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Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in children.

ABSTRACT: INTRODUCTION:Intravenous insertion (IVI) is a very common procedure in the emergency department (ED). IVI is often painful and stressful for both children and their families. Currently, distraction therapy is not used as a standard of care for IVI in North America. We propose that interaction with a humanoid robot may effectively distract children during IVI thereby reducing their pain and distress. METHODS AND ANALYSIS:This randomised controlled superiority trial will be conducted in a Canadian paediatric ED. We plan to recruit 80 patients. Children will be eligible if they (1) are 6 to 11 years of age, (2) need an IVI, (3) are fully conscious and alert, (4) have sufficient knowledge of the English language to understand and complete the study assessments and (5) are accompanied by a legal guardian. Our primary objective is to compare patient-reported pain and distress with the use of distraction (via a humanoid robot) versus standard care in children. The primary outcomes will be (1) self-reported pain, as measured by the Faces Pain Scale-Revised and (2) observed distress, as measured by the Observational Scale of Behavioural Distress-Revised. Secondary outcomes will include (1) measuring parental anxiety, (2) examining the association between parental anxiety and child outcomes and (3) children's degree of engagement with the humanoid robot via the Intrinsic Motivation Inventory tool. First enrolment occurred in April 2017 and is ongoing. ETHICS AND DISSEMINATION:This study has been approved by the Health Research Ethics Board (University of Alberta). Informed consent to participate will be obtained from all participants' parents/guardian, in conjunction with assent from the participant themselves. This study data will be submitted for publication regardless of results. Purchase of the robot was facilitated through a Stollery Children's Hospital Foundation donation. Recruitment costs are supported by the Women and Children's Health Research Institute. TRIAL REGISTRATION NUMBER:NCT02997631; Pre-results.

SUBMITTER: Ali S

PROVIDER: S-EPMC6303653 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in children.

Ali Samina S Sivakumar Mithra M Beran Tanya T Scott Shannon D SD Vandermeer Ben B Curtis Sarah S Jou Hsing H Hartling Lisa L

BMJ open 20181214 12

<h4>Introduction</h4>Intravenous insertion (IVI) is a very common procedure in the emergency department (ED). IVI is often painful and stressful for both children and their families. Currently, distraction therapy is not used as a standard of care for IVI in North America. We propose that interaction with a humanoid robot may effectively distract children during IVI thereby reducing their pain and distress.<h4>Methods and analysis</h4>This randomised controlled superiority trial will be conducte ...[more]

PMID: 30552264

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Project description:IntroductionInterventions using robot-assisted therapy may be beneficial for the social skills development of children with autism spectrum disorder (ASD); however, randomised controlled trials (RCTs) are lacking. The present research aims to assess the feasibility of conducting an RCT evaluating the effectiveness of a social skills intervention using Kinesics and Synchronisation in Personal Assistant Robotics (Kaspar) with children with ASD.Methods and analysisForty children will be recruited. Inclusion criteria are the following: aged 5-10 years, confirmed ASD diagnosis, IQ over 70, English-language comprehension, a carer who can complete questionnaires in English and no current participation in a private social communication intervention. Children will be randomised to receive an intervention with a therapist and Kaspar, or with the therapist only. They will receive two familiarisation sessions and six treatment sessions for 8?weeks. They will be assessed at baseline, and at 10?and 22?weeks after baseline. The primary outcome of this study is to evaluate whether the predetermined feasibility criteria for a full-scale trial are met. The potential primary outcome measures for a full-scale trial are the Social Communication Questionnaire and the Social Skills Improvement System. We will conduct a preliminary economic analysis. After the study has ended, a sample of 20 participants and their families will be invited to participate in semistructured interviews to explore the feasibility and acceptability of the study's methods and intervention.Ethics and disseminationParents/carers will provide informed consent, and children will give assent, where appropriate. Care will be taken to avoid pressure or coercion to participate. Aftercare is available from the recruiting NHS Trust, and a phased withdrawal protocol will be followed if children become excessively attached to the robot. The results of the study will be disseminated to academic audiences and non-academic stakeholders, for example, families of children with ASD, support groups, clinicians and charities.Trial registration numberISRCTN registry (ISRCTN14156001); Pre-results.

Project description: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.

Project description:IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023.

