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/NCT05997550</url>
    </required_header>
    <id_info>
      <org_study_id>COPD.NURSİNG.YUKSEK</org_study_id>
      <nct_id>NCT05997550</nct_id>
    </id_info>
    <brief_title>The Effect of Pursed Lip Breathing Exercise and Laughter Therapy Individuals With The COPD</brief_title>
    <official_title>The Effect of Pursed Lip Breathing Exercise and Laughter Therapy on Dyspnea, Health Status, and Care Dependence in Individuals With Chronic Obstructive Pulmonary Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yuksek Ihtisas University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yuksek Ihtisas 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>
        Chronic Obstructive Pulmonary Disease is a chronic disease with increasing mortality,&#xD;
        morbidity and prevalence in the world and in our country, and in which serious symptoms,&#xD;
        especially dyspnea, develop. Due to dyspnea and symptoms, patients experience deterioration&#xD;
        in their health status and an increase in care dependency. This research is a single-blind,&#xD;
        randomized controlled experimental study designed to determine the effects of pursed lip&#xD;
        breathing exercise and laughter therapy on dyspnea severity, health status and care&#xD;
        dependence in individuals with COPD. The research will be carried out with a total of 63&#xD;
        patients in Ankara City Hospital Chest Diseases unit. The patients will be stratified&#xD;
        according to smoking status and COPD Assessment Test scores with the randomization program&#xD;
        and assigned to 2 intervention groups and 1 control group. During the first interview,&#xD;
        patients in the 1st intervention group will be provided with pursed lip breathing exercise&#xD;
        training and application, and training videos and brochures will be given. 2. The patients in&#xD;
        the intervention group will be given laughter therapy training and practice, and an&#xD;
        educational brochure will be given. The patients in the control group will also receive&#xD;
        face-to-face training on lung structure and functioning, and a brochure will be given.&#xD;
        Patients in the laughter therapy and pursed lip breathing exercise intervention groups will&#xD;
        be asked to perform these practices three days a week (Monday, Wednesday, Friday) for 8&#xD;
        weeks. At the beginning of the study, at the 4th, 8th, and 12th weeks, the Dyspnea 12-TR&#xD;
        Scale, the COPD Evaluation Test, and the Care Dependency Scale will be administered to both&#xD;
        the intervention and control group patients. In the application of the scales and the&#xD;
        analysis of the data, the groups will be blinded, and the scale application will be made by&#xD;
        an independent interviewer. After the analysis of the data in terms of normal distribution&#xD;
        was done with the Kolmogorow Smirnov test, in the comparison of the data of the patients in&#xD;
        the intervention and control groups; One Way Analysis of Variance or Kruskal-Wallis Analysis&#xD;
        of Variance will be applied. Analysis of Variance in Repeated Measurements or Freidman's test&#xD;
        will be used to calculate the change in groups over time. The statistical significance limit&#xD;
        will be accepted as p&lt;0.05.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research is a single-blind, randomized controlled experimental study in order to&#xD;
        determine the effect of pursed lip breathing exercise and laughter therapy on dyspnea&#xD;
        severity, health status and care dependence in individuals with COPD.&#xD;
  &#xD;
        Research hypotheses H0-1: Pursed lip breathing exercise has no effect on the severity of&#xD;
        dyspnea in individuals with COPD.&#xD;
  &#xD;
        H0-2: Laughter therapy has no effect on the severity of dyspnea in individuals with COPD.&#xD;
  &#xD;
        H0-3: Pursed lip breathing exercise has no effect on health status in individuals with COPD.&#xD;
  &#xD;
        H0-4: Laughter therapy has no effect on health status in individuals with COPD. H0-5: Pursed&#xD;
        lip breathing exercise has no effect on care dependence in individuals with COPD.&#xD;
  &#xD;
        H0-6: Laughter therapy has no effect on care dependence in individuals with COPD.&#xD;
  &#xD;
        Population: COPD patients receiving service in Ankara City Hospital Chest Diseases&#xD;
        polyclinics and clinics constitute the population of the research.&#xD;
  &#xD;
        Sample: Since there is no study in the literature examining the effects of pursed lip&#xD;
        breathing exercise and laughter therapy in COPD patients, El-saidy et al. (2019) based on the&#xD;
        study data, a sample calculation was made; Dyspnea 12 Scale scores before and after pursed&#xD;
        lip breathing exercise (31.05± 9.2 and 22.31 ± 7.76, respectively) were found to be&#xD;
        statistically significant (p &lt; 0.001) (66). The effect size was calculated as 1.026 using the&#xD;
        Priori method and the G Power program, and a total of 63 patients, at least 21 for each&#xD;
        group, should be included in the study with a confidence interval of 95% and a power of 90%.&#xD;
  &#xD;
        Research Group The patients in the institution where the study was conducted were evaluated&#xD;
