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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Respiratory Exercise Applied to COPD Patients With Virtual Reality Glasses on Dyspnea, Anxiety and Quality of Life

Conditions
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Copd, Breathing Exercises

Intervention / Treatment
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* Other: Breathing exercise application with virtual reality glasses
* Other: routine treatment and care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pretest posttest single blind parallel group randomized controlled experimental study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Breathing exercise will be applied to the experimental group with virtual reality glasses. Each application consists of 20 minutes. It is planned to perform the exercises 3 times a week for eight weeks, in total 24 sessions. | Other: Breathing exercise application with virtual reality glasses<br>* 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 transformed into a viewable form with these glasses. The exercise video is 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.<br>|
| Active Comparator: Control group<br>Routine treatment and care will be continued in the control group and no additional intervention will be applied. | Other: routine treatment and care<br>* routine treatment and care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation | refers to the oxygen saturation in the blood | pretest, week 4, week 8 | 
| respiratory rate | refers to the number of breaths per minute | pretest, week 4, week 8 | 
| forced vital capacity (FVC) | This value is the maximum volume of air that can be removed from the lungs by exhaling forcefully, deeply and rapidly after taking a deep breath. | pretest, week 4, week 8 | 
| volume of air exhaled in 1 second of forced expiration (FEV1) | It is the volume expelled in the first second of forced expiration. | pretest, week 4, week 8 | 
| Peak Expiratory Flow Rate (PEF) | It is measured by the maximum exhalation maneuver following the maximum inspiration. | pretest, week 4, week 8 | 
| FEV1/FVC | It is a parameter used to detect the presence of obstruction. | pretest, week 4, week 8 | 
| COPD Evaluation Test (CAT) | Jones et al. (2009) developed this test is used to evaluate the health status of patients with COPD. | pretest, week 4, week 8 | 
| Modifiye Medical Research Council (mMRC) | The scale developed by Fletcher and later edited by the American Thoracic Society was developed to compare the level of dyspnea between individuals with lung disease and those without. The scale is scored between 0-4. The cut off score is 2. High scores indicate severe dyspnea. | pretest, week 4, week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | It is a state of fear and anxiety that occurs due to dyspnea in patients with COPD. In this study, the Hospital Anxiety Scale developed by Zigmond and Snaith in 1983 will be used.The scale is scored in a four-likert type. The cutoff score is 10-11. A score above this score means an increased risk in terms of anxiety. | pretest, week 4, week 8 | 
| St George's Respiratory Questionnaire (SGRQ) | It was developed by Jones et al. in 1991 to measure the health-related quality of life of patients with COPD, and its Turkish validity and reliability were performed by Polatlı in 2013. The lowest 0 and the highest 100 points can be obtained. An increase in score indicates worsening of the disease. | pretest, week 4, week 8 | 
| Virtual Reality Experience Evaluation Form | This form was created by scanning the literature in order to evaluate the patient's satisfaction with the breathing exercise with virtual reality glasses applied to the patient. | pretest, week 4, week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, dyspnea, COPD, virtual reality, breathing exercises, quality of life