- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04942561
VR to Reduce Pain/Anxiety During IV Starts
2021년 6월 28일 업데이트: Jeffrey I Gold, PhD, Children's Hospital Los Angeles
Effect of Immersive Virtual Reality on Pain and Anxiety in Pediatric Peripheral Intravenous Catheter Access: A Randomized Clinical Trial
This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center at CHLA, as measured by self- and proxy-report.
연구 개요
상세 설명
Distraction is a form of non pharmacological intervention for reducing pain and anxiety in children during painful medical procedures (e.g., venipuncture, IV placement).
Recent technological developments in the area of virtual reality (VR) provide new and potentially more effective ways of distracting children from the pain and anxiety associated with medical procedures.
While initial studies of VR pain distraction are promising, few have studied the effectiveness of the technology in children, using a multi-method approach.
The current study aims to recruit 115 children ages 10-21 years and their caregivers who arrive at the hospital for peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center.
Children and their parents will be randomly assigned to one of two treatment conditions: 1) existing hospital standard of care or 2) standard of care plus distraction via VR.
Children and caregivers will be asked to complete measures assessing pain and anxiety both before and after the procedure.
In addition, objective measures of child pain and distress during the PIVC access will be taken using coding of behavioral/verbal expressions.
Univariate Analysis of Variance (ANOVA) will be used to compare differences in primary and secondary outcome variables in VR + standard of care to standard of care only conditions when pre and post-operative measures are available.
Univariate ANOVA will be used to compare conditions on post-operative variables.
연구 유형
중재적
등록 (실제)
107
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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California
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Los Angeles, California, 미국, 90027
- Children's Hospital Los Angeles
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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
10년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria for Children:
- Children who are 10-21 years old
- Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
- Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.
- Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.
Inclusion criteria for healthcare providers:
- Healthcare providers must be 18 years old or older
- Healthcare providers must be Children's Hospital Los Angeles staff
- Healthcare providers may participate if they have witnessed and/or administered the medical procedure
Exclusion Criteria:
- Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.
- Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
- Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
- Children with a history of seizure disorder.
- Children currently sick with flu-like symptoms or experiencing a headache or earache.
- Children with known or suspected motion sickness
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Standard of Care (No VR) Randomization
In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for PIVC placement (i.e., a topical numbing spray and Buzzy® Bee, a vibrating device placed near the PIVC site for pain distraction).
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실험적: VR Randomization
Children in the VR condition will undergo the invasive procedure while distracted by interaction with an immersive virtual environment (VE) presented via a head mounted display (HMD).
The intervention group will receive standard CHLA treatment with VR distraction.
Patients began gameplay <5 minutes before their PIVC placement and concluded after successful vascular access.
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Participants 13 -21 years old can use the Samsung Gear VR.
The VE is mobile based (Samsung with the Gear VR) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image.
Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears.
The VR game is equipped with a head-tracking system, enabling the player to look around the VE.
Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience.
While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased.
The VR glasses will be sanitized before every use to minimize chance of infection.
Participants 10-21 years can use the Merge.
The VE to be used in this study is mobile based (Pixel with the Merge) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image.
Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears.
The VR game is equipped with a head-tracking system, enabling the player to look around the VE.
Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience.
While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased.
The VR glasses will be sanitized before every use to minimize chance of infection.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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얼굴 통증 척도 수정(FPS-R)
기간: 시술 약 5분~1시간 전
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Revised는 Wong-Baker Faces Pain Rating Scale의 업데이트된 버전으로, 원래 척도의 웃는 얼굴과 비교하여 통증 없음을 중립적 표현으로 묘사합니다.
아이에게 고통 때문에 현재 느끼는 감정을 묘사한 얼굴 만화를 가리키도록 요청합니다.
안면 측정은 통증 강도를 측정하는 것으로 생각되며 Wong-Baker Faces 측정은 우수한 신뢰성과 타당성을 입증했습니다.
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시술 약 5분~1시간 전
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Visual Analogue Scale (VAS)
기간: Approximately 5 minutes to one hour before procedure
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The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task.
The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top.
Prior research used the VAS to rate anticipatory anxiety and pain in children
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Approximately 5 minutes to one hour before procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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아동기 불안 민감도 지수(CASI)
기간: 시술 약 5분~1시간 전
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이 18개 항목 측정은 3점 리커트 척도(없음(1), 약간(2), 많이(3))를 사용하여 환자가 불안 증상을 얼마나 부정적으로 보는지 평가합니다.
항목은 더 높은 불안 감도를 나타내는 더 높은 점수로 합산됩니다.
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시술 약 5분~1시간 전
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Gold & Rizzo Immersion/Presence (GRIP) Inventory
기간: Approximately 5 minutes to one hour before procedure
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Gold & Rizzo Immersion/Presence (GRIP) Inventory is a Child Presence Questionnaire was developed out of a content analysis of the entire domain of adult presence items and selection and adaptation of appropriate items for assessing the child's sense of believability of their experience.
This 16-item measure is verbally administered to children and asks them to respond according to a 3-point Likert-like format.
Items assess the child's sense of involvement, realism, and transportation into the experience.
Patients in the VR condition will complete the Child Presence Questionnaire post-procedure to assess level of VR immersion.
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Approximately 5 minutes to one hour before procedure
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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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)
2017년 4월 12일
기본 완료 (실제)
2019년 7월 24일
연구 완료 (실제)
2019년 7월 24일
연구 등록 날짜
최초 제출
2021년 6월 18일
QC 기준을 충족하는 최초 제출
2021년 6월 18일
처음 게시됨 (실제)
2021년 6월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 7월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 6월 28일
마지막으로 확인됨
2021년 6월 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. .