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Effect of Utilizing Virtual Reality With Pulmonary Rehabilitation on Depression in COPD Patients

Effect of Utilzing Virtual Reality With Pulmonary Rehabilitation on Depression in COPD Patients: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07790627
Enrollment
40
Registered
2026-08-27
Start date
2026-02-02
Completion date
2026-05-21
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Patients, Depression in Chronic Obstructive Pulmonary Disease

Brief summary

The goal of this study is to find the effect of utilizing virtual reality with pulmonary rehabilitation on depression in COPD patients. The main question it aims to answer is: Does utilizing virtual reality with pulmonary rehabilitation reduce depression in COPD patients?

Interventions

DEVICEvirtual reality with pulmonary rehabilitation

Virtual reality was utilized with pulmonary rehabilitation in COPD patients in the expiremental group

OTHERcontrolled group received pulmonary rehabilitation without utilizing virtual reality

controlled group received pulmonary rehabilitation without utilizing virtual reality

Sponsors

Imam Abdulrahman Bin Faisal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients with a confirmed diagnosis of COPD, aged between 45 and 85 years and presenting with depression according to the score of BDI-II with a cut off of 14 at the baseline assessment.

Exclusion criteria

* Absence of depression based on BDI-II score, presence of serious psychiatric disorders at the time of evaluation or documented in the medical records, initiation of psychiatric treatment during the study period, contraindications for virtual reality exposure such as (significant vision issues, significant hearing issues, severe motion sickness, seizure disorders) and the patient's refusal to participate.

Design outcomes

Primary

MeasureTime frameDescription
depression6 weeksThe primary outcome was the change in the depression score from baseline to post intervention. Depression was assessed prior to the first session of pulmonary rehabilitation program and reassessed after the completion of the twelfth session by Beck's Depression Inventory-II (BDI-II). BDI-II is a 21 item questionnaire which measures the severity of depression in adults and adolescents. It is structured on a 4 point rating scale for each question from 0 indicating no presence of any symptoms and 3 indicating that symptoms strongly present. Total scores from 0 to 13 indicate no or minimal depression, scores from 14 to 19 indicate mild depression, while scores from 20 to 28 indicate moderate depression, and scores from 29 to 63 indicate severe depression (Beck, A. T., 1996; NaviauxLab., 2020; Rahat et al., 2012). Patients with depressive symptoms score with a cut off of 14 as mild score indicating clinically significant were included in the study.

Secondary

MeasureTime frameDescription
anxiety6 weeksAnxiety was assessed and reassessed by the anxiety subscale of Hospital Anxiety and Depression Scale (HADS-A) (Rishi et al., 2017). The HAD is considered a valid research tool (Mihalca \& Pilecka, 2015). Anxiety was assessed and reassessed pre and post intervention as a secondary outcome measure. HADS is a 14 item scale designed to assess the anxiety and depression. Every question of the 14 items has a score between 0 and 3. It includes two subscales: seven questions (HADS-A) to assess anxiety and seven questions (HADS-D) to assess depression. With an acceptable score of 8/21 for anxiety and 8/21 for depression, the total score is from 0 to 42.
functional capacity6 weeksThe functional capacity was assessed and reassessed by the 6 minute walking test (6MWT) (heartonline, 2024). 6MWT is a self-paced exercise assessment widely utilized in hospitals and community settings to evaluate functional capacity, especially in patients with cardiovascular and respiratory conditions. It measures the distance a patient can walk over a period of six minutes on a flat hard surface. It is based on guidelines established by the European Respiratory Society and the American Thoracic Society (heartonline, 2024).
sequential attendance of pulmonary rehabilitation sessions12 sessionsSequential attendance of pulmonary rehabilitation sessions was recorded by a data sheet. It was calculated as frequencies. This means to calculate patients attendance of the twelve sessions within the prescribed six weeks period at frequency of two sessions per week in sequence without absence in between.
compliance with medication12 sessionsCompliance with medication was recorded using a data sheet. It was obtained every session subjectively according to the patients' words regarding their compliance with their medications. It was calculated as frequency and percentage.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026