The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trial

IntroductionPain caused by routine immunisations is distressing to children, their parents and those administering injections. If poorly managed, it can lead to anxiety about future medical procedures, needle phobia and avoidance of future vaccinations and other medical treatment. Several strategies, such as distraction, are used to manage the distress associated with routine immunisations. Virtual reality (VR), a technology which transports users into an immersive ‘virtual world’, has been used to manage pain and distress in various settings such as burns dressing changes and dental treatments. In this study, we aim to compare the effectiveness of VR to standard care in a general practice setting as a distraction technique to reduce pain and distress in 4-year-old children receiving routine immunisations.Methods and analysisThe study is a randomised controlled clinical trial comparing VR with standard care in 100 children receiving routine 4-year-old vaccination. Children attending a single general practice in metropolitan Melbourne, Australia will be allocated using blocked randomisation to either VR or standard care. Children in the intervention group will receive VR intervention prior to vaccination in addition to standard care; the control group will receive standard care. The primary outcome is the difference in the child’s self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised. Secondary outcomes include another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100 mm visual analogue scales) and adverse effects.Ethics and disseminationEthics approval has been obtained in Australia from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC 18-010). Recruitment commenced in July 2019. We plan to submit study findings for publication in a peer-reviewed journal and presentation at relevant conferences.Trial registration numberACTRN12618001363279.

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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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Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-021071 ◽

2018 ◽

Vol 8 (7) ◽

pp. e021071 ◽

Cited By ~ 5

Author(s):

Cho Lee Wong ◽

Wan Yim Ip ◽

Blondi Ming Chau Kwok ◽

Kai Chow Choi ◽

Bobby King Wah Ng ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Age Groups ◽

Intervention Group ◽

Control Group ◽

Play Intervention ◽

Score Difference ◽

Randomised Controlled ◽

Therapeutic Play

ObjectivesTo examine (1) the effectiveness of therapeutic play in reducing anxiety and negative emotional manifestations among children undergoing cast-removal procedures and (2) the satisfaction of parents and cast technicians with cast-removal procedures.DesignA randomised controlled trial.SettingAn orthopaedic outpatient department of a regional teaching hospital in Hong Kong.ParticipantsChildren (n=208) aged 3–12 undergoing cast-removal procedure were invited to participate.InterventionsEligible children were randomly allocated to either the intervention (n=103) or control group (n=105) and stratified by the two age groups (3–7 and 8–12 years). The intervention group received therapeutic play intervention, whereas the control group received standard care only. Participants were assessed on three occasions: before, during and after completion of the cast-removal procedure.Outcome measuresChildren’s anxiety level, emotional manifestation and heart rate. The satisfaction ratings of parents and cast technicians with respect to therapeutic play intervention were also examined.ResultsFindings suggested that therapeutic play assists children aged 3–7 to reduce anxiety levels with mean differences between the intervention and control group was −20.1 (95% CI −35.3 to −4.9; p=0.01). Overall, children (aged 3–7 and 8–12) in the intervention groups exhibited fewer negative emotional manifestations than the control group with a mean score difference −2.2 (95% CI −3.1 to −1.4; p<0.001). Parents and technicians in the intervention group also reported a higher level of satisfaction with the procedures than the control group with a mean score difference of 4.0 (95% CI −5.6 to 2.3; p<0.001) and 2.6 (95% CI 3.7 to 1.6; p<0.001), respectively.ConclusionTherapeutic play effectively reduces anxiety and negative emotional manifestations among children undergoing cast-removal procedures. The findings highlight the importance of integrating therapeutic play into standard care, in particular for children in younger age.Trial registration numberChiCTR-IOR-15006822; Pre-results.

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The SMARTscreen Trial: a randomised controlled trial investigating the efficacy of a GP-endorsed narrative SMS to increase participation in the Australian National Bowel Cancer Screening Program

Trials ◽

10.1186/s13063-021-05877-3 ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

Anna Wood ◽

Jon D. Emery ◽

Mark Jenkins ◽

Patty Chondros ◽

Tina Campbell ◽

...

