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Strengths and Limitations | SECONDARY, BLIND | Strengths of our study include the use of between-group structural equivalence and blind assessment. Furthermore, outcomes of interest (methadone doses and number of treatment days) were based on objective measures, extracted from patient records.This trial has limitations. It was not powered to detect group differences for outcomes other than methadone dose; secondary outcome differences could be artifactual. Additionally, open-label interventions are inherently incompatible with double-blinding. Previous open-label RCTs have been only assessor blinded; ours is one of the few in which the blind extended to the clinicians. Personal communications between the lead author (A.M.B.) and these individuals (treatment physicians [A.D.G., E.W.] and the nurse practitioner) suggest that this blind was not broken (ie, clinicians were not even aware of their patients’ study involvement). Despite this, the possibility still exists that C-OLP participants discussed the study with treatment team members. Furthermore, this study was conducted in a single setting—findings from which may not be generalizable to other treatment settings and populations. A planned larger trial will address this shortcoming. A final limitation is that we did not quite achieve our intended sample size of 60 participants in the TAU group. | PMC10099063 |
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Conclusions | OUD | To our knowledge, this is the first RCT to assess the efficacy of a harnessed placebo intervention in a clinical OUD treatment context. Our findings of C-OLP–enhanced treatment retention and ameliorated sleep merit further investigation, especially considering the unchecked OUD epidemic that continues in the US. | PMC10099063 |
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Background | depression, anxiety | Some studies indicate that more than 10% of pregnant women are affected by psychological problems. The current COVID‐19 pandemic has increased mental health problems in more than half of pregnant women. The present study compared the effectiveness of virtual (VSIT) and semi-attendance Stress Inoculation Training (SIT) techniques on the improvement of the symptoms of anxiety, depression, and stress of pregnant women with psychological distress. | PMC10176276 |
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Methods | psychological distress | This study was conducted on 96 pregnant women with psychological distress in a 2-arm parallel-group, randomized control trial between November 2020 and January 2022. The semi-attendance SIT received treatment for six sessions, sessions 1, 3 and 5 as individual face-to-face and sessions 2, 4 and 6 as virtual once a week for 60 min continuously [ | PMC10176276 |
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Results | depression, psychological distress, anxiety | The post-intervention results showed that the stress inoculation training technique in both VSIT and SIT interventions effectively reduced anxiety, depression, psychological distress, pregnancy-specific stress and general perceived stress [ | PMC10176276 |
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Conclusion | The semi-attendance SIT group has been a more effective and practical model than the VSIT group, for reducing psychological distress. Therefore, semi-attendance SIT is recommended for pregnant women. | PMC10176276 |
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Keywords | PMC10176276 |
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Introduction | infection, depression, sleep disorders, anxiety | INFECTION, MATERNAL DISTRESS, DISORDERS | Pregnancy, as a critical period of a woman’s life, can be affected by various psychological factors [Given the fundamental role of maternal health during pregnancy on the long-term health of the developing fetus, it is essential to identify prenatal interventions to reduce maternal distress [A study examining the effect of SIT on pregnant women’s anxiety and sleep disorders concluded that this approach significantly reduced sleep disorders and pregnancy anxiety [Consequently, further research is needed in this area. Moreover, in addition to face-to-face therapies, today, due to the COVID-19 pandemic and mothers’ reluctance to receive face-to-face therapy regarding the risk of infection, emphasis has been placed on virtual education and therapy. Therefore, the present study aimed to compare the effectiveness of virtual and semi-attendance SIT techniques in improving the symptoms of anxiety, depression and stress in pregnant women with psychological distress. | PMC10176276 |
Materials and methods | PMC10176276 |
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Design | The present study is a multicenter randomized clinical trial with two parallel intervention groups. It was registered in the Iranian Clinical Trial registry under the number IRCT.20200122046228N1. | PMC10176276 |
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Participant recruitment | bleeding, psychiatric | PRETERM DELIVERY, BLEEDING, MISCARRIAGE, DISORDERS | The study population consisted of all pregnant women of 14–32 weeks’ gestation referred to selected hospitals. It was performed in two educational and therapeutic centers affiliated with the Babol University of Medical Sciences in Iran between November 2020 and January 2022.The sample consisted of women meeting the eligibility criteria to enter the study during the trial. A total of 96 individuals who obtained the necessary scores based on the relevant questionnaires were enrolled through the convenience sampling method. Afterward, an independent midwife outside the research team randomly assigned samples into two intervention groups [SIT and VSIT], using the blocking method and computer-generated randomization [Inclusion criteria included the willingness to participate in the study, 14–32 weeks of gestation, obtaining a score higher than 0.5 based on the BSI-18 questionnaire, not attending similar classes, no severe psychiatric disorders [such as bipolar] based on self-report, the educational level of at least the third year of middle school, age over 16, and access to the Internet and WhatsApp messenger. Exclusion criteria included inactive and irregular attendance, unwillingness to continue attending meetings, a pregnancy accompanied by high-risk situations [such as bleeding, miscarriage, preterm delivery] and migration. | PMC10176276 |
Sample size calculation | The sample size was calculated at 48 participants for each group using G-Power and Mohammadi et al.’s article [First type errors (α):0.05 s type error (β): 0.1To implement the intervention, the researcher first provided the necessary explanations about the study objectives to the subjects and obtained their informed written consent if they agreed to participate in the study. Participants were also reassured about the right to withdraw from the study in case of reluctance to participate. | PMC10176276 |
