Nursing CariesNCT07001683
The Effect of Virtual Reality on Self-Efficacy and Quality of Life in COPD Patients
A study testing VR SHINECON VIRTUAL REALITY GLASES in people with Nursing Caries and Copd, run by Emrah Ay at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Chronic obstructive pulmonary disease (COPD) is a serious chronic disease worldwide with significant adverse effects on patients' quality of life, family economic burden and social health care burden. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Copd, Cough
- What is being tested?
- VR SHINECON VIRTUAL REALITY GLASES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 10 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those diagnosed with COPD as a result of pulmonary function tests (FEV1/FVC < 70%)
- Having no psychiatric problems,
- Having COPD group B or C for at least three months according to the GOLD (2019) classification,
- Those who have not received breathing exercise training before and have not participated in a rehabilitation program,
- Living in the city center where the study is carried out,
- Sufficient to understand the questions,
Show all 9Show fewer
- Having no problems with vision or hearing,
- Open to communication and collaboration,
- Patients who volunteered to participate in the study were included.
Who cannot join
- being under 18 years old unwilling to cooperate not diagnosed with COPD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Respiratory and Physical Exercises on Self-Efficacy and Quality of Life in COPD Patients
Introduction: Chronic obstructive pulmonary disease (COPD) is a serious chronic disease worldwide with significant adverse effects on patients' quality of life, family economic burden and social health care burden. The aim of this study was to investigate the effects of breathing and cough exercises performed with virtual reality technology on quality of life and self-efficacy in COPD patients.
Methods: The study was conducted as a pre-test post-test randomised controlled experimental study. The study included 64 patients with COPD, randomly assigned to receive virtual reality-based breathing and exercises (experimental group n=32) and patients receiving routine clinical treatment (control group, n=32). Interventions were conducted three times a week for 6 weeks. Google VR SDK (Google Virtual Reality Software Development Kit) was used for the training of the experimental group. In the evaluation of the data; mean, number, percentage distributions, dependent and independent groups t-test analysis methods were used.
Read the detailed description
Research Type This research; It was planned as a randomized controlled study to determine the effects of breathing and physical exercises performed with virtual reality on self-efficacy and quality of life in COPD patients.
Location and Characteristics of the Research Research data was collected between December 2021 and June 2022 at the Atatürk University Research and Application Center Chest Diseases clinic and polyclinic.
Atatürk University Research and Application Center Chest Diseases Clinic has 36 beds and approximately 60 patients are admitted per month, and patients stay in the clinic for an average of 5-15 days. The clinic operates 24 hours a day, 7 days a week, throughout the year. In the clinic, 2 doctors, 2 nurses, 1 secretary and 2 assistant staff work in the 08:00-16:00 shift, and 1 doctor, 1 nurse and 1 assistant work in the 16:00-24:00 shift. 00-08:00 shift. personnel are on duty. The chest diseases outpatient clinic serves patients on weekdays and has two examination rooms in total. There are two separate rooms in the chest clinic where respiratory function tests are performed, and these test measurements are made by nurses.
Population and Sample of the Research The population of this research consisted of individuals receiving inpatient treatment at the Atatürk University Research and Application Center Chest Diseases Clinic between December 2021 and June 2022 and COPD patients who applied to the outpatient clinic.
A priori power analysis was performed to determine the number of samples. Cohen's standard effect sizes were used as the reference method in the power analysis. In the power analysis, there must be at least 26 people in both groups to reach 80% power with a p<0.05 significance level, a high effect size and a 95% confidence interval in two groups with pre-test and post-test. Scale. It was determined that a total of 52 participants were needed. 123 However, considering that there would be data loss, 32 patients were included in both groups.
Research Inclusion Criteria
Those diagnosed with COPD as a result of pulmonary function tests (FEV1/FVC < 70%) Does not have any psychiatric problems, Having COPD group B or C for at least three months according to the GOLD (2019) classification, Those who have not received breathing exercise training before and have not participated in any rehabilitation program, Residing in the city center where the research is conducted, Enough to understand the questions Does not have any vision or hearing problems, Open to communication and collaboration, Patients who volunteered to participate in the study were included.
- Conditions
- Nursing Caries, Copd, Cough, Quality of Life, Self Efficacy
- Being tested
- VR SHINECON VIRTUAL REALITY GLASES
- Keywords
- breathing exercise,, COPD, PHYSICAL EXERCISE, quality of life, virtual reality, self efficacy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cough, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR SHINECON VIRTUAL REALITY GLASESDevice
Also called Software Developed for Virtual Reality Module
Unity program; It is a game engine that is used for the development of 2D, 3D, virtual reality and augmented reality applications and also has mobile support. 3D objects and animations necessary to develop the application have been prepared. These objects and animations; It was developed in the Autodesk 3ds Max program, where 3D modeling and animations are made.
The virtual reality aspect of the application is integrated into the Google VR SDK (Google Virtual Reality Software Development Kit). Interactions in the virtual environment and 360° viewing operations in the virtual world are provided through this Google VR SDK. The development process was completed by writing application codes in C#, one of the languages supported by the Unity program, using the methods included in the SDK.
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUP PATIENT | Experimental | Through the video content, patients are given practical breathing and physical exercises through a mentor in a virtual environment. Before the videos were shown to the patients, detailed information was given about how to use the glasses, what to do and the video content, and they were asked to apply the visual and verbal commands given on the screen. Virtual reality application was performed outside the treatment and examination hours when the patient felt well, at a time when his vital signs and oxygen saturation were within normal limits. The first virtual reality application was made in the hospital and the patients were observed. Patients who could not perform the exercises were completed the exercises according to the step-by-step instructions given by the researcher as support. Patients who could perform the exercises without any problems were loaned glasses for virtual reality applications and were asked to do the exercises on their own at home for 6 weeks. Receives: Device: VR SHINECON VIRTUAL REALITY GLASES |
| CONTROL GROUP PATIENT(unattended) | Active comparator | Control Group (unattended) The patients were interviewed face to face and completed the questionnaires, then they were told to use their medications as prescribed by the doctors, and they were interviewed again after 6 weeks and the forms were filled out. No intervention was applied to the patients in the control group. Interviews lasted approximately 30 minutes for each patient. Receives: Device: VR SHINECON VIRTUAL REALITY GLASES |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Assessment Test (CAT
COPD Assessment Test (CAT) mean score decreases, and patients' health status improves with the decrease in CAT scores
Measured: before application
Secondary outcomes (1)
COPD Assessment Test (CAT
COPD Assessment Test (CAT) mean score decreases, and patients' health status improves with the decrease in CAT scores.
Measured: 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Dec 2021
- Primary completion1 Jan 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies 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
- Population and Sample of the Research The population of this research consisted of individuals receiving inpatient treatment at the Chest Diseases Clinic of Atatürk University Research and Application Center between December 2021 and June 2022, and patients with COPD who applied to the outpatient clinic. In the study, post-test data could not be collected due to the death of two patients in the control group, and the control group was terminated with 30 patients, and the study was completed with 62 patients in total, 32 experimental and 30 control. Reporting of the study was done according to the CONSORT (Consolidated Standards of Reporting Trials) randomized controlled trials guide. The patients were randomly divided into 2 groups: experimental group n=32 and control group n=32, by block randomization method using the "random.org" website. The Randomization Scheme according to the CONSORT 2018 diagram.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emrah Ay
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University, Prof. Dr. Mağfiret Kaşıkçı
- Responsible party
- Sponsor-investigator, Emrah Ay, Ataturk University
- Investigators
- MAĞFİRET KAŞIKÇI, Study director, Advısor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001683
- Sponsor's protocol ID
- AtaturkU-EAy-001
- Status last verified
- May 2025
- First submitted
- 13 Sep 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agusti A, Vogelmeier C, Faner R. COPD 2020: changes and challenges. Am J Physiol Lung Cell Mol Physiol. 2020 Nov 1;319(5):L879-L883. doi: 10.1152/ajplung.00429.2020. Epub 2020 Sep 23. No abstract available.
PubMed 32964724Kara M, Asti T. Effect of education on self-efficacy of Turkish patients with chronic obstructive pulmonary disease. Patient Educ Couns. 2004 Oct;55(1):114-20. doi: 10.1016/j.pec.2003.08.006.
PubMed 15476998Xie X, Fan J, Chen H, Zhu L, Wan T, Zhou J, Fan D, Hu X. Virtual Reality Technology Combined with Comprehensive Pulmonary Rehabilitation on Patients with Stable Chronic Obstructive Pulmonary Disease. J Healthc Eng. 2021 Aug 2;2021:9987200. doi: 10.1155/2021/9987200. eCollection 2021.
