Virtual Reality for Pain Reduction During IUD Insertion
Virtual Reality as a Non-Pharmacological Distraction Intervention During Intrauterine Device Insertion: A Quasi-Experimental Study
This study aims to evaluate the effectiveness of virtual reality (VR) as a non-pharmacological distraction intervention during intrauterine device (IUD) insertion. IUD insertion is commonly associated with pain and anxiety, which may negatively affect patient experience and acceptance of the procedure.
In this quasi-experimental study, women undergoing IUD insertion were allocated into two groups: a virtual reality group receiving immersive audiovisual distraction during the procedure and a control group receiving standard care. Pain intensity and anxiety levels were assessed and compared between the two groups.
The findings of this study are expected to support the use of VR as a safe, simple, and non-invasive method to reduce procedural pain and anxiety and improve patient satisfaction during IUD insertion.
연구 개요
상세 설명
This quasi-experimental pretest-posttest study with a non-equivalent control group was conducted to evaluate the effectiveness of virtual reality (VR) as a non-pharmacological distraction intervention during intrauterine device (IUD) insertion.
A total of 90 women undergoing IUD insertion were enrolled and allocated into two groups using clinic registration numbers: an intervention group (VR group) and a control group. The control group received standard care, including routine pre-procedural counseling and IUD insertion, while the intervention group received the same standard care in addition to a virtual reality-based intervention.
The VR intervention consisted of both pre-procedural and intra-procedural components. Before the procedure, participants viewed a structured educational video explaining the IUD insertion process. During the procedure, participants wore a head-mounted virtual reality device displaying immersive calming audiovisual content, such as natural landscapes accompanied by soft music, to provide distraction and reduce attention to procedural stimuli.
The primary outcome was pain intensity, assessed during IUD insertion using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Secondary outcomes included state anxiety, measured using the State-Trait Anxiety Inventory (STAI) State subscale (score range: 20-80, with higher scores indicating greater anxiety), and patient satisfaction with the procedure.
Outcome measures were assessed at baseline (immediately before the procedure) and immediately after IUD insertion. The study was conducted in a clinical setting at Tanta University, and ethical approval was obtained prior to data collection.
This study aims to provide evidence regarding the effectiveness of VR as a safe, non-invasive, and cost-effective intervention to reduce pain and anxiety and improve the overall patient experience during IUD insertion procedures.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tanta, 이집트, 74322
- Tanta university hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Women eligible for intrauterine device (IUD) insertion
- Age between 18 and 45 years
- Willing to participate and provide informed consent
Exclusion Criteria:
- Contraindications to IUD insertion
- History of severe anxiety disorders
- Previous adverse reaction to virtual reality
- Refusal to participate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Virtual Reality
Participants receive virtual reality distraction during intrauterine device insertion.
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Use of virtual reality headset as a distraction method during IUD insertion.
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간섭 없음: Control Group
Participants receive routine care during intrauterine device insertion without virtual reality.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain intensity measured using Visual Analog Scale (VAS)
기간: During IUD insertion procedure
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Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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During IUD insertion procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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State anxiety level measured by the State-Trait Anxiety Inventory (STAI) - State subscale (S-Anxiety)
기간: Baseline (immediately before IUD insertion) and immediately after the procedure
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State anxiety will be assessed using the STAI State subscale (S-Anxiety), a validated 20-item self-report tool.
Items are rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate greater levels of state anxiety.
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Baseline (immediately before IUD insertion) and immediately after the procedure
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공동 작업자 및 조사자
스폰서
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
- VR-IUD-2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
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