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Measurements | anxiety, infertility, psychological distress, depression, Prenatal Distress | SECONDARY | The demographic and fertility information questionnaire included the mother’s age, job, and education level, the father’s education level and job, the family’s economic status, place of residence, gestational age, number of pregnancies, number of living children and history of infertility.The primary outcome of this study was anxiety, depression and psychological distress by Brief Symptom Inventory [BSI-18] and Revised Prenatal Distress [NuPDQ] were used.BSI-18 [Brief Symptom Inventory] assesses three factors: depression, anxiety and somatization. Scoring is based on a five-point Likert scale. [0 = not at all, 1 = a little bit, 2 = moderate, 3 = quite a bit, 4 = extremely]. Pregnant women with a score higher than 0.5 were diagnosed with psychological distress and entered the study. The validated Persian version was used in the study that Reliability coefficients and retest coefficients were 0.90 and 0.81 respectively [NuPDQ-17 [Prenatal Distress Questionnaire] includes 17 items and three subscales. The subscales include 1- concerns about giving birth and the infant, 2- concerns about body image/weight and 3- concerns about relationships and emotions. Participants’ responses are scored on a 3-point Likert scale [0 = not at all, 1 = somewhat, 2 = very much] with a cut-off of 16. Reliability coefficients [Cronbach’s alpha] for 3 Persian NuPDQ-17 subscales were 0.73 to 0.93. The total Cronbach’s alpha of this instrument was 0.78 [The secondary outcome of this study was the general stress of pregnant women measured by the Perceived Stress Scale [PSS-14]. PSS-14 [Cohen’s General Perceived Stress Scale]; This tool consists of 14 items which are all measured scored on a 5-point Likert scale from [Never = 0, almost never = 1, sometimes = 2, often = 3 and very often = 4], [Before initiating the therapy, all pregnant women completed a demographic information questionnaire, BSI-18 questionnaire, NuPDQ-17 Prenatal Distress Questionnaire and General Perceived Stress Questionnaire [PSS-14] with the assistance of an expert outside the research team. | PMC10176276 |
Interventions | The sessions are six consecutive sessions, one day a week. The content of the sessions is the same for both groups. The structure of SIT therapy sessions was described in Table Outline of the training sessions | PMC10176276 |
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SIT group | The session outline for intervention group 1 was as follows: SIT technique was conducted by a female expert psychotherapist (author MF) who had a license in psychology. The psychologist and Perinatologist (author ZP) organized weekly 60-min face-to-face group sessions for a period of 6 weeks. A female assistant (author AF), who was trained in SIT technique before the trial, helped the therapist in the sessions. sessions 1, 3 and 5 as individual face-to-face and sessions 2, 4 and 6 as virtual SIT held on WhatsApp messenger. Each session lasted for 60 min. | PMC10176276 |
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VSIT group | depression, bleeding, anxiety, abortion | PRETERM DELIVERY, SECONDARY, BLEEDING | Intervention VSIT group subjects received six sessions of virtual SIT treatment simultaneously. Virtual group meetings were held on WhatsApp messenger through which podcasts [consultant’s voice messages], videos, similar examples in PDF format and relaxation audio files were sent. To receive a consultation, the first researcher contacted participants individually every week for at least 30 min.During the week, a supportive voice message was prepared and sent to subjects to maintain contact with them. Furthermore, the first researcher contacted both groups weekly to prevent sample loss. All study subjects completed the BSI-18, NuPDQ-17 and PSS-14 questionnaires after six weeks of intervention. The primary outcomes of this intervention were anxiety, depression and pregnancy-specific stress and the secondary outcome was perceived stress. In the semi-attendance intervention group, two patients were excluded due to abortion and severe bleeding and six patients withdrew from the study due to reluctance to continue treatment. One and two patients were excluded from the virtual intervention group due to preterm delivery and abortion respectively. Moreover, five participants withdrew from the study due to unwillingness to continue treatment. Finally, 80 patients were analyzed (Fig. Flow-Chart of the Participants | PMC10176276 |
Data management and analysis | REGRESSION | The mean and the relevant standard deviation for presenting patients’ characteristics and the study outcomes were used as summary measures in tables and results. An intention-to-treat analysis was used to manage the missing outcomes. Multiple Imputation technique was applied for addressing the missing observations. MI Impute Chained (MICE) was chosen as an iterative process. Sixteen imputations of variables with missing values on the observed dataset were added. A multiple regression approach for analysis of covariance (ANCOVA) was used to estimate the differences of scores between pre-intervention and post-intervention phases in the two groups. Pre-test scores were considered as a covariate variable and trial intervention as the fixed factor. Also, partial eta squared (η | PMC10176276 |
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Ethical considerations | The trial was approved by the Ethics Committee of the National Institute [IR.MUBABOL. HIR.REC.1399.277] and registered in the IRCT | PMC10176276 |
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Discussion | Anxiety, mental distress, anxiety, SIT, depression | The present study was conducted to compare the effectiveness of virtual and semi-attendance Stress Inoculation Training on improving the symptoms of anxiety, depression and stress in pregnant women with mental distress. So far, this method has not been used to compare groups virtually or as semi-attendance. The results showed that anxiety, depression, pregnancy-specific stress and general perceived stress in pregnant women of both groups decreased after the intervention. This treatment reduced anxiety, depression, psychological distress in SIT intervention compared to VSIT intervention. There was no significant difference between SIT and VSIT intervention in terms of their effects on pregnancy-specific stress and general stress.Anxiety is one of the most common accompanying symptoms in pregnant mothers, which causes various problems for both mother and fetus. This technique can reduce pregnant women’s misconceptions that lead to anxiety. The results of this study were in line with the study by Jokar et al. They showed that Stress Inoculation Training reduced anxiety in pregnant women [Askari et al., in their research, showed that positive psychoeducation training and SIT reduced depression in pregnant women [Stress is one of the most common concerns among pregnant women directly related to fetal developmental processes that cause irreversible effects on the fetus. The present study results are consistent with Khorsandi et al.’s study conducted to investigate the effect of Stress Inoculation Training on pregnant women’s perceived stress. They showed that SIT could significantly reduce stress in pregnant women [ | PMC10176276 |
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Limitations of the study | depression, anxiety | SECONDARY | This study had strengths and limitations that should be noted. One of the main strengths is that the present study was the first randomized clinical trial to compare the effectiveness of Virtual with face-to-face Semi-Attendance SIT techniques in Pregnant Women with Psychological distress for improving the symptoms of anxiety, depression and stress. In addition, we used validated scales to assess primary and secondary outcomes. Another strength of the randomized clinical trial design was the blinding of the outcome assessor and statistician to the type of intervention.This study has some limitations, which demand caution for the generalization of the results. Firstly, to evaluate depression, anxiety and stress in pregnant women, Self-report scales were used. It is suggested that in future studies, a clinical interview be implemented by an expert since it can be a better indicator. Secondly, we did not measure the effect of SIT intervention on pregnancy outcome. It is recommended to measure the effect of this method on improving maternal and newborn outcomes. Also, the lack of a passive control group made the relative effectiveness of the intervention against the passive intervention not investigated. | PMC10176276 |
Acknowledgements | We would like to thank the staff of Rouhani and Yaheinejad hospitals for their cooperation in the implementation of this study. Also, we thank Midwifes Ms. Shafirizi and Ms Mirtabar they helped with sampling, and the outcome assessor, as well as respected professors and all participating pregnant mothers. | PMC10176276 |
