A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology. (HYPNO-VR)
Patients undergoing interventional radiology procedures frequently experience significant anxiety and procedural pain despite standard care. Virtual reality (VR) has emerged as a promising non-pharmacological tool for anxiety and pain reduction in various medical settings.
The HYPNO-VR study is a prospective randomized controlled trial designed to evaluate the effect of immersive virtual reality during interventional radiology procedures. Participants will be randomized in a 1:1 ratio to either a virtual reality group or a standard care control group.
The primary objective is to assess the impact of VR on procedural anxiety and pain using validated anxiety questionnaires (State-Trait Anxiety Inventory, STAI) and a numerical pain rating scale.
Secondary and exploratory objectives include assessment of patient satisfaction, operator experience, procedural duration, analgesic use, and feasibility of VR integration in interventional radiology practice.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Interventional radiology procedures are frequently associated with significant procedural anxiety and pain, which may negatively affect patient experience, cooperation during the procedure, and overall procedural conditions. Although pharmacological analgesia and anxiolysis are commonly used, non-pharmacological approaches aimed at improving patient comfort are increasingly being explored.
Immersive virtual reality (VR) has demonstrated promising effects on anxiety and pain reduction in several medical and surgical settings. By providing immersive audiovisual stimulation and distraction, VR may reduce the emotional and sensory perception associated with stressful medical procedures. However, data regarding its use in interventional radiology remain limited.
The HYPNO-VR study is a prospective randomized controlled monocentric study evaluating the impact of immersive virtual reality during interventional radiology procedures performed under local anesthesia.
Eligible adult patients undergoing an interventional radiology procedure will be randomized in a 1:1 ratio to either :
- a virtual reality group receiving immersive VR during the procedure in addition to standard care ;
- or a control group receiving standard care alone.
The primary objective is to evaluate the effect of VR on procedural anxiety and pain. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-Y), including trait anxiety assessment before the procedure and state anxiety assessment immediately before and after the procedure. Procedural pain will be evaluated using a numerical rating scale.
Secondary and exploratory objectives include evaluation of patient satisfaction, operator experience, procedural duration, analgesic use during the procedure, and feasibility of VR integration into routine interventional radiology practice.
The study aims to assess whether immersive VR may represent a simple, feasible, and effective complementary tool to improve patient experience during interventional radiology procedures.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Lise Laclautre
- 전화번호: 0473754963
- 이메일: promo_interne_drci@chu-clermontferrand.fr
연구 장소
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Clermont-Ferrand, 프랑스
- CHU clermont-ferrand
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수석 연구원:
- Pascal Chabrot
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연락하다:
- Lise Laclautre
- 전화번호: 0473754963
- 이메일: promo_interne_drci@chu-clermontferrand.fr
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria :
- Age ≥18 years.
- Scheduled to undergo an interventional radiology procedure performed under local anesthesia without sedation.
- Affiliation to a health insurance system.
- Received complete information about the study and provided written informed consent.
- Ability to understand the study information and complete the questionnaires.
Exclusion Criteria :
- Refusal to participate or withdrawal of consent.
- Patients under legal protection preventing valid informed consent according to regulatory requirements.
- Inability to understand study-related information or to use the virtual reality device due to severe visual, auditory, or cognitive impairment, as clinically assessed by the investigator.
- History of photosensitive epilepsy or uncontrolled epilepsy, constituting a contraindication to virtual reality use.
- Known contraindication to virtual reality use (history of severe cybersickness).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Virtual Reality Group
Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
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Use of an immersive virtual reality headset during interventional radiology procedures performed under local anesthesia in order to reduce procedural anxiety and pain.
다른 이름들:
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간섭 없음: Control Group
Participants receive standard care during the interventional radiology procedure without immersive virtual reality.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Procedural Anxiety and Procedural Pain
기간: From immediately before the procedure to immediately after the procedure
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Evaluation of procedural anxiety using the State-Trait Anxiety Inventory State scale (STAI-Y1) before and after the procedure.
STAI-Y1 scores range from 20 to 80, with higher scores indicating greater anxiety.
Procedural pain is assessed immediately after the procedure using a numerical rating scale ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain.
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From immediately before the procedure to immediately after the procedure
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Satisfaction
기간: Immediately after the procedure
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Patient satisfaction assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Operator Experience
기간: Immediately after the procedure
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Operator experience regarding the procedure assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Procedure Duration
기간: During the procedure
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Duration of the interventional radiology procedure, measured in minutes from the beginning to the end of the intervention.
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During the procedure
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Analgesic Use During the Procedure
기간: During the procedure
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Use and type of analgesic medications administered during the procedure.
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During the procedure
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Feasibility of Immersive Virtual Reality Use
기간: During and immediately after the procedure
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Feasibility of immersive virtual reality use during interventional radiology procedures, assessed descriptively through device-related incidents and interruptions of device use.
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During and immediately after the procedure
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Pascal Chabrot, University Hospital, Clermont-Ferrand
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- RBHP 2025 CHABROT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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