Clinical trial NCT06021106: 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
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Breathing Exercises
Keywords: anxiety
dyspnea
COPD
virtual reality
breathing exercises
quality of life
Lead sponsor: Ardahan University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2023-09-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pretest posttest single blind parallel group randomized controlled experimental study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Oxygen saturation
timeFrame: pretest, week 4, week 8
measure: respiratory rate
timeFrame: pretest, week 4, week 8
measure: forced vital capacity (FVC)
timeFrame: pretest, week 4, week 8
measure: volume of air exhaled in 1 second of forced expiration (FEV1)
timeFrame: pretest, week 4, week 8
measure: Peak Expiratory Flow Rate (PEF)
timeFrame: pretest, week 4, week 8
measure: FEV1/FVC
timeFrame: pretest, week 4, week 8
measure: COPD Evaluation Test (CAT)
timeFrame: pretest, week 4, week 8
measure: Modifiye Medical Research Council (mMRC)
timeFrame: pretest, week 4, week 8
Secondary outcomes:
measure: Anxiety
timeFrame: pretest, week 4, week 8
measure: St George's Respiratory Questionnaire (SGRQ)
timeFrame: pretest, week 4, week 8
measure: Virtual Reality Experience Evaluation Form
timeFrame: pretest, week 4, week 8
Other outcomes:
Locations:
city: Ardahan
country: Turkey
facility: Ardahan University
Study officials:
affiliation: Ataturk University
name: Mehtap TAN, Prof. dr.
role: STUDY_DIRECTOR
References:
citation: Jang MH, Shin MJ, Shin YB. Pulmonary and Physical Rehabilitation in Critically Ill Patients. Acute Crit Care. 2019 Feb;34(1):1-13. doi: 10.4266/acc.2019.00444. Epub 2019 Feb 28.
citation: Lu Y, Li P, Li N, Wang Z, Li J, Liu X, Wu W. Effects of Home-Based Breathing Exercises in Subjects With COPD. Respir Care. 2020 Mar;65(3):377-387. doi: 10.4187/respcare.07121. Epub 2019 Nov 12.
citation: Marotta N, Demeco A, Moggio L, Marinaro C, Pino I, Barletta M, Petraroli A, Pepe D, Lavano F, Ammendolia A. Comparative effectiveness of breathing exercises in patients with chronic obstructive pulmonary disease. Complement Ther Clin Pract. 2020 Nov;41:101260. doi: 10.1016/j.ctcp.2020.101260. Epub 2020 Nov 17.
citation: Rutkowski S, Szczegielniak J, Szczepanska-Gieracha J. Evaluation of the Efficacy of Immersive Virtual Reality Therapy as a Method Supporting Pulmonary Rehabilitation: A Randomized Controlled Trial. J Clin Med. 2021 Jan 18;10(2):352. doi: 10.3390/jcm10020352.
citation: Condon C, Lam WT, Mosley C, Gough S. A systematic review and meta-analysis of the effectiveness of virtual reality as an exercise intervention for individuals with a respiratory condition. Adv Simul (Lond). 2020 Nov 19;5(1):33. doi: 10.1186/s41077-020-00151-z.
citation: Kanik EA, Taşdelen B, Erdoǧan S. Klinik denemelerde randomizasyon. Marmara Med J. 2011;24(3):149-55. doi: 10.5472/MMJ.2011.01981.1
citation: Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019 Jun;72(3):221-232. doi: 10.4097/kja.19049. Epub 2019 Apr 1.
citation: Yorgancioglu A, Polatli M, Aydemir O, Yilmaz Demirci N, Kirkil G, Nayci Atis S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Reliability and validity of Turkish version of COPD assessment test]. Tuberk Toraks. 2012;60(4):314-20. doi: 10.5578/tt.4321. Turkish.
citation: Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
citation: Aydemir Ö, Güvenir T, Küey L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlilik ve Güvenilirlik Çalışması. Türk Psikiyatr Derg. 1997;8(4):280-7.
citation: Polatli M, Yorgancioglu A, Aydemir O, Yilmaz Demirci N, Kirkil G, Atis Nayci S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Validity and reliability of Turkish version of St. George's respiratory questionnaire]. Tuberk Toraks. 2013;61(2):81-7. doi: 10.5578/tt.5404. Turkish.
citation: Moorhouse N, Jung T, Shi X, Amin F, Newsham J, McCall S. Pulmonary Rehabilitation in Virtual Reality for COPD Patients. 2019;277-90.
citation: Garvey C, Bayles MP, Hamm LF, Hill K, Holland A, Limberg TM, Spruit MA. Pulmonary Rehabilitation Exercise Prescription in Chronic Obstructive Pulmonary Disease: Review of Selected Guidelines: AN OFFICIAL STATEMENT FROM THE AMERICAN ASSOCIATION OF CARDIOVASCULAR AND PULMONARY REHABILITATION. J Cardiopulm Rehabil Prev. 2016 Mar-Apr;36(2):75-83. doi: 10.1097/HCR.0000000000000171.
citation: Gloeckl R, Marinov B, Pitta F. Practical recommendations for exercise training in patients with COPD. Eur Respir Rev. 2013 Jun 1;22(128):178-86. doi: 10.1183/09059180.00000513.
citation: Mayer AF, Karloh M, Dos Santos K, de Araujo CLP, Gulart AA. Effects of acute use of pursed-lips breathing during exercise in patients with COPD: a systematic review and meta-analysis. Physiotherapy. 2018 Mar;104(1):9-17. doi: 10.1016/j.physio.2017.08.007. Epub 2017 Aug 31.
citation: Sumedi ., Philip K, Hafizurrachman M. The effect of Pursed Lips Breathing Exercises on the Oxygen Saturation Levels of Patients with Chronic Obstructive Pulmonary Disease in Persahabatan Hospital, Jakarta. KnE Life Sci. 2021;2021:35-64.