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Authors’ contributions | A.F. and F.N.A wrote the main manuscript text and M.F. prepared Counseling sessions. M.C performed the statistical analysis. H.A.R and Z.P reviewed the literature and prepared the manuscript. All authors reviewed the manuscript. The authors read and approved the final manuscript. | PMC10176276 |
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Funding | The article was funded by Babol University of Medical Sciences (Grant No. 724132937). | PMC10176276 |
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Availability of data and materials | The data sets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10176276 |
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Declarations | PMC10176276 |
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Ethics approval and consent to participate | In order to do ethical consideration, this study followed the guidelines set by declaration of Helsinki and received ethical approval for human subject by the Ethics Committee of Babol University of Medical Science approved the study.[Code of Ethics: MUBABOL.HIR.REC. 1399.277]. The pregnant women all provided written informed consent to participate in the study. | PMC10176276 |
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Consent for publication | Not applicable. | PMC10176276 |
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Competing interests | The authors declare no competing interests. | PMC10176276 |
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References | PMC10176276 |
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Objective | SE, Status epilepticus | STATUS EPILEPTICUS | Status epilepticus (SE) is an emergency condition for which rapid and secured cessation is crucial. Although fosphenytoin (FPHT) is recommended as a second-line treatment, levetiracetam (LEV) reportedly has similar efficacy, but higher safety. Therefore, we herein compared LEV with FPHT in adult SE. | PMC9763167 |
Methods | convulsive, seizure | We initiated a multicentre randomised control trial in emergency departments with adult patients with convulsive SE. Diazepam was initially administered, followed intravenously by FPHT at 22.5 mg/kg or LEV at 1000–3000 mg. The primary outcome was assigned as the seizure cessation rate within 30 min of the administration of the study drug. | PMC9763167 |
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Results | SE, Seizure, seizure | ADVERSE EVENTS, RECURRENCE | A total of 176 adult patients with SE were enrolled (82 FPHT and 94 LEV), and 3 were excluded from the full analysis set. Seizure cessation rates within 30 min were 83.8% (67/80) in the FPHT group and 89.2% (83/93) in the LEV group. The difference in these rates was 5.5% (95% CI −4.7 to 15.7, p=0.29). The non-inferiority of LEV to FPHT was confirmed with p<0.001 by the Farrington-Manning test. No significant differences were observed in the seizure recurrence rate or intubation rate within 24 hours. Serious adverse events developed in three patients in the FPHT group and none in the LEV group (p=0.061). | PMC9763167 |
Conclusion | SE | The efficacy of LEV was similar to that of FPHT for adult SE following the administration of diazepam. LEV may be recommended as a second-line treatment for SE along with phenytoin/FPHT. | PMC9763167 |
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Trial registration number | jRCTs031190160. | PMC9763167 |
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WHAT IS ALREADY KNOWN ON THIS TOPIC | STATUS EPILEPTICUS, ADVERSE EVENTS | Phenytoin/fosphenytoin are recommended as a second-line treatment for status epilepticus; however, these drugs are associated with serious adverse events. Levetiracetam is expected to be as effective, but with less serious adverse events because previous randomised control trials (RCTs) that compared them reported similar efficacies. | PMC9763167 |
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WHAT THIS STUDY ADDS | status epilepticus | STATUS EPILEPTICUS, ADVERSE EVENTS | There has yet to be a study with a positive result or non-inferiority designed RCT, particularly for adult status epilepticus. We herein conducted a multicentre non-inferiority designed RCT, in which adult patients with status epilepticus were randomised into levetiracetam and fosphenytoin groups as a second-line treatment after diazepam. The non-inferiority of levetiracetam to fosphenytoin was confirmed with less serious adverse events in the levetiracetam group. | PMC9763167 |
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY | status epilepticus | STATUS EPILEPTICUS | Levetiracetam may be used as a second-line treatment for adult status epilepticus. Each guideline and clinical practice for status epilepticus may add it as an alternative to phenytoin/fosphenytoin. | PMC9763167 |
Background | SE, Status epilepticus, convulsive SE, cerebral damage | STATUS EPILEPTICUS | Status epilepticus (SE) is an emergency condition that is life-threatening with respiratory and circulatory system failure and may cause irreversible cerebral damage.Phenytoin is recommended as an effective second-line therapy for SE.Levetiracetam (LEV), which primarily binds to synaptic vesicle protein 2A and regulates the release of neurotransmitters,To establish intravenous LEV for the treatment of SE, we herein conducted a multicentre non-inferiority RCT, in which adult patients with convulsive SE transported to an emergency room were randomised into LEV and FPHT groups as a second-line treatment after the administration of diazepam, a typical benzodiazepine and their efficacies were compared. Since the participating facilities were recruited around Ibaraki in Japan, this study was entitled the | PMC9763167 |
Materials and methods | PMC9763167 |
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Design | SE | A multicentre, prospective and non-blinded RCT was conducted to compare the efficacy and safety of intravenous LEV and intravenous FPHT for the treatment of adult SE in the emergency room. The primary aim of the present study was to examine the non-inferiority of the efficacy of LEV to that of FPHT as a second-line treatment for SE after the administration of diazepam. The present study was conducted as a Japanese Association for Acute Medicine initiative study. It was registered at the Japan Registry of Clinical Trials ( | PMC9763167 |
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Participants, setting | SE, convulsive SE, seizures | Between 23 December 2019 and 31 March 2022, 176 consecutive patients with convulsive SE transported to nine emergency departments were enrolled. We finished the study when 176 patients were enrolled, irrespective of the patient number in each group. Since scheduled enrolment was achieved earlier, patient registration was stopped and the study was completed in September 2021.The definition of SE is ‘continuous seizures longer than 5 min or discrete seizures longer than 2 min with intervening consciousness disturbanceInformed consent was obtained from a proxy before the study procedure. If no proxy was contactable, the study was conducted immediately without informed consent and researchers then obtained consent when the patient became alert or the proxy was found. Even if consent was obtained from a proxy, the researchers attempted to inform the patient after they become alert and then obtained consent. If enrolment was rejected, data from that patient were not used in analyses. If patients were unconscious and there was no proxy during hospitalisation, we included them in the analysis. | PMC9763167 |
