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Clinical Trials/NCT07001683
NCT07001683CompletedNot Applicable

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

Emrah Ay1 site in 1 country62 target enrollmentStarted: December 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
62
Locations
1
Primary Endpoint
COPD Assessment Test (CAT

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

EXPERIMENTAL GROUP PATIENT

Experimental

Through the video content, patients are given practical breathing and physical exercises through a mentor in a virtual environment. Before the videos were shown to the patients, detailed information was given about how to use the glasses, what to do and the video content, and they were asked to apply the visual and verbal commands given on the screen. Virtual reality application was performed outside the treatment and examination hours when the patient felt well, at a time when his vital signs and oxygen saturation were within normal limits. The first virtual reality application was made in the hospital and the patients were observed. Patients who could not perform the exercises were completed the exercises according to the step-by-step instructions given by the researcher as support. Patients who could perform the exercises without any problems were loaned glasses for virtual reality applications and were asked to do the exercises on their own at home for 6 weeks.

Intervention: VR SHINECON VIRTUAL REALITY GLASES (Device)

CONTROL GROUP PATIENT(unattended)

Active Comparator

Control Group (unattended) The patients were interviewed face to face and completed the questionnaires, then they were told to use their medications as prescribed by the doctors, and they were interviewed again after 6 weeks and the forms were filled out. No intervention was applied to the patients in the control group. Interviews lasted approximately 30 minutes for each patient.

Intervention: VR SHINECON VIRTUAL REALITY GLASES (Device)

Outcomes

Primary Outcomes

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

  • COPD Assessment Test (CAT(6 weeks later)

Investigators

Sponsor
Emrah Ay
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Emrah Ay

research assistant

Ataturk University

Study Sites (1)

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