Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department
2019년 10월 7일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
58
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G 1X8
- Hospital for Sick Children
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
8년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Pain Intensity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment log
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 2월 1일
기본 완료 (실제)
2019년 9월 30일
연구 완료 (실제)
2019년 9월 30일
연구 등록 날짜
최초 제출
2018년 1월 19일
QC 기준을 충족하는 최초 제출
2018년 2월 9일
처음 게시됨 (실제)
2018년 2월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 7일
마지막으로 확인됨
2019년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Virtual Reality Program에 대한 임상 시험
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Region Skane초대로 등록
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Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)모병
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Emrah AyAtaturk University; Prof. Dr. Mağfiret Kaşıkçı완전한
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Children's Hospital Medical Center, CincinnatiNational Institute of Mental Health (NIMH)완전한
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The Hospital for Sick Children모집하지 않고 적극적으로
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Sakarya UniversityThe Scientific and Technological Research Council of Turkey아직 모집하지 않음
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Chang Gung University of Science and Technology아직 모집하지 않음
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Hospital Universitari Vall d'Hebron Research Institute알려지지 않은