PubMed 34394902
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Respiratory and Physical Exercises on Self-Efficacy and Quality of Life in COPD Patients
- ClinicalTrials.gov ID
- NCT07001683
- Acronym / sponsor ID
- AtaturkU-EAy-001
- Conditions
- Nursing Caries, Copd, Cough, Quality of Life, Self Efficacy
- Keywords
- breathing exercise,, COPD, PHYSICAL EXERCISE, quality of life, virtual reality, self efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Emrah AyUniversity, hospital or other
- Collaborators
- Ataturk University, Prof. Dr. Mağfiret Kaşıkçı
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 3 Jun 2025 (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.
Introduction: Chronic obstructive pulmonary disease (COPD) is a serious chronic disease worldwide with significant adverse effects on patients' quality of life, family economic burden and social health care burden. The aim of this study was to investigate the effects of breathing and cough exercises performed with virtual reality technology on quality of life and self-efficacy in COPD patients.
Methods: The study was conducted as a pre-test post-test randomised controlled experimental study. The study included 64 patients with COPD, randomly assigned to receive virtual reality-based breathing and exercises (experimental group n=32) and patients receiving routine clinical treatment (control group, n=32). Interventions were conducted three times a week for 6 weeks. Google VR SDK (Google Virtual Reality Software Development Kit) was used for the training of the experimental group. In the evaluation of the data; mean, number, percentage distributions, dependent and independent groups t-test analysis methods were used.
Detailed description
Research Type This research; It was planned as a randomized controlled study to determine the effects of breathing and physical exercises performed with virtual reality on self-efficacy and quality of life in COPD patients.
Location and Characteristics of the Research Research data was collected between December 2021 and June 2022 at the Atatürk University Research and Application Center Chest Diseases clinic and polyclinic.
Atatürk University Research and Application Center Chest Diseases Clinic has 36 beds and approximately 60 patients are admitted per month, and patients stay in the clinic for an average of 5-15 days. The clinic operates 24 hours a day, 7 days a week, throughout the year. In the clinic, 2 doctors, 2 nurses, 1 secretary and 2 assistant staff work in the 08:00-16:00 shift, and 1 doctor, 1 nurse and 1 assistant work in the 16:00-24:00 shift. 00-08:00 shift. personnel are on duty. The chest diseases outpatient clinic serves patients on weekdays and has two examination rooms in total. There are two separate rooms in the chest clinic where respiratory function tests are performed, and these test measurements are made by nurses.
Population and Sample of the Research The population of this research consisted of individuals receiving inpatient treatment at the Atatürk University Research and Application Center Chest Diseases Clinic between December 2021 and June 2022 and COPD patients who applied to the outpatient clinic.
A priori power analysis was performed to determine the number of samples. Cohen's standard effect sizes were used as the reference method in the power analysis. In the power analysis, there must be at least 26 people in both groups to reach 80% power with a p<0.05 significance level, a high effect size and a 95% confidence interval in two groups with pre-test and post-test. Scale. It was determined that a total of 52 participants were needed. 123 However, considering that there would be data loss, 32 patients were included in both groups.
Research Inclusion Criteria
Those diagnosed with COPD as a result of pulmonary function tests (FEV1/FVC < 70%) Does not have any psychiatric problems, Having COPD group B or C for at least three months according to the GOLD (2019) classification, Those who have not received breathing exercise training before and have not participated in any rehabilitation program, Residing in the city center where the research is conducted, Enough to understand the questions Does not have any vision or hearing problems, Open to communication and collaboration, Patients who volunteered to participate in the study were included.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Population and Sample of the Research The population of this research consisted of individuals receiving inpatient treatment at the Chest Diseases Clinic of Atatürk University Research and Application Center between December 2021 and June 2022, and patients with COPD who applied to the outpatient clinic. In the study, post-test data could not be collected due to the death of two patients in the control group, and the control group was terminated with 30 patients, and the study was completed with 62 patients in total, 32 experimental and 30 control. Reporting of the study was done according to the CONSORT (Consolidated Standards of Reporting Trials) randomized controlled trials guide. The patients were randomly divided into 2 groups: experimental group n=32 and control group n=32, by block randomization method using the "random.org" website. The Randomization Scheme according to the CONSORT 2018 diagram.
