Virtual Reality in ICU Patients With COPD (VR-ICU-COPD)
The Effect of Virtual Reality Glasses Application on Sleep Quality, Anxiety and Vital Signs in Intensive Care Patients With COPD
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Melikgazi
-
Kayseri, Melikgazi, Turkey (Türkiye), 38260
- Faculty of Health Sciences Erciyes University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Ceren TUNÇ YILDIZ, nurse, TC Erciyes University
- Study Director: Tülay BÜLBÜL, Doc.Dr, TC Erciyes University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- ERU-MSN-CTY-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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