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Interventions | SE, convulsions, seizures | Resuscitation and stabilisation were simultaneously performed. Diazepam was intravenously administered at 1–20 mg. The physician selected the dose of diazepam to stop seizures. Following the intravenous administration of diazepam, electronic data capturing (EDC) (TXP Medical) was registered using a smartphone or personal computer, after which data were rapidly randomised and allocated to the FPHT and LEV groups. Block randomisation was performed using EDC, in which a random sequence was automatically generated for the two, four and eight participant units in each hospital. Either of the two, four or eight blocks was also randomly assigned. Therefore, stratification was performed only for the facilities.In the FPHT group, FPHT at 22.5 mg/kg (phenytoin equivalent dose of 15 mg/kg) was intravenously administered in 100 mL of normal saline after diazepam at an administration rate not exceeding 3 mg/kg/min or 150 mg/min. In the LEV group, LEV at 1000–3000 mg was intravenously administered in 100 mL of normal saline after diazepam at an administration rate of 2–5 mg/kg/min. In both groups, height and body weight were estimated from body habitus, family information or patient records. All intervention medication doses were approved by the Japanese SE guidelines.If convulsions were not stopped by these treatments, midazolam, propofol, thiopental or thiamylal was administered as a third-line treatment according to the Japanese guidelines. | PMC9763167 |
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Outcomes | convulsions, arrhythmia, seizure, respiratory arrest, Seizure, hypotension, SE | RECURRENCE, ARRHYTHMIA, RESPIRATORY ARREST, CARDIAC ARREST, LIVER DISEASE, ADVERSE EVENT | The primary outcome was the seizure cessation rate within 30 min of starting administration of the study drug. Seizure cessation in each patient was defined as the cessation of an apparent seizure 30 min after the administration of FPHT or LEV. Seizure cessation was not achieved when convulsions continued, convulsions reoccurred within 30 min, or a third-line treatment, described above, was introduced within 30 min.Secondary outcomes were as follows: (1) the seizure recurrence rate within 24 hours, which was confirmed by an apparent seizure or non-convulsive seizure detected by EEG; (2) the serious adverse event rate throughout the observational period potentially induced by the study drugs, such as cardiac arrest, life-threatening arrhythmia, respiratory arrest and hypotension; and (3) the intubation rate within 24 hours.Other observation items were as follows: (1) basic information on age, sex, height and body weight; (2) the type of SE; (3) seizure duration before treatment; (4) the cause of SE; (5) the modified Rankin Scale 7 days after admission; (6) the administered dose of diazepam and the time between intravenous diazepam and intravenous study drugs; (7) the administered dose of FPHT and LEV at loading and within 24 hours; (8) a previous history of liver disease; and (9) serum creatinine levels on admission. | PMC9763167 |
Adverse events reporting, monitoring and interim analysis | ADVERSE EVENTS, ADVERSE EVENT | On-site monitoring was performed at each hospital by monitors appointed by the monitoring committee. Central monitoring was also conducted. Adverse events were reported on medical records and EDC, with causal associations with intervention drugs, dates, severity, with/without any treatments and outcomes. Serious adverse events were immediately reported to the principal investigator, who then reported them to The Certified Review Board and Minister of Health, Labour and Welfare. The Certified Review Board had the power to stop the study when a marked difference was noted in safety based on reports of serious adverse events or safety monitoring. Other adverse events were reported on EDC. Spontaneous reporting was used over the course of the trial to non-systematically collect these adverse events. An efficacy interim analysis was not performed because this study was a non-inferiority RCT. | PMC9763167 |
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Sample size estimation | SE | The rate of effectiveness of each AED for SE was not assessed, | PMC9763167 |
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Statistical analysis | SECONDARY | Statistical analyses were performed with a full analysis set (FAS) and safety analysis set (SAS). FAS was defined as all subjects without violations of the main eligibility criteria (selection and exclusion criteria) or conflicts with discontinuation and dropout criteria. SAS was defined as all subjects who received the study treatment. An efficacy analysis was performed with FAS. The safety analysis was conducted with SAS.In the primary efficacy analysis, non-inferiority was examined using the Farrington-Manning test for efficacy differences from a non-inferiority margin of 20%. Differences in secondary outcomes were evaluated using χ | PMC9763167 |
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Results | status epilepticus, pseudoseizures, Coma, seizure, Seizure, convulsive | STATUS EPILEPTICUS, ADVERSE EVENTS, COMA | Among the 176 adult patients with convulsive SE enrolled during the study period, 82 were assigned to the FPHT group and 94 to the LEV group. The protocol was performed and completed on all patients. We did not obtain consent from 13 patients because they were unconscious and there was no proxy during hospitalisation, and we included them in the analysis according to the study design. No patient rejected enrolment after providing informed consent. Following considerations of safety, seven patients were administered 500 mg of LEV only, while one patient was administered 120 mg of FPHT only. Other protocol deviations were not observed. We included these eight patients in the analysis set. Three out of the 176 patients enrolled, 2 in the FPHT group and 1 in the LEV group, were diagnosed with pseudoseizures and removed from the analysis. Therefore, we included 176 patients in SAS and 173 patients in FAS after the exclusion of 3 dropout patients. The study outline and main outcomes are shown in Study outline and outcomes. The study protocol was immediately performed on patients with status epilepticus who met the eligibility criteria in the emergency department. Registration was simultaneously conducted with the administration of diazepam and patients were randomised to the FPHT or LEV group. In both groups, diazepam was intravenously administered at 1–20 mg. In the 82 patients in the FPHT group, FPHT was intravenously administered at 22.5 mg/kg after diazepam at an administration rate not exceeding 3 mg/kg/min or 150 mg/min. In the 94 patients in the LEV group, LEV was intravenously administered at 1000–3000 mg after diazepam at an administration rate of 2–5 mg/kg/min. Two patients in the FPHT group and one in the LEV group were excluded because they were diagnosed with pseudoseizures. Seizure cessation rates within 30 min were 83.8% in the FPHT group and 89.2% in the LEV group. DIV, drip intravenous injection;FPHT, fosphenytoin; IV, intravenously; LEV, levetiracetam;JCS, Japan Coma Scale.Basic characteristics are shown in
Basic characteristicsOthers were causes other than those listed, which each physician was unable to categorise. Continuous variables with a normal distribution are expressed as the mean±SD and compared using the Student’s t-test. Non-parametric continuous variables are expressed as medians (IQRs) and compared using the Mann-Whitney U test. Categorical variables are expressed as n (%) and compared using the χFPHT, fosphenytoin; LEV, levetiracetam.Others were causes other than those listed, which each physician was unable to categorise. Continuous variables with a normal distribution are expressed as the mean±SD and compared using the Student’s t-test. Non-parametric continuous variables are expressed as medians (IQRs) and compared using the Mann-Whitney U test. Categorical variables are expressed as n (%) and compared using the χTreatments are shown in Treatments for status epilepticusEach variable is expressed as a median (IQR) and compared using the Mann-Whitney U test.FPHT, fosphenytoin; LEV, levetiracetam.As the primary outcome, seizure cessation rates within 30 min from study drug administration were 83.8% (67/80) in the FPHT group and 89.2% (83/93) in the LEV group (OutcomesEach variable is expressed as n (%) and compared using the χFPHT, fosphenytoin; LEV, levetiracetam.The occurrence of serious adverse events related to the study drugs is shown in Serious adverse events related to study drugsEach variable is expressed as n (%) and compared using the χFPHT, fosphenytoin; LEV, levetiracetam. | PMC9763167 |
Discussion | arrhythmia, seizure, epilepsy, hypotension, convulsive, SE, respiratory/circulatory arrest | ADVERSE EVENTS, ARRHYTHMIA, EPILEPSY | We compared the efficacies of intravenous LEV and intravenous FPHT as second-line treatments following the administration of diazepam for adult convulsive SE with a non-inferiority RCT. Similar efficacies for seizure cessation within 30 min were observed. No significant differences were noted in other efficacies and safety; however, serious adverse events potentially related to the study drugs were only detected in the FPHT group.This is the first study to confirm the non-inferior efficacy of LEV for the treatment of adult SE after the administration of diazepam in comparisons with FPHT. LEV has frequently been compared with phenytoin as a second-line treatment for SE.Nevertheless, the occasional adverse events of phenytoin/FPHT, such as hypotension, arrhythmia or respiratory/circulatory arrest, need to be considered in the treatment of SE.The present study focused on emergency clinical practice. Under life-threatening conditions, physicians cannot devote time to obtaining informed consent, registry and randomisation. A large RCT of SE was recently performed with the establishment of a system for after-acquired consent.The present study had several limitations. Physicians who treated patients and performed outcome assessments were not blinded. While the dose of phenytoin was 22.5 mg/kg, that of LEV ranged between 1000 mg and 3000 mg according to the Japanese epilepsy guidelines. | PMC9763167 |
Data availability statement | Data are available upon reasonable request. The data sets generated and/or analysed during the present study are available from the corresponding author upon reasonable request. | PMC9763167 |
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Ethics statements | PMC9763167 |
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Patient consent for publication | Consent obtained from parent(s)/guardian(s). | PMC9763167 |
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Ethics approval | The Institutional Certified Review Board of Tsukuba University approved the present study (TCRB18-006). Participants gave informed consent to participate in the study before taking part. | PMC9763167 |
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References | PMC9763167 |
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Background | MetS, overweight, Metabolic Syndrome | METABOLIC SYNDROME | Metabolomic dysregulation following a meal in overweight individuals with the Metabolic Syndrome (MetS) involves multiple pathways of nutrient storage and oxidation. | PMC10349757 |
Objective | The aim of the current study was to perform an acute cross-over intervention to examine the interactive actions of meal glycaemic load (GL) on the dynamic responses of the plasma metabolome in overweight females. | PMC10349757 |
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Methods | Postmenopausal women [63 ± 1.23y; Healthy ( | PMC10349757 |
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Results | MetS | In the overweight women with MetS, there were suppressed postprandial responses for several amino acids (AAs), including phenylalanine, leucine, valine, and tryptophan, | PMC10349757 |
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Supplementary Information | The online version contains supplementary material available at 10.1007/s00394-023-03151-7. | PMC10349757 |
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Keywords | Open Access funding enabled and organized by CAUL and its Member Institutions | PMC10349757 |
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Introduction | T2D, CVD, MetS, metabolic syndrome, type 2 diabetes | CVD, METABOLIC SYNDROME, TYPE 2 DIABETES, CARDIOVASCULAR DISEASE | The metabolic syndrome (MetS) is a cluster of conditions highly predictive for the subsequent development of type 2 diabetes (T2D) and cardiovascular disease (CVD) [Analysis of the metabolomic complexity of MetS is most frequently conducted on the fasting state, although it is apparent that disordered metabolic flux is evident following nutrient ingestion [Therefore, the aim of this study was to examine the complex metabolomic responses to mixed test meals, containing either high glycaemic index (HGI) or low GI (LGI) carbohydrates in a cross-over study. For this, a cohort of female participants selected on the basis of the presence or absence of MetS were recruited. Analysis was undertaken of metabolome profiling using hydrophilic interaction chromatography (HILIC) coupled with high-resolution mass spectrometry (HRMS). Based on the available literature, it was hypothesised that using an exploratory metabolomics approach, dynamic alterations in amino acids and related metabolites would be identified and these metabolites would be a key discretionary feature of the altered circulating metabolomic responses to carbohydrate-rich meals [ | PMC10349757 |
Methods | PMC10349757 |
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Ethics | Written informed consent was obtained from all subjects. The experimental protocol was reviewed and approved by the University of Auckland Human Participants and Ethics Committee (Ref #014501). The trial was retrospectively registered at Australia New Zealand Clinical Trials Registry (ANZCTR; ACTRN12615001108505). | PMC10349757 |
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Participants | The study recruited 40 postmenopausal Caucasian women from the Auckland region through newspaper advertisements and from the university community. Eligible subjects were required to have a BMI between 18 and 34 kg/mDue to the complexity of untargeted metabolomics, there remains no standard method for sample size estimation [ | PMC10349757 |
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Metabolomic analysis | The extraction was performed using a slightly modified protocol based on the method used by [ | PMC10349757 |
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Liquid chromatography–mass spectrometry | Plasma extracts and blanks were analysed through LC–MS streams using both positive and negative ionisation modes separately, as previously described [ | PMC10349757 |
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Data integration | XCMS software [ | PMC10349757 |
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Statistical analysis | Metabolomics data were analysed with a linear mixed-effects model (LMM) approach. Statistical analysis was performed using R (version 3.1.2) [ | PMC10349757 |
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Compound identification | Annotation was performed on significant features generated from LMMs for each interaction by matching peak identification data (accurate mass and retention time) against a local library of authentic standards run under identical conditions. If no hit was obtained, significant features were searched against the public domain databases HMDB and METLIN [ | PMC10349757 |