Project description:IntroductionVirtual reality (VR) offers an innovative method to deliver non-pharmacological pain management. Distraction-based VR (VR-D) using immersive games to redirect attention has shown short-term pain reductions in various settings. To create lasting pain reduction, VR-based strategies must go beyond distraction. Guided relaxation-based VR (VR-GR) integrates pain-relieving mind-body based guided relaxation with VR, a novel therapy delivery mechanism. The primary aim of this study is to assess the impact of daily VR-GR, VR-D and 360 video (passive control) on pain intensity. We will also assess the impact of these interventions on pain unpleasantness, anxiety and opioid and benzodiazepine consumption. The secondary aim of this study will assess the impact of psychological factors (anxiety sensitivity and pain catastrophising) on pain following VR.Methods and analysisThis is a single centre, prospective, randomised, clinical trial. Ninety children/adolescents, aged 8-18 years, presenting for Nuss repair of pectus excavatum will be randomised to 1 of 3 study arms (VR-GR, VR-D and 360 video). Patients will use the Starlight Xperience (Google Daydream) VR suite for 10 min. Patients randomised to VR-GR (n=30) will engage in guided relaxation/mindfulness with the Aurora application. Patients randomised to VR-D (n=30) will play 1 of 3 distraction-based games, and those randomised to the 360 video (n=30) will watch the Aurora application without audio instructions or sound. Primary outcome is pain intensity. Secondary outcomes include pain unpleasantness, anxiety and opioid and benzodiazepine consumption.Ethics and disseminationThis study follows Standard Protocol Items: Recommendations for Interventional Trials guidelines. The protocol was approved by the Cincinnati Children's Hospital Medical Center's institutional review board. Patient recruitment began in July 2020. Written informed consent will be obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals.Trial registration numberNCT04351776.

Project description:BackgroundVenipuncture is one of the most painful and distressing procedure experienced by pediatric patients. Evidence suggests that distraction combined with age-appropriate procedural information can effectively decrease procedural pain and anxiety in pediatric patients. Immersive virtual reality (IVR) can simultaneously provide complete distraction and procedural information to patients.MethodsGuided by the gate control theory and Lazarus and Folkman's theory, this study aims to examine the effects of IVR intervention on reducing the pain, anxiety and stress, the duration of venipuncture, and the satisfaction of healthcare providers for the procedure. A randomized controlled trial with repeated assessments will be conducted. A total of 200 pediatric patients aged 4-12?years will be recruited from a regional public hospital and randomly assigned to either the intervention or control group. The study will use two age-appropriate IVR modules that consist of procedural information. The intervention group will receive IVR intervention, whereas the control group will receive standard care only. The cost-effectiveness of IVR intervention will be compared with that of standard care. Outcome evaluation will be conducted at four time points: 10?min before, during, immediately after, and 30?min after the procedure. Intention to treat and generalized estimating equation model will be used to analyze the data.DiscussionThis study is the first of its kind to adopt IVR intervention with age-appropriate procedural information for pediatric patients undergoing venipuncture. Findings of the proposed study may: (1) provide a novel, facile, and cost-effective intervention that can be used virtually at any time and place to manage pain and anxiety; and (2) shed light on the global trends of research and clinical development of IVR as an intervention for other painful and stressful medical procedures.Trial registrationChinese Clinical Trial Registry, ChiCTR1800018817 . Registered on 11 October 2018.

Project description:BACKGROUNDIn recent years, the number of arthroscopic shoulder surgeries has increased given that the intervention is minimally invasive. However, postoperative pain is one of the most common symptoms of patients who undergo arthroscopic surgery. Although pharmacological treatments and brachial plexus blocks for reducing pain are currently used, the adherence rate of interventions is low, and adverse effects often occur. Chimsband, made up of silver and optic fibres, is a novel taping therapy that stimulates patients' acupoints and is expected to relieve pain with few adverse effects. The aim of this study is to explore the effectiveness of Chimsband to relieve pain following arthroscopic shoulder surgery.METHODS/DESIGNThis is a randomised, parallel, controlled, exploratory clinical trial. Thirty participants who undergo arthroscopic shoulder surgery will be randomly allocated to an intervention or a control group. Both groups will receive 10 sessions of interferential current therapy within a period of 2 weeks, while the intervention group will additionally receive taping therapy after undergoing physical therapy. Two follow-up visits will be scheduled after the last treatment session. The primary outcome variable will be the difference in the visual analogue scale (VAS) scores between baseline and first follow-up evaluation after the end of 10 treatment sessions. The secondary outcomes will be VAS at the end of the second week, shoulder pain and disability index, range of motion, VAS while sleeping, questionnaire of blood stasis pattern identification at two follow-up visits, and number of bands used per visit. Outcomes will be evaluated at baseline, 2 weeks from visit 1 (+ within 6 days) after commencement, and at 4 weeks from visit 1 (+ within 6 days) follow-up.DISCUSSIONThis study will be the first clinical trial to explore the effect and safety of Chimsband on postoperative shoulder pain. It would provide clinical evidence to conduct further taping therapy studies for relieving musculoskeletal pain.TRIAL REGISTRATIONKorean Clinical Trial Registry, KCT0002355 . Registered on 13 June 2017.

Project description:INTRODUCTION:Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS:The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION:This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER:ACTRN12617001288314.

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Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in children.

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Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in children.

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