CopdNCT06021106
Respiratory Exercise to Copd With Virtual Reality Glasses on Dyspnea, Anxiety and Qualıty of Life
A study testing Breathing exercise application with virtual reality glasses and routine treatment and care in people with Copd and Breathing Exercises, run by Ardahan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Breathing Exercises
- What is being tested?
- Breathing exercise application with virtual reality glasses and routine treatment and care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2023to 13 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Exacerbation of COPD in the last 4 weeks
- pneumonia
- Using psychiatric medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Respiratory Exercise Applied to COPD Patients With Virtual Reality Glasses on Dyspnea, Anxiety and Quality of Life
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.
Read the 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.
- Conditions
- Copd, Breathing Exercises
- Being tested
- Breathing exercise application with virtual reality glasses, routine treatment and care
- Keywords
- anxiety, dyspnea, COPD, virtual reality, breathing exercises, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercise application with virtual reality glassesOther
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 careOther
routine treatment and care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: routine treatment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
refers to the oxygen saturation in the blood
Measured: pretest, week 4, week 8
respiratory rate
refers to the number of breaths per minute
Measured: 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.
Measured: 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.
Measured: pretest, week 4, week 8
Peak Expiratory Flow Rate (PEF)
It is measured by the maximum exhalation maneuver following the maximum inspiration.
Measured: pretest, week 4, week 8
FEV1/FVC
It is a parameter used to detect the presence of obstruction.
Measured: 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.
Measured: 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.
Measured: pretest, week 4, week 8
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: pretest, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start13 Mar 2023
- Primary completion13 Nov 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pretest posttest single blind parallel group randomized controlled experimental study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardahan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor
- Investigators
- Mehtap TAN, Prof. dr., Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021106
- Sponsor's protocol ID
- ArdahanU-Simsekli-DS-01
- Status last verified
- Feb 2024
- First submitted
- 26 Aug 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31723900Lu 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.
PubMed 31719191Marotta 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.
PubMed 33221632Rutkowski 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.
PubMed 33477733Condon 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.
PubMed 33292807Kanik EA, Taşdelen B, Erdoǧan S. Klinik denemelerde randomizasyon. Marmara Med J. 2011;24(3):149-55. doi: 10.5472/MMJ.2011.01981.1
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.
PubMed 30929415Yorgancioglu 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.
PubMed 23289460Bestall 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.
PubMed 10377201Aydemir 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.
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.
PubMed 23875584Moorhouse N, Jung T, Shi X, Amin F, Newsham J, McCall S. Pulmonary Rehabilitation in Virtual Reality for COPD Patients. 2019;277-90.
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.
PubMed 26906147Gloeckl 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.
PubMed 23728873Mayer 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.
PubMed 28969859
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiratory Exercise Applied to COPD Patients With Virtual Reality Glasses on Dyspnea, Anxiety and Quality of Life
- ClinicalTrials.gov ID
- NCT06021106
- Acronym / sponsor ID
- ArdahanU-Simsekli-DS-01
- Conditions
- Copd, Breathing Exercises
- Keywords
- anxiety, dyspnea, COPD, virtual reality, breathing exercises, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ardahan UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pretest posttest single blind parallel group randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Breathing exercise application with virtual reality glassesBreathing 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. |
| Control group | Active comparator | Other: routine treatment and careIn the control group, routine treatment and care continued and no additional intervention was made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Exacerbation of COPD in the last 4 weeks
- pneumonia
- Using psychiatric medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exercise application with virtual reality glassesIn 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. | Other | Experimental group |
| routine treatment and careroutine treatment and care | Other | Control group |
Primary outcome
Oxygen saturation
Time frame: pretest, week 4, week 8
refers to the oxygen saturation in the blood
respiratory rate
Time frame: pretest, week 4, week 8
refers to the number of breaths per minute
forced vital capacity (FVC)
Time frame: pretest, week 4, week 8
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)
Time frame: pretest, week 4, week 8
It is the volume expelled in the first second of forced expiration.
Peak Expiratory Flow Rate (PEF)
Time frame: pretest, week 4, week 8
It is measured by the maximum exhalation maneuver following the maximum inspiration.
FEV1/FVC
Time frame: pretest, week 4, week 8
It is a parameter used to detect the presence of obstruction.
COPD Evaluation Test (CAT)
Time frame: pretest, week 4, week 8
Jones et al. (2009) developed this test is used to evaluate the health status of patients with COPD.
Modifiye Medical Research Council (mMRC)
Time frame: pretest, week 4, week 8
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.
3 secondary outcomes
Anxiety
Time frame: pretest, week 4, week 8
St George's Respiratory Questionnaire (SGRQ)
Time frame: pretest, week 4, week 8
Virtual Reality Experience Evaluation Form
Time frame: pretest, week 4, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 31723900Jang 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.
- Background: PubMed 31719191Lu 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.
- Background: PubMed 33221632Marotta 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.
- Background: PubMed 33477733Rutkowski 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.
- Background: PubMed 33292807Condon 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.
- BackgroundKanik EA, Taşdelen B, Erdoǧan S. Klinik denemelerde randomizasyon. Marmara Med J. 2011;24(3):149-55. doi: 10.5472/MMJ.2011.01981.1
- Background: PubMed 30929415Lim 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.
- Background: PubMed 23289460Yorgancioglu 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.
- Background: PubMed 10377201Bestall 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.
- BackgroundAydemir 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: PubMed 23875584Polatli 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.
- BackgroundMoorhouse N, Jung T, Shi X, Amin F, Newsham J, McCall S. Pulmonary Rehabilitation in Virtual Reality for COPD Patients. 2019;277-90.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehtap TAN, Prof. dr. study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise application with virtual reality glasses and routine treatment and care in people with Copd and Breathing Exercises, run by Ardahan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation (time frame: pretest, week 4, week 8). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021106, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.