%) was observed for the overall study population. | PMC10359740 |
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Data collection | birth injuries | The demographic data included the background information of the women’s age, period of gestation, last menstrual period (LMP), expected date of delivery (EDD), parity, years of marriage, religion, type of family, education, occupation, family income, height, current weight, and total weight gained during pregnancy. Maternal and neonatal outcomes were measured using structured observational records on the outcome of labour. This tool consisted of 12 items; maternal outcome included the onset of labour, duration of labour, the rate of episiotomy, and mode of delivery. Gestational age at birth, birth weight, birth injuries, APGAR score, and presence/absence of birth injuries were the parameters for neonatal outcomes. The performance of antepartum breathing exercises by the women during the active phase of labour was observed by the labour room nurses using an observation checklist. This tool included a stepwise performance of breathing patterns with ‘yes’ or ‘no’ options. If the women followed the steps, a score of ‘1’was given and if they failed to demonstrate, a score of ‘0’ was given. | PMC10359740 |
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Data analysis | Categorical data were expressed as frequency and percentages and analyzed with the χ
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Results | PMC10359740 |
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Participant characteristics | RECRUITMENT | Out of 290 participants recruited, 280 participants were randomized into intervention or standard care groups. Nineteen women (2 from intervention group and 17 from the standard care group) were excluded from the study because they had elective caesarean deliveries and non-reassuring NST. Ultimately, 261 participants were enrolled with 138 in intervention group and 123 in standard care groups as shown in CONSORT flow diagram (Figure 1). The mean age was 26.51 (SD 2.88) years. The majority (92%) were married for 1-3 years. Most (66%) belonged to a joint family. Two-thirds (64%) were homemakers. The mean period of gestation at the time of recruitment for the study was 36.76 (SD 0.83) weeks. Since no significant differences were found, the groups were homogenous concerning demographic characteristics at the time of recruitment to the study (
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Baseline characteristics of participants. | weight gain | DISORDERS | Chi-square test was used for comparison of the proportion of categorical data including years of marriage, religion, type of family, occupation, medical disorders during pregnancy. One way ANOVA was used for comparison of continuous data including age, period of gestation, haemoglobin, and weight gain. | PMC10359740 |
Primary outcome | rupture | REGRESSION, CONTRACTIONS |
A statistically and clinically significant difference was found in the onset of true labour in our study. Among 138 primigravid women in the intervention group, 98 (70%) had spontaneous onset of labour (women came with term gestation, vertex presentation and spontaneous uterine contractions with or without rupture of membranes) as compared to those women in the standard care group. The logistic regression analysis (
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Onset of labour in the intervention and standard care group. | vaginal deliveries |
Women in the intervention group 67 (48%) were more likely to experience a spontaneous vaginal birth, 33% of women had induced vaginal deliveries and 19% had caesarean deliveries (
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Nature of delivery in the intervention and standard care group. | The
A statistically and clinically significant difference was found in the mean duration of labour (in hours) between intervention 5.5127 (SD 1.998) hours and standard care group 7.238 ± 3.678 hours, resulting in a mean of 132 minutes,
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Mean profile plot showing duration of labor between intervention and standard care group. | PMC10359740 |
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Secondary outcome | PROLONGED SECOND STAGE OF LABOUR | Among 98 women in the intervention group who had spontaneous onset of labour, 68% had a spontaneous vaginal delivery with episiotomy, 18% had assisted vaginal delivery with outlet forceps due to failure of maternal power, decreased bearing down efforts and prolonged second stage of labour and 13% had vacuum delivery. Whereas in the standard care group, 26% had a spontaneous vaginal delivery, 34% had forceps and 40% had vacuum vaginal delivery (Data not shown). | PMC10359740 |
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Discussion | weight gain | PRETERM BIRTH, EVENT | Findings from our study suggested that breathing patterns when done regularly during the antenatal period as well as the active phase of labour had a positive impact on outcomes of labour. Excessive interventions at the time of labour were minimized preserving autonomy and ultimately enabling women to attain self-control. The biological characteristics in the study such as age and period of gestation were consistent with the findings of the earlier reports.
The benefits of control over maternal weight gain during pregnancy seen in our study supports the findings of study by Narendran S,
The most convincing reason to let labour begin on its own is the activation and stimulation of hormones like oxytocin, endorphins, catecholamines, and prolactin which regulate labour and birth.
Breathing exercises during pregnancy revealed various beneficial effects like reduction in preterm birth, longer gestational age, increase in birth weight, reduction in the rate of caesarean birth and assisted vaginal birth.
Labour is a multidimensional physiological event that involves the balance of hormonal factors.
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Limitations | HIGH-RISK PREGNANCY, RECRUITMENT, COMPLICATIONS | First, the participants were low-risk pregnant women above 36 weeks of gestation without any major complications and thus the study did not focus on the high-risk pregnancy population. Second, as it was a single-blinded study, the researcher was aware of the group assignment. Hence, a reporting bias may have occurred. Third, generalizability was limited as participants were recruited from a single centre and recruitment from many centres is needed to replicate the findings. | PMC10359740 |
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Implications for practice | The study provides policymakers with the evidence of incorporating comprehensive childbirth education that introduces women to a variety of options, which is not commonly practiced in India, especially in a setting where research was carried out. Instituting midwifery-led collaborative care services in community health centres and rural centres will aid in the utilization of these strategies and thus be sustainable. Secondly, a combination of evidence-based practice framework with an active-learning approach supports the development of an educational intervention that is intended to bring about a change in practice and meet the learning needs of labour and delivery. | PMC10359740 |
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Conclusion | Considering the special needs of childbearing women, a personalized and focused protocol is best indicated, that adapts to a variety of practices, and which provides and promotes a holistic approach to health. It must also fosters participants with a framework with which they can integrate this practice during pregnancy and childbirth. Evidence from various studies and the present study support that antepartum breathing exercises are suitable for pregnancy and have an optimistic outcome. To add strength to the study, more standardized programs along with obstetricians should be conducted, which would bring improvements to evidence-based evaluations in a research environment. | PMC10359740 |
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Data availability | PMC10359740 |
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Underlying data | OSFHOME: Underlying data for “Effectiveness of antepartum breathing exercises on the outcome of labour: A randomized controlled trial”,
This project contains the following underlying data:
Deidentified demographic informationDeidentified comparison scores of primary outcomes between standard care and intervention group.Data are available under the terms of the
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Reporting guidelines | Figshare: CONSORT checklist for‘[Effectiveness of antepartum breathing exercises on the outcome of labour: A randomized controlled trial]’.
[CONSORT flowchart]
Data are available under the terms of the
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Author contribution | PMC10359740 |
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Acknowledgements | The researcher is very grateful to all participants for their valuable contribution to the study. | PMC10359740 |
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References | INBORN ERRORS OF METABOLISM |
The authors have changed the context of the questionable section providing general reasoning which would be prohibitive to the routine practice of labor care without giving references, which would not affect the validity of the study's findings.Is the work clearly and accurately presented and does it cite the current literature?YesIf applicable, is the statistical analysis and its interpretation appropriate?YesAre all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?YesAre the conclusions drawn adequately supported by the results?YesAre sufficient details of methods and analysis provided to allow replication by others?YesReviewer Expertise:Pathology, inborn errors of metabolism, early neonatal care, gender based violenceI confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.
The manuscript discusses about the antepartum breathing exercises on maternal outcomes of labour among primigravid women in the form of a randomised controlled trial. The authors have given training on antepartum breathing exercises to be practiced during antepartum period and the active stage of labour to the intervention group and the primary outcome had been assessed based on maternal outcome of labour in terms of onset of labour, nature of delivery, duration of labour, and need for augmentation. The manuscript reads effortlessly and clearly points out the major facts. The abstract provides a clear understanding to the readers of the content.
The introduction is well written to lay the basis for the intended study supported by available evidence.Suggest rewording the following sentence:
Briefly indicate what factors (e.g: X, Y, & Z) may prevent the routine use of above-mentioned treatments in India with references as this creates the basis for application of the suggested intervention. E.g.: X, Y, & Z can be prohibitive to the routine use of medications, intravenous fluids, continuous electronic foetus monitoring, and other procedures carried out during labour in most birth centres in India.The methodology is written including an adequate description of the methods to allow recreation of the study following CONSORT guidance.The interventions are well-described and appropriately executed. Suggest making the educational video on breathing exercises available as supplementary material if possible.Robust statistical analysis has been applied to analyse data and results are presented appropriately.The authors correlate the current findings with existing evidence to come to a conclusion indicating the statistically significant outcome with the suggested intervention.The application of breathing exercises in labour is a good and feasible practice to be introduced in low-resource settings. This study provides statistically significant evidence supporting its applications.Is the work clearly and accurately presented and does it cite the current literature?YesIf applicable, is the statistical analysis and its interpretation appropriate?YesAre all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?YesAre the conclusions drawn adequately supported by the results?YesAre sufficient details of methods and analysis provided to allow replication by others?YesReviewer Expertise:Pathology, inborn errors of metabolism, early neonatal care, gender based violenceI confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
I am satisfied with the correction and explanations incorporated to the review comments/suggestions.Is the work clearly and accurately presented and does it cite the current literature?YesIf applicable, is the statistical analysis and its interpretation appropriate?YesAre all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?PartlyAre the conclusions drawn adequately supported by the results?YesAre sufficient details of methods and analysis provided to allow replication by others?YesReviewer Expertise:NAWe confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.
The writing style of the manuscript is very captivating. The guidelines of writing manuscripts are appropriately followed. The grant information is delineated adequately. The abstract of the manuscript is written in a crisp and clear manner. Introduction incorporates scientific evidences depicting the current scenario and need of the study. Research methodology is written adequately with relevant explanations and covered all the important elements of planning and conducting research. However, participants’ information is not matched with the CONSORT flowchart (290) with the information available at Pg no: 5 (292) of the manuscript under participants characteristics heading. Clarification is also required about randomizing the samples of 280 from recruited samples of 292. Explanation is also required for reason/s for excluding 09 participants while assessing for eligibility. The researcher crafted intervention is very extensively planned and implemented. The researcher is competent in providing the crafted interventions with added credentials. Analysis and interpretation of the data are well organized as per the research objectives. Extensive and Exhaustive analysis of the data done and presented with robust statistical operations. Summary, discussion, implications, conclusion of the research is presented and discussed in accordance with the findings of the present study.Is the work clearly and accurately presented and does it cite the current literature?YesIf applicable, is the statistical analysis and its interpretation appropriate?YesAre all the source data underlying the results available to ensure full reproducibility?YesIs the study design appropriate and is the work technically sound?PartlyAre the conclusions drawn adequately supported by the results?YesAre sufficient details of methods and analysis provided to allow replication by others?YesReviewer Expertise:NAWe confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above.