        for eligibility for the study. Voluntary consent is obtained by giving information about the&#xD;
        research. In the study, stratified randomization method is used to ensure homogeneity between&#xD;
        groups. Using the randomization program (https://www.randomizer.org); Stratified according to&#xD;
        COPD Assessment Test (CAT) score (10≤ CAT≤ 25 and 25≤ CAT≤ 40) and smoking status (smoker and&#xD;
        non-smoker); Patient lists were created as pursed lip breathing exercise intervention group,&#xD;
        laughter therapy intervention group and control group&#xD;
  &#xD;
        Research Group The patients in the institution where the study was conducted were evaluated&#xD;
        for eligibility for the study. Voluntary consent is obtained by giving information about the&#xD;
        research. In the study, stratified randomization method is used to ensure homogeneity between&#xD;
        groups. Using the randomization program (https://www.randomizer.org); Stratified according to&#xD;
        COPD Assessment Test (CAT) score (10≤ CAT≤ 25 and 25≤ CAT≤ 40) and smoking status (smoker and&#xD;
        non-smoker); Patient lists were created as pursed lip breathing exercise intervention group,&#xD;
        laughter therapy intervention group and control group.&#xD;
  &#xD;
        The evaluation of the eligibility of the patients in the institution where the research was&#xD;
        carried out, in line with the criteria of inclusion and exclusion from the research, is made&#xD;
        by the thesis student. After the patient was informed about the study and their voluntary&#xD;
        consent was obtained, the &quot;Patient Information Form&quot; was filled by the thesis student and&#xD;
        according to the patient lists obtained through the https://www.randomizer.org program and&#xD;
        stratified randomization, the patients were pursed lip breathing exercise intervention group,&#xD;
        laughter therapy intervention group. and assigned to control groups.&#xD;
  &#xD;
        Intervention Groups&#xD;
  &#xD;
        Intervention Group (A):&#xD;
  &#xD;
        During the first interview, the training and demonstration of pursed lip breathing exercise&#xD;
        is performed by the thesis student in a single session, lasting approximately 40 minutes. The&#xD;
        effects of pursed lip breathing exercise on health and its application steps are explained to&#xD;
        the patient, and purse lip breathing exercise is performed together with the patient. In&#xD;
        addition, the training is reinforced by giving a pursed lip breathing exercise brochure to&#xD;
        the patient and sending a pursed lip breathing exercise application video prepared by the&#xD;
        thesis student via whatsapp. Patients who do not have Whatsapp application are sent a video&#xD;
        to one of their family members. After this information session, the pursed lip breathing&#xD;
        exercise taught from the patients; They are asked to do it in their own homes, 3 days a week&#xD;
        on Monday, Wednesday and Friday, for about 30 minutes each session, for a total of eight&#xD;
        weeks. In order to support patients' compliance with the research; During the application&#xD;
        process, on Mondays, Wednesdays and Fridays, the patient was contacted by the thesis student&#xD;
        at a predetermined time, and the situation of performing pursed lip breathing exercise was&#xD;
        questioned and recorded in the control chart . In addition, one day a week (on a day&#xD;
        determined by the patient, Monday, Wednesday or Friday), the thesis student makes a video&#xD;
        call to the patient on WhatsApp, and the practice of pursed lip breathing exercise is&#xD;
        performed during the video call. After the end of the eighth week, the patients are asked to&#xD;
        take a break from the pursed lip breathing exercise for 4 weeks (weeks 9-12), and no&#xD;
        application is made during this period.&#xD;
  &#xD;
        Intervention Group (B) During the first interview, laughter therapy training and&#xD;
        demonstration is carried out by the thesis student in a single session, lasting approximately&#xD;
        50 minutes. The effects of laughter therapy on health and its application steps are explained&#xD;
        to the patient, and the laughter therapy practice is carried out together with the patient.&#xD;
        In addition, the training is reinforced by giving a laughter therapy training brochure to the&#xD;
        patient and sending the laughter therapy application video prepared by the thesis student via&#xD;
        whatsapp. Patients who do not have Whatsapp application are sent a video to one of their&#xD;
        family members. After this information session, the laughter therapy taught from the&#xD;
        patients; They are asked to do this in their own homes, 3 days a week on Monday, Wednesday&#xD;
        and Friday, 30 minutes each session, for a total of eight weeks. In order to support&#xD;
        patients' compliance with the research; During the application process, on Mondays,&#xD;
        Wednesdays and Fridays, the patient is contacted by the thesis student at a predetermined&#xD;
        time, and their status of doing laughter therapy is questioned and recorded in the laughter&#xD;
        therapy application control chart. In addition, once a week (on a day determined by the&#xD;
