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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06021106
Enrollment
48
Registered
2023-09-01
Start date
2023-03-13
Completion date
2023-12-13
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing Exercises, Copd

Keywords

anxiety, dyspnea, COPD, virtual reality, breathing exercises, quality of life

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.

Interventions

OTHERBreathing 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.

routine treatment and care

Sponsors

Ardahan University
Lead SponsorOTHER
Ataturk University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants were not informed about which group they were in, patients in the experimental and control groups were recruited at different times, and separate consent forms were created for the experimental and control groups. The statistician was not informed about the experimental and control groups, and the experimental and control groups were coded as A and B.

Intervention model description

Pretest posttest single blind parallel group randomized controlled experimental study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modifiye Medical Research Council (mMRC)pretest, week 4, week 8The 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.
Peak Expiratory Flow Rate (PEF)pretest, week 4, week 8It is measured by the maximum exhalation maneuver following the maximum inspiration.
FEV1/FVCpretest, week 4, week 8It is a parameter used to detect the presence of obstruction.
COPD Evaluation Test (CAT)pretest, week 4, week 8Jones et al. (2009) developed this test is used to evaluate the health status of patients with COPD.
Oxygen saturationpretest, week 4, week 8refers to the oxygen saturation in the blood
respiratory ratepretest, week 4, week 8refers to the number of breaths per minute
forced vital capacity (FVC)pretest, week 4, week 8This 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.
volume of air exhaled in 1 second of forced expiration (FEV1)pretest, week 4, week 8It is the volume expelled in the first second of forced expiration.

Secondary

MeasureTime frameDescription
St George's Respiratory Questionnaire (SGRQ)pretest, week 4, week 8It 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.
Virtual Reality Experience Evaluation Formpretest, week 4, week 8This 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.
Anxietypretest, week 4, week 8It 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026