Dear Dr Lily Podder, I appreciate the time and effort that you have dedicated to provide your valuable feedback on my manuscript. Here are my clarifications for the comments:
Will correct the error in Table 1, as the total samples enrolled based on eligibility criteria was 290.Based on the sample size calculation, 140 samples to be recruited in each arm (140x2), thus 280 samples were selected through block randomization.Nine samples were excluded as they opted government hospital for delivery. | PMC10359740 |
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Objectives | rheumatoid arthritis, periodontitis, RA | RHEUMATOID ARTHRITIS, PERIODONTITIS | We aimed to investigate prolactin (PRL) levels in gingival crevicular fluid (GCF), synovial fluid, and serum in patients suffering from moderately active rheumatoid arthritis (RA) with and without periodontitis (P). Further, to evaluate the effect of non-surgical periodontal treatment on these levels compared to controls. | PMC10264271 |
Materials and methods | periodontitis, RA | PERIODONTITIS | Eighty subjects were divided into 4 groups: group 1: 20 patients with RA + P, group 2: 20 periodontitis patients (systemically healthy), group 3: RA patients (periodontally healthy), and group 4: healthy controls. Patients with periodontitis received scaling and root planning (SRP). PRL was measured using enzyme‐linked immunosorbent assay. | PMC10264271 |
Results | RA | At baseline, in GCF of RA + P group showed the highest mean PRL levels, followed by P group whereas groups 3 and 4 showed a statistically less values than the first 2 groups. Serum values showed non-significant difference between the first three groups, although higher than healthy controls. SRP reduced GCF and serum levels of PRL in both P groups as well as synovial fluid PRL in group 1. SRP caused no change in DAS scores while reduced ESR values were observed in group 1 after treatment. | PMC10264271 |
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Conclusions | rheumatoid arthritis, periodontitis | RHEUMATOID ARTHRITIS, PERIODONTITIS, DISEASE | Local GCF and synovial levels of PRL seem to be linked to the disease process of both periodontitis and rheumatoid arthritis than serum levels. SRP reduced these local levels. | PMC10264271 |
Clinical relevance | RA | In patients with RA and CP, local PRL seems to play a role in the association between the two conditions; further, periodontal treatment is essential to improve periodontal condition in RA patients. | PMC10264271 |
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Trial registration | Clinicaltrials.gov. Identifier: NCT04279691. | PMC10264271 |
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Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10264271 |
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Introduction | inflammation, RA, periodontitis, teeth loss | RHEUMATIC DISEASES, INFLAMMATION, PERIODONTITIS, RECRUITMENT, PITUITARY, PERIODONTITIS | Hormones are involved in various aspects of the immune response and rheumatic diseases; the interest in the crosstalk between hormones and cytokines acting on inflammation and bone metabolism has recently grown [Periodontitis (P) is another chronic inflammatory disease of teeth supporting structures, mainly induced by bacterial biofilm dysbiosis with a multifactorial contribution. Bacteria-derived factors stimulate a local inflammatory reaction, cytokines release, followed by recruitment and activation of T and B lymphocytes causing periodontal tissue destruction and teeth loss. Treatment of periodontitis aims mainly at reduction of microbial load and associated inflammation by mechanical debridement. However, due to the multifactorial nature of periodontitis, standard treatment may not be a sufficient to achieve long-term clinical improvements [Since the association between periodontitis and RA has been confirmed long ago by almost all the population‐based studies, now, there is a need to investigate possible mechanisms that might be responsible for such an association [Prolactin (PRL) is a neuroendocrine hormone that mainly regulates lactation; however, it also acts as a cytokine with both autocrine, endocrine, and paracrine effects. PRL is mainly secreted by pituitary gland besides many extra-pituitary tissues and cells. Pituitary and extra-pituitary released PRL are structurally identical and bind to the same receptors that are expressed in the pituitary as well as many other tissue cells including the heart, immune system cells, and osteoblasts. Regulation of extra-pituitary PRL is mainly site specific and independent from pituitary PRL [Rahajoe et al. stated that “analysis of gingival crevicular fluid of RA patients reveals that the relationship between periodontitis and RA is bidirectional, and studying cytokines in the periodontal inflammatory exudate of RA patients might provide insight into the association between periodontitis and RA” [ | PMC10264271 |
Materials and methods | PMC10264271 |
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Study design and ethical aspects | In this case controlled clinical trial, subjects were recruited from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry, October University for Modern Sciences and Arts (MSA) and Al-Azhar Universities and from Rheumatology Department, Al-Zahraa Hospital, Al-Azhar University, Cairo, Egypt, from October 2019 to December 2020. The study was conducted according to the Declaration of Helsinki (1964, revision 2008). All subjects participated voluntary and received detailed information about the study. A written consent was obtained from each participant before the start of the trial. This trial was registered on | PMC10264271 |
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Sample size calculation | Sample size calculation was performed using G*Power version 3.1.9.2. Prolactin level in GCF after treatment was the primary outcome. A pilot study was conducted on three patients in each group (included in the study groups afterwards). Mean values were 22, 18.8, 17.5, and 18 for the four groups, respectively. Standard deviation within each group was assumed to be 4. The effect size | PMC10264271 |
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Study population | A detailed medical history of each participant was obtained according to the modified Cornell Medical Index questionnaire [ | PMC10264271 |
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Inclusion criteria
| Group 1: patients with chronic moderately active RA [ | PMC10264271 |
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Exclusion criteria | PD, RA | SYSTEMIC DISEASE | (1) Pregnancy or lactation; (2) any known systemic disease other than RA for groups 1 and 3; (3) previous periodontal treatment (surgical or non-surgical) in last 6 months; (4) antibiotics in the past 3 months; (5) previous intra-articular drug injections; (6) smoking; (7) biological DMARD therapy; (8) abnormal body mass index (more than 29.9 kg/mOne rheumatologist (S.A.) did the rheumatologic examination and synovial fluid sampling and one periodontist (Z.S.) did the periodontal examination and GCF sampling; both examiners were blinded from each other for the rheumatologic, periodontal conditions and study groups. Calibration exercises for probing measurements were performed in five patients before the study, with a 0.82 k value for PD and 0.76 for CAL. Laboratory analysis was conducted by O.S. who was blinded to the study groups. | PMC10264271 |