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Discussion | MetS.Despite, generalised, MetS, diabetes | DIABETES, INSULIN RESISTANCE, LGL | The current study compares the plasma metabolomic responses in postmenopausal women with or without MetS to two carbohydrate-rich meals, differing on the basis of GL. Using an untargeted LC–MS strategy, the results demonstrate a predominance of differences in circulating AAs between the healthy and MetS women. There were far fewer and more subtle differences in the circulating AA response between the HGL and LGL meals. Of the responses evident, these tended to be within the first hour following the meal, with no effect evident over the subsequent 2 h of analysis. The untargeted metabolomic analysis also identified metabolites related to energy utilisation pathways, including lactic acid and carnitine that exhibited a greater post-meal excursion in the women with MetS.Despite the design of the meals to alter the calculated GL, the measured blood glucose concentrations demonstrated only a small transient heightened response in the MetS women, following ingestion of the HGL meal. For all study participants, blood glucose exhibited a bi-phasic response, with a nadir between 45 and 60 min after meal ingestion. Although the bi-phasic nature of blood glucose response to a mixed meal has been previously reported [Increased circulating BCAA has been demonstrated to be predictive of diabetes risk [The dispensable amino acid tyrosine exhibited the tendency for increased abundances from 60 min till the study completion (300 min) in the MetS women, irrespective of the meal. These results are consistent with the observation of greater plasma tyrosine responses following different high protein meals in those individuals exhibiting insulin resistance [In the current study, further two-way associations in the response of several amino acids and energy metabolites was demonstrated. Of the identified AAs, alanine was notable in that the post-meal response tended to be greater in the women with MetS. Alanine provides a physiological balance for glucose and proline via glutamate in the tricarboxylic acid cycle (TCA) [Of particular interest is whether variations in the GL of a meal can be identified to modify the concentration of metabolites indicative of altered oxidative metabolism. Lactic acid is the end product of glycolysis, with plasma concentrations indicative of flux in the Cori cycle, where it is exported from glycolytically active tissues into the plasma for synthesis to glucose in the liver [Fasted creatine has previously been associated with MetS [There are important considerations and limitations of the current study. These investigations are limited to older Caucasian females who are postmenopausal, and hence, caution is required in generalising these results to males, younger adults, or to multiple ethnicities. Furthermore, whilst metabolomics has provided significant insight into the differences between postprandial profiles of healthy and MetS women, it does not provide a detailed understanding of the variations in the either the rate of absorption or the rate of tissue clearances due to breakdown of meals between phenotypes. Additionally, the choice of meal is likely to impact on the extent to which these results can be generalised. Future studies can address this issue by incorporating stable isotopes into the food, enabling the precise analysis of metabolite fluxes. Given that there was no formal estimation of sample size calculation and the untargeted nature of the LC–MS analysis, this study should be viewed as a potential pilot to provide guidance for future investigations. | PMC10349757 |
Conclusion | MetS, overweight | In summary, the use of an untargeted metabolomic analysis of plasma samples in postprandial women demonstrated small and transient differences in a range of AAs and several energy-related metabolites for overweight women, characterised as having the MetS, when compared to aged-matched leaner and metabolic healthier women. Further, the choice of meals used in this study did not markedly impact on the measured metabolomic responses. This study therefore cannot convincingly demonstrate whether differences in meal GL are important in altering postprandial metabolism in a manner that can either be beneficial for body weight regulation and metabolic health. However, the data emphasise the complexity of the postprandial responses to meals, composed of whole food, with the continued need to develop a more detailed understanding of the systems’ biological responses to differing meal types. | PMC10349757 |
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Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file 1 (DOCX 890 KB) | PMC10349757 |
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Abbreviations | controlType 2 diabetes, Diabetes | DIABETES | Amino acidsAromatic amino acidArea under the curveBranched chain amino acidBody mass indexCardiovascular diseaseGlycaemic indexInternational Diabetes FederationLiquid chromatography–mass spectrometryLinear mixed-effects modelMetabolic syndromeOral glucose tolerance testQuality controlType 2 diabetes | PMC10349757 |
Acknowledgements | This work was funded by Agency for Science, Technology and Research (A*STAR), Singapore; Singapore-New Zealand Foods for Health Grant (BMRC grant 14/1/16/24/008), Ministry of Business, Innovation and Employment, New Zealand; Singapore–New Zealand Foods for Health Grant (MAUX1309), and AgResearch Limited through the Strategic Science Investment Fund (Contract Nos. A19079 and A21246: Nutritional strategies for an ageing population). | PMC10349757 |
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Funding | Open Access funding enabled and organized by CAUL and its Member Institutions. | PMC10349757 |
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Data availability | The data that support the findings of this study are available from the corresponding author, [DCS], upon reasonable request. | PMC10349757 |
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References | PMC10349757 |
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1. Introduction | death, Stroke, stroke, AIS, disability, acute ischemic stroke | STROKE, STROKE, ISCHEMIC STROKE | The care model composed of a multidisciplinary team is the best model to promote stroke rehabilitation. The objective of this study was to explore the effect of nurse-led rapid rehabilitation on mechanical thrombectomy (MT) in patients with acute ischemic stroke (AIS). This study used a non-randomized, historically controlled clinical trial design to compare the efficacy of nurse-led rapid and routine rehabilitation after thrombectomy in patients with ischemic stroke. Treatment outcomes, including hospitalization duration, hospitalization costs, scores on multiple scales at discharge, and clinical outcomes 3 months post-discharge, were assessed and compared between the 2 rehabilitation approaches. Our report is based on the STROBE guidelines. The differences in length of stay in hospital (Stroke ranks as the leading cause of death and disability in Chinese people. | PMC10344476 |
2. Methods | PMC10344476 |
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2.1. Study design | ISCHEMIC STROKE | This study used a non-randomized, pre- and post-historical controlled clinical trial design to compare the efficacy of rapid and routine rehabilitation after thrombectomy in patients with ischemic stroke. Patients hospitalized from January 1 to December 31 2020, were included in the control group for regular rehabilitation care. During this period, nurses do not play a dominant role in the rehabilitation of patients, and rehabilitation physicians develop rehabilitation plans to complete the rehabilitation of patients with AIS during the recovery period. It mainly includes movement training, active or passive limb training, pulmonary rehabilitation training, etc. There are few types and single forms of rehabilitation. And patients hospitalized from January 1 to December 31, 2021, were included in the intervention group for rapid rehabilitation. The length of hospital stay, hospital cost, quality of life, mRS, and daily living ability of patients in different schemes were compared. Treatment outcomes were compared, such as length of stay and cost of hospitalization, scores on various scales at discharge, and clinical results 3 months after discharge. Given the nature of the intervention, intervention nurses and study participants could not be blinded. The 2 groups of patients received the same social support from the hospital, government, family, friends, etc. | PMC10344476 |
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2.2. Target population | PMC10344476 |
