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

Primary Purpose

Copd, Breathing Exercises

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breathing exercise application with virtual reality glasses
routine treatment and care
Sponsored by
Ardahan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Copd focused on measuring anxiety, dyspnea, COPD, virtual reality, breathing exercises, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ardahan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

Routine treatment and care will be continued in the control group and no additional intervention will be applied.

Outcomes

Primary Outcome Measures

Oxygen saturation
refers to the oxygen saturation in the blood
respiratory rate
refers to the number of breaths per minute
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.
volume of air exhaled in 1 second of forced expiration (FEV1)
It is the volume expelled in the first second of forced expiration.
Peak Expiratory Flow Rate (PEF)
It is measured by the maximum exhalation maneuver following the maximum inspiration.
FEV1/FVC
It is a parameter used to detect the presence of obstruction.
COPD Evaluation Test (CAT)
Jones et al. (2009) developed this test is used to evaluate the health status of patients with COPD.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 26, 2023
Last Updated
September 25, 2023
Sponsor
Ardahan University
Collaborators
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT06021106
Brief Title
Respiratory Exercise to Copd With Virtual Reality Glasses on Dyspnea, Anxiety and Qualıty of Life
Official Title
The Effect of Respiratory Exercise Applied to COPD Patients With Virtual Reality Glasses on Dyspnea, Anxiety and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardahan University
Collaborators
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Breathing Exercises
Keywords
anxiety, dyspnea, COPD, virtual reality, breathing exercises, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pretest posttest single blind parallel group randomized controlled experimental study
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will not be informed about which group they are in, patients in the experimental and control groups will be taken at different times, and separate consent forms will be created for the experimental and control groups. The statistician will not be informed about the experimental and control groups, they will be coded with the letters A and B.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Routine treatment and care will be continued in the control group and no additional intervention will be applied.
Intervention Type
Other
Intervention Name(s)
Breathing exercise application with virtual reality glasses
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
routine treatment and care
Intervention Description
routine treatment and care
Primary Outcome Measure Information:
Title
Oxygen saturation
Description
refers to the oxygen saturation in the blood
Time Frame
pretest, week 4, week 8
Title
respiratory rate
Description
refers to the number of breaths per minute
Time Frame
pretest, week 4, week 8
Title
forced vital capacity (FVC)
Description
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.
Time Frame
pretest, week 4, week 8
Title
volume of air exhaled in 1 second of forced expiration (FEV1)
Description
It is the volume expelled in the first second of forced expiration.
Time Frame
pretest, week 4, week 8
Title
Peak Expiratory Flow Rate (PEF)
Description
It is measured by the maximum exhalation maneuver following the maximum inspiration.
Time Frame
pretest, week 4, week 8
Title
FEV1/FVC
Description
It is a parameter used to detect the presence of obstruction.
Time Frame
pretest, week 4, week 8
Title
COPD Evaluation Test (CAT)
Description
Jones et al. (2009) developed this test is used to evaluate the health status of patients with COPD.
Time Frame
pretest, week 4, week 8
Title
Modifiye Medical Research Council (mMRC)
Description
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.
Time Frame
pretest, week 4, week 8
Secondary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
pretest, week 4, week 8
Title
St George's Respiratory Questionnaire (SGRQ)
Description
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.
Time Frame
pretest, week 4, week 8
Title
Virtual Reality Experience Evaluation Form
Description
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.
Time Frame
pretest, week 4, week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehtap TAN, Prof. dr.
Organizational Affiliation
Ataturk University
Official's Role
Study Director
Facility Information:
Facility Name
Ardahan University
City
Ardahan
ZIP/Postal Code
75100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31723900
Citation
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Respiratory Exercise to Copd With Virtual Reality Glasses on Dyspnea, Anxiety and Qualıty of Life

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