- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07475650
Virtual Reality in ICU Patients With COPD (VR-ICU-COPD)
March 11, 2026 updated by: Ceren Tunc Yildız, TC Erciyes University
The Effect of Virtual Reality Glasses Application on Sleep Quality, Anxiety and Vital Signs in Intensive Care Patients With COPD
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Melikgazi
-
Kayseri, Melikgazi, Turkey (Türkiye), 38260
- Faculty of Health Sciences Erciyes University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Patients in the experimental group received a virtual reality intervention for seven consecutive days.
Each evening at 23:30, patients were placed in a supine position in their beds and a virtual reality headset was fitted comfortably around the head.
The intervention lasted 30 minutes.
During the session, patients watched 360-degree virtual reality videos with background music available including themes such as nature scenes, seaside walks, underwater views, and museum tours.
Patients were allowed to choose the theme they preferred.
Vital signs were measured immediately before the intervention at 23:30 and again at 00:00 after the intervention, and were recorded in the Vital Signs Follow-up Form.
Sleep quality was assessed every morning at 09:00 using the Richard-Campbell Sleep Scale for seven days.
Anxiety levels were evaluated using the Beck Anxiety Scale on the first and seventh days of the study.
Other Names:
|
|
No Intervention: control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Richard-Campbell Sleep Scale
Time Frame: 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.
|
1 weeks
|
|
Beck Anxiety Scale
Time Frame: 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.
|
1 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ceren TUNÇ YILDIZ, nurse, TC Erciyes University
- Study Director: Tülay BÜLBÜL, Doc.Dr, TC Erciyes University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2022
Primary Completion (Actual)
January 28, 2024
Study Completion (Actual)
February 2, 2024
Study Registration Dates
First Submitted
March 7, 2026
First Submitted That Met QC Criteria
March 11, 2026
First Posted (Actual)
March 16, 2026
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 11, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Mental Disorders
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Pulmonary Disease, Chronic Obstructive
- Anxiety Disorders
- Sleep Initiation and Maintenance Disorders
Other Study ID Numbers
- ERU-MSN-CTY-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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