Keyword(s):

General Practice ◽

Screening Program ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Cancer Screening Program ◽

Sms Intervention ◽

Bowel Cancer Screening ◽

General Practices ◽

Randomised Controlled

Abstract Background Increasing participation in the Australian National Bowel Cancer Screening Program (NBCSP) is the most efficient and cost-effective way of reducing mortality associated with colorectal cancer by detecting and treating early-stage disease. Currently, only 44% of Australians aged 50–74 years complete the NBCSP. This efficacy trial aims to test whether this SMS intervention is an effective method for increasing participation in the NBCSP. Furthermore, a process evaluation will explore the barriers and facilitators to sending the SMS from general practice. Methods We will recruit 20 general practices in the western region of Victoria, Australia to participate in a cluster randomised controlled trial. General practices will be randomly allocated with a 1:1 ratio to either a control or intervention group. Established general practice software will be used to identify patients aged 50 to 60 years old who are due to receive a NBCSP kit in the next month. The SMS intervention includes GP endorsement and links to narrative messages about the benefits of and instructions on how to complete the NBCSP kit. It will be sent from intervention general practices to eligible patients prior to receiving the NBCSP kit. We require 1400 eligible patients to provide 80% power with a two-sided 5% significance level to detect a 10% increase in CRC screening participation in the intervention group compared to the control group. Our primary outcome is the difference in the proportion of eligible patients who completed a faecal occult blood test (FOBT) between the intervention and control group for up to 12 months after the SMS was sent, as recorded in their electronic medical record (EMR). A process evaluation using interview data collected from general practice staff (GP, practice managers, nurses) and patients will explore the feasibility and acceptability of sending and receiving a SMS to prompt completing a NBCSP kit. Discussion This efficacy trial will provide initial trial evidence of the utility of an SMS narrative intervention to increase participation in the NBCSP. The results will inform decisions about the need for and design of a larger, multi-state trial of this SMS intervention to determine its cost-effectiveness and future implementation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12620001020976. Registered on 17 October 2020.

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Virtual reality environment using a dome screen for procedural pain in young children during intravenous placement: A pilot randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0256489 ◽

2021 ◽

Vol 16 (8) ◽

pp. e0256489

Author(s):

Ha Ni Lee ◽

Woori Bae ◽

Joong Wan Park ◽

Jae Yun Jung ◽

Soyun Hwang ◽

...

Keyword(s):

Virtual Reality ◽

Young Children ◽

Controlled Trial ◽

Intervention Group ◽

Pediatric Emergency ◽

Control Group ◽

Blood Collection ◽

Randomized Controlled ◽

The Difference ◽

Study Process

We assessed the feasibility and potential efficacy of a virtual reality (VR) environment using a dome screen as a distraction method in young children during intravenous (IV) placement in the pediatric emergency department. This randomized controlled pilot study enrolled children aged 2 to 6 years who underwent IV placement into either the intervention group or the control group. Children in the intervention group experienced VR using a dome screen during IV placement. The child’s pain intensity was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at four time points of IV placement: immediately after arrival to the blood collection room (base); immediately after the child laid down on the bed (preparation); when the tourniquet was applied (tourniquet); and the moment at which the needle penetrated the skin (venipuncture). The guardian’s satisfaction and rating of the child’s distress were assessed using a 5-point Likert-type questionnaire. We recruited 19 children (9 in the intervention group and 10 in the control group). Five children in the control group were excluded from the analysis because of missing video recordings (n = 3), failed first attempt at IV placement (n = 1), and the child’s refusal to lie on the bed during the procedure (n = 1). No side effects of VR were reported during the study period. Although the average FLACC scale score at each time point (preparation, tourniquet, venipuncture) was lower in the intervention group than the control group, the difference was not statistically significant (2.3, interquartile range [IQR]: 2.0–3.0; vs. 3.3, IQR: 2.7–6.7, P = 0.255). There were no statistically significant differences between the groups in the guardian’s satisfaction and anxiety or his/her rating of the child’s pain and anxiety. The guardians and emergency medical technicians reported satisfaction with the use of VR with a dome screen and considered it a useful distraction during the procedure. VR using a dome screen is a feasible distraction method for young children during IV placement. A larger clinical trial with further development of the VR environment and study process is required to adequately evaluate the efficacy of VR using a dome screen.

