Effects of Peer-Facilitated, Video-Based and Combined Peer-and-Video Education on Anxiety Among Patients Undergoing Coronary Angiography: Randomised controlled trial

Objectives: Coronary angiography can be stressful for patients and anxiety-caused physiological responses during the procedure increase the risk of dysrhythmia, coronary artery spasms and rupture. This study therefore aimed to investigate the effects of peer, video and combined peer-and-video training on anxiety among patients undergoing coronary angiography. Methods: This single-blinded randomised controlled clinical trial was conducted at two large educational hospitals in Iran between April and July 2016. A total of 120 adult patients undergoing coronary angiography were recruited. Using a block randomisation method, participants were assigned to one of four groups, with those in the control group receiving no training and those in the three intervention groups receiving either peer-facilitated training, video-based training or a combination of both. A Persian-language validated version of the State-Trait Anxiety Inventory was used to measure pre- and post-intervention anxiety. Results: There were no statistically significant differences in mean pre-intervention anxiety scores between the four groups (F = 0.31; P = 0.81). In contrast, there was a significant reduction in post-intervention anxiety among all three intervention groups compared to the control group (F = 27.71; P <0.01); however, there was no significant difference in anxiety level in terms of the type of intervention used. Conclusion: Peer, video and combined peer-and-video education were equally effective in reducing angiography-related patient anxiety. Such techniques are recommended to reduce anxiety amongst patients undergoing coronary angiography in hospitals in Iran.

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A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

Hip International ◽

10.1177/11207000211005762 ◽

2021 ◽

pp. 112070002110057

Author(s):

Niels H Bech ◽

Inger N Sierevelt ◽

Sheryl de Waard ◽

Boudijn S H Joling ◽

Gino M M J Kerkhoffs ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Femoroacetabular Impingement ◽

Hip Arthroscopy ◽

Controlled Trial ◽

Poor Quality ◽

Control Group ◽

Treatment Groups ◽

Significant Difference ◽

Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

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Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

BioMed Research International ◽

10.1155/2014/610591 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 5

Author(s):

Charlotte Loumann Krogh ◽

Charlotte Ringsted ◽

Charles B. Kromann ◽

Maria Birkvad Rasmussen ◽

Tobias Todsen ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Global Rating ◽

Training Performance ◽

Significant Difference ◽

Training Format ◽

Peer Performance ◽

And Performance ◽

Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

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Out-patient triple chronotherapy for the rapid treatment and maintenance of response in depression: feasibility and pilot randomised controlled trial

BJPsych Open ◽

10.1192/bjo.2021.1044 ◽

2021 ◽

Vol 7 (6) ◽

Author(s):

David Veale ◽

Marc Serfaty ◽

Clara Humpston ◽

Andriani Papageorgiou ◽

Sarah Markham ◽

...

Keyword(s):

Rating Scale ◽

Clinical Sample ◽

Controlled Trial ◽

Bright Light ◽

Light Therapy ◽

Control Group ◽

Intention To Treat ◽

Significant Difference ◽

Randomised Controlled ◽

Rapid Treatment

Background Triple chronotherapy (sleep deprivation for 36 h, followed by 4 days of advancing the time of sleep and daily morning bright-light therapy for 6 months) has demonstrated benefits for the rapid treatment of depressive symptoms in four small controlled trials of in-patients. Aims To test the feasibility of recruitment and delivery of triple chronotherapy for out-patients with depression (ISRCTN17706836; NCT03405493). Method In a single-blind trial, 82 participants were randomised to triple chronotherapy or a control intervention. The primary outcome was the number of participants recruited per month and adherence to the protocol. Secondary outcomes included the 6-item Hamilton Rating Scale for Depression (HRSD-6) at 1 week. Timings of observer ratings were baseline and 1, 2, 4, 8 and 26 weeks after randomisation. Results The triple chronotherapy group stayed awake for the planned 36 h and 89.9% adhered to the plan of phase advance of their sleep over the following 4 days. We achieved our recruitment target (60 participants completed the trial within 13 months). There were no reported adverse side-effects. We found a significant difference between the groups by intention-to-treat analysis for the HRSD-6 at weeks 1, 8 and 26. There was a large effect size of Cohen's d = 0.8 on HRSD-6 score at week 1, increasing to d = 1.30 at week 26. A response (≥50% reduction in symptoms) was achieved by 33.3% in the triple chronotherapy group and 16.2% in the control group. This stayed relatively steady until week 26 (35.9 v. 13.9%). Conclusions Triple chronotherapy produced a significant and rapid benefit after 1 week in out-patients with depression that was sustained at 26 weeks. Cost-effectiveness trials with a larger clinical sample are required.

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Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

BIRDEM Medical Journal ◽

10.3329/birdem.v7i3.33783 ◽

2017 ◽

Vol 7 (3) ◽

pp. 216-220

Author(s):

Md Mehedi Hasan ◽

Samira Rahat Afroze ◽

Muhammad Abdur Rahim ◽

Muhammad Abdus Salam

Keyword(s):

Controlled Trial ◽

Ethical Review ◽

Control Group ◽

Controlled Clinical Trial ◽

Transurethral Resection Of Prostate ◽

Randomized Controlled ◽

Significant Difference ◽

Group A ◽

The Mean ◽

Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

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Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

10.21203/rs.3.rs-36678/v1 ◽

2020 ◽

Author(s):

Ricard Carrillo Muñoz ◽

Jose Luis Ballve Moreno ◽

Ivan Villar Balboa ◽

Yolanda Rando Matos ◽

Oriol Cunillera Puertolas ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Perceived Disability ◽