        patient, Monday, Wednesday or Friday), the thesis student makes a video call to the patient&#xD;
        on WhatsApp, and laughter therapy is practiced during the video call. After the end of the&#xD;
        eighth week, the patients are asked to take a break from the laughter therapy for 4 weeks&#xD;
        (weeks 9-12), and no application is made during this period.&#xD;
  &#xD;
        Control Group(C) Attention-match training is given to the patients in the control group.&#xD;
        During the first interview, attention matching training is carried out by the thesis student&#xD;
        for one time, about &quot;Lung structure and functioning&quot;, lasting approximately 20 minutes. In&#xD;
        addition, a brochure about lung structure and functioning is given to patients. The patients&#xD;
        in the control group are not subjected to any other interventions throughout the study.&#xD;
  &#xD;
        Data Collection The evaluation of the eligibility of the patients in the institution where&#xD;
        the research was carried out, in line with the criteria of inclusion and exclusion from the&#xD;
        research, is made by the thesis student. After the patient was informed about the study and&#xD;
        their voluntary consent was obtained, the &quot;Patient Information Form&quot; was filled by the thesis&#xD;
        student and according to the patient lists obtained through the https://www.randomizer.org&#xD;
        program and stratified randomization, the patients were pursed lip breathing exercise&#xD;
        intervention group, laughter therapy intervention group. and assigned to control groups. The&#xD;
        scales used in the research are filled by an independent interviewer. In order to provide&#xD;
        blinding during the data collection phase of the study, the information about which groups&#xD;
        the patients belong to is hidden from the interviewer. In addition, patients are told not to&#xD;
        share the information of which group they belong to during the data collection process.&#xD;
  &#xD;
        Dyspnea-12 Scale, COPD Assessment Test and Care Dependence Scale 1.,2. all patients in the&#xD;
        intervention and control groups; On the first interview day, they are told to take a break&#xD;
        from the 4th, 8th and pursed lip breathing exercise and laughter therapy programs for 4&#xD;
        weeks, and they are applied again in the 12th week. The scales are filled by an independent&#xD;
        interviewer by telephone after the completion of pursed lip breathing exercise and laughter&#xD;
        therapy on Friday of the 4th, 8th and 12th weeks. The interviewer was given a training that&#xD;
        included the structure, application and purpose of the scale by the thesis student.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">March 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2024</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dyspnea in the COPD</measure>
      <time_frame>12 week</time_frame>
      <description>Dyspnea-12 Scale, all patients in the intervention and control groups; On the first interview day, they are told to take a break from the 4th, 8th and pursed lip breathing exercise and laughter therapy programs for 4 weeks, and they are applied again in the 12th week.&#xD;
  Dyspnea -12 scale, Yorke et al (2010) to measure the severity of dyspnea and to evaluate it with emotional and physical dimensions. The first 7 items measure whether the inhaled air fills all the lungs, the difficulty in breathing and the physical limitations of dyspnea in which the required effort is questioned. The other 5 items of the scale question emotional states such as stress, irritability and depression that may arise from shortness of breath. The severity of dyspnea is directly proportional to the scores obtained from the scale, and as the scores increase, the severity of dyspnea increases</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health Status in The COPD</measure>
      <time_frame>12 week</time_frame>
      <description>COPD assessment test, all patients in the intervention and control groups; On the first interview day, they are told to take a break from the 4th, 8th and pursed lip breathing exercise and laughter therapy programs for 4 weeks, and they are applied again in the 12th week.&#xD;
  COPD assessment test, Jones et al. (2009) to measure health status in COPD and to evaluate the disease effect and severity. The eight-question test provides information on the grading of the disease, the scoring of symptoms, and the impact on the patient's quality of life. It covers problems such as shortness of breath, cough, and sputum production, as well as symptoms such as fatigue and sleep problems. Perfect health status: 0 points (minimum score), worst health status: 40 points (maximum score).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Care Dependence in The COPD</measure>
      <time_frame>12 week</time_frame>
      <description>COPD assessment test, all patients in the intervention and control groups; On the first interview day, they are told to take a break from the 4th, 8th and pursed lip breathing exercise and laughter therapy programs for 4 weeks, and they are applied again in the 12th week.&#xD;
