Operation Calm: VR Nature-Based Mindfulness to Reduce Pediatric Surgical Anxiety
2026년 8월 11일 업데이트: Brandon Benchimol-Elkaim, McGill University
Operation Calm is a pilot randomized controlled trial investigating the feasibility, acceptability, and preliminary effectiveness of a virtual reality (VR) nature-based mindfulness intervention for reducing preoperative anxiety in children and adolescents aged 10-17 years undergoing surgery.
Participants are randomly assigned to either a VR mindfulness condition, which combines immersive 360° nature environments with guided mindfulness exercises, or a standard mindfulness control condition.
The study also examines changes in trait mindfulness, wellbeing, and nature connectedness, while monitoring participant engagement and tolerability.
Findings will help determine whether VR-enhanced mindfulness is a practical and promising approach for supporting youth facing surgical procedures and will inform the design of future larger-scale clinical trials.
연구 개요
상태
상태
빼는
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Operation Calm is a research study exploring whether virtual reality (VR) can help reduce anxiety in children and adolescents before surgery. Many young people experience significant worry, fear, or stress while preparing for a medical procedure, which can affect both their emotional wellbeing and their overall healthcare experience.
The study evaluates a novel VR mindfulness intervention designed for youth aged 10 to 17 years. Participants are randomly assigned to one of two groups: a VR-based mindfulness program or a standard mindfulness program. The VR intervention combines immersive 360-degree nature environments, such as forests, beaches, and underwater scenes, with guided mindfulness exercises that encourage relaxation, focused attention, and awareness of the present moment.
Researchers will examine whether the VR experience is feasible to deliver in a hospital setting, whether participants find it enjoyable and acceptable, and whether it shows promise for reducing anxiety before surgery. The study will also explore potential benefits for mindfulness, wellbeing, and feelings of connection to nature.
By investigating innovative and engaging ways to support young patients, Operation Calm aims to improve the surgical experience for children and adolescents and contribute to the development of accessible, evidence-based mental health supports within pediatric healthcare settings.
연구 유형
연구 유형
중재적
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Brandon Benchimol-Elkaim
- 전화번호: 5147154402
- 이메일: brandon.benchimol-elkaim@mail.mcgill.ca
연구 장소
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Montreal, 캐나다
- 모병
- Shriners Hospital for Children - Canada
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연락하다:
- Argerie Tsimicalis
- 이메일: argerie.tsimicalis@mcgill.ca
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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
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Pediatric patients aged 10-17 years.
- Ability to use Virtual Reality (VR) equipment, including wearing VR goggles and following mindfulness program instructions.
- No reported experience with a VR-MBI intervention for anxiety reduction.
- Sufficient proficiency in English or French to understand and follow the VR mindfulness program, complete study-related questionnaires/forms.
Exclusion Criteria:
- Participant being screened report cognitive or physical impairments that limit the ability to participate in mindfulness exercises or use VR technology (self or parent-report).
- Participant being screened reports severe psychiatric conditions or use of medications that significantly alter anxiety levels (as assessed using the Youth Pediatric Symptom Checklist (self or parent-report).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Virtual reality condition
This arm will receive the virtual reality intervention
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Operation Calm is a virtual reality (VR) nature-based mindfulness intervention for youth aged 10-17 years awaiting surgery.
Participants engage in brief (<10 minute) immersive 360° nature experiences (e.g., forests, beaches, underwater environments) paired with guided mindfulness exercises focused on breathing, grounding, sensory awareness, and reflection on sources of calm and safety.
The intervention is specifically designed for use in pediatric surgical settings and aims to enhance engagement with mindfulness through immersive VR technology.
Participants in the control condition receive comparable mindfulness activities without the use of VR.
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간섭 없음: Control group
This arm receives the standard of care from the hospital
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Preoperative Anxiety
기간: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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Measured using the Preoperative Anxiety Scale (PAS).
Anxiety levels will be assessed before and after the intervention to evaluate the effect of the VR mindfulness program on preoperative anxiety in youth undergoing surgery.
The Pediatric Anxiety Scale is a self-report measure of state anxiety.
Total scores range from 0 to 100, with higher scores indicating greater anxiety (i.e., a worse outcome).
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From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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State-Trait Anxiety Inventory for Children (STAIC)
기간: From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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State-Trait Anxiety Inventory for Children (STAIC), State Anxiety Scale: A self-report questionnaire that assesses current ("state") anxiety.
Scores range from 20 to 60, with higher scores indicating greater state anxiety (worse outcome).
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From baseline immediately before the intervention to immediately following the intervention, prior to surgery.
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Current Pain and Anxiety Scale (CPAS)
기간: From immediately before each intervention session to immediately after each intervention session.
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Current Pain and Anxiety Scale: A self-report numeric rating scale used to assess participants' current pain and current anxiety.
Pain and anxiety are each rated separately on a scale from 0 to 10, where 0 indicates no pain/anxiety and 10 indicates the worst possible pain/anxiety.
Higher scores indicate greater pain or anxiety (worse outcomes).
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From immediately before each intervention session to immediately after each intervention session.
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Child and Adolescent Mindfulness Measure (CAMM)
기간: From baseline prior to the intervention to up to 4 weeks following surgery.
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Child and Adolescent Mindfulness Measure (CAMM): A 10-item self-report questionnaire that assesses trait mindfulness in children and adolescents.
Total scores range from 0 to 40, with higher scores indicating greater mindfulness (better outcome).
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From baseline prior to the intervention to up to 4 weeks following surgery.
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Stirling Children's Well-being Scale (SCWBS)
기간: From baseline prior to the intervention to up to 4 weeks following surgery.
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Stirling Children's Well-being Scale (SCWBS): A 15-item self-report questionnaire that assesses psychological well-being in children and adolescents.
Total scores range from 15 to 75, with higher scores indicating greater psychological well-being (better outcome).
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From baseline prior to the intervention to up to 4 weeks following surgery.
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Nature Connectedness Index (NCI)
기간: From baseline prior to the intervention to up to 4 weeks following surgery.
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Nature Connection Index (NCI): A self-report questionnaire that assesses an individual's subjective sense of connectedness with the natural world.
Total scores range from 0 to 100, with higher scores indicating greater nature connectedness (better outcome).
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From baseline prior to the intervention to up to 4 weeks following surgery.
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Intervention completion rate
기간: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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The proportion of participants randomized to the intervention who complete at least one virtual reality mindfulness session before surgery.
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From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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Acceptability of the virtual reality mindfulness intervention measured by the Acceptability Questionnaire
기간: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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Participant-rated acceptability of the intervention will be assessed using a post-intervention survey questionnaire about participants' experience.
Qualitative data will be obtained.
This is a custom-made questionnaire for this study.
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From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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Simulator sickness measured by the Pediatric Simulator Sickness Questionnaire (Peds SSQ)
기간: From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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Pediatric Simulator Sickness Questionnaire (Peds SSQ): A self-report questionnaire assessing simulator sickness symptoms following virtual reality exposure.
Total scores range from 0 to 90, with higher scores indicating greater simulator sickness (worse tolerability).
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From enrollment through completion of the final study assessment, up to 4 weeks following surgery.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
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)
연구 시작
2026년 3월 10일
기본 완료 (추정된)
기본 완료
2026년 12월 1일
연구 완료 (추정된)
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2026년 12월 1일
연구 등록 날짜
최초 제출
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처음 게시됨 (실제)
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2026년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
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마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- MMRL Operation Calm
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .