xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06021106</url>
    </required_header>
    <id_info>
      <org_study_id>ArdahanU-Simsekli-DS-01</org_study_id>
      <nct_id>NCT06021106</nct_id>
    </id_info>
    <brief_title>Respiratory Exercise to Copd With Virtual Reality Glasses on Dyspnea, Anxiety and Qualıty of Life</brief_title>
    <official_title>The Effect of Respiratory Exercise Applied to COPD Patients With Virtual Reality Glasses on Dyspnea, Anxiety and Quality of Life</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ardahan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ardahan University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        It was planned to examine the effects of breathing exercises applied with virtual reality&#xD;
        glasses on dyspnea, anxiety and quality of life in COPD patients. The study was planned to be&#xD;
        conducted in a single-blind pre-test post-test parallel group randomized controlled&#xD;
        experimental design. Hypotheses created for the research; H0a: There is no difference between&#xD;
        the dyspnea scores of the experimental group and the control group in the post-test in COPD&#xD;
        patients. H0b: There is no difference between the anxiety scores of the experimental group&#xD;
        and the control group in the post-test in COPD patients. H0c: There is no difference between&#xD;
        the quality of life scores of the experimental group and the control group in the post-test&#xD;
        in COPD patients. H1a: There is a difference between the dyspnea scores of the experimental&#xD;
        group and the control group in the post-test in COPD patients. H1b: There is a difference&#xD;
        between the anxiety scores of the experimental group and the control group in the post-test&#xD;
        in COPD patients. H1c: There is a difference in quality of life scores between the&#xD;
        experimental group and the control group in the post-test in COPD patients. It is planned to&#xD;
        apply breathing exercise through virtual reality glasses for 8 weeks to the experimental&#xD;
        group. It is planned that the exercises will be done three times a week in a total of 24&#xD;
        sessions. No intervention will be applied to the control group. It is planned to collect the&#xD;
        research data in the pre-test, four weeks after the pre-assessment, and in the post-test (in&#xD;
        the eighth week of the study). Inclusion criteria for the study; Being over 18 years old,&#xD;
        being GOLD Stage II-III COPD (FEV1/FVC&lt;70%, FEV1&lt;80%), being &gt;24 as a result of the mini&#xD;
        mental state assessment test, residing in the city center where the research was conducted.&#xD;
        Exclusion criteria; exacerbation of COPD for the last four weeks, pneumonia, use of&#xD;
        psychiatric medication.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Breathing exercises are the most important part of pulmonary rehabilitation for COPD&#xD;
        patients. It helps patients to increase their lung capacity, allowing them to breathe more&#xD;
        easily (Jang et al., 2019). At the same time, since the patient can easily do breathing&#xD;
        exercises by himself, it is also beneficial to provide disease control and self-management&#xD;
        (Lu et al., 2020; Marotta et al., 2020). Although breathing exercises are simple and easy to&#xD;
        apply, difficulties in the disease process can prevent the individual from doing this. For&#xD;
        this reason, there is a need for applications that will attract the attention and interest of&#xD;
        patients or direct them, but that will not create commitment to the hospital. In this sense,&#xD;
        it has been reported that breathing exercises to be applied through virtual reality glasses&#xD;
        will attract the attention and interest of the patient, increase their motivation and make&#xD;
        breathing exercises more regular (Condon et al., 2020; Rutkowski et al., 2021). Therefore,&#xD;
        this study was planned to determine the effect of breathing exercises applied with virtual&#xD;
        reality glasses on dyspnea, anxiety and quality of life in COPD patients. Material and&#xD;
        Method: The study was conducted in a single-blind pre-test post-test parallel group&#xD;
        randomized controlled experimental design. The sample size of the study was determined as a&#xD;
        result of the power analysis made by taking FEV1% in a study (Rutkowski et al., 2021), and&#xD;
        considering the losses, it was planned to form the sample of the study of 48 patients, 24 in&#xD;
        the experimental and 24 in the control group. In the study, block randomization was chosen to&#xD;
        reduce selection bias and distribute patients equally to groups (Kanik et al., 2011; Lim &amp;&#xD;
        In, 2019). Patients who accept to participate in the study who meet the inclusion criteria&#xD;
        will be pre-tested and assigned to the groups. Since the intervention will be applied in the&#xD;
        research, investigator blinding will not be possible, and it is planned to blind the&#xD;
        participants, whose consent forms have been prepared separately for the patients in the&#xD;
        experimental and control groups. Statistician will be blinded. COPD Patient Identification&#xD;
        Form, Pulmonary Function Test Evaluation Form, COPD Evaluation Test (CAT) (Yorgancioğlu et&#xD;
        al., 2012), Modified Medical Research Council (mMRC) Dyspnea Scale (Bestall et al., 1999),&#xD;
        Hospital Anxiety and Depression Scale (HADS) (Aydemir et al., 1997), St George Respiratory&#xD;
        Questionnaire (Polatli et al., 2013) and Virtual Reality Experience Evaluation Form&#xD;
        (Moorhouse et al., 2019). Research data will be collected in the pre-test, the fourth week of&#xD;
        the research and the post-test (the eighth week of the research). Breathing exercise will be&#xD;