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Evidence of high bednet usage from a list randomization experiment in rural Gambia

10.21203/rs.2.17453/v1 ◽

2019 ◽

Author(s):

Joe Brew ◽

Margaret Pinder ◽

Umberto Dalessandro ◽

Steven W Lindsay ◽

Carloine Jones ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Malaria Prevention ◽

Accurate Estimate ◽

Control Group ◽

Previous Night ◽

Novel Method ◽

The Difference ◽

Randomised Controlled ◽

Study Participants

Abstract Background Recording behaviours that have the potential to impact health can be doubly challenging if the behaviour takes place in private spaces that cannot be observed directly and where there is potential for social desirability bias, i.e. where the respondent may give an answer that they think the recorder wants to hear. Sleeping under a long-lasting insecticidal net (LLIN) is an important intervention for malaria prevention, yet it is difficult to gauge the extent to which coverage (how many nets are in the community) differs from usage (how many people sleep under a net). We employed a novel method, list randomization, which partially obscures respondents' answers to sensitive questions, as a mean to provide an accurate estimate of LLIN usage in The Gambia.Methods We surveyed 196 residents from 196 households recruited into a randomised controlled trial assessing the effect of a housing intervention on malaria. In the current experiment, 98 of the 196 study participants were randomly assigned to the control group and received a four-question list about non-sensitive behaviours; the other participants in the intervention group, received the same list, with the addition of one question on a sensitive behaviour; whether or not they had used a bednet the previous night. Participants were read the list of questions and then said how many of the statements were true. We estimated bednet usage by calculating the difference in means between the total number of affirmative items between the two groups, and quantified uncertainty using a t-test.Results The mean number of affirmative responses in the control group was 2.60 of four statements (95% confidence interval, 95% CI, = 2.50-2.70), compared with 3.68 (95% CI = 3.59-3.78) in the intervention group. Such difference (1.08; 95% CI = 94.9-100%) suggests approximately 100% bednet usage.Conclusions Our findings suggest complete universal bednet usage in the study area. Further validation of the list randomization method in areas with lower net coverage is required.

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The SMARTscreen Trial: A Randomised Controlled Trial Investigating The Efficacy of a GP-Endorsed Narrative SMS To Increase Participation in The Australian National Bowel Cancer Screening Program.

10.21203/rs.3.rs-757642/v1 ◽

2021 ◽

Author(s):

Anna Wood ◽

Jon David Emery ◽

Mark Jenkins ◽

Patty Chondros ◽

Tina Campbell ◽

...

Keyword(s):

General Practice ◽

Screening Program ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Cancer Screening Program ◽

Sms Intervention ◽

Bowel Cancer Screening ◽

General Practices ◽

Randomised Controlled

Abstract Background: Increasing participation in the Australian National Bowel Cancer Screening Program (NBCSP) is the most efficient and cost-effective way of reducing mortality associated with colorectal cancer by detecting and treating early-stage disease. Currently only 44% of Australians aged 50 -74 years complete the NBCSP. This efficacy trial aims to test whether this SMS intervention is an effective method for increasing participation in the NBCSP. Furthermore, a process evaluation will explore the barriers and facilitators to sending the SMS from general practice.Methods: We will recruit 20 general practices in the western region of Victoria, Australia to participate in a cluster randomised controlled trial. General practices will be randomly allocated with a 1:1 ratio to either a control or intervention group. Established general practice software will be used to identify patients aged 50 to 60 years old who are due to receive a NBCSP kit in the next month. The SMS intervention includes GP endorsement and links to narratives messages about the benefits of and instructions on how to complete the NBCSP kit. It will be sent from intervention general practices to eligible patients prior to receiving the NBCSP kit. We require 1400 eligible patients to provide 80% power with two-sided 5% significance level to detect a 10% increase in CRC screening participation in the intervention group compared to control group. Our primary outcome is the difference in the proportion of eligible patients who completed a faecal occult blood test (FOBT) between the intervention and control group for up to twelve months after the SMS was sent, as recorded in their electronic medical record (EMR). A process evaluation using interview data collected from general practice staff (GP, practice managers, nurses) and patients will explore the feasibility and acceptability of sending and receiving a SMS to prompt completing a NBCSP kit.Discussion: This efficacy trial will provide initial trial evidence of the utility of an SMS narrative intervention to increase participation in the NBCSP. The results will inform decisions about the need for and design of a larger, multi-state trial of this SMS intervention to determine its cost-effectiveness and future implementationTrial registration: Australian New Zealand Clinical Trials Registry: ACTRN12620001020976, 17th October 2020

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Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study

BMJ Open ◽

10.1136/bmjopen-2019-033842 ◽

2020 ◽

Vol 10 (5) ◽

pp. e033842 ◽

Cited By ~ 1

Author(s):