  Care Dependence Scale (CDS) Dijkstra et al. (1999) to evaluate the individual's dependence on care and to deal with addiction with its physical and psychological dimensions .The scale includes nutrition, continence, body posture, mobility, sleep, dressing, body temperature, body cleanliness, avoiding danger, verbal communication, communicating with others, worshiping, obeying rules, daily activities, recreational activities, memory and learning ability. A high scale score indicates that the patient is independent in meeting his/her care needs, while a low scale score indicates that the patient is dependent on others to meet their care needs.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pursed Lip Breathing Exercise and Laughter Therapy in Individuals with Chronic Obstructive Pulmonary Disease</measure>
      <time_frame>The time interval for each patient is 12 weeks.</time_frame>
      <description>The independent variable of the study consists of pursed lip breathing exercise, laughter therapy, demographics and introductory information about the disease. In the study, severity of dyspnea, health status and level of care dependency are the dependent variables of the study.&#xD;
  In the analysis of socio-demographic data in the study, the mean and standard deviation for numerical variables with normal distribution; For numerical variables that are not normally distributed, median, percentiles, minimum and maximum values will be used. Descriptive statistics of categorical variables will be given in the form of frequency distributions (number, percentage). In addition, the demographic and disease-related descriptive data of the patients and the relationship between dyspnea severity, health status and care dependency will be examined.Finally, the interventions (pursed lip breathing exercise, laughter therapy) will be compared with each other and with the control groups.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">63</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <arm_group>
      <arm_group_label>Pursed Lip Breathing Exercise Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>During the first interview, the training and demonstration of pursed lip breathing exercise is performed by the thesis student in a single session. After this information session, the pursed lip breathing exercise taught from the patients; They are asked to do it in their own homes, 3 days a week on Monday, Wednesday and Friday, for about 30 minutes each session, for a total of eight weeks. In addition, one day a week (on a day determined by the patient, Monday, Wednesday or Friday), the thesis student makes a video call to the patient on WhatsApp, and the practice of pursed lip breathing exercise is performed during the video call.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Laughter Therapy Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>During the first interview, laughter therapy training and demonstration is carried out by the thesis student in a single session. After this information session, the laughter therapy taught from the patients; They are asked to do this in their own homes, 3 days a week on Monday, Wednesday and Friday, 30 minutes each session, for a total of eight weeks. . In addition, once a week (on a day determined by the patient, Monday, Wednesday or Friday), the thesis student makes a video call to the patient on WhatsApp, and laughter therapy is practiced during the video call.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Attention-match training is given to the patients in the control group. During the first interview, attention matching training is carried out by the thesis student for one time, about &quot;Lung structure and functioning&quot;, lasting approximately 20 minutes. In addition, a brochure about lung structure and functioning is given to patients. The patients in the control group are not subjected to any other interventions throughout the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pursed Lip Breathing Exercise</intervention_name>
      <description>Pursed Lip Breathing Exercise for The COPD</description>
      <arm_group_label>Pursed Lip Breathing Exercise Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Laughter Therapy</intervention_name>
      <description>Laughter Therapy for the COPD</description>
      <arm_group_label>Laughter Therapy Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>the control group.</intervention_name>
      <description>Attention-match training is given to the patients in the control group.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Those aged 40 and over,&#xD;
  &#xD;
            -  He was diagnosed with COPD as a result of medical history, physical examination and&#xD;
               pulmonary function tests, and his CAT score is 10 and above according to the COPD&#xD;
               Unified Assessment* of the GOLD guide; In Group B and D (1),&#xD;
  &#xD;
            -  There is no diagnosis of a disease that may affect the cognitive state,&#xD;
  &#xD;
            -  Not having a diagnosis of a physical or mental illness that will prevent&#xD;
               communication, and able to use a telephone.&#xD;
  &#xD;
            -  Individuals who agree to participate in the research are included in the study&#xD;
  &#xD;
          Non-Inclusion Criteria:&#xD;
  &#xD;
          Those who have difficulty in verbal communication (intubation, tracheostomy, delirium,&#xD;
          etc.)&#xD;
  &#xD;
            -  With a CAT score of less than 10 and in Groups A and C according to the COPD Combined&#xD;
