Effectiveness of a Single Education and Counseling Intervention in Reducing Anxiety in Women Undergoing Hysterosalpingography: A Randomized Controlled Trial

Hysterosalpingography (HSG) is generally considered a stressful and painful procedure; we aimed to evaluate whether a single education and counseling intervention could reduce women’s distress and pain after undergoing HSG for infertility. Patients were randomized into control group (n=108) and intervention group (n=109). All patients filled the following questionnaires before and after HSG: Zung self-rating anxiety scale (Z-SAS), Zung self-rating depression scale (Z-SDS), and an ad hoc questionnaire designed to evaluate HSG procedure knowledge. Pain was scored using a visual analog scale. The intervention consisted in a 45-minute individualised session 48 h before HSG. We observed a reduction of anxiety and depression scores in the intervention arm compared to the control group. After controlling for potential confounding variables, intervention was an independent predictor of the difference of Z-SAS score before and after HSG. This is the first randomised controlled trial to assess the potential effectiveness of a single education and counseling intervention to lower anxiety in a diagnostic setting.

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Evaluation of teaching an integrated case formulation approach on the quality of case formulations: randomised controlled trial

The Psychiatrist ◽

10.1192/pb.bp.110.033746 ◽

2012 ◽

Vol 36 (4) ◽

pp. 140-145 ◽

Cited By ~ 3

Author(s):

Mohammed Abbas ◽

Ruth Walton ◽

Allan Johnston ◽

Millicent Chikoore

Keyword(s):

Randomised Controlled Trial ◽

Rating Scale ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Case Formulation ◽

New Approach ◽

Before And After ◽

Randomised Controlled

Aims and methodThis paper introduces a new approach to producing case formulations, the integrated case formulation (ICF) approach, and a rating scale, the Case Formulation Scale (CFS). Twenty-four psychiatrists participated in a single-blind randomised controlled trial to evaluate the effectiveness of teaching using this new approach. The intervention group (n = 12) received teaching about using ICF, whereas the control group (n = 12) received teaching as usual. The scores on the CFS were compared before and after teaching.ResultsPrior to teaching, psychiatric trainees had poor scores on the CFS. The CFS score for the group taught the ICF approach improved five times more than the control group.Clinical implicationsThis study demonstrates that case formulation skills can be taught. With further improvements, the ICF approach might be useful in the teaching of case formulation.

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Brief mindfulness-based intervention of ‘STOP (Stop, Take a Breath, Observe, Proceed) touching your face’: a study protocol of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-041364 ◽

2020 ◽

Vol 10 (11) ◽

pp. e041364

Author(s):

Yanhui Liao ◽

Ling Wang ◽

Tao Luo ◽

Shiyou Wu ◽

Zhenzhen Wu ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Intervention Group ◽

Analysis Of Covariance ◽

Control Group ◽

Psychological Traits ◽

Study Results ◽

Before And After ◽

Randomised Controlled

IntroductionFace-touching behaviour often happens frequently and automatically, and poses potential risk for spreading infectious disease. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of behaviour disorders. This study aims to evaluate an online mindfulness-based brief intervention skill named ‘STOP (Stop, Take a Breath, Observe, Proceed) touching your face’ in reducing face-touching behaviour.Methods and analysisThis will be an online-based, randomised, controlled, trial. We will recruit 1000 participants, and will randomise and allocate participants 1:1 to the ‘STOP touching your face’ (both 750-word text and 5 min audio description by online) intervention group (n=500) and the wait-list control group (n=500). All participants will be asked to monitor and record their face-touching behaviour during a 60 min period before and after the intervention. Primary outcome will be the efficacy of short-term mindfulness-based ‘STOP touching your face’ intervention for reducing the frequency of face-touching. The secondary outcomes will be percentage of participants touching their faces; the correlation between the psychological traits of mindfulness and face-touching behaviour; and the differences of face-touching behaviour between left-handers and right-handers. Analysis of covariance, regression analysis, χ2 test, t-test, Pearson’s correlations will be applied in data analysis. We will recruit 1000 participants from April to July 2020 or until the recruitment process is complete. The follow-up will be completed in July 2020. We expect all trial results to be available by the end of July 2020.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of Sir Run Run Shaw Hospital, an affiliate of Zhejiang University, Medical College (No. 20200401-32). Study results will be disseminated via social media and peer-reviewed publications.Trial registration numberNCT04330352.

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Conductive Education as a Method of Stroke Rehabilitation: A Single Blinded Randomised Controlled Feasibility Study

Stroke Research and Treatment ◽

10.1155/2016/5391598 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Judith Bek ◽

Melanie R. Brown ◽

Jagjeet Jutley-Neilson ◽

Nicholas C. C. Russell ◽

Pia A. J. Huber ◽

...

Keyword(s):

Local Community ◽

Controlled Trial ◽

Intervention Group ◽

Depression Scale ◽

Control Group ◽

Stroke Survivors ◽

Baseline Assessment ◽

Timed Up And Go ◽

Waiting Period ◽

Randomised Controlled

Background.Conductive Education for stroke survivors has shown promise but randomised evidence is unavailable. This study assessed the feasibility of a definitive randomised controlled trial to evaluate efficacy.Methods.Adult stroke survivors were recruited through local community notices. Those completing the baseline assessment were randomised using an online program and group allocation was independent. Intervention group participants received 10 weekly 1.5-hour sessions of Conductive Education at the National Institute of Conductive Education in Birmingham, UK. The control group participants attended two group meetings. The study evaluated the feasibility of recruitment procedures, delivery of the intervention, retention of participants, and appropriateness of outcome measures and data collection methods. Independent assessments included the Barthel Index, the Stroke Impact Scale, the Timed Up and Go test, and the Hospital Anxiety and Depression Scale.Results.Eighty-two patients were enrolled; 77 completed the baseline assessment (46 men, mean age 62.1 yrs.) and were randomised. 70 commenced the intervention (n=37) or an equivalent waiting period (n=33). 32/37 completed the 10-week training and 32/33 the waiting period. There were no missing items from completed questionnaires and no adverse events.Discussion.Recruitment, intervention, and assessment methods worked well. Transport issues for intervention and assessment appointments require review.Conclusion.A definitive trial is feasible. This trial is registered withISRCTN84064492.