Rheumatologic examinations | RA | Diagnosis of RA was verified according to the 2010 RA classification criteria of the American College of Rheumatology and EULAR [ | PMC10264271 |
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Periodontal examination and treatment | PD | Dental clinical and radiographic examinations were performed to all study subjects. All teeth were examined excluding the third molars and implants (WHO, 1997). The following measurements were recorded: (1) clinical attachment loss (CAL), (2) probing pocket depth (PD), (3) gingival index [ | PMC10264271 |
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Fluid sampling and examination | inflammation, Periodontitis, RA, attachment loss, trauma | INFLAMMATION, PLAQUE, PERIODONTITIS | Synovial fluid and serum samples were collected the same day of baseline clinical examination whereas the GCF samples were collected the day after to avoid the contamination of crevicular fluid with blood associated with the probing of inflamed sites. Patients of all study groups provided serum and GCF samples at baseline; only the RA patients agreed to provide synovial fluid samples. Periodontitis patients in our study who received SRP provided GCF samples 3 months after treatment.Synovial fluid sample collection was performed via arthrocentesis from inflamed knee joint. GCF samples were obtained from the buccal aspects of two interproximal sites in teeth that had the highest signs of inflammation and attachment loss. Selected site was first isolated with cotton rolls and air-dried and samples were collected after meticulous removal of supragingival plaque. For the periodontally healthy groups, samples were collected from the upper first molar. Filter paper strip (Periopaper; ProFlow Inc., Amityville, NY, USA) was placed in the selected sites for 30 s. Care was taken to avoid mechanical trauma and blood strips contaminated were discarded. For serum sample, 5 ml aliquot of blood was obtained. After collection, samples were immediately centrifuged and stored at − 80 °C until further use. Samples were assayed for PRL by using ELISA kits (Prechek Bio, Inc. CA, USA), according to manufacturer’s instructions using human recombinant standards. Results were expressed as concentrations in nanograms per milliliter (ng/ml); sensitivity of the kit was 5 ng/ml. | PMC10264271 |
Statistical analysis | PLAQUE | Numerical data were explored for normality by Kolmogorov–Smirnov and Shapiro–Wilk tests. All data showed parametric distribution except for plaque index and gingival index. Data were presented as mean and standard deviation (mean ± SD) values. For parametric data, one-way ANOVA and repeated measures ANOVA tests were used to compare between the groups as well as to study the changes after treatment within each group. Bonferroni’s post hoc test was used for pair-wise comparisons when ANOVA test is significant. Paired | PMC10264271 |
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Results | PMC10264271 |
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Clinical parameters | PD, RA | For RA parameters, a non-significant change in DAS scores after treatment was reported; mean values (mean ± SD) were 4.2 ± 0.6 and 4.1 ± 0.6 pre- and post-treatment, respectively. The mean values (mean ± SD) for ESR were 29.4 ± 3.3 and 28.1 ± 3.3 pre- and post-treatment, with a significant decrease (Table Descriptive statistics and results of Mann–Whitney *Significant at For periodontal parameters at baseline, RA + P group showed statistically significantly higher mean PD, CAL, and PI records compared to P group—except for GI—that showed a non-significant difference. After treatment, groups 1 and 2 reported a significant decrease in all recorded parameters compared to pretreatment levels within each group. For post-treatment records comparison, group 1 reported a significant increase compared to group 2 (except for the PD values that showed a non-significant difference between the 2 groups). Post-treatment values of groups 1 and 2 remained significantly higher than group 3 (Table | PMC10264271 |
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Discussion | periodontitis, cancer, inflammation, infection, systemic lupus, RA, active disease process | PERIODONTITIS, CANCER, INFLAMMATION, INFECTION, PSORIATIC ARTHRITIS, PERIODONTAL INFLAMMATION, MULTIPLE SCLEROSIS, LEAKAGE, PATHOLOGY, DISEASES | The present study reports, for the first time, gingival crevicular fluid, synovial fluid, and serum levels of prolactin hormone in RA patients with and without periodontitis and the effect of non-surgical periodontal therapy on these levels. We included a well distinguished group of RA patients with moderate severity, not consuming biological DMARDs and those with periodontitis had equal affection between stages III and IV. The RA + P patients had significantly worsened periodontal condition at baseline compared to periodontitis group patients and healthy controls. This is consistent with previous data that reported the same findings [In this work, RA patients treated with the biologic DMARDs were excluded to avoid its possible effect on the inflammatory status and hence, PRL expression. Earlier studies reported that biologic DMARDs ameliorate periodontal inflammation in patients with RA and increase patient’s susceptibility to infection [The non-surgical periodontal therapy caused significant reduction in periodontal parameters in this study, supporting earlier data that reported improvement of the periodontal condition after treatment in both RA + P and P groups [The concept of the locally produced PRL at sites of tissue pathosis via activating its receptor on target cells has emerged as a new mechanism in various pathologic contexts, including inflammation and cancer [The high GCF expression of PRL in periodontitis patients with and without RA and its reduction after SRP agrees with earlier reports in which the local expression of prolactin increases with active disease process and reduced significantly after treatment; this further supports the value of this hormone in the inflammatory process associated with periodontitis [The pronounced synovial PRL expression in our RA patient agrees with Tang et al. findings; they attributed this to possible partial vascular leakage of the pituitary originated hormone into synovial tissue and from peripheral monocytes capable of PRL production, PRL and its receptors were suggested to be linked to RA pathology by local crosstalk (either by autocrine or paracrine ways), between the immune and endocrine systems [High PRL serum levels in patients with immune-inflammatory conditions like RA, psoriatic arthritis, multiple sclerosis, and systemic lupus were reported, highlighting the relation between PRL and these diseases [ | PMC10264271 |
Author contribution | N.E.: original idea, writing main manuscript, review and editing, conceptualization, data analysis, project administration. Z.S., R.F., and S.A.: data collection, writing original draft, review and editing, visualization. O.S.: data collection, writing original draft, review and editing. | PMC10264271 |
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Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). The study was self-funded by the authors. | PMC10264271 |
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Declarations | PMC10264271 |
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Competing interests | The authors declare no competing interests. | PMC10264271 |