Xiaochang Zhang ◽

Xiao Hu ◽

Jixiang Ma ◽

Puhong Zhang ◽

Yuan Li ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Salt Intake ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Cluster Randomised ◽

The Difference ◽

Randomised Controlled

IntroductionSalt intake in China is twice the upper limit recommended by the WHO, and nearly 80% of salt is added during cooking. This study will develop a package of salt reduction interventions targeting home cooks and evaluate its effectiveness and feasibility for scale-up.Methods and analysisA cluster randomised controlled trial design is adopted in this study, which will be conducted in six provinces covering northern, central and southern China. For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member) will be selected in each cluster for evaluation. In total, 780 home cooks and 780 adult family members will be recruited. The home cooks in the intervention group will be provided with the intervention package, including community-based standardised offline and online health education and salt intake monitoring. The duration of the intervention will be 1 year. The primary outcome is the difference between the intervention and control group in change in salt intake as measured by 24 hours urinary sodium from baseline to the end of the trial. The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).Ethics and disseminationThe study has been approved by The Queen Mary Research Ethics Committee (QMERC2018/13) and Institutional Review Board of the Chinese Center for Disease Control and Prevention (No. 201801). The study findings will be disseminated widely through conference presentations and peer-reviewed publications and the general media.Trial registration numberChiCTR1800016804.

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Postcards from the EDge: 24-month outcomes of a randomised controlled trial for hospital-treated self-poisoning

The British Journal of Psychiatry ◽

10.1192/bjp.bp.107.038406 ◽

2007 ◽

Vol 191 (6) ◽

pp. 548-553 ◽

Cited By ~ 83

Author(s):

Gregory L. Carter ◽

Kerrie Clover ◽

Ian M. Whyte ◽

Andrew H. Dawson ◽

Catherine D'Este

Keyword(s):

Randomised Controlled Trial ◽

Risk Ratio ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Treatment As Usual ◽

Incidence Risk ◽

The Difference ◽

Randomised Controlled ◽

Incidence Risk Ratio

BackgroundRepetition of self-poisoning is common.AimsTo report the 24-month outcomes of a non-obligatory postcard intervention (plus treatment as usual) compared with treatment as usual.MethodIn a randomised-controlled trial (Zelen design) conducted in Newcastle, Australia, eight postcards were sent to participants over a 12-month period. The principal outcomes were the proportion of participants with one or more repeat episodes of self-poisoning and the number of repeat episodes per person.ResultsNo significant reduction was observed in the proportion of people repeating self-poisoning in the intervention group (21.2%, 95% CI 17.0–25.3) compared with the control group (22.8%, 95% CI 18.7–27.0;χ2=0.32, d.f. = 1,P= 0.57); the difference between groups was −1.7% (95% CI −7.5 to 4.2). There was a significant reduction in the rate of repetition, with an incidence risk ratio of 0.49 (95% CI 0.33–0.73).ConclusionsA postcard intervention maintained the halving of the rate of repetition of hospital-treated self-poisoning events over a 2-year period, although it did not significantly reduce the proportion of individuals who repeated self-poisoning.

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The effect of vitamin D and magnesium supplementation on the mental health status of attention-deficit hyperactive children: a randomized controlled trial

BMC Pediatrics ◽

10.1186/s12887-021-02631-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mostafa Hemamy ◽

Naseh Pahlavani ◽

Alireza Amanollahi ◽

Sheikh Mohammed Shriful Islam ◽

Jenna McVicar ◽

...

Keyword(s):

Mental Health ◽

Vitamin D ◽

Attention Deficit ◽

Controlled Trial ◽

Neurodevelopmental Disorder ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Magnesium Supplementation ◽

Children With Adhd

Abstract Background Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD. Methods We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children’s mental health at baseline and the end of the study. Results After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo. Conclusion Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed. Trial registration IRCT2016030326886N1.

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Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Healthcare ◽

10.3390/healthcare9040463 ◽

2021 ◽

Vol 9 (4) ◽

pp. 463

Author(s):

Mar Gomis-Pastor ◽

Sonia Mirabet Perez ◽

Eulalia Roig Minguell ◽

Vicenç Brossa Loidi ◽

Laura Lopez Lopez ◽

...

Keyword(s):

Heart Transplantation ◽

Patient Experience ◽

Mobile Application ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Group Versus ◽

Control Group ◽

P Value ◽

Adherence Score

Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.

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