Randomised Controlled ◽

The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

BMC Public Health ◽

10.1186/s12889-020-09878-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lucie Waedel ◽

Anne Daubmann ◽

Antonia Zapf ◽

Olaf Reis

Keyword(s):

Substance Use ◽

Randomised Controlled Trial ◽

Intellectual Disabilities ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Post Intervention ◽

Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

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Effects of the Conceptual Model of Health Literacy as a Risk: A Randomised Controlled Trial in a Clinical Dental Context

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph15081630 ◽

2018 ◽

Vol 15 (8) ◽

pp. 1630 ◽

Cited By ~ 4

Author(s):

Linda Stein ◽

Maud Bergdahl ◽

Kjell Sverre Pettersen ◽

Jan Bergdahl

Keyword(s):

Health Literacy ◽

Conceptual Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Convenience Sample ◽

Communication Techniques ◽

The Mean ◽

Randomised Controlled

Numerous conceptual models of health literacy have been proposed in the literature, but very few have been empirically validated in clinical contexts. The aim of this study was to test the effects of the conceptual model of health literacy as a risk in a clinical dental context. A convenience sample of 133 Norwegian-speaking adults was recruited. Participants were randomly allocated to an intervention group (n = 64, 54% women, mean age = 50 years) and a control group (n = 69, 49% women, mean age = 46 years). Clinical measurements were conducted pre-intervention and six months post-intervention. In the intervention group, communication regarding patients’ oral health was tailored to their health literacy levels using recommended communication techniques, whereas the control group received brief information not tailored to health literacy levels. The ANCOVA showed significant between-group effects, finding reduced post-intervention mean gingival (p < 0.000) and mean plaque (p < 0.000) indices in the intervention group when controlling for baseline index scores. The adjusted Cohen’s d indicated large effect sizes between the intervention group and the control group for both the mean gingival index (−0.98) and the mean plaque index (−1.33). In conclusion, the conceptual model of health literacy as a risk had a large effect on important clinical outcomes, such as gingival status and oral hygiene. The model may be regarded as a suitable supplement to patient education in populations.

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Family education for people with schizophrenia in Beijing, China

The British Journal of Psychiatry ◽

10.1192/bjp.187.4.339 ◽

2005 ◽

Vol 187 (4) ◽

pp. 339-345 ◽

Cited By ~ 60

Author(s):

Zheng Li ◽

David Arthur

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Family Education ◽

Control Group ◽

Large Hospital ◽

Significant Difference ◽

Symptom Scores ◽

Randomised Controlled ◽

Beijing China ◽

Experimental Group

BackgroundMuch of China lacks well-developed services for people with schizophrenia and their families, and most of the existing services focus on hospitals. There is a need for culturally sensitive family treatments offered by nurses.AimsTo conduct a longitudinal experimental study examining the effect of patient and family education in a sample of Chinese people with schizophrenia.MethodA randomised controlled trial was conducted in a large hospital with a sample of 101 patients with schizophrenia and their families. Data were collected at admission and at discharge, and then at 3 and 9 months after discharge. The intervention group received family education, and data on their knowledge about schizophrenia, symptoms, functioning, psychosocial behaviour, relapse and medication adherence were collected and compared with the control group.ResultsThere was a significant improvement in knowledge about schizophrenia in the experimental group and a significant difference in symptom scores and functioning at 9 months after discharge. Patients who were non-adherent to medication regimens were more likely to relapse.ConclusionsFamily education on schizophrenia by nurses in China was effective in improving knowledge and promoting improvement in patients' symptoms.

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A Prospective and Controlled Clinical Trial on Stromal Vascular Fraction Enriched Fat Grafts in Secondary Breast Reconstruction

Stem Cells International ◽

10.1155/2016/2636454 ◽

2016 ◽

Vol 2016 ◽

pp. 1-12 ◽

Cited By ~ 22

Author(s):

L. A. L. Tissiani ◽

N. Alonso

Keyword(s):

Breast Reconstruction ◽

Controlled Trial ◽

Statistical Significance ◽

Stromal Vascular Fraction ◽

Cell Counting ◽

Fat Graft ◽

Control Group ◽

Controlled Clinical Trial ◽

Fat Grafts ◽

Significant Difference

Background.Fat grafting is a tremendous tool in secondary breast reconstruction. Stromal vascular fraction (SVF) enriched fat grafts have been presenting promising results regarding volume maintenance.Methods.We developed a method that produces a superior SVF enrichment rate (2 : 1) in the operating theatre. This prospective and controlled trial analyzed quantitatively and qualitatively fat grafts with (stem cells group, SG) and without (control group, CG) SVF enrichment in secondary breast reconstruction, through MRI-based volumetry, immunophenotyping, and cell counting. Also, patient satisfaction, aesthetic outcomes, and complications were analyzed.Results.Volumetric persistence in the SG was 78,9% and 51,4% in the CG; however it did not reach statistical significant difference. CD90 was the only marker highly expressed in the SG and showed a positive correlation with volumetric persistence (r=0.651,p=0.03). Fat necrosis occurred in 4 patients in the SG and in none in the CG. Patients in the CG showed a trend to be more satisfied. Considering aesthetics, both groups presented improvements. No locoregional recurrences were observed.Conclusions.Results are encouraging despite the fact that SVF enrichment in a higher supplementation rate did not improve, with statistical significance, fat graft volumetric persistence. Enriched fat grafts have proven to be safe in a 3-year follow-up.

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