Respiratory Exercise to Copd With Virtual Reality Glasses on Dyspnea, Anxiety and Qualıty of Life

NCT ID: NCT06021106

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2023-12-13

Brief Summary

It was planned to examine the effects of breathing exercises applied with virtual reality glasses on dyspnea, anxiety and quality of life in COPD patients. The study was planned to be conducted in a single-blind pre-test post-test parallel group randomized controlled experimental design. Hypotheses created for the research; H0a: There is no difference between the dyspnea scores of the experimental group and the control group in the post-test in COPD patients. H0b: There is no difference between the anxiety scores of the experimental group and the control group in the post-test in COPD patients. H0c: There is no difference between the quality of life scores of the experimental group and the control group in the post-test in COPD patients. H1a: There is a difference between the dyspnea scores of the experimental group and the control group in the post-test in COPD patients. H1b: There is a difference between the anxiety scores of the experimental group and the control group in the post-test in COPD patients. H1c: There is a difference in quality of life scores between the experimental group and the control group in the post-test in COPD patients. It is planned to apply breathing exercise through virtual reality glasses for 8 weeks to the experimental group. It is planned that the exercises will be done three times a week in a total of 24 sessions. No intervention will be applied to the control group. It is planned to collect the research data in the pre-test, four weeks after the pre-assessment, and in the post-test (in the eighth week of the study). Inclusion criteria for the study; Being over 18 years old, being GOLD Stage II-III COPD (FEV1/FVC<70%, FEV1<80%), being >24 as a result of the mini mental state assessment test, residing in the city center where the research was conducted. Exclusion criteria; exacerbation of COPD for the last four weeks, pneumonia, use of psychiatric medication.

Detailed Description

Breathing exercises are the most important part of pulmonary rehabilitation for COPD patients. It helps patients to increase their lung capacity, allowing them to breathe more easily. At the same time, since the patient can easily do breathing exercises by himself, it is also beneficial to provide disease control and self-management. Although breathing exercises are simple and easy to apply, difficulties in the disease process can prevent the individual from doing this. For this reason, there is a need for applications that will attract the attention and interest of patients or direct them, but that will not create commitment to the hospital. In this sense, it has been reported that breathing exercises to be applied through virtual reality glasses will attract the attention and interest of the patient, increase their motivation and make breathing exercises more regular. Therefore, this study was planned to determine the effect of breathing exercises applied with virtual reality glasses on dyspnea, anxiety and quality of life in COPD patients. Material and Method: The study was conducted in a single-blind pre-test post-test parallel group randomized controlled experimental design. The sample size of the study was determined as a result of the power analysis made by taking FEV1% in a study, and considering the losses, it was planned to form the sample of the study of 48 patients, 24 in the experimental and 24 in the control group. In the study, block randomization was chosen to reduce selection bias and distribute patients equally to groups. Patients who accept to participate in the study who meet the inclusion criteria will be pre-tested and assigned to the groups. Since the intervention will be applied in the research, investigator blinding will not be possible, and it is planned to blind the participants, whose consent forms have been prepared separately for the patients in the experimental and control groups. Statistician will be blinded. COPD Patient Identification Form, Pulmonary Function Test Evaluation Form, COPD Evaluation Test (CAT), Modified Medical Research Council (mMRC) Dyspnea Scale, Hospital Anxiety and Depression Scale (HADS), St George Respiratory Questionnaire and Virtual Reality Experience Evaluation Form. Research data will be collected in the pre-test, the fourth week of the research and the post-test (the eighth week of the research). Breathing exercise will be applied to the experimental group with virtual reality glasses. In adapting breathing exercises to virtual reality glasses; The exercise video was first shot by the researcher in front of a green screen. Then, a 3d background design was made by a software developer and it was transformed into a viewable form with these glasses. The exercise video was prepared as 20 minutes. The exercises will be done in the homes of the patients by making home visits. It is planned that the exercises will be done three times a week in a total of 24 sessions. No intervention will be applied to the control group. It is planned to evaluate the research data with the SPSS 26 package program.

Conditions

Copd; Breathing Exercises

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Breathing exercises were applied to the experimental group with virtual reality glasses. Each application consists of 20 minutes. The exercises were performed 3 days a week for eight weeks, a total of 24 sessions.

Group Type: EXPERIMENTAL

Breathing exercise application with virtual reality glasses

Intervention Type: OTHER

In adapting breathing exercises to virtual reality glasses; The exercise video was first shot by the researcher in front of a green screen. Then, a 3D background design was made by a software developer, a 360-degree printout was taken, and it was converted into a form that can be viewed with glasses. The exercise video is prepared as 20 minutes. Exercises were performed at patients' homes through home visits. A total of 24 sessions of exercises were performed three days a week.

Control group

In the control group, routine treatment and care continued and no additional intervention was made.

Group Type: ACTIVE_COMPARATOR

routine treatment and care

Intervention Type: OTHER

routine treatment and care

Interventions

Breathing exercise application with virtual reality glasses

In adapting breathing exercises to virtual reality glasses; The exercise video was first shot by the researcher in front of a green screen. Then, a 3D background design was made by a software developer, a 360-degree printout was taken, and it was converted into a form that can be viewed with glasses. The exercise video is prepared as 20 minutes. Exercises were performed at patients' homes through home visits. A total of 24 sessions of exercises were performed three days a week.

Intervention Type: OTHER

routine treatment and care

routine treatment and care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being over 18 years old
• Being GOLD Stage II-III COPD (FEV1/FVC<70%, FEV1<80%)
• Being oriented and cooperative
• No communication problem
• Being >24 in mini mental state assessment test
• Voluntarily agreeing to participate in the research
• Residing in the center of Ardahan

Exclusion Criteria

• Exacerbation of COPD in the last 4 weeks
• pneumonia
• Using psychiatric medication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: collaborator

Ardahan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehtap TAN, Prof. dr.

Role: STUDY_DIRECTOR

Ataturk University

Locations

Ardahan University

Ardahan, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

ArdahanU-Simsekli-DS-01

Identifier Type: -

Identifier Source: org_study_id