               Assessment* of the GOLD guide,&#xD;
  &#xD;
            -  Having a disorder that disrupts the cognitive process such as schizophrenia or&#xD;
               dementia&#xD;
  &#xD;
            -  Alcohol, substance addiction,&#xD;
  &#xD;
            -  Laughter therapy was not deemed appropriate due to the diagnosis of abdominal surgery,&#xD;
               uncontrolled hypertension, glaucoma, abdominal hernia, epilepsy in the last three&#xD;
               months,&#xD;
  &#xD;
            -  Using complementary and integrative treatments such as acupuncture, meditation, yoga,&#xD;
               massage, relaxation exercises,&#xD;
  &#xD;
            -  Patients who do not agree to participate in the study are excluded from the study.&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Not complying with pursed lip breathing exercise and laughter therapy and program,&#xD;
  &#xD;
            -  Developing a disease that may affect the health status or a condition requiring&#xD;
               hospitalization (COPD exacerbation, etc.) during the 12-week period during which the&#xD;
               research will take place,&#xD;
  &#xD;
            -  Changes in bronchodilator and oxygen therapy regimens,&#xD;
  &#xD;
            -  A situation that is not suitable for laughter therapy due to the diagnosis of surgery&#xD;
               in the abdominal region, uncontrollable hypertension, glaucoma, abdominal hernia,&#xD;
               epilepsy,&#xD;
  &#xD;
            -  Patients who want to withdraw from the study are excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Goncagul ALDAN</last_name>
      <role>Principal Investigator</role>
      <affiliation>yüksek İhtisas University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Goncagul ALDAN</last_name>
      <phone>05448211224</phone>
      <email>gonc.afa15@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Leyla Özdemir, prof</last_name>
      <email>leylac@hacettepe.edu.tr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Yuksek Ihtisas University</investigator_affiliation>
      <investigator_full_name>Goncagul Aldan</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <keyword>Chronic Obstructive Pulmonary Disease</keyword>
    <keyword>Dyspnea</keyword>
    <keyword>Health Status</keyword>
    <keyword>Pursed Lip Breathing Exercise</keyword>
    <keyword>Laughter Therapy</keyword>
    <keyword>care Dependence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05997550
  org study id: COPD.NURSİNG.YUKSEK
  nct id: NCT05997550
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic Obstructive Pulmonary Disease is a chronic disease with increasing mortality,
        morbidity and prevalence in the world and in our country, and in which serious symptoms,
        especially dyspnea, develop. Due to dyspnea and symptoms, patients experience deterioration
        in their health status and an increase in care dependency. This research is a single-blind,
        randomized controlled experimental study designed to determine the effects of pursed lip
        breathing exercise and laughter therapy on dyspnea severity, health status and care
        dependence in individuals with COPD. The research will be carried out with a total of 63
        patients in Ankara City Hospital Chest Diseases unit. The patients will be stratified
        according to smoking status and COPD Assessment Test scores with the randomization program
        and assigned to 2 intervention groups and 1 control group. During the first interview,
        patients in the 1st intervention group will be provided with pursed lip breathing exercise
        training and application, and training videos and brochures will be given. 2. The patients in
        the intervention group will be given laughter therapy training and practice, and an
        educational brochure will be given. The patients in the control group will also receive
        face-to-face training on lung structure and functioning, and a brochure will be given.
        Patients in the laughter therapy and pursed lip breathing exercise intervention groups will
        be asked to perform these practices three days a week (Monday, Wednesday, Friday) for 8
        weeks. At the beginning of the study, at the 4th, 8th, and 12th weeks, the Dyspnea 12-TR
        Scale, the COPD Evaluation Test, and the Care Dependency Scale will be administered to both
        the intervention and control group patients. In the application of the scales and the
        analysis of the data, the groups will be blinded, and the scale application will be made by
        an independent interviewer. After the analysis of the data in terms of normal distribution
        was done with the Kolmogorow Smirnov test, in the comparison of the data of the patients in
        the intervention and control groups; One Way Analysis of Variance or Kruskal-Wallis Analysis
        of Variance will be applied. Analysis of Variance in Repeated Measurements or Freidman's test
        will be used to calculate the change in groups over time. The statistical significance limit
        will be accepted as p<0.05.
  This research is a single-blind, randomized controlled experimental study in order to
        determine the effect of pursed lip breathing exercise and laughter therapy on dyspnea
        severity, health status and care dependence in individuals with COPD.
  