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP PATIENT | Experimental | Device: VR SHINECON VIRTUAL REALITY GLASESThrough the video content, patients are given practical breathing and physical exercises through a mentor in a virtual environment. Before the videos were shown to the patients, detailed information was given about how to use the glasses, what to do and the video content, and they were asked to apply the visual and verbal commands given on the screen. Virtual reality application was performed outside the treatment and examination hours when the patient felt well, at a time when his vital signs and oxygen saturation were within normal limits. The first virtual reality application was made in the hospital and the patients were observed. Patients who could not perform the exercises were completed the exercises according to the step-by-step instructions given by the researcher as support. Patients who could perform the exercises without any problems were loaned glasses for virtual reality applications and were asked to do the exercises on their own at home for 6 weeks. |
| CONTROL GROUP PATIENT(unattended) | Active comparator | Device: VR SHINECON VIRTUAL REALITY GLASESControl Group (unattended) The patients were interviewed face to face and completed the questionnaires, then they were told to use their medications as prescribed by the doctors, and they were interviewed again after 6 weeks and the forms were filled out. No intervention was applied to the patients in the control group. Interviews lasted approximately 30 minutes for each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Those diagnosed with COPD as a result of pulmonary function tests (FEV1/FVC < 70%)
- Having no psychiatric problems,
- Having COPD group B or C for at least three months according to the GOLD (2019) classification,
- Those who have not received breathing exercise training before and have not participated in a rehabilitation program,
- Living in the city center where the study is carried out,
Key exclusion criteria (1 listed)
- being under 18 years old unwilling to cooperate not diagnosed with COPD
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 |
|---|---|---|
| VR SHINECON VIRTUAL REALITY GLASESAlso: Software Developed for Virtual Reality ModuleUnity program; It is a game engine that is used for the development of 2D, 3D, virtual reality and augmented reality applications and also has mobile support. 3D objects and animations necessary to develop the application have been prepared. These objects and animations; It was developed in the Autodesk 3ds Max program, where 3D modeling and animations are made. The virtual reality aspect of the application is integrated into the Google VR SDK (Google Virtual Reality Software Development Kit). Interactions in the virtual environment and 360° viewing operations in the virtual world are provided through this Google VR SDK. The development process was completed by writing application codes in C#, one of the languages supported by the Unity program, using the methods included in the SDK. | Device | CONTROL GROUP PATIENT(unattended), EXPERIMENTAL GROUP PATIENT |
Primary outcome
COPD Assessment Test (CAT
Time frame: before application
COPD Assessment Test (CAT) mean score decreases, and patients' health status improves with the decrease in CAT scores
1 secondary outcome
COPD Assessment Test (CAT
Time frame: 6 weeks later
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 3 Jun 2025.
- Background: PubMed 32964724Agusti A, Vogelmeier C, Faner R. COPD 2020: changes and challenges. Am J Physiol Lung Cell Mol Physiol. 2020 Nov 1;319(5):L879-L883. doi: 10.1152/ajplung.00429.2020. Epub 2020 Sep 23. No abstract available.
- Background: PubMed 15476998Kara M, Asti T. Effect of education on self-efficacy of Turkish patients with chronic obstructive pulmonary disease. Patient Educ Couns. 2004 Oct;55(1):114-20. doi: 10.1016/j.pec.2003.08.006.
- Background: PubMed 34394902Xie X, Fan J, Chen H, Zhu L, Wan T, Zhou J, Fan D, Hu X. Virtual Reality Technology Combined with Comprehensive Pulmonary Rehabilitation on Patients with Stable Chronic Obstructive Pulmonary Disease. J Healthc Eng. 2021 Aug 2;2021:9987200. doi: 10.1155/2021/9987200. eCollection 2021.
- goldcopdLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
MAĞFİRET KAŞIKÇI study director
Advısor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR SHINECON VIRTUAL REALITY GLASES in people with Nursing Caries and Copd, run by Emrah Ay 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 9 inclusion and 1 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 3 Jun 2025. 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?
COPD Assessment Test (CAT (time frame: before application). 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 NCT07001683, which also lists 3 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 3 Jun 2025.