Clinical trial NCT07001683: The Effect of Virtual Reality on Self-Efficacy and Quality of Life in COPD Patients
Official title: The Effect of Virtual Reality Respiratory and Physical Exercises on Self-Efficacy and Quality of Life in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Copd
Cough
Quality of Life
Self Efficacy
Keywords: breathing exercise,
COPD
PHYSICAL EXERCISE
quality of life
virtual reality
self efficacy
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: Ataturk University
name: Prof. Dr. Mağfiret Kaşıkçı
First posted: 2025-06-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Population and Sample of the Research The population of this research consisted of individuals receiving inpatient treatment at the Chest Diseases Clinic of Atatürk University Research and Application Center between December 2021 and June 2022, and patients with COPD who applied to the outpatient clinic.

In the study, post-test data could not be collected due to the death of two patients in the control group, and the control group was terminated with 30 patients, and the study was completed with 62 patients in total, 32 experimental and 30 control. Reporting of the study was done according to the CONSORT (Consolidated Standards of Reporting Trials) randomized controlled trials guide. The patients were randomly divided into 2 groups: experimental group n=32 and control group n=32, by block randomization method using the "random.org" website. The Randomization Scheme according to the CONSORT 2018 diagram.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: Chronic obstructive pulmonary disease (COPD) is a serious chronic disease worldwide with significant adverse effects on patients' quality of life, family economic burden and social health care burden. The aim of this study was to investigate the effects of breathing and cough exercises performed with virtual reality technology on quality of life and self-efficacy in COPD patients.

Methods: The study was conducted as a pre-test post-test randomised controlled experimental study. The study included 64 patients with COPD, randomly assigned to receive virtual reality-based breathing and exercises (experimental group n=32) and patients receiving routine clinical treatment (control group, n=32). Interventions were conducted three times a week for 6 weeks. Google VR SDK (Google Virtual Reality Software Development Kit) was used for the training of the experimental group. In the evaluation of the data; mean, number, percentage distributions, dependent and independent groups t-test analysis methods were used.

Detailed description: Research Type This research; It was planned as a randomized controlled study to determine the effects of breathing and physical exercises performed with virtual reality on self-efficacy and quality of life in COPD patients.

Location and Characteristics of the Research Research data was collected between December 2021 and June 2022 at the Atatürk University Research and Application Center Chest Diseases clinic and polyclinic.

Atatürk University Research and Application Center Chest Diseases Clinic has 36 beds and approximately 60 patients are admitted per month, and patients stay in the clinic for an average of 5-15 days. The clinic operates 24 hours a day, 7 days a week, throughout the year. In the clinic, 2 doctors, 2 nurses, 1 secretary and 2 assistant staff work in the 08:00-16:00 shift, and 1 doctor, 1 nurse and 1 assistant work in the 16:00-24:00 shift. 00-08:00 shift. personnel are on duty. The chest diseases outpatient clinic serves patients on weekdays and has two examination rooms in total. There are two separate rooms in the chest clinic where respiratory function tests are performed, and these test measurements are made by nurses.

Population and Sample of the Research The population of this research consisted of individuals receiving inpatient treatment at the Atatürk University Research and Application Center Chest Diseases Clinic between December 2021 and June 2022 and COPD patients who applied to the outpatient clinic.

A priori power analysis was performed to determine the number of samples. Cohen's standard effect sizes were used as the reference method in the power analysis. In the power analysis, there must be at least 26 people in both groups to reach 80% power with a p\<0.05 significance level, a high effect size and a 95% confidence interval in two groups with pre-test and post-test. Scale. It was determined that a total of 52 participants were needed. 123 However, considering that there would be data loss, 32 patients were included in both groups.

Research Inclusion Criteria

Those diagnosed with COPD as a result of pulmonary function tests (FEV1/FVC \< 70%) Does not have any psychiatric problems, Having COPD group B or C for at least three months according to the GOLD (2019) classification, Those who have not received breathing exercise training before and have not participated in any rehabilitation program, Residing in the city center where the research is conducted, Enough to understand the questions Does not have any vision or hearing problems, Open to communication and collaboration, Patients who volunteered to participate in the study were included.

Eligibility criteria: Inclusion Criteria:

* Those diagnosed with COPD as a result of pulmonary function tests (FEV1/FVC \< 70%)
* Having no psychiatric problems,
* Having COPD group B or C for at least three months according to the GOLD (2019) classification,
* Those who have not received breathing exercise training before and have not participated in a rehabilitation program,
* Living in the city center where the study is carried out,
* Sufficient to understand the questions,
* Having no problems with vision or hearing,
* Open to communication and collaboration,
* Patients who volunteered to participate in the study were included.

Exclusion Criteria:

* being under 18 years old unwilling to cooperate not diagnosed with COPD

Primary outcomes:
measure: COPD Assessment Test (CAT
timeFrame: before application
Secondary outcomes:
measure: COPD Assessment Test (CAT
timeFrame: 6 weeks later
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk Üniversitesi
Study officials:
affiliation: Advısor
name: MAĞFİRET KAŞIKÇI
role: STUDY_DIRECTOR
References:
citation: Agusti A, Vogelmeier C, Faner R. COPD 2020: changes and challenges. Am J Physiol Lung Cell Mol Physiol. 2020 Nov 1;319(5):L879-L883. doi: 10.1152/ajplung.00429.2020. Epub 2020 Sep 23. No abstract available.
citation: Kara M, Asti T. Effect of education on self-efficacy of Turkish patients with chronic obstructive pulmonary disease. Patient Educ Couns. 2004 Oct;55(1):114-20. doi: 10.1016/j.pec.2003.08.006.
citation: Xie X, Fan J, Chen H, Zhu L, Wan T, Zhou J, Fan D, Hu X. Virtual Reality Technology Combined with Comprehensive Pulmonary Rehabilitation on Patients with Stable Chronic Obstructive Pulmonary Disease. J Healthc Eng. 2021 Aug 2;2021:9987200. doi: 10.1155/2021/9987200. eCollection 2021.