The Effect of Virtual Reality Game Preparation for Children scheduled for MRI (IMAGINE): a Randomized Controlled Trial Protocol (Preprint)

2021 ◽  
Author(s):  
Sylvie Le May ◽  
Christine Genest ◽  
Stéphane Guay ◽  
Nicole Hung ◽  
Maxime Francoeur
Keyword(s):  
Virtual Reality ◽  
Usual Care ◽  
Field Test ◽  
Controlled Trial ◽  
Muscle Tension ◽  
Test Phase ◽  
Therapeutic Modality ◽  
Care Group ◽  
Anxiety Management ◽  
Experimental Group

BACKGROUND Magnetic resonance imaging (MRI) has been known for almost forty years to generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI to be repeated and reschedule with sedation. Very few studies seemed to have looked at the effect of virtual reality (VR) on anxiety in children scheduled for an MRI and how this intervention could help identify which children are more responsive to VR. OBJECTIVE The aims of this study are three-fold: 1- to develop an algorithm of predictability based on biofeedback ; 2- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management in children scheduled for an MRI (field test phase) and 3- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety in children undergoing an MRI (RCT). METHODS This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to initiate the development of a predictive algorithm for biofeedback solution requiring actual participants and to address the feasibility and acceptability of the VR intervention and research process. Following the field test, a randomized clinical trial will be completed using a parallel design with two groups: 1) experimental group (pre-procedural IVR game preparation), 2) usual care group (standard care as per radiology department’s protocol) in an equal ratio of 49 participants per group for a total of 98 participants. Recruitment will be done at CIUSSS de l’Est de l’Île de Montréal, Quebec, Canada. The experimental group will receive a pre-procedural IVR game preparation (IMAGINE) that offers an immersive and fun simulation of the MRI environment. Participants will complete a questionnaire to assess the acceptability, feasibility and incidence of side effects related to the intervention and the biofeedback device. Data collected will include socio-demographic and clinical characteristics and measures of procedure related-anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (STAIC-F) and the Child Fear Scale (CFS, 0-4). Physiological signs (heart rate, skin conductance, hand temperature and muscle tension) and levels of satisfaction of healthcare professionals, parents, and participants will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05. RESULTS Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. The biofeedback will help predict which children are more responsive to this type of intervention. CONCLUSIONS This study will guide future medical practice by providing evidence-based knowledge on a non-pharmacological therapeutic modality for anxiety management in children scheduled for MRI. CLINICALTRIAL NCT04988516

Effects of home-based virtual reality telerehabilitation system in people with multiple sclerosis: A randomized controlled trial

2021 ◽  
pp. 1357633X2110548
Author(s):  
Chiara Pagliari ◽  
Sonia Di Tella ◽  
Johanna Jonsdottir ◽  
Laura Mendozzi ◽  
Marco Rovaris ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Virtual Reality ◽  
Usual Care ◽  
Controlled Trial ◽  
Care Group ◽  
Randomized Controlled ◽  
Home Based ◽  
Rehabilitation System ◽  
Virtual Reality Rehabilitation

Background and objective Multiple sclerosis is an inflammatory and neurodegenerative disorder of the central nervous system that can lead to severe motor disability. The aim of this study was to verify the health care effects of an integrated telerehabilitation approach involving dual-domains (motor and cognitive) in people with multiple sclerosis using a virtual reality rehabilitation system compared to a home-based conventional rehabilitative intervention usual care for patient-relevant outcomes (motor, cognitive and participation). Methods This multicentre interventional, randomized controlled trial included 70 participants with multiple sclerosis, 35 in the telerehabilitation group (30 sessions of home-based virtual reality rehabilitation system training, five sessions for week each lasting 45 min) and 35 in the usual care group (30 sessions of conventional treatment, five sessions for week). Participants completed the assessment of motor, cognitive and participation outcomes at baseline and after 6 weeks of treatment. Results In total, 63.3% of the telerehabilitation group exhibited improvement in the physical domain of the quality of life ( p = 0.045). The telerehabilitation group showed greater improvement than the usual care group in Mini-BESTest domains of balance ( p = 0.014), postural control ( p = 0.024), and dynamic walking ( p = 0.020) at post-treatment. Higher adherence was registered for telerehabilitation compared with usual care (86.67% vs . 80.0%). Discussion This study provides evidence that people with multiple sclerosis can benefit from telerehabilitation treatment in the physical domain of the quality of life and motor symptoms. Moreover, considering the persistent COVID-19 emergency, telerehabilitation can represent an effective telemedicine solution for safely delivering effective rehabilitation care to people with multiple sclerosis. Trial registration number and trial register This trial was registered at ClinicalTrials.gov (NCT03444454).

Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

2022 ◽  
Author(s):  
Maryam Zahid ◽  
Ume Sughra
Keyword(s):  
Nutritional Status ◽  
Usual Care ◽  
Usual Care Group ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
Randomized Controlled ◽  
Nutritional Status Of Children ◽  
Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

The Natural History of Back Pain after a Randomised Controlled Trial of Acupuncture Vs Usual Care – Long Term Outcomes

2007 ◽  
Vol 25 (4) ◽  
pp. 121-129 ◽  
Author(s):  
Stephanie L Prady ◽  
Kate Thomas ◽  
Lisa Esmonde ◽  
Simon Crouch ◽  
Hugh MacPherson
Keyword(s):  
Back Pain ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Bodily Pain ◽  
Care Group ◽  
Long Term Outcomes ◽  
Short Term Treatment ◽  
Randomised Controlled

Introduction There is growing evidence about the effectiveness of acupuncture in the short term treatment of chronic low back pain but little is known about long term outcomes. To address this question we followed up participants of a past randomised controlled trial of acupuncture to assess outcomes after 5.5 to 7 years. Methods A postal questionnaire assessing pain, quality of life, disability, experience with back pain and healthcare resource use was sent to all 239 participants of the York Acupuncture for Back Pain trial. Results Response to the survey was low at 43.9%. Pain measured by the SF-36 Bodily Pain dimension was maintained in the acupuncture group since the last follow up 3.5 to 5 years previously. The usual care group had improved over the intervening years and there was now no evidence of a difference between the groups (difference −0.4 points, 95% confidence interval −10.1 to 9.7). The results were unchanged on sensitivity analysis using multiple imputation. In both groups back pain had not completely resolved and worry about back health was moderate. Physiotherapy and acupuncture were used at similar rates for continuing treatment. Discussion We theorise that exposure to a short course of acupuncture speeds natural recovery from a back pain episode, but improvements plateau after two years. Acupuncture is often accessed privately for long term management of back pain but is rarely available within the health service. While our study methods were robust, the low response rate means that our findings should be interpreted with caution.

Using Moxibustion in Primary Healthcare to Correct Non-Vertex Presentation: A Multicentre Randomised Controlled Trial

2013 ◽  
Vol 31 (1) ◽  
pp. 31-38 ◽  
Author(s):  
Jorge Vas ◽  
José Manuel Aranda-Regules ◽  
Manuela Modesto ◽  
María Ramos-Monserrat ◽  
Mercedes Barón ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Primary Healthcare ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Acupuncture Point ◽  
Care Group ◽  
Moxibustion Group ◽  
Vertex Presentation ◽  
Randomised Controlled

Objective To compare the effectiveness of additional moxibustion at point BL67 with moxibustion at a non-specific acupuncture point and with usual care alone to correct non-vertex presentation. Methods This was a multicentre randomised controlled trial in which 406 low-risk pregnant women with a fetus in ultrasound breech presentation, with a gestational age of 33–35 weeks, were assigned to (1) true moxibustion at point BL67 plus usual care; (2) moxibustion at SP1, a non-specific acupuncture point (sham moxibustion) plus usual care; or (3) usual care alone. The primary outcome was cephalic presentation at birth. Women were recruited at health centres in primary healthcare. Results In the true moxibustion group, 58.1% of the full-term presentations were cephalic compared with 43.4% in the sham moxibustion group (RR 1.34, 95% CI 1.05 to 1.70) and 44.8% of those in the usual care group (RR 1.29, 95% CI 1.02 to 1.64). The reduction in RR of the primary outcome in women allocated to the true moxibustion group compared with the usual care group was 29.7% (95% CI 3.1% to 55.2%) and the number needed to treat was 8 (95% CI 4 to 72). There were no severe adverse effects during the treatment. Conclusions Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus. Trial Registration Current Controlled Trials ISRCTN10634508.

scholarly journals Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

2020 ◽  
Vol 17 (7) ◽  
pp. 2465
Author(s):  
Alfonso Javier Ibáñez-Vera ◽  
Jerónimo Carmelo García-Romero ◽  
José Ramón Alvero-Cruz ◽  
Rafael Lomas-Vega
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Sham Group ◽  
Controlled Trial ◽  
Depression Scale ◽  
Physical Factor ◽  
Control Group ◽  
Local Pain ◽  
Randomized Controlled ◽  
Experimental Group