        Research hypotheses H0-1: Pursed lip breathing exercise has no effect on the severity of
        dyspnea in individuals with COPD.
  
        H0-2: Laughter therapy has no effect on the severity of dyspnea in individuals with COPD.
  
        H0-3: Pursed lip breathing exercise has no effect on health status in individuals with COPD.
  
        H0-4: Laughter therapy has no effect on health status in individuals with COPD. H0-5: Pursed
        lip breathing exercise has no effect on care dependence in individuals with COPD.
  
        H0-6: Laughter therapy has no effect on care dependence in individuals with COPD.
  
        Population: COPD patients receiving service in Ankara City Hospital Chest Diseases
        polyclinics and clinics constitute the population of the research.
  
        Sample: Since there is no study in the literature examining the effects of pursed lip
        breathing exercise and laughter therapy in COPD patients, El-saidy et al. (2019) based on the
        study data, a sample calculation was made; Dyspnea 12 Scale scores before and after pursed
        lip breathing exercise (31.05± 9.2 and 22.31 ± 7.76, respectively) were found to be
        statistically significant (p < 0.001) (66). The effect size was calculated as 1.026 using the
        Priori method and the G Power program, and a total of 63 patients, at least 21 for each
        group, should be included in the study with a confidence interval of 95% and a power of 90%.
  
        Research Group The patients in the institution where the study was conducted were evaluated
        for eligibility for the study. Voluntary consent is obtained by giving information about the
        research. In the study, stratified randomization method is used to ensure homogeneity between
        groups. Using the randomization program (https://www.randomizer.org); Stratified according to
        COPD Assessment Test (CAT) score (10≤ CAT≤ 25 and 25≤ CAT≤ 40) and smoking status (smoker and
        non-smoker); Patient lists were created as pursed lip breathing exercise intervention group,
        laughter therapy intervention group and control group
  
        Research Group The patients in the institution where the study was conducted were evaluated
        for eligibility for the study. Voluntary consent is obtained by giving information about the
        research. In the study, stratified randomization method is used to ensure homogeneity between
        groups. Using the randomization program (https://www.randomizer.org); Stratified according to
        COPD Assessment Test (CAT) score (10≤ CAT≤ 25 and 25≤ CAT≤ 40) and smoking status (smoker and
        non-smoker); Patient lists were created as pursed lip breathing exercise intervention group,
        laughter therapy intervention group and control group.
  
        The evaluation of the eligibility of the patients in the institution where the research was
        carried out, in line with the criteria of inclusion and exclusion from the research, is made
        by the thesis student. After the patient was informed about the study and their voluntary
        consent was obtained, the "Patient Information Form" was filled by the thesis student and
        according to the patient lists obtained through the https://www.randomizer.org program and
        stratified randomization, the patients were pursed lip breathing exercise intervention group,
        laughter therapy intervention group. and assigned to control groups.
  
        Intervention Groups
  
        Intervention Group (A):
  
        During the first interview, the training and demonstration of pursed lip breathing exercise
        is performed by the thesis student in a single session, lasting approximately 40 minutes. The
        effects of pursed lip breathing exercise on health and its application steps are explained to
        the patient, and purse lip breathing exercise is performed together with the patient. In
        addition, the training is reinforced by giving a pursed lip breathing exercise brochure to
        the patient and sending a pursed lip breathing exercise application video prepared by the
        thesis student via whatsapp. Patients who do not have Whatsapp application are sent a video
        to one of their family members. After this information session, the pursed lip breathing
        exercise taught from the patients; They are asked to do it in their own homes, 3 days a week
        on Monday, Wednesday and Friday, for about 30 minutes each session, for a total of eight
        weeks. In order to support patients' compliance with the research; During the application
        process, on Mondays, Wednesdays and Fridays, the patient was contacted by the thesis student
        at a predetermined time, and the situation of performing pursed lip breathing exercise was
        questioned and recorded in the control chart . In addition, one day a week (on a day
        determined by the patient, Monday, Wednesday or Friday), the thesis student makes a video
        call to the patient on WhatsApp, and the practice of pursed lip breathing exercise is
        performed during the video call. After the end of the eighth week, the patients are asked to
        take a break from the pursed lip breathing exercise for 4 weeks (weeks 9-12), and no
        application is made during this period.
  
