- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07639320
Benefits of Using Virtual Reality Preoperatively in Managing Anxiety During Outpatient Foot Bone Surgery (Parcours RV)
Forefoot bone surgeries, such as surgical correction of hallux valgus, are routine orthopedic procedures. Outpatient surgery is offered in the vast majority of cases with regional anesthesia. Even though it is a simple and quick surgical procedure, it affects the patient's body image, who will worry about the outcome. Furthermore, because the anesthesia is regional, the patient can hear the surgical procedures being performed, which generates anxiety. Finally, the lack of information about the preoperative process, from arrival at the hospital and then in the ward to the operating room, can generate additional anxiety for the patient. One way to reduce anxiety related to surgery could be the use of virtual reality (VR) techniques. VR uses technologies that simulate a user's physical presence in an environment artificially generated by software.
VR has already been used in studies to distract patients from pain and stress. During surgery, wearing a VR headset can reduce anxiety and stress related to the procedure. However, there are currently few studies investigating the use of VR to reduce preoperative anxiety and postoperative pain.
This research is based on the hypothesis that visualizing the perioperative journey via a VR headset, some time before the procedure, would reduce preoperative anxiety and postoperative pain.
The main objective is to evaluate the effect of using virtual reality on preoperative anxiety, through the visualization of a virtual perioperative journey by patients before surgery.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Saint-Jean, 프랑스, 31240
- Clinique de l'Union
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patient aged 18 years or older at the time of study enrollment
- Patient hospitalized for scheduled outpatient forefoot bone surgery with regional anesthesia
- Patient capable and willing to follow the protocol procedures as directed by the investigator
- Patient with a compatible smartphone
- Patient with a personal email address
- Patient affiliated with or covered by a social security plan
- Patient who has given their free, informed, and explicit written consent
Exclusion Criteria:
- Patient with a contraindication to regional anesthesia
- Emergency patient
- Epileptic patient
- Patient with significant visual impairment or uncorrected strabismus
- Patient with a cognitive barrier (dementia, major psychiatric disorders, etc.)
- Patient taking medication for stress or anxiety (benzodiazepines, anxiolytics, antidepressants, etc.) or analgesics chronically
- Patient with agoraphobia
- Patient with a history of motion sickness, vertigo, or vestibular neuritis
- Patient who does not understand or speak French
- Pregnant, breastfeeding, or parturient patient
- Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Patient with virtual reality headset
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Watching a movie in virtual reality
satisfaction questionnaire Amsterdam Preoperative Anxiety and Information Scale Score MSP-9
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위약 비교기: Patient with standard information about surgery
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satisfaction questionnaire Amsterdam Preoperative Anxiety and Information Scale Score MSP-9
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Score of the self-questionnaire "Amsterdam Preoperative Anxiety and Information Scale" (APAIS)
기간: 17 months
|
a questionnaire with 6 items and each item has a score between 1 and 5.
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17 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2023-A00921-44
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. .