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Toe Clearance Rehabilitative Slippers for Older Adults With Fall Risk: A Randomized Controlled Trial

Geriatric Orthopaedic Surgery & Rehabilitation ◽

10.1177/21514593211029102 ◽

2021 ◽

Vol 12 ◽

pp. 215145932110291

Author(s):

Atsuko Satoh ◽

Yukoh Kudoh ◽

Sangun Lee ◽

Masumi Saitoh ◽

Miwa Miura ◽

...

Keyword(s):

Older Adults ◽

Fall Risk ◽

Controlled Trial ◽

Intervention Group ◽

Berg Balance Scale ◽

Control Group ◽

Mobility Assessment ◽

Before And After ◽

Day Services ◽

And Control

Introduction: To evaluate fall-prevention rehabilitative slippers for use by self-caring, independent older adults. Materials and Methods: This assessor-blinded, randomized, and controlled 1-year study included 59 self-caring, independent participants (49 women) who attended day services. The mean age of participants was 84.0 ± 5.3 years. Participants were randomly selected from 8 nursing homes. We tested slippers top-weighted with a lead bead (200, 300, or 400 g). Intervention group participants walked while wearing the slippers for 10-20 min, 1-3 days/week at the day service center. Fall risk was measured using the Berg Balance Scale and the Tinetti Performance-Oriented Mobility Assessment (POMA) before and at 3-month intervals after the intervention/control phase. Results: After 12 months, the intervention group demonstrated significant improvement. Berg Balance and POMA compared to the control group ( p < .05 p < .01, respectively). Mobility scores improved significantly for both measurements in the intervention group before and after ( p < .01), but the control group had significantly lower scores. Discussion: Overall, falls decreased in the intervention group from 10 to 7, and control group falls increased from 9 to 16 ( p = .02). No adverse events related to the intervention were reported. Conclusions: Rehabilitation training slippers may reduce falls in older adults.

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Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-040108 ◽

2020 ◽

Vol 10 (12) ◽

pp. e040108

Author(s):

Rowan W Johnson ◽

Sian A Williams ◽

Daniel F Gucciardi ◽

Natasha Bear ◽

Noula Gibson

Keyword(s):

Exercise Prescription ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Programme ◽

Home Exercise ◽

Control Group ◽

Neurodevelopmental Disabilities ◽

Home Exercise Programme ◽

Exercise Programmes ◽

Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

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A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

BMC Public Health ◽

10.1186/s12889-021-11357-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

M. A. Greidanus ◽

A. E. de Rijk ◽

A. G. E. M. de Boer ◽

M. E. M. M. Bos ◽

P. W. Plaisier ◽

...

Keyword(s):

Return To Work ◽

Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Work Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Secondary Effect ◽

Quality Of Working Life ◽

Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

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The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0245 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Asieh Mehdipour ◽

Parvin Abedi ◽

Somayeh Ansari ◽

Maryam Dastoorpoor

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Moderate Depression ◽

Before And After ◽

The Mean ◽

And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

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Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽

10.1136/bmjopen-2018-026086 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026086

Author(s):

Yasutake Tomata ◽

Fumiya Tanji ◽

Dieta Nurrika ◽

Yingxu Liu ◽

Saho Abe ◽

...

Keyword(s):

Financial Incentives ◽

Primary Outcome ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Sample Size Calculation ◽

Community Dwelling ◽

Control Group ◽

Modifiable Factors ◽

Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

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Effect of Communication Skills Training Program for Oncologists Based on Patient Preferences for Communication When Receiving Bad News: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2013.51.2756 ◽

2014 ◽

Vol 32 (20) ◽

pp. 2166-2172 ◽

Cited By ~ 91

Author(s):

Maiko Fujimori ◽

Yuki Shirai ◽

Mariko Asai ◽

Kaoru Kubota ◽

Noriyuki Katsumata ◽

...

Keyword(s):

Communication Skills ◽

Patient Preferences ◽

Controlled Trial ◽

Intervention Group ◽

Depression Scale ◽

Skills Training ◽

Control Group ◽

Communication Skills Training ◽

Communication Performance

Purpose The aim of this study was to identify the effects of a communication skills training (CST) program for oncologists, developed based on patient preferences regarding oncologists' communication. Participants and Methods Thirty oncologists were randomly assigned to either an intervention group (IG; 2-day CST workshop) or control group (CG). Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up. A total of 1,192 patients (response rate, 84.6%) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale, satisfaction with the consultation, and trust in their oncologist after the consultation. Results At the follow-up survey, the performance scores of the IG had improved significantly, in terms of their emotional support (P = .011), setting up a supportive environment (P = .002), and ability to deliver information (P = .001), compared with those of the CG. Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves (P = .001). Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG (P = .027). However, the CST program did not affect patient satisfaction with oncologists' style of communication. Conclusion A CST program based on patient preferences is effective for both oncologists and patients with cancer. Oncologists should consider CST as an approach to enhancing their communication skills.

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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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