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

Perioperative Multicomponent Interdisciplinary Program Reduces Delirium Incidence in Elderly Patients With Hip Fracture

2020 ◽  
pp. 107839032091525
Author(s):  
Xin Zhao ◽  
Wei Yuan
Keyword(s):  
Hip Fracture ◽  
Elderly Patients ◽  
Usual Care ◽  
Usual Care Group ◽  
Postoperative Delirium ◽  
Care Group ◽  
Interdisciplinary Program ◽  
Study Results ◽  
Experimental Group ◽  
Interdisciplinary Intervention

BACKGROUND: Delirium is common in elderly patients with hip fracture. Although several multicomponent care pathways have been developed, few nurse-led perioperative multicomponent programs have been evaluated. OBJECTIVES: The current study aimed to evaluate the effect of a nurse-led perioperative multicomponent interdisciplinary program in preventing postoperative delirium in elderly patients with hip fracture. METHOD: The participants in the usual care group were recruited from March 2012 to February 2013, and these in the experimental group were recruited from May 2013 to June 2014. The participants in the usual care group ( n = 174) received usual medical and nursing care from admission to hospital discharge and the participants in the experimental group ( n = 192) received the nurse-led perioperative multicomponent interdisciplinary intervention. The STROBE checklist was used to report this study. RESULTS: There were no statistical differences between the two cohorts in terms of the baseline data such as gender, age, fracture type, and so on. The experimental group had a lower incidence of delirium and postoperative hypoxia than the usual care group. No statistical differences in terms of delirium severity, delirium duration, and mean hospitalization length were observed. CONCLUSIONS: The nurse-led perioperative multicomponent interdisciplinary program described in the current study is feasible and effective in reducing the incidence of postoperative delirium in elderly patients with hip fracture.

scholarly journals Home-based Reach-to-Grasp training for people after stroke is feasible: a pilot randomised controlled trial

2016 ◽  
Vol 31 (7) ◽  
pp. 891-903 ◽  
Author(s):  
AJ Turton ◽  
P Cunningham ◽  
F van Wijck ◽  
HJM Smartt ◽  
CA Rogers ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Usual Care Group ◽  
Controlled Trial ◽  
Care Group ◽  
Reach To Grasp ◽  
Arm Pain ◽  
Home Based ◽  
Wolf Motor Function Test ◽  
Randomised Controlled

Objective: To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke. Design: single-blind parallel group RCT. Participants: Residual arm deficit less than 12 months post-stroke. Interventions: Reach-to-Grasp training in 14 one-hour therapist’s visits over 6 weeks, plus one hour self-practice per day (total 56 hours). Control: Usual care. Main Measures: Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation. Results: Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment. Conclusions: An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.

scholarly journals Acupuncture versus Usual Care for Postoperative Nausea and Vomiting in Children after Tonsillectomy/Adenoidectomy: A Pragmatic, Multicentre, Double-Blinded, Randomised Trial

2015 ◽  
Vol 33 (3) ◽  
pp. 196-203 ◽  
Author(s):  
Ingrid Liodden ◽  
Leiv Sandvik ◽  
Berit Taraldsen Valeberg ◽  
Einar Borud ◽  
Arne Johan Norheim
Keyword(s):  
Usual Care ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Care Group ◽  
Placebo Effects ◽  
Expectancy Effects ◽  
Double Blinded

Objectives To investigate the effect of a standardised acupuncture on nausea and vomiting in children after tonsillectomy with or without adenoidectomy when possible placebo effects were precluded. Methods A pragmatic, multicentre, double-blinded, randomised controlled trial. The study was conducted over 10 months in 2012–2013 at three ambulatory clinics. Two hundred and eighty-two children, age 1–11 years, American Society of Anesthesiologists grade ≤II, were included. To equalise expectancy effects, all parents were told that their child would receive acupuncture. However, children were randomly allocated to perioperative bilateral needling acupuncture at PC6, depth 7 mm, mean time 17 min (SD 5–45) during anaesthesia plus usual care, or to usual care only. The regional ethics committee approved this approach. Primary endpoints were nausea and vomiting 24 h postoperatively. Results This study did not demonstrate any effect of acupuncture (95% CI) compared with standard care. The overall vomiting in the acupuncture and usual-care groups was 44.2% and 47.9%, respectively. Nausea was experienced by 31.7% in the acupuncture group and by 32.6% in the usual-care group. The test power was acceptable for comparisons of vomiting. Conclusions The findings suggest that when controlling for possible placebo effects standardised PC6 acupuncture needling during anaesthesia without further stimulation of PC6 is not effective in reducing nausea and vomiting in children after tonsillectomy with or without adenoidectomy. Future studies should investigate acupuncture treatment which balances adequate dose and technique and a feasible, child-friendly acupuncture treatment. Trial Registration Number ClinicalTrials.gov NCT01729052.

