Virtual Reality for Pain Management Study
2021년 6월 1일 업데이트: Mark B. Powers, University of Texas at Austin
Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective means of decreasing pain levels following treatment, and for significant periods of time.
Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity associated with pain.
While VR is clearly a promising, drug-free option for pain treatment, existing VR systems are expensive and use unconvincing graphics.
Recent advances in VR technology (i.e., improved realism and immersion using 360-degree 3D technology and more affordable delivery systems) allow the development of more realistic and more cost-effective applications.
Capitalizing on these advances and the investigators' experiences with VR intervention development and evaluation, the current study will test a state-of-the-art VR experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and compare it to established standard computer generated imagery (CGI) 360° VVR content for pain management intervention in a medical setting.
The participant's participation will help the investigators determine which VR intervention is most effective in reducing acute pain in hospital patients.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
103
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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Texas
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Austin, Texas, 미국, 78712
- University of Texas at Austin
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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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Between the ages of 18 and 65
- Reports experiencing current pain not typical of day-to-day experience during Pre-Treatment Pain Questionnaire at the onset of study visit by answering "Yes" to the first question of the questionnaire. There is no specific threshold of how much pain the participant must be in to be eligible for this study. The participant must be experiencing current pain that is not related to day-to-day, normal experiences (such as minor headaches, sprains, and toothaches).
- Scores a 15 on the Glasgow Coma Scale and a 7 or above on the abbreviated Mini Mental Status Exam.
- Patient in the acute and critical palliative care units, post surgical units, or acute care orthopedic units at University Medical Center Brackenridge in Austin, TX.
- Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.
Exclusion Criteria:
- Hearing or visually impaired where participant cannot use the Samsung Gear VR.
- Does not report experiencing current pain during Pre-Treatment Pain Questionnaire at the onset of study visit.
- Scores below a 15 on the Glasgow Coma Scale and/or below a 7 on the abbreviated Mini Mental Status Exam
- Limited mental competency and the inability to give informed, voluntary, written consent to participate.
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: Live-Action 360° Video Virtual Reality
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360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event.
Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD).
Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event.
Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video.
The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
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활성 비교기: CGI 360° Video Virtual Reality
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Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display.
Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
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간섭 없음: Waitlist
Participants randomized to the waitlist group will complete all study procedures except the VR exposure.
After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Post-Treatment Pain Questionnaire
기간: Immediately following intervention
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The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment.
It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad.
Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine.
Pain is current
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Immediately following intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Follow-Up Pain Questionnaire
기간: Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
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The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment.
It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad.
Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine.
Pain is current
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Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
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Presence Inventory
기간: Immediately following intervention
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Self-report measure that assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention.
Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree.
Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence.
Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity.
Higher for these two subscales indicate a better outcome.
Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects.
Higher scores for this subscale indicate a worse outcome.
Questions on the scale are summed.
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Immediately following intervention
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Absorption Survey
기간: Immediately after intervention
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Self-report measure that assesses participant engagement with the virtual world.
Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree.
There are 12 questions with a total score of 120.
Higher scores indicate a better outcome and increased participant engagement.
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Immediately after intervention
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Present Mood Questionnaire
기간: Every 10 minutes for 40 minutes following intervention
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The Present Mood Questionnaire was used to assess the participant's current mood.
The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil.
It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden.
Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.
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Every 10 minutes for 40 minutes following intervention
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Attitudes Toward the Experience Survey
기간: Immediately after intervention
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Self-report measure that assesses the participant's attitude toward the VR experience.
Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree.
There are 12 questions for a total score of 120.
Higher scores mean a more positive attitude towards the experience and is a better outcome.
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Immediately after intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mark Powers, Ph.D., University of Texas at Austin
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 1월 1일
기본 완료 (실제)
2018년 7월 1일
연구 완료 (실제)
2018년 7월 1일
연구 등록 날짜
최초 제출
2016년 12월 15일
QC 기준을 충족하는 최초 제출
2016년 12월 15일
처음 게시됨 (추정)
2016년 12월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 6월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 6월 1일
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. .