        Intervention Group (B) During the first interview, laughter therapy training and
        demonstration is carried out by the thesis student in a single session, lasting approximately
        50 minutes. The effects of laughter therapy on health and its application steps are explained
        to the patient, and the laughter therapy practice is carried out together with the patient.
        In addition, the training is reinforced by giving a laughter therapy training brochure to the
        patient and sending the laughter therapy application video prepared by the thesis student via
        whatsapp. Patients who do not have Whatsapp application are sent a video to one of their
        family members. After this information session, the laughter therapy taught from the
        patients; They are asked to do this in their own homes, 3 days a week on Monday, Wednesday
        and Friday, 30 minutes each session, for a total of eight weeks. In order to support
        patients' compliance with the research; During the application process, on Mondays,
        Wednesdays and Fridays, the patient is contacted by the thesis student at a predetermined
        time, and their status of doing laughter therapy is questioned and recorded in the laughter
        therapy application control chart. In addition, once a week (on a day determined by the
        patient, Monday, Wednesday or Friday), the thesis student makes a video call to the patient
        on WhatsApp, and laughter therapy is practiced during the video call. After the end of the
        eighth week, the patients are asked to take a break from the laughter therapy for 4 weeks
        (weeks 9-12), and no application is made during this period.
  
        Control Group(C) Attention-match training is given to the patients in the control group.
        During the first interview, attention matching training is carried out by the thesis student
        for one time, about "Lung structure and functioning", lasting approximately 20 minutes. In
        addition, a brochure about lung structure and functioning is given to patients. The patients
        in the control group are not subjected to any other interventions throughout the study.
  
        Data Collection The evaluation of the eligibility of the patients in the institution where
        the research was carried out, in line with the criteria of inclusion and exclusion from the
        research, is made by the thesis student. After the patient was informed about the study and
        their voluntary consent was obtained, the "Patient Information Form" was filled by the thesis
        student and according to the patient lists obtained through the https://www.randomizer.org
        program and stratified randomization, the patients were pursed lip breathing exercise
        intervention group, laughter therapy intervention group. and assigned to control groups. The
        scales used in the research are filled by an independent interviewer. In order to provide
        blinding during the data collection phase of the study, the information about which groups
        the patients belong to is hidden from the interviewer. In addition, patients are told not to
        share the information of which group they belong to during the data collection process.
  
