Qatif Central Hospital
Dammam, Eastern Province, Saudi Arabia
NCT Number: NCT07790627
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?
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Notify Me45 year–85 year
All sexes
Interventional
Not applicable
Dammam, Eastern Province, Saudi Arabia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Virtual reality was utilized with pulmonary rehabilitation in COPD patients in the expiremental group
controlled group received pulmonary rehabilitation without utilizing virtual reality
Time frame: 6 weeks
The 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.
Time frame: 6 weeks
Anxiety 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.
Time frame: 6 weeks
The 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).
Time frame: 12 sessions
Sequential 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.
Time frame: 12 sessions
Compliance 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.
Imam Abdulrahman Bin Faisal University
Other
Effect of Utilzing Virtual Reality With Pulmonary Rehabilitation on Depression in COPD Patients: A Randomized Controlled Trial
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