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2.2.1. Inclusion and exclusion criteria | organ dysfunction diseases | LUNG DISEASE, KIDNEY DISEASE, HEART DISEASE, LIVER DISEASE, MALIGNANT TUMORS | The inclusion criteria were as follows: AIS patients who met the relevant requirements for MT surgery during hospitalization and were selected according to AHA/ASA 2018 AIS Early Management Guidelines; over 18 years of age; signed informed consent for vascular interventional therapy by themselves or their representatives; and first episode of AIS; Informed consent was obtained from patients or family members.The exclusion criteria were as follows: severe heart disease, lung disease, liver disease, kidney disease, and other organ dysfunction diseases or malignant tumors; lost contact or failure to complete follow-up visits; Patients who give up treatment due to severe condition after thrombectomy. | PMC10344476 |
2.3. Implementation plan of rapid rehabilitation | PMC10344476 |
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2.3.1. Build multidisciplinary teams. | A multidisciplinary rehabilitation management team was established through group discussion, including nurses, neurologists, rehabilitation physicians, respiratory therapists, rehabilitation therapists, occupational therapists, speech therapists, and dietitians. After the formation of the protocol and before the formal implementation of the study, we developed a training plan for team members, and the department managers formulated the corresponding training and assessment content according to different rehabilitation duties. The teaching method was mainly a combination of online teaching and special lectures in the Department of Neurology. We were including but not limited to nurses. They were trained for 3 months for 24 hours from October 1, 2020 to December 31, 2020, and completed and passed the examination within the deadline. | PMC10344476 |
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2.3.2. Responsibilities of team members. | ’ overall disease, pain | PAT, COMPLICATIONS | The nurse responsibility is to lead the whole process of rapid rehabilitation of patients during hospitalization, carry out targeted pain care, posture management, respiratory management, personalized health education, emotional, rollover, assessment and training of swallowing function, and pat the patient on the back and sleep management, and most importantly, patient assessment and data collection of outcome indicators. Neurologists mainly diagnose and treat patients’ overall disease and complications. Before the implementation of rehabilitation, the rehabilitation protocol was reconsulted with the patient neurologist physician to ensure that the protocol did not present safety concerns for the patient. Rehabilitation physicians, respiratory therapists, rehabilitation therapists, occupational therapists, and speech therapists are responsible for developing rehabilitation programs and implementing physical therapy, including occupational therapy, staged exercise rehabilitation training, respiratory exercise, and speech therapy. Each thrombectomy patient implemented a multidisciplinary rehabilitation diagnosis and treatment program, with members performing their respective duties to jointly promote the patient recovery. | PMC10344476 |
2.3.3. Rapid recovery implementation process. | cough | RECRUITMENT | The nurses started the corresponding early rehabilitation program when the patient entered the ward. Through process optimization, all links are integrated and sorted, and the fast recovery standard and process of the whole process from postoperative to rehabilitation are established. When the patient is ready to be sent to the ward after the operation, the ward nurse needs to know the basic information about the patient in the operating room in advance, including the patient vital signs, whether tracheal intubation is performed, the operation method, and the operation site. The doctor decides whether to place the ventilator according to the basic situation, and the ward prepares the corresponding supplies for the patient early recovery.Routine nursing after MTIt mainly includes airway and nutrition management, close monitoring of vital signs, observation of consciousness, pupils, and muscle strength, close observation of blood pressure and control of blood pressure, improvement of postoperative review results, and observation of puncture sites and arteria dorsalis pedis.Rehabilitation trainingSwallowing function trainingIt is mainly guided by rehabilitation physicians and assisted by nurses. It includes explicitly swallowing organ training, mouth opening movement, lip movement, tongue movement, breathing training, sensory training, swallowing posture training, and eating training.Position trainingNurses step by step into position training for patients with AIS, including good limb position training, semirecumbent position training, position adaptability training, and autonomous position training.Pulmonary rehabilitationIt mainly includes breathing training, cough training, lung recruitment training, aerosol inhalation of diluted sputum, and chest percussion to promote sputum discharge.PhysicotherapeuticsThe rehabilitation physician and neurologist assess the patient condition and specify a specific physical therapy program administered by the nurse and the rehabilitation physician, including but not limited to active and passive limb joint movements, individual recognized training, acupuncture, and moxibustion therapy, neuromuscular electrical stimulation, tension and grip training, ankle pumping exercises, and bedside activities such as left and standing. After meeting the discharge requirements, patients can be discharged from the hospital or choose more professional rehabilitation institutions for professional rehabilitation treatment.Psychological rehabilitationIn the timely assessment of awake patients, there are related psychological problems, and they immediately seek expert consultations. Nurses also should comfort patients in their daily work and give patients confidence in treatment. | PMC10344476 |
2.4. Data collection | Stroke | STROKE, SECONDARY, MRS, CHRONIC DISEASE | The primary outcome was disability status, measured by the MRS. The prognosis was the primary endpoint measure in this study and was evaluated using MRS scores.The following secondary outcomes were assessed:The nurse assessed the activities of daily living and MRS scores at discharge and 3 months after discharge. The Modified Barthel Index (MBI) is the most commonly used scale to evaluate the ability of daily living activities globally.When assessed 3 months after discharge, nurses also evaluated the patient quality of life using parts EQ-5D (Five Questions of Euro Qol 5D Quality of Life Self-esteem Questionnaire).In addition, we collected several potential covariates. The clinical data of patients were based on the clinical medical record system. We collected the general characteristics of all AIS patients after MT in our hospital from January 2020 to December 2021. It mainly includes demographic data complicated with chronic disease. Preoperative intravenous thrombolysis was performed with alteplase (rt-PA). The National Institutes of Health Stroke Scale score (NIHSS) | PMC10344476 |
2.5. Statistical methods | MRS | Continuous variables are expressed as the means and standard deviations or medians with the 25th and 75th percentiles. The compromise between the 2 groups was compared by The GEE model was used to compare the differential changes in each outcome (MRS) at the time point 3 months after discharge (T2) to the time point of discharge (T1) between groups, with adjustment for the covariates identified as described above. The time and group interaction term (Group*Time) was used to measure the differential change in each variable across time points between the groups. All tests were 2-sided; results with | PMC10344476 |
