NCT07475650

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 7, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

COPDVIRTUAL REALITY GLASSESNURSINGSLEEP QUALITYANXIETYVITAL SIGNS

Outcome Measures

Primary Outcomes (2)

  • Richard-Campbell Sleep Scale

    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

    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

Study Arms (2)

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.

Device: virtual reality glasses

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.

Interventions

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.

Also known as: VR
experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences Erciyes University

Kayseri, Melikgazi, 38260, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAnxiety DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ceren TUNÇ YILDIZ, nurse

    TC Erciyes University

    PRINCIPAL INVESTIGATOR
  • Tülay BÜLBÜL, Doc.Dr

    TC Erciyes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

March 7, 2026

First Posted

March 16, 2026

Study Start

November 29, 2022

Primary Completion

January 28, 2024

Study Completion

February 2, 2024

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations