Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department
2019年10月7日 更新者：Jennifer Stinson、The Hospital for Sick Children
Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department: A Feasibility Pilot Study
Venipuncture and intravenous (IV) access continue to be the most common causes of pain and distress among children in the pediatric emergency department.
Virtual reality has been successful for reducing pain and fear in many clinical scenarios, including port access in oncology patients, anxiety disorders, phobias, burn and wound care and others.
There is only one previous study examining virtual reality distraction to reduce procedural pain during IV insertion in pediatric patients and no previous studies examining this in the emergency department setting.
In this study, the investigators will compare immersive virtual reality (an interactive underwater environment) to the current standard (tablet device/iPad playing a movie) for distraction to reduce procedural pain during IV insertion.
The investigators hypothesize that the immersive quality of the virtual reality will reduce patient's pain scores, fear scores and tachycardia during and after the procedure, and have minimal effect on departmental flow and nursing satisfaction.
If this feasibility pilot study yields positive results, the investigators plan to expand to a larger randomized control trial.
研究概览
详细说明
This study is a pilot randomized control trial that aims to (a) to determine the differences in self-reported and proxy-reported pain and fear during IV insertion between the interactive VR intervention and control group, and (b) to assess the feasibility (safety, acceptability) of the VR intervention to children/families and the healthcare team in the pediatric emergency department.
The study will consist of two study arms, where both study arms will be screened and recruited using the same procedure.
Participants will be randomized into either (1) Control group: child life specialist plays an age-appropriate video on a tablet device, or (2) Intervention (VR Distraction): child life specialist facilitates immersive VR experience.
Both the intervention and control groups will receive standard medical care (e.g., topical anesthetics).
A convenience sample of 80 children and adolescents with cancer (40 participants per treatment arm; 20 boys and 20 girls per treatment arm) will be recruited.
In addition to usual care, children in the experimental condition will wear the VR headset plus headphones.
In the control condition, children will watch a video (i.e., an age-appropriate video selected by an emergency department affiliated child life specialist) on an iPad, while wearing the same headphones as in the experimental condition.
Implementation outcomes include accrual and retention rates, acceptability and technical difficulties.
Effectiveness outcomes include child pain, distress, and fear, as well as parent distress.
研究类型
介入性
注册 (实际的)
58
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G 1X8
- Hospital for Sick Children
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria will be:
- aged 8-17 years
- able to speak and understand English
- parent/guardian present
- medically stable (CTAS 2, 3, 4 or 5; IV insertion +/-20 minutes will not impact the safety of the patient according to treating medical team)
- requires IV insertion
Exclusion criteria will be:
- visual, auditory or cognitive impairments precluding interaction with the VR intervention or reporting pain and fear
- psychiatric conditions that could be exacerbated by the VR environment (i.e. hallucinations)
- skin, face or ear infections or injuries, which could contaminate the intervention equipment
- medically unstable (CTAS 1; patient requires immediate IV insertion)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention Group (VR)
The patient will be allowed to 'try-out' the VR system (including all auditory and visual features) for ~5 minutes prior to the start of the procedure.
In addition to usual care, consisting of child-life presence and topical analgesics if ordered by the treating medical team, children in the experimental condition will wear the VR HMD plus headphones and hold the VR controller.
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VR with head mounted display (HMD) and headphones.
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有源比较器：Control Group (Standard Care - Video)
The patient will be allowed to watch an age-appropriate video on a tablet device.
The patient will be offered to wear the same headphones as in the experimental condition.
The patient will have the tablet and headphones for ~5 minutes prior to the start of the procedure.
In addition, the patient will receive standard care consisting of a child life specialist and topical analgesics (if ordered by the treating medical team).
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iPad with headphones
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Pain Intensity
大体时间：Baseline, 30 minutes after baseline
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Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their pain and parents, nurses and the researcher will report children's pain BOTH prior to and following the procedure.
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Baseline, 30 minutes after baseline
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Change in Child Distress
大体时间：Baseline, 30 minutes after baseline
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Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their distress and parents, nurses and the researcher will report children's distress BOTH prior to and following the procedure
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Baseline, 30 minutes after baseline
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Change in Child Fear
大体时间：Baseline, 30 minutes after baseline
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Children will report fear BOTH prior to and following the procedure using the Child Fear Scale (CFS) which is a 5-face visual scale that measures fear intensity and is validated in children as young as 5 years.
It consists of a 1-question scale rating fear from 0 - 4, based on the faces provided.
A higher number represents higher fear intensity.
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Baseline, 30 minutes after baseline
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Child Pain Catastrophizing
大体时间：Baseline
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Children will report baseline tendencies to catastrophize about pain using the Pain Catastrophizing Scale - Child (PCS-C).
This is a self-report measure of children's tendency to catastrophize about pain validated in children 8-18 years of age.
6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher pain catastrophizing.
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Baseline
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Parent Pain Catastrophizing
大体时间：Baseline
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Parents will report baseline tendencies to catastrophize about their child's pain using the Pain Catastrophizing Scale - Parent (PCS-P), which is a self-report measure of parents' tendency to catastrophize about their child's pain validated in parents of children 8-18 years of age.
6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher parental pain catastrophizing of their child's pain.
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Baseline
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Parent Distress
大体时间：30 minutes after baseline measures are completed
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Parents will report on their own level of distress following the child's procedure using the Parent Distress Questionnaire.
This measure consists of 4-items responded to on an 11-point numeric rating scale from 0 ("not at all") to 10 ("extremely").
A higher number value represents higher distress levels.
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30 minutes after baseline measures are completed
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Child Presence Measure
大体时间：30 minutes after baseline measures are completed
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This child self-report measure assesses effectiveness of the immersive aspect of the VR toolkit/iPad using 12 questions, a choice of three answers ("no", "a little", and "a lot").
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30 minutes after baseline measures are completed
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment log
大体时间：through study completion, an average of 1 year
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Using an investigator-generated recruitment log, accrual rates will be measured by counting the number eligible children per recruitment day, participants enrolled, reasons for ineligibility, reasons for non-participation and reasons for study attrition.
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through study completion, an average of 1 year
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Acceptability
大体时间：30 minutes after baseline measures are completed
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Measured using the VR Distraction Satisfaction Questionnaire completed by children, parents and nurses and will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.
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30 minutes after baseline measures are completed
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Outcome measure feasibility
大体时间：through study completion, an average of 1 year
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Will be measured as the percentage of completed outcome measures at baseline and study completion and will be recorded on the VR Distraction Activity Log.
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through study completion, an average of 1 year
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Technical Difficulties Log
大体时间：through study completion, an average of 1 year
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Using an investigator-generated technical difficulties log, researchers will record data related to technical difficulties associated with the VR intervention, observed difficulties in implementing the trial protocol in the clinic and time to complete IV needle insertion.
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through study completion, an average of 1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年2月1日
初级完成 (实际的)
2019年9月30日
研究完成 (实际的)
2019年9月30日
研究注册日期
首次提交
2018年1月19日
首先提交符合 QC 标准的
2018年2月9日
首次发布 (实际的)
2018年2月19日
研究记录更新
最后更新发布 (实际的)
2019年10月9日
上次提交的符合 QC 标准的更新
2019年10月7日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Virtual Reality Program的临床试验
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Southern Methodist UniversityKing's College London完全的
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IRCCS Eugenio Medea招聘中
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Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de Barcelona招聘中
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Leiden University Medical CenterUMC Utrecht邀请报名
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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Hospital Universitari Vall d'Hebron Research Institute主动，不招人