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2.6. Ethical considerations | WEST | The hospital ethics committee approved this study. This study was approved by the West China Hospital, Sichuan University ethics committee, number 2019 (728). All participants were thoroughly informed about the voluntary nature of their participation and their right to withdraw from the study at any time. Data collection was only performed after obtaining the participants’ written informed consent. This study is a hospital nursing quality improvement and non-randomized controlled study, so it is not registered. We carefully considered the study questionnaire design, collection, and data analysis stages to protect participants’ privacy. First, we only collected essential basic information anonymously, and no identified personal privacy data was recorded in this study. Second, all researchers were informed and agreed to abide by the confidentiality of the study, and these data would be only used for research analysis. | PMC10344476 |
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3. Results | PMC10344476 |
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3.1. Description of the sample | death, ischemic stroke | ISCHEMIC STROKE | For the intervention group, 251 patients with ischemic stroke who underwent MT with admission dates 01/01/2021 to 12/31/2021 were identified as potentially eligible, of which 11 were subsequently classified as unsuitable. Among the 240 eligible patients, 211 enrolled, and 50 participants withdrew due to death, resulting in 161 participants who completed the study. For the control group, 251 patients with ischemic stroke who underwent MT with admission date 01/01/2020 to 12/31/2020 were identified as potentially eligible, of which 26 were subsequently classified as unsuitable. Among the 181 eligible patients, 155 enrolled, and then 31 participants withdrew due to death, resulting in 124 participants who completed the study. This information is visually presented in Figure Shows the patient flow chart. It shows how the patients in our study who were finally included were determined.124 and 161 patients were in the intervention and control groups, respectively. The characteristics of the patients in each study group at the time of admission are shown in Table Demographic and clinical characteristics of patients, N = 285.SD = standard deviation.P value for independent samples t test.P value for χ | PMC10344476 |
3.2. Comparison of outcomes between the 2 groups of stroke survivors | PMC10344476 |
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3.2.1. Outcomes during hospitalization. | The length of hospital stay, hospitalization expense, mRS score, ADL score, and NIHSS score were compared between the 2 groups. Table The treatment outcomes of both groups (N = 285).IQR = interquartile range, M = mean, MED = median, SD = standard deviation. | PMC10344476 |
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3.2.2. Outcomes of the 2 groups 3 months after discharge. | MRS | There was no significant difference in MRS score (The treatment outcomes of both groups (N = 285). | PMC10344476 |
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3.3. Effects of the Intervention on MRS | Table Generalized estimating equation model (N = 285).This parameter is set to zero because it is redundant. | PMC10344476 |
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4. Discussion | stroke, AIS, ischemic stroke, ’ | STROKE, PERIOPERATIVE COMPLICATION, MRS, ISCHEMIC STROKE | Our study observed that stroke patients’ mortality rates within 3 months following thrombectomy were 20.0% in 2020 and 23.7% in 2021. However, the difference between the 2 years was not statistically significant. Similarly, the in-hospital mortality rates were 19.4% and 22.3%.Nonetheless, the clinical outcomes of these patients have not shown substantial improvement, and they continue to face high perioperative complications and mortality rates.Better rehabilitation training is essential in improving ischemic stroke patients.Furthermore, the intervention group patients were discharged when the MRS score was higher than that of the control group, but the NIHSS score was lower than that of the control group. Here, we can see that we are labeling patients who can be discharged when the choice, mainly on the recovery of neurological function, is consistent with the idea of rapid recovery. After neural function in patients with basic replies, they can continue to rest after discharge or choose more professional rehabilitation hospitals. Corresponding neurological function exercises can improve the prognosis of patients.This study results suggest no difference in disability status and self-care ability after 3 months but that psychological status and overall quality of life were better. The better psychological condition may be related to implementing psychological rehabilitation during hospitalization. Patients can receive better psychological support through professional psychological guidance, consistent with Lee research results.In conclusion, the rapid rehabilitation model for patients with AIS after MT has a significant effect and is worthy of reference and clinical promotion. | PMC10344476 |
5. Limitations | This study was historically controlled and non-randomized. Although the difference in baseline data was not statistically significant, the influence of individual differences and medical progress cannot be eliminated due to the limitation of the study type. This study was single-center, and patients’ subjective feelings were not evaluated. In the future, expanding the sample size and synthesizing more effective rehabilitation methods are suggested to optimize the rehabilitation nursing program further. | PMC10344476 |
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Acknowledgments | stroke | WEST, STROKE | Thanks to all medical staff of the Department of Neurology, West China Hospital, Sichuan University, for supporting this study. LF, the corresponding author, is the head nurse in the Department of Neurology. She has been in stroke nursing for over 20 years and has rich experience in stroke nursing management. | PMC10344476 |
Abbreviations: | acute ischemic stroke, Stroke | WEST, STROKE | acute ischemic strokegeneralized estimating equationmodified Barthel indexmodified Rankin scalemechanical thrombectomyNational Institutes of Health Stroke Scale scoreThis study was approved by the West China Hospital, Sichuan University ethics committee, number 2019 (728).Consent for publication: The participants were provided with informed consent forms before completing the survey.The West China Nursing Discipline Special Fund Project, Sichuan University, under Grant number HXHL20021, supported this work.The authors have no conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.How to cite this article: He Y, Wang R, Dong S, Long S, Zhang P, Feng L. Nurse-led rapid rehabilitation following mechanical thrombectomy in patients with acute ischemic stroke: A historical control study. Medicine 2023;102:28(e34232). | PMC10344476 |
References | PMC10344476 |
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Keywords | Single-parent adolescents are vulnerable individuals and it is necessary to improve their health, particularly during epidemics. This study aimed to investigate the effects of virtual logotherapy (VL) on health-promoting lifestyle (HPL) among single-parent adolescent girls during the COVID-19 pandemic. This single-blind randomized clinical trial was conducted on 88 single-parent adolescent girls recruited from the support organization for vulnerable individuals in Tehran, Iran. They were randomly allocated to a control and an intervention group through block randomization. Participants in the intervention group received VL in three–five person groups in 90 min biweekly sessions. The Adolescent Health Promotion Short-Form was used to assess HPL. Data were analyzed using the SPSS software (v. 26.0) and through the independent-sample
This research was registered (17/05/2020) in the | PMC10198750 |
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