- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07572305
Effects of Virtual Reality After Liver Transplantation (VR-LT)
Effects of Virtual Reality on Pain, Fatigue and Vital Signs After Liver Transplantation A Randomized Controlled Trial
This randomized controlled study aims to evaluate the effects of a virtual reality intervention on pain, fatigue and vital signs in patients during the early postoperative period after liver transplantation. Postoperative symptoms such as pain and fatigue may negatively affect recovery and patient comfort. Virtual reality has emerged as a non-pharmacological method that may help reduce these symptoms by providing distraction and relaxation.
A total of 84 patients were randomly assigned to an experimental group or a control group. The experimental group received a 20-minute virtual reality session, while the control group received standard care. Pain, fatigue and vital signs were measured before and after the intervention.
This study aims to determine whether virtual reality can improve patient comfort and physiological stability and support recovery after liver transplantation.
연구 개요
상세 설명
This study was designed as a prospective, randomized controlled, single-blind trial to evaluate the effects of a virtual reality intervention on pain, fatigue, and vital signs in patients during the early postoperative period after liver transplantation.
Liver transplantation is a life-saving procedure; however, patients frequently experience postoperative symptoms such as pain and fatigue, which may negatively affect recovery, physiological stability, and overall patient comfort. Non-pharmacological interventions have gained increasing attention in recent years as supportive approaches to improve postoperative outcomes. Virtual reality is an emerging technology that provides immersive distraction and relaxation, potentially reducing symptom perception and enhancing patient well-being.
The study was conducted in the organ transplantation clinic of a university hospital between May 2025 and January 2026. A total of 84 patients who met the inclusion criteria were randomly assigned to either the experimental group (n=42) or the control group (n=42) using a computer-based randomization method.
Patients in the experimental group received a 20-minute virtual reality intervention during the early postoperative period, while patients in the control group received standard care without additional intervention. Pain levels were assessed using the Numerical Rating Scale (NRS), fatigue levels were measured using the Brief Fatigue Inventory (BFI), and vital signs including heart rate, respiratory rate, and blood pressure were recorded. All measurements were obtained before the intervention and 15 minutes after the intervention.
The primary objective of the study was to determine the effect of virtual reality on fatigue levels. Secondary outcomes included pain and vital signs. Data were analysed using appropriate statistical methods, and statistical significance was set at p<0.05.
This study aims to contribute to the evidence base regarding the effectiveness of virtual reality as a non-pharmacological nursing intervention and to support its integration into clinical practice to improve postoperative care in liver transplantation patients.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Malatya, 터키 (Türkiye)
- Inonu University Liver Transplantation Institute
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥18 years
- Underwent liver transplantation
- In the early postoperative period
- Able to communicate verbally
- No diagnosed psychiatric disorder
- Hemodynamically stable
- Pain score ≥4 on the Numerical Rating Scale (NRS)
- Willing to participate in the study
Exclusion Criteria:
- Presence of severe postoperative complications
- Cognitive impairment or inability to understand instructions
- Visual or hearing impairments preventing use of virtual reality
- History of motion sickness or vertigo related to virtual reality use
- Chronic diseases that may affect fatigue or vital signs (e.g., uncontrolled cardiovascular or respiratory diseases)
- Refusal to participate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental Group
Participants received a 20 minute virtual reality intervention during the early postoperative period following liver transplantation.
The intervention was administered using a head mounted display and aimed to reduce fatigue and improve physiological parameters
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A 20 minute immersive virtual reality session was administered using a headmounted display during the early postoperative period following liver transplantation.
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활성 비교기: Control Group
Participants received routine postoperative care without any additional intervention
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Participants received routine postoperative care without any additional intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in fatigue severity
기간: Baseline and 15 minutes after intervention
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Change in fatigue severity measured using the Brief Fatigue Inventory (BFI) total score (range: 0-10; higher scores indicate greater fatigue)
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Baseline and 15 minutes after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in pain intensity
기간: Baseline and 15 minutes after intervention
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Measured using the Numerical Rating Scale (NRS) (range: 0-10; higher scores indicate greater pain)
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Baseline and 15 minutes after intervention
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Change in heart rate (beats per minute)
기간: Baseline and 15 minutes after intervention
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Change in heart rate measured in beats per minute (bpm).
Heart rate was recorded as part of routine vital sign monitoring to evaluate the physiological response to the virtual reality intervention.
Lower values may indicate improved relaxation and autonomic stability.
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Baseline and 15 minutes after intervention
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Change in systolic and diastolic blood pressure (mmHg)
기간: Baseline and 15 minutes after intervention
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Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Blood pressure was recorded as part of routine vital sign monitoring to evaluate the cardiovascular response to the virtual reality intervention.
Lower values may indicate improved physiological stability and relaxation.
|
Baseline and 15 minutes after intervention
|
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Change in systolic and diastolic blood pressure (mmHg)
기간: Baseline and 15 minutes after intervention
|
Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Blood pressure was assessed as part of routine vital sign monitoring to evaluate the cardiovascular response to the intervention.
Lower values may indicate improved physiological stability.
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Baseline and 15 minutes after intervention
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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
- 25H04 (기타 보조금/기금 번호: Malatya Turgut Ozal University Scientific Research Projects Unit)
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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