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Ethical approval | All procedures performed were in accordance with the ethical institutional standards and with the Helsinki Declaration. | PMC10264271 |
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Informed consent | Informed consent was obtained from all study participants. | PMC10264271 |
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Conflict of interest | The authors declare no competing interests. | PMC10264271 |
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References
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Background | Clinical Record (CR) writing is a fundamental skill for healthcare professionals, but the best e-learning methods for teaching it remain unstudied. Therefore, we investigated speech therapy students’ differences in the quality production of CR at the placement and their experience after following asynchronous or synchronous e-learning courses. | PMC10439640 |
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Methods | A multi-method randomised controlled trial. Fifty speech therapist students were equally and randomly divided into two groups attending asynchronous or synchronous e-learning classes to learn how to write a CR. The quality of the CR was tested through an ad hoc checklist (score 0–32) and the groups’ scores were compared. The assessors and the statistician were blinded to students’ group assignment. Students’ experience was assessed through semi-structured interviews analysed with a reflexive thematic analysis. | PMC10439640 |
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Results | ’ | INTERACTION | No score differences between the two groups were found (Cohen’s d = 0.1; 95% Confidence Interval [-0.6; 0.7]). Four themes were generated: (1) ‘Different Forms of Learning Interaction’, as the synchronous group reported a positive experience with being fed back immediately by the lecturer, whereas the asynchronous group reported that pushing back the question time allows for reflecting more on the learning experience; (2) ‘Different Ways to Manage the Time’, as the synchronous group had to stick to the lecturer’s schedule and the asynchronous group felt the possibility to manage its time; (3) ‘To Be or Not To Be (Present)?’ due to the different experiences of having (or not) the lecturer in front of them; (4) ‘Inspiring Relationships With The Peers’, where both groups preferred a peer-to-peer discussion instead of contacting the lecturer. | PMC10439640 |
Discussion | Asynchronous and synchronous e-learning courses appeared equally effective in teaching CR writing. However, students perceive and experience these methods differently. The choice or blend of these methods should be based on students’ needs and preferences, teacher input, as well as organisational requirements rather than solely on students’ attended performance. | PMC10439640 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12909-023-04528-2. | PMC10439640 |
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Keywords | PMC10439640 |
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Introduction | Clinical Records (CR) are fundamental to keeping track of patients’ conditions, transmitting essential information among healthcare professionals working on a team and from a legal point of view [In the last few years, online resources opened up many innovative possibilities for teaching, with distance and blended lessons, whether delivered synchronously or asynchronously, becoming increasingly frequent in healthcare professional degree courses [Regarding the difference between these two teaching methods, several studies concluded that the educational and assessment scores reached by students (when it comes to different topic knowledge) were similar for both groups, and there was no evidence that the asynchronous online delivery of the module content disadvantaged one group over the other [Regarding the production of CRs, there is no evidence of the best e-learning way to teach this skill, whether synchronously or asynchronously. Furthermore, no studies explored students’ experiences of attending CR-related courses online. Thus, this study investigated the differences in the quality of the production of CR among speech therapy students and their experience after following an asynchronous e-learning course compared to a synchronous one through a multi-method randomised controlled trial. | PMC10439640 |
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Materials and methods | PMC10439640 |
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Trial design | A multi-method randomised controlled two-arms parallel-groups trial was conducted, wherein the assessors and the statistician were blinded to the groups the students were assigned. This study is reported in line with the Consolidated Standards of Reporting Trials [ | PMC10439640 |
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Setting and participants | This trial was conducted at the Bachelor of Science (BSc) degree course in ‘Speech Therapy’ at the University of Verona (Verona, Italy). The targeted study population consisted of third- and second-year students who attended the second semester of this three-year course before starting the placement. Participants were eligible if they were students enrolled in the third or second year of the abovementioned BSc programme and were willing to participate in the study. Hence, a potential cohort of 50 students was identified: 25 from the second year and 25 of the third year. Information about the study’s objectives was thoroughly provided to the students, after which their willingness to participate was ascertained through written informed consent. In case of unwillingness, they were told that they would receive the synchronous course in preparation for the placement but that their data would not be collected. | PMC10439640 |
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Interventions | Participants were randomised in a 1:1 ratio into one of the two groups described below. The two groups were composed of students in the second and third years. Group 1 attended an asynchronous course, whereas Group 2 attended a synchronous one. Both courses took place in March 2021. Both classes were held by two speech therapists and tutors of the course (GDB and LD). They are both experts in speech therapy clinical practice and were thoroughly trained in both synchronous and asynchronous didactics methods. Regardless of the administration way, the two classes aimed at providing the students of the second and third year of the BSc in ‘Speech therapy’ with the necessary knowledge to produce a CR that contained the assessment and the treatment of a patient they would see during their placement [ | PMC10439640 |
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Intervention group | The intervention group received an asynchronous course conducted by LD. The asynchronous course was carried out through the use of Google Classroom. The course consisted of four modules with videos that lasted a maximum of 15 min each. The first module presented the course. The second one explained how to write a CR from a formal point of view (paragraphs, writing style, syntactic form etc.). The third and fourth modules dealt with the contents of the CR and the skills students were supposed to achieve by writing it [ | PMC10439640 |
