- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03304769
Virtual Reality Distraction During Pediatric Intravenous Line Placement
Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study
연구 개요
상세 설명
Children often describe procedures involving needles as the most stressful portion of the hospital experience. 1,2 Many studies involving the perception of pain have highlighted the importance of attention for the perception of pain, and, conversely, the benefit of distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a number of different ways. 5,6 While small studies have demonstrated the use of VR to be effective in diminishing pain during intravenous (IV) placement for outpatient imaging in pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR during venipuncture and IV placement also frequently focus on self-reported or parent-reported pain, rather than objectively quantifying number of IV sticks and time to successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have not been well-established, with some studies citing benefits only in patients over 10 years of age, and others showing improvements in all age groups.7,9,10
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Austin, Texas, 미국, 78723
- 모병
- Dell Children's Medical Center of Central Texas
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연락하다:
- Matthew Wilkinson, MD
- 전화번호: 512-547-8362
- 이메일: mhwilkinson@ascension.org
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient aged 4-17 years
- Requiring IV placement
- Child Life unavailable
Exclusion Criteria:
- Previous enrollment in the study
- Physically/ developmentally unable to tolerate headset
- Skin/eye pathology
- Critically ill patient
- Language other than English or Spanish
- Student Nurse placing IV
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: IV placement no Virtual reality
Patient will have IV placed in traditional manner, with no virtual reality headset
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실험적: IV placement with Virtual Reality
Patient will have IV placed with Virtual Reality headset distraction
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Virtual Reality Headset applied to the patient during placement of IV.
Control is patient group without headset applied.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Successful IV placement with first attempt
기간: 6 months
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success in first attempt in VR group vs non VR group
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
number of attempts before successfully establishing IV
기간: 6 months
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number of attempts before successful IV placement in VR group vs non VR group
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6 months
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time to establishing successful IV
기간: 6 months
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time to establishing successful IV in VR group vs non VR group
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6 months
|
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Pre vs Post FACES revised pain scale parents
기간: 6 months
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Pre vs Post FACES pain scale in VR group vs non VR group
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6 months
|
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Pre vs Post FACES revised pain Scale patients
기간: 6 months
|
Pre vs Post FACES pain scale in VR group vs non VR group
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6 months
|
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Pre vs Post Likert-Type Anxiety Scale - parents
기간: 6 months
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Pre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group
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6 months
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Pre vs Post Likert-Type Anxiety Scale- patients
기간: 6 months
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Pre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group
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6 months
|
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age range of patients that tolerate VR
기간: 6 months
|
Which of evaluated age range of 4-17 years tolerate VR placement
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6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ASalinas
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
Pediatric IV Placement에 대한 임상 시험
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Peter SzmukLuminex Corporation; Outcomes Research Consortium완전한
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Virtual Reality에 대한 임상 시험
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Region Skane초대로 등록
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