        applied to the experimental group with virtual reality glasses. In adapting breathing&#xD;
        exercises to virtual reality glasses; The exercise video was first shot by the researcher in&#xD;
        front of a green screen. Then, a 3d background design was made by a software developer and it&#xD;
        was transformed into a viewable form with these glasses. The exercise video was prepared as&#xD;
        20 minutes (Garvey et al., 2016; Gloeckl et al., 2013; Mayer et al., 2018; Sumedi et al.,&#xD;
        2021). The exercises will be done in the homes of the patients by making home visits. It is&#xD;
        planned that the exercises will be done three times a week in a total of 24 sessions. No&#xD;
        intervention will be applied to the control group. It is planned to evaluate the research&#xD;
        data with the SPSS 26 package program.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">March 13, 2023</start_date>
    <completion_date type="Anticipated">December 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Pretest posttest single blind parallel group randomized controlled experimental study</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Oxygen saturation</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <description>refers to the oxygen saturation in the blood</description>
    </primary_outcome>
    <primary_outcome>
      <measure>respiratory rate</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <description>refers to the number of breaths per minute</description>
    </primary_outcome>
    <primary_outcome>
      <measure>forced vital capacity (FVC)</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>volume of air exhaled in 1 second of forced expiration (FEV1)</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <description>It is the volume expelled in the first second of forced expiration.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peak Expiratory Flow Rate (PEF)</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <description>It is measured by the maximum exhalation maneuver following the maximum inspiration.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FEV1/FVC</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <description>It is a parameter used to detect the presence of obstruction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>COPD Evaluation Test (CAT)</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <description>Jones et al. (2009) developed this test is used to evaluate the health status of patients with COPD.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modifiye Medical Research Council (mMRC)</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>St George's Respiratory Questionnaire (SGRQ)</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Virtual Reality Experience Evaluation Form</measure>
      <time_frame>pretest, week 4, week 8</time_frame>
      <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 (Jung et al., 2020; Moorhouse et al., 2019).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Copd</condition>
    <condition>Breathing Exercises</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Routine treatment and care will be continued in the control group and no additional intervention will be applied.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Breathing exercise application with virtual reality glasses</intervention_name>
      <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.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>routine treatment and care</intervention_name>
      <description>routine treatment and care</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being over 18 years old&#xD;
  &#xD;
            -  Being GOLD Stage II-III COPD (FEV1/FVC&lt;70%, FEV1&lt;80%)&#xD;
  &#xD;
            -  Being oriented and cooperative&#xD;
  &#xD;
            -  No communication problem&#xD;
  &#xD;
            -  Being &gt;24 in mini mental state assessment test&#xD;
  &#xD;
            -  Voluntarily agreeing to participate in the research&#xD;
  &#xD;
            -  Residing in the center of Ardahan&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exacerbation of COPD in the last 4 weeks&#xD;
  &#xD;
            -  pneumonia&#xD;
  &#xD;
            -  Using psychiatric medication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mehtap TAN, Prof. dr.</last_name>
      <role>Study Director</role>
      <affiliation>Ataturk University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ardahan University</name>
        <address>
          <city>Ardahan</city>
          <zip>75100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <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>
      <PMID>31723900</PMID>
    </reference>
    <reference>
      <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>
      <PMID>31719191</PMID>
    </reference>
    <reference>
      <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>
      <PMID>33221632</PMID>
    </reference>
    <reference>
      <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>
      <PMID>33477733</PMID>
    </reference>
    <reference>
      <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>
      <PMID>33292807</PMID>
    </reference>
    <reference>
      <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>
    </reference>
    <reference>
      <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. Erratum In: Korean J Anesthesiol. 2019 Aug;72(4):396.</citation>
      <PMID>30929415</PMID>
    </reference>
    <reference>
      <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>
      <PMID>23289460</PMID>
    </reference>
    <reference>
      <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>
      <PMID>10377201</PMID>
    </reference>
    <reference>
      <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>
    </reference>
    <reference>
      <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>