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Control group | The control group received a synchronous course conducted by GDB. The synchronous lesson lasted 2 h, was conducted via ‘Zoom’ in March 2021 and consisted of a frontal lecture using slides and a mobile audience response system (i.e., ‘Mentimeter’). The topics covered were the same as those treated in the asynchronous intervention group. The lectures in the intervention (asynchronous) group were shorter than those in the control group because it is recommended to shorten the duration of asynchronous lectures compared to face-to-face ones to enhance the effectiveness of asynchronous teaching [ | PMC10439640 |
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Randomisation | An external person to this study generated a random allocation sequence using a computer-generated random number list with simple randomisation ( | PMC10439640 |
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Outcome | PMC10439640 |
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Primary outcome – quality of CRs | The primary outcome was the differences between the two groups in the quality of production of a CR that contained the assessment and the treatment of a patient they saw during their placement. A literature search was conducted to look for a checklist to assess CR. Since no checklists were retrieved, an ad hoc checklist was developed following a similar strategy to the one reported by Rossettini et al. [The checklist comprised 16 items divided into two parts: a formal and a content one (6 in the formal part and 10 in the content part). Briefly, the former evaluated the presence or absence and the adequacy or inadequacy of some formal characteristics (font, heading, meeting the deadlines, syntactic form, appropriate language etc.) that needed to be present in the CR. The latter evaluated the contents of the CR based on the skills that the students were supposed to reach (patients’ assessment and treatment).The preliminary version of the checklist was then validated for face and content validity through a Delphi Procedure [GDB and LD then tested the final checklist to evaluate the CRs of 10 students not involved in the study. Thus, Cronbach’s alpha was calculated to estimate internal consistency, and the intraclass correlation coefficient (ICC) was calculated to assess Inter-rater agreement. The internal consistency was adequate with Cronbach’s alpha α = 0.82 (95% confidence interval (CI) [0.56–0.94]). Inter-rater agreement was also high (ICC 0.96, 95% CI [0.85–0.99]).Finally, two blinded assessors used the checklist to evaluate the primary outcome. One had experience in speech therapy clinical practice for developmental age and assessed the 25 reports in that area, and one in speech therapy clinical practice for adulthood and corrected the remaining 25 reports focussed on adults. The evaluators were unaware of the study objectives and participants’ groups and were preliminarily trained using the checklist. The evaluators independently assessed the recorded performance. A comparison between the two groups was made based on the marks obtained. Moreover, upon completion of the data collection processes, feedback on the quality of the report was offered individually to all students in both groups. | PMC10439640 |
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Secondary outcome – students’ experience | Semi-structured interviews were conducted with each student to investigate students’ experience of attending asynchronous or synchronous lectures. The interviews were performed online, by videoconferencing, and they were conducted only with the interviewee. GDB and LD produced and transcribed an audio-visual recording of each interview verbatim. Questions were asked about the feelings, emotions and impressions that the students have experienced in participating in the synchronous and asynchronous lessons.The interview guide (Supplementary Material The semi-structured interviews were performed by GDB and LD and lasted approximately 15 min each. GDB performed the interviews with the students who participated in the asynchronous course, whereas LD performed the interviews with those who participated in the synchronous course. Participants were aware of their professional background and knew GDB and LD as lecturers. | PMC10439640 |
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Data and statistical analysis | PMC10439640 |
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Primary outcome (quality of CRs) | Statistical analyses were performed by one researcher (SB) that did not know to which group participants belonged. Descriptive analysis was carried out to describe the participants’ profile, evaluating the homogeneity between the groups’ data and the demographic variables of the sample (age, gender they identified with, year of course). Continuous variables were reported as mean ± standard deviation (SD), whilst categorical variables were reported as absolute and percentage frequencies.Since data did not follow a normal distribution after inspections of q-q plots (stata function ‘qnorm’) between-group analyses were performed using the Mann-Whitney test (stata function ‘ranksum’) to assess differences between the two groups (synchronous and asynchronous) in the quality production of their CRs at the placement. Effect sizes were calculated and reported following Cohen’s d [ | PMC10439640 |
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Secondary outcome (students’ experience) | Data were analysed following the six steps of the ‘Thematic Analysis’ reported by Braun and Clarke (Table
Steps of the ‘Reflexive Thematic Analysis’The use of thematic analysis in this study was majorly inductive, as we took the dataset as starting point for our data analysis [ | PMC10439640 |
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Sample size | PMC10439640 |
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Primary outcome (quality of CRs) | A priori analysis was run to calculate the sample size needed. It was based on G * Power 3.1 application. Based on other studies on online lecturing, an effect size of d = 0.70 was set [ | PMC10439640 |
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Secondary outcome (students’ experience) | All study participants were interviewed, and their interviews were subsequently analysed chronologically based on the dates they were conducted. The analysis was conducted collaboratively by GDB and LD, who maintained continuous communication to refine the coding process and develop subsequent themes. The analysis of interviews was concluded when it was determined that no further interviews were necessary, and the final themes were generated [ | PMC10439640 |
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Results | A total of 50 students were included in the study (25 in the intervention group and 25 in the control group). The intervention (asynchronous) group was composed of 24 women (96%) and one man (4%) and 12 (48%) students from the second year, and 13 (52%) from the third year. The control (synchronous) group was composed of 24 women (96%) and one man (4%), 13 (52%) students from the second year and 11 (48%) from the third year). Table
Descriptive analysis of the whole cohort of students divided per groupLegend: N, number; W, women; M, men; SD, standard deviation | PMC10439640 |
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Primary outcome (quality of the CRs) | Table
Students’ score30.0[26.0; 32.0]30.0[23.5; 31.5]d = 0.1[-0.6; 0.7]12.0[11.0; 12.0]12.0[11.0; 12.0]d = 0.3[-0.3; 0.8]18.0[15.0; 20.0]18.0[13.0; 19.5]d = 0.2[-0.5; 0.8]Legend: Q1, first quartile; Q3, third quartile | PMC10439640 |