scholarly journals Evaluating the Effects of 5-Hz Repetitive Transcranial Magnetic Stimulation With and Without Wrist-Ankle Acupuncture on Improving Spasticity and Motor Function in Children With Cerebral Palsy: A Randomized Controlled Trial

2021 ◽  
Vol 15 ◽  
Author(s):  
Jiamin Li ◽  
Cen Chen ◽  
Shenyu Zhu ◽  
Xiulian Niu ◽  
Xidan Yu ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Motor Function ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Muscle Tension ◽  
Spastic Cerebral Palsy ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Objective: The goal of this study is to explore the effect of wrist-ankle acupuncture combined with 5-Hz repetitive transcranial magnetic stimulation (rTMS) on improving spastic state and motor function of children with spastic cerebral palsy by measuring electrophysiological parameters and behaviors.Methods: Twenty-five children with spastic cerebral palsy were enrolled in a single-blind and randomized controlled trial. The control group received 20 sessions of 5-Hz rTMS over the affected hemisphere with 1,000 pulses. The experimental group was given wrist-ankle acupuncture on the basis of the control group. Gross motor function measure (GMFM-66), muscle tension, and electrophysiological parameters of the two groups were assessed at baseline and after intervention.Results: After treatment, the GMFM-66 scores in the same groups were significantly improved (p < 0.001). Besides, the R-value of soleus, gastrocnemius, and hamstring muscle decreased (p < 0.05), and the results showed a trend of shortening MEP latency, increasing amplitude and duration (p < 0.05). Compared to the controlled group, the experimental group displayed more excellent changes in the GMFM-66 scores and motor evoked potential (MEP) latency. The statistical results showed that the increase of GMFM-66 score and the shortening of MEP latency in the experimental group were greater than that in the control group (p < 0.05). However, no significant differences were found in the assessment of muscle tension, amplitude, and duration of MEPs between two groups (p > 0.05).Conclusion: Wrist-ankle acupuncture combined with 5-Hz rTMS is optimal to improve gross motor function and enhance the conductivity of corticospinal tract in children with cerebral palsy but cannot highlight its clinical superiority in improving spasticity.Clinical Trial Registration: [http://www.chictr.org.cn/index.aspx], identifier [chictr2000039495].

scholarly journals Doctor Referral of Overweight People to Low Energy total diet replacement Treatment (DROPLET): pragmatic randomised controlled trial

BMJ ◽  
2018 ◽  
pp. k3760 ◽  
Author(s):  
Nerys M Astbury ◽  
Paul Aveyard ◽  
Alecia Nickless ◽  
Kathryn Hood ◽  
Kate Corfield ◽  
...  
Keyword(s):  
Weight Loss ◽  
Usual Care ◽  
Usual Care Group ◽  
Practice Nurse ◽  
Controlled Trial ◽  
Care Group ◽  
Metabolic Risk ◽  
Behavioural Support ◽  
Total Diet ◽  
Randomised Controlled

Abstract Objective To test the effectiveness and safety of a total diet replacement (TDR) programme for routine treatment of obesity in a primary care setting. Design Pragmatic, two arm, parallel group, open label, individually randomised controlled trial. Setting 10 primary care practices in Oxfordshire, UK. Participants 278 adults who were obese and seeking support to lose weight: 138 were assigned to the TDR programme and 140 to usual care. 73% of participants were re-measured at 12 months. Interventions The TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months, with formula food products providing 810 kcal/day (3389 kJ/day) as the sole food during the first eight weeks followed by reintroduction of food. Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction. Main outcome measures The primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models. Secondary outcomes included biomarkers of cardiovascular and metabolic risk. Adverse events were recorded. Results Participants in the TDR group lost more weight (−10.7 kg) than those in the usual care group (−3.1 kg): adjusted mean difference −7.2 kg (95% confidence interval −9.4 to −4.9 kg). 45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more. The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group. 11% of participants in the TDR group and 12% in the usual care group experienced adverse events of moderate or greater severity. Conclusions Compared with regular weight loss support from a practice nurse, a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable, and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease. Trial registration International Standard Randomised Controlled Trials No ISRCTN75092026 .

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