      <PMID>23875584</PMID>
    </reference>
    <reference>
      <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>
    </reference>
    <reference>
      <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>
      <PMID>26906147</PMID>
    </reference>
    <reference>
      <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>
      <PMID>23728873</PMID>
    </reference>
    <reference>
      <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>
      <PMID>28969859</PMID>
    </reference>
    <reference>
      <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.</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>anxiety</keyword>
    <keyword>dyspnea</keyword>
    <keyword>COPD</keyword>
    <keyword>virtual reality</keyword>
    <keyword>breathing exercises</keyword>
    <keyword>quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</mesh_term>
      <mesh_term>Dyspnea</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06021106
  org study id: ArdahanU-Simsekli-DS-01
  nct id: NCT06021106
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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 (Jang et al., 2019). 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
        (Lu et al., 2020; Marotta et al., 2020). 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 (Condon et al., 2020; Rutkowski et al., 2021). 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 (Rutkowski et al., 2021), 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 (Kanik et al., 2011; Lim &
        In, 2019). 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) (Yorgancioğlu et
        al., 2012), Modified Medical Research Council (mMRC) Dyspnea Scale (Bestall et al., 1999),
        Hospital Anxiety and Depression Scale (HADS) (Aydemir et al., 1997), St George Respiratory
        Questionnaire (Polatli et al., 2013) and Virtual Reality Experience Evaluation Form
        (Moorhouse et al., 2019). 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 (Garvey et al., 2016; Gloeckl et al., 2013; Mayer et al., 2018; Sumedi et al.,
        2021). 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Pretest posttest single blind parallel group randomized controlled experimental study
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes 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.
  measure: Oxygen saturation
  time frame: pretest, week 4, week 8
  description: refers to the oxygen saturation in the blood
  measure: respiratory rate
  time frame: pretest, week 4, week 8
  description: refers to the number of breaths per minute
  measure: forced vital capacity (FVC)
  time frame: pretest, week 4, week 8
  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.
  measure: volume of air exhaled in 1 second of forced expiration (FEV1)
  time frame: pretest, week 4, week 8
  description: It is the volume expelled in the first second of forced expiration.
  measure: Peak Expiratory Flow Rate (PEF)
  time frame: pretest, week 4, week 8
  description: It is measured by the maximum exhalation maneuver following the maximum inspiration.
  measure: FEV1/FVC
  time frame: pretest, week 4, week 8
  description: It is a parameter used to detect the presence of obstruction.
  measure: COPD Evaluation Test (CAT)
  time frame: pretest, week 4, week 8
  description: Jones et al. (2009) developed this test is used to evaluate the health status of patients with COPD.
  measure: Modifiye Medical Research Council (mMRC)
  time frame: pretest, week 4, week 8
  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.
  measure: Anxiety
  time frame: pretest, week 4, week 8
  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.
  measure: St George's Respiratory Questionnaire (SGRQ)
  time frame: pretest, week 4, week 8
  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.
  measure: Virtual Reality Experience Evaluation Form
  time frame: pretest, week 4, week 8
  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 (Jung et al., 2020; Moorhouse et al., 2019).
  arm group label: Experimental group
  arm group type: Experimental
  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 group label: Control group
  arm group type: Active Comparator
  description: Routine treatment and care will be continued in the control group and no additional intervention will be applied.
  intervention type: Other
  intervention name: Breathing exercise application with virtual reality glasses
  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.
  arm group label: Experimental group
  intervention type: Other
  intervention name: routine treatment and care
  description: routine treatment and care
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mehtap TAN, Prof. dr.
  role: Study Director
  affiliation: Ataturk University
  facility: 
  country: Turkey
  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.
  PMID: 31723900
  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.
  PMID: 31719191
  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.
  PMID: 33221632
  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.
  PMID: 33477733
  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.
  PMID: 33292807
  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. Erratum In: Korean J Anesthesiol. 2019 Aug;72(4):396.
  PMID: 30929415
  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.
  PMID: 23289460
  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.
  PMID: 10377201
  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.
  PMID: 23875584
  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.
  PMID: 26906147
  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.
  PMID: 23728873
  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.
  PMID: 28969859
  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.
  responsible party type: Sponsor
  mesh term: Respiratory Aspiration
  mesh term: Dyspnea
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)