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Secondary outcome (students’ experience) | INTERACTION | Among the fifty students who were interviewed, only 30 interviews were analysed (15 from the synchronous group and 15 from the asynchronous group). Descriptive data of this subgroup is reported in Table
Demographic characteristics of intervieweesLegend: Async, asynchronous; Sync, synchronous; W, woman; M, manAnalysis of the interview data generated four main themes related to speech therapist students’ experience at the placement following online asynchronous or synchronous courses: (1) ‘Different Forms of Learning Interaction’; (2) ‘Different Ways to Manage the Time’; (3) ‘To Be or Not to Be (Present)?’; (4) ‘Inspiring Relationships With The Peers’. | PMC10439640 |
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Theme 1: different forms of learning interaction | INTERACTION | The participants shared the advantages of both asynchronous and synchronous teaching modalities, highlighting how each modality facilitated their learning through distinct mechanisms. Therefore, we generated the theme: ‘Different Forms of Learning Interaction’. Participants in the synchronous group reported a positive experience induced by the possibility of having immediate feedback from the course lecturer. This possibility allowed them to quickly modify, correct, and adjust their assumptions and doubts about the lessons through direct questions.“It gave us the opportunity to ask questions, to receive live answers, feedback and having someone to talk to. In my opinion, these are important aspects.” (P28, woman, 24y, Synchronous Group).Instead, the asynchronous group reported that this way of lecturing allows them to reflect more on their learning and knowledge and, therefore, to ask more reasoned questions.“… whereas in the synchronous lesson, everything happens at the moment, meaning that it becomes a bit more time-consuming if you don’t immediately think of the questions and write them down. In the asynchronous one, on the other hand, you have more time to contemplate the question.“ (Participant 5, female, 23 years old, Asynchronous Group). | PMC10439640 |
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Theme 2: different ways to manage the time | ’ | The students reported a common thread in their narration, namely, how they managed their time to deal with their lectures, which differed between the synchronous and asynchronous groups. Hence, we created the theme ‘Different Ways to Manage the Time’. The disadvantage in the synchronous mode was being unable to manage one’s own time and thus being ‘forced’ to be there at that moment. As a result, the students had to stick to the lecturer’s schedule.“In my opinion, the biggest limitation is perhaps the fact that you are ‘forced’ to be there in that moment. In the sense that if you have an appointment, you clearly don’t have the possibility to see it [the lesson] when you want…” (P23, woman, 22y, Synchronous Group).Conversely, the students in the asynchronous group positively perceived this modality, primarily due to its flexibility in managing their time based on individual commitments. This flexibility allowed them to engage with the course material at their own pace, accommodating other responsibilities and obligations they may have had.“Well, certainly, in a period like this, it is much more practical in terms of organisation. I’m not talking about Covid, but the intense period between exams, training, etc. Managing your own time is much more practical.” (P4, woman, 23y, Asynchronous Group). | PMC10439640 |
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Theme 3: to be or not to be (present)? | SAID, COLD | The students highlighted the impact of the lecturer’s physical presence (or absence) on their learning experiences. Consequently, we generated the theme: ‘To Be or Not To Be (Present)? In the synchronous group, the students experienced the physical presence of the lecturer positively. They felt it was an advantage as having a person in front of them was perceived as stimulating.“…having a person in front of you is also more stimulating because you are aware of the direct contact, even if it is online. The fact that you know another person is talking to you in real-time, in my opinion, adds something extra compared to just listening to a recording”. (P21, woman, 22y, Synchronous Group)Moreover, the lecturer’s presence during the synchronous experience allowed the students to feel secure as they felt they had a person to rely on when needed, someone they could interact with in real-time.“Well, they [the lecturers] are certainly a reference point”. (P19, woman, 22y, Synchronous Group)In the asynchronous group, the students lacked physical contact with the lecturer. They said that having someone physically in front of them (even if online) makes the experience more “familiar” and less cold and aseptic.“The disadvantage is that maybe when you have a person in front of you, it’s a little more familiar, let’s say less cold, as an impact…” (P2, woman, 22y, Asynchronous Group).However, acknowledging this limit, they reported that they did not perceive discomfort in not having the lecturer present during the asynchronous course, conveying a sense of tranquillity.“I didn’t have any problems. I felt comfortable.” (P7, woman, 37y, Asynchronous Group).Furthermore, a positive aspect of not having the lecturer physically present was that students felt more at ease, as they were not required to engage in an academic performance that typically involved preparing and being conscious of their physical appearance.“I am happy with asynchronous because I can stay at home, and I don’t have the social pressure to attend a lesson physically”. (P8, woman, 22y, Asynchronous Group) | PMC10439640 |
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Theme 4: Inspiring relationships with the peers | doubts | A shared experience among the students, regardless of their respective groups, was the strong bond they formed with their peers. This bond was so impactful that the students preferred engaging with their peers rather than the lecturer, irrespective of the teaching modalities. As a result, we established the theme: ‘Inspiring Relationship with the Peers’. Moreover, the participants in the synchronous group strongly felt the presence of their peers. The possibility of asking direct questions and relating to peers allowed them to be included in constant confrontations with the other students. So, they felt they could increase the knowledge and skills they learned not only from the lecturer of the course but also from their peers.“…the beauty of doing a synchronous course is any way this: the interaction, also perhaps with other participants, and also the exchange of ideas, or at least learning from each other’s questions…” (P23, woman, 22y, Synchronous Group).Irrespective of their group, the interviewees preferred engaging in peer-to-peer discussions rather than contacting the lecturer directly. Consequently, they initially felt more at ease expressing their doubts and concerns to their peers before approaching the lecturer.“… I did not contact the lecturer directly, but through the course representatives. We brought our doubts and problems in a shared way”. (P19, woman, 23y, Synchronous Group) | PMC10439640 |
