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临床试验/CTRI/2025/11/097859
CTRI/2025/11/097859尚未招募2/3 期

The efficacy of virtual reality on physiological parameters, anxiety, stress and depression among patients admitted in intensive care unit at tertiary care hospital - A randomized controlled trial

Sri Ramachandra Institute of Higher Education and Research Deemed to be University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Virtual Reality intervention is positively impact in physiological parameters and decrease anxiety, depression, and stress levels in ICU patients

研究概览

简要总结

Purpose:

The study aims to evaluate the efficacy of virtual reality  in reducing depression, anxiety, stress and improving physiological parameters in comparison with standard intensive care unit (ICU) care.

Methods:

Study Design: Randomized controlled trial using block randomization to ensure balanced allocation of participants into intervention and control groups.

A total of 120 patients will be recruited based on inclusion criteria and randomly assigned into two groups: study group (n = 60) and control group (n = 60). On Day 1, a pre-test will be conducted for both groups. Following this, participants in the study group will receive a 15-minute virtual reality (VR) video session using a VR device, while the control group will continue to receive standard ICU care. Immediately after the intervention, a post-test I will be conducted to both groups. On Day 2 and Day 3, the study group will again receive VR video sessions, whereas the control group will continue with standard care. Subsequently, post-test II and post-test III will be conducted for both groups to evaluate outcomes over time.

Proposed Results:

The virtual reality intervention is very much useful for ICU patients to reduce the depression, anxiety, stress and gives the positive impact in physiological parameters that reduce the length of ICU stay for the patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 64.00 Year(s)(—)
性别
All

入选标准

  • Patients age greater than 19 years and less than 65years conscious oriented patient Willingness to participate.

排除标准

  • patients who have visual and hearing impairment Unconscious and intubated patients Severe mental health disorder Severe or life.
  • threatening condition.

结局指标

主要结局

Virtual Reality intervention is positively impact in physiological parameters and decrease anxiety, depression, and stress levels in ICU patients

时间窗: Pre-test- After 24 hours of ICU Admission | Post-test- 1 After 24 hours of ICU Admission | Post-test- 2 After 48 hours of ICU Admission | Post-test- 3 After 72 hours of ICU Admission

次要结局

  • Virtual reality interventions decrease levels of depression, anxiety, and stress, leading to a shorter ICU stay for patients(Pre-test- After 24 hours of ICU Admission)

研究者

发起方
Sri Ramachandra Institute of Higher Education and Research Deemed to be University
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

VVignesh

Sri Ramachandra Institute of Higher Education and Research Deemed to be University

研究点 (1)

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