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临床试验/NCT07572305
NCT07572305已完成不适用

Effects of Virtual Reality on Pain, Fatigue and Vital Signs After Liver Transplantation A Randomized Controlled Trial

Malatya Turgut Ozal University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors were blinded to group allocation. Participants and care providers were not blinded due to the nature of the intervention.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Malatya Turgut Ozal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bilsev DEMIR

Researcher

Malatya Turgut Ozal University

研究点 (1)

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