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Discussion | doubts, anxiety, reduction of social anxiety | This study evaluated the effectiveness of asynchronous and synchronous classes aimed at teaching to speech therapy students how to write a CR during the placement. Moreover, this study explored the students’ experiences of attending those courses. From what was retrieved from this study, it is possible to bring to the forefront that asynchronous lecture is as effective as synchronous one in teaching how to write CRs, as it was already seen for other skills [In the synchronous group, the students asked a question in real time and received immediate feedback from the lecturer. In the asynchronous mode, the answer could only be posed in a second moment through different media outlets (e.g., email, forum etc.) as there is no immediate exchange. However, the possibility of pushing back the question time seemed to allow the students to reflect deeper on what they had learned, making the questions more targeted and well-reasoned. Reflection is a valuable tool that helps students to get the most from their education and other activities [Another aspect highlighted by the interviews was the different time management between synchronous and asynchronous groups. In the synchronous group, students felt obligated to attend sessions at specific times. In contrast, in the asynchronous group, students appreciated the flexibility to manage their learning based on their commitments. It is worth noting that students’ perceived control over their time was found to correlate significantly with their cumulative grade point average [Then, students in the asynchronous group found this modality much more comfortable, not for being at home per se, but because they did not have to participate in a social performance in front of their lecturer and peers. As a result, the interviewees felt a reduction of social anxiety. Asynchronous computer-mediated communication is often less stressful than real-life interaction because the participants do not need to respond immediately. Social anxiety is lower during online than face-to-face interaction [As far as the contact with the lecturer is concerned, two different views emerged during the analysis of the interviews. Those who participated in the synchronous group stated that the course tutor’s presence made them feel more guided, safer and less alone. However, despite the lack of contact in the asynchronous group, the students who attended this course reported feeling relaxed in not having anyone in front of them. The students reported that they are now becoming accustomed to this type of teaching and no longer suffer from this type of lesson as they did at the beginning of the pandemic. Therefore, in this case, the blended method can be the best solution to exploit the benefits of both approaches. According to its teaching objectives, the lecturer can select which content to deliver in synchronous and which in asynchronous mode [In our study, interviewees complained about not feeling comfortable enough to express their doubts to the tutors of the course, but they preferred to ask general questions in the group. This attitude can be a disadvantage as there could be a transmission of biassed information and misunderstanding. So, it is the lecturer’s responsibility to find strategies to engage students in the discussion, whether synchronous or asynchronous (i.e., trust, positive and unconditional consideration, respect, acknowledgement, empathy etc.) [The present study has several limitations. First, the participants and the lecturers involved knew to which groups the students belonged. However, the evaluators and the statistician were blinded. Second, our sample comprises speech therapy students; therefore, we are not sure about the transferability/generalisability of our results. Third, the tool used for performance evaluation was explicitly developed by the research team for this study. Despite promising results for the form and content validity processes, further studies are recommended to create a checklist with robust psychometric properties. Fourth, the study was conducted following the signing of an informed consent inviting students not to exchange materials and information between the two groups (synchronous and asynchronous). However, it is not possible to exclude that the students did so. To reduce this possibility, the students were informed that they would change their group at the end of the first placement: the asynchronous intervention group carried out the course synchronously and vice versa. In this way, the students would have obtained all the materials provided by the tutors to each group. The students could revise their CRs after completing the other course. The revised CR was considered for the final grade registered for their university career. Fifth, the students interviewed were in different years of the degree course, and their experience may change during the other years. Finally, standardisation was not possible regarding the CR cases since each student was assigned a different individual during their placement. However, to ensure consistency, we implemented a standardised checklist that focused on evaluating the quality of the reported information rather than the complexity of each analysed case. This approach can be also seen as a strength of the study as it reflects the real-world scenario of a typical placement, where each student is responsible for managing a different patient.Both synchronous and asynchronous teaching methods have their strengths and weaknesses. Therefore, a blended learning system has been proposed in other teaching areas since it allows students to learn under the best condition [ | PMC10439640 |
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Acknowledgements | DEL | This work was developed within the DINOGMI Department of Excellence framework of MIUR 2018–2022 (Legge 232 del 2016). | PMC10439640 |
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Authors’ contributions | All authors made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data. All authors drafted the work or revised it critically for important intellectual content. All authors approved the version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. | PMC10439640 |
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Funding | This study did not receive any external funding. | PMC10439640 |
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Data Availability | Data are available upon reasonable request to the corresponding author. | PMC10439640 |
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Declarations | PMC10439640 |
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Ethics approval and consent to participate | All methods were performed in accordance with the relevant guidelines and regulations following the Declaration of Helsinki. Ethics approval was obtained from the Ethics Committee of the Department of Human Sciences, University of Verona (17 February 2021, code 2021_04). The participants signed informed consent to participate before participation. | PMC10439640 |
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Consent for publication | The participants signed informed consent for publication before participation. | PMC10439640 |
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Competing interests | The authors declare no competing interests. | PMC10439640 |
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List of Abbreviations | Clinical recordConfidence intervalReflexive thematic analysis | PMC10439640 |
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