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

NCT06021106 | Completed

• 1 other identifier: ArdahanU-Simsekli-DS-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; Breathing Exercises

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Anxiety

  pretest, week 4, week 8

• St George's Respiratory Questionnaire (SGRQ)

  pretest, week 4, week 8

• Virtual Reality Experience Evaluation Form

  pretest, week 4, week 8

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: Breathing exercise application with virtual reality glasses

Control group

ACTIVE COMPARATOR

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

Other: routine treatment and care

Interventions

Breathing exercise application with virtual reality glasses 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.

Experimental group

routine treatment and care OTHER

routine treatment and care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ardahan University: lead
• Ataturk University: collaborator

Study Sites (1)

Ardahan University

Ardahan, 75100, Turkey (Türkiye)

Location

Related Publications (16)

• 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.

  PMID: 31723900 BACKGROUND

• 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.

  PMID: 31719191 BACKGROUND

• 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.

  PMID: 33221632 BACKGROUND

• 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.

  PMID: 33477733 BACKGROUND

• 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.

  PMID: 33292807 BACKGROUND

• Kanik EA, Taşdelen B, Erdoǧan S. Klinik denemelerde randomizasyon. Marmara Med J. 2011;24(3):149-55. doi: 10.5472/MMJ.2011.01981.1

  BACKGROUND

• 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.

  PMID: 30929415 BACKGROUND

• 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.

  PMID: 23289460 BACKGROUND

• 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.

  PMID: 10377201 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23875584 BACKGROUND

• Moorhouse N, Jung T, Shi X, Amin F, Newsham J, McCall S. Pulmonary Rehabilitation in Virtual Reality for COPD Patients. 2019;277-90.

  BACKGROUND

• 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.

  PMID: 26906147 BACKGROUND

• 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.

  PMID: 23728873 BACKGROUND

• 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.

  PMID: 28969859 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Mehtap TAN, Prof. dr.

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pretest posttest single blind parallel group randomized controlled experimental study

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 1, 2023
• Study Start: March 13, 2023
• Primary Completion: November 13, 2023
• Study Completion: December 13, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

TU (1)