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临床试验/NCT07475650
NCT07475650已完成不适用

The Effect of Virtual Reality Glasses Application on Sleep Quality, Anxiety and Vital Signs in Intensive Care Patients With COPD

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Beck Anxiety Scale

研究概览

简要总结

This study aims to evaluate the effect of a virtual reality glasses application on sleep quality, anxiety, and vital signs in patients with chronic obstructive pulmonary disease hospitalized in the intensive care unit. The study was conducted as a randomized controlled intervention study with 50 patients (25 experimental and 25 control) in the 2nd and 3rd level general intensive care units of Kayseri State Hospital. Patients in the experimental group received a 30 minute virtual reality session every evening for one week, while the control group received routine care. Sleep quality was assessed daily using the Richard-Campbell Sleep Scale, and anxiety levels were measured using the Beck Anxiety Scale. Vital signs were recorded before and after each VR session.

详细描述

The research was conducted as a randomized control group intervention study to determine the effect of virtual reality glasses application on sleep quality, anxiety and vital signs in COPD patients in intensive care. The sample of the study consisted of 50 patients (25 experimental and 25 control) who were diagnosed with COPD and met the study criteria in the 2nd and 3rd Level General ICU at Kayseri State Hospital between 29 November 2022 and 2 February 2024. In this study, for which ethics committee, institutional permission and participant approval were obtained, data were collected using virtual reality glasses, Patient Information Form, Vital Signs Follow-up Form, Richard-Campbell Sleep Scale and Beck Anxiety Scale. In the research, virtual reality glasses were applied to the patients in the experimental group for 30 minutes every evening at 23.30 for a week. Vital signs were measured immediately before and after the application and recorded in the Vital Signs Followup Form. Sleep quality was evaluated every day for a week with the RichardCampbell Sleep Scale. Anxiety levels were measured on the first and seventh days with the Beck Anxiety Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Conscious and oriented, able to cooperate
  • Aged 18 years and older
  • Diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2022 criteria (Stage II, Stage III, or Stage IV)
  • Hospitalized in the intensive care unit for at least 24 hours in order to evaluate sleep problems
  • No history of psychiatric disorders or cognitive impairment
  • No complaints such as migraine, dizziness, active nausea, vomiting, or headache
  • No visual, hearing, or cognitive impairments

排除标准

  • Patients with a Richmond Agitation-Sedation Scale (RASS) score less than -1
  • Patients receiving invasive or non-invasive mechanical ventilation
  • Discontinuation Criteria:
  • Experience problems with the virtual reality headset or report feeling unwell during the intervention
  • Initiation of any medication that affects sleep
  • Requirement for intubation
  • Initiation of medication for anxiety or sedation
  • Need for Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BPAP) during the virtual reality intervention

研究组 & 干预措施

experimental

Experimental

In the research, virtual reality glasses were applied to the patients in the experimental group for 30 minutes every evening at 23.30 for a week. Vital signs were measured immediately before and after the application and recorded in the Vital Signs Followup Form. Sleep quality was evaluated every day for a week with the Richard-Campbell Sleep Scale. Anxiety levels were measured on the first and seventh days with the Beck Anxiety Scale.

干预措施: virtual reality glasses (Device)

control

No Intervention

Patients in the control group received routine intensive care and standard COPD treatment without the virtual reality intervention. Sleep quality was evaluated every morning at 09:00 using the Richard-Campbell Sleep Scale for seven consecutive days. Anxiety levels were assessed using the Beck Anxiety Scale on the first and seventh days of the study. Vital signs were measured at 23:30 and 00:00 and recorded in the Vital Signs Follow-up Form.

结局指标

主要结局

Beck Anxiety Scale

时间窗: 1 weeks

The Beck Anxiety Scale was administered to patients in both the experimental and control groups at 09:00 on the first and seventh days and their anxiety levels were determined.

Richard-Campbell Sleep Scale

时间窗: 1 weeks

Patients in both the experimental and control groups were administered the Richard-Campbell Sleep Scale daily at 09:00 for one week to measure sleep depth, time to fall asleep, frequency of awakenings, wakefulness duration after waking, sleep quality, and ambient noise levels, and their overall sleep quality was observed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ceren Tunc Yildız

Nurse

TC Erciyes University

研究点 (1)

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