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Completed

NCT Number: NCT07001683

The Effect of Virtual Reality on Self-Efficacy and Quality of Life in COPD Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR SHINECON VIRTUAL REALITY GLASES

Device

Unity program; It is a game engine that is used for the development of 2D, 3D, virtual reality and augmented reality applications and also has mobile support. 3D objects and animations necessary to develop the application have been prepared. These objects and animations; It was developed in the Autodesk 3ds Max program, where 3D modeling and animations are made.

The virtual reality aspect of the application is integrated into the Google VR SDK (Google Virtual Reality Software Development Kit). Interactions in the virtual environment and 360° viewing operations in the virtual world are provided through this Google VR SDK. The development process was completed by writing application codes in C#, one of the languages supported by the Unity program, using the methods included in the SDK.

Other names: Software Developed for Virtual Reality Module

Primary outcomes

  1. COPD Assessment Test (CAT

    Time frame: before application

    COPD Assessment Test (CAT) mean score decreases, and patients' health status improves with the decrease in CAT scores

Secondary outcomes

  1. COPD Assessment Test (CAT

    Time frame: 6 weeks later

    COPD Assessment Test (CAT) mean score decreases, and patients' health status improves with the decrease in CAT scores.

Sponsors and collaborators

Lead sponsor

Emrah Ay

Other

Collaborators

  • Ataturk University
  • Prof. Dr. Mağfiret Kaşıkçı

Registry information

Official study title

The Effect of Virtual Reality Respiratory and Physical Exercises on Self-Efficacy and Quality of Life in COPD Patients

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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