        Dyspnea-12 Scale, COPD Assessment Test and Care Dependence Scale 1.,2. all patients in the
        intervention and control groups; On the first interview day, they are told to take a break
        from the 4th, 8th and pursed lip breathing exercise and laughter therapy programs for 4
        weeks, and they are applied again in the 12th week. The scales are filled by an independent
        interviewer by telephone after the completion of pursed lip breathing exercise and laughter
        therapy on Friday of the 4th, 8th and 12th weeks. The interviewer was given a training that
        included the structure, application and purpose of the scale by the thesis student.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Dyspnea in the COPD
  time frame: 12 week
  description: Dyspnea-12 Scale, all patients in the intervention and control groups; On the first interview day, they are told to take a break from the 4th, 8th and pursed lip breathing exercise and laughter therapy programs for 4 weeks, and they are applied again in the 12th week.
  Dyspnea -12 scale, Yorke et al (2010) to measure the severity of dyspnea and to evaluate it with emotional and physical dimensions. The first 7 items measure whether the inhaled air fills all the lungs, the difficulty in breathing and the physical limitations of dyspnea in which the required effort is questioned. The other 5 items of the scale question emotional states such as stress, irritability and depression that may arise from shortness of breath. The severity of dyspnea is directly proportional to the scores obtained from the scale, and as the scores increase, the severity of dyspnea increases
  measure: Health Status in The COPD
  time frame: 12 week
  description: COPD assessment test, all patients in the intervention and control groups; On the first interview day, they are told to take a break from the 4th, 8th and pursed lip breathing exercise and laughter therapy programs for 4 weeks, and they are applied again in the 12th week.
  COPD assessment test, Jones et al. (2009) to measure health status in COPD and to evaluate the disease effect and severity. The eight-question test provides information on the grading of the disease, the scoring of symptoms, and the impact on the patient's quality of life. It covers problems such as shortness of breath, cough, and sputum production, as well as symptoms such as fatigue and sleep problems. Perfect health status: 0 points (minimum score), worst health status: 40 points (maximum score).
  measure: Care Dependence in The COPD
  time frame: 12 week
  description: COPD assessment test, all patients in the intervention and control groups; On the first interview day, they are told to take a break from the 4th, 8th and pursed lip breathing exercise and laughter therapy programs for 4 weeks, and they are applied again in the 12th week.
  Care Dependence Scale (CDS) Dijkstra et al. (1999) to evaluate the individual's dependence on care and to deal with addiction with its physical and psychological dimensions .The scale includes nutrition, continence, body posture, mobility, sleep, dressing, body temperature, body cleanliness, avoiding danger, verbal communication, communicating with others, worshiping, obeying rules, daily activities, recreational activities, memory and learning ability. A high scale score indicates that the patient is independent in meeting his/her care needs, while a low scale score indicates that the patient is dependent on others to meet their care needs.
  measure: Pursed Lip Breathing Exercise and Laughter Therapy in Individuals with Chronic Obstructive Pulmonary Disease
  time frame: The time interval for each patient is 12 weeks.
  description: The independent variable of the study consists of pursed lip breathing exercise, laughter therapy, demographics and introductory information about the disease. In the study, severity of dyspnea, health status and level of care dependency are the dependent variables of the study.
  In the analysis of socio-demographic data in the study, the mean and standard deviation for numerical variables with normal distribution; For numerical variables that are not normally distributed, median, percentiles, minimum and maximum values will be used. Descriptive statistics of categorical variables will be given in the form of frequency distributions (number, percentage). In addition, the demographic and disease-related descriptive data of the patients and the relationship between dyspnea severity, health status and care dependency will be examined.Finally, the interventions (pursed lip breathing exercise, laughter therapy) will be compared with each other and with the control groups.
  arm group label: Pursed Lip Breathing Exercise Group
  arm group type: Active Comparator
  description: During the first interview, the training and demonstration of pursed lip breathing exercise is performed by the thesis student in a single session. After this information session, the pursed lip breathing exercise taught from the patients; They are asked to do it in their own homes, 3 days a week on Monday, Wednesday and Friday, for about 30 minutes each session, for a total of eight weeks. In addition, one day a week (on a day determined by the patient, Monday, Wednesday or Friday), the thesis student makes a video call to the patient on WhatsApp, and the practice of pursed lip breathing exercise is performed during the video call.
  arm group label: Laughter Therapy Group
  arm group type: Active Comparator
  description: During the first interview, laughter therapy training and demonstration is carried out by the thesis student in a single session. After this information session, the laughter therapy taught from the patients; They are asked to do this in their own homes, 3 days a week on Monday, Wednesday and Friday, 30 minutes each session, for a total of eight weeks. . In addition, once a week (on a day determined by the patient, Monday, Wednesday or Friday), the thesis student makes a video call to the patient on WhatsApp, and laughter therapy is practiced during the video call.
  arm group label: Control Group
  arm group type: Placebo Comparator
  description: Attention-match training is given to the patients in the control group. During the first interview, attention matching training is carried out by the thesis student for one time, about "Lung structure and functioning", lasting approximately 20 minutes. In addition, a brochure about lung structure and functioning is given to patients. The patients in the control group are not subjected to any other interventions throughout the study.
  intervention type: Other
  intervention name: Pursed Lip Breathing Exercise
  description: Pursed Lip Breathing Exercise for The COPD
  arm group label: Pursed Lip Breathing Exercise Group
  intervention type: Other
  intervention name: Laughter Therapy
  description: Laughter Therapy for the COPD
  arm group label: Laughter Therapy Group
  intervention type: Other
  intervention name: the control group.
  description: Attention-match training is given to the patients in the control group.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Goncagul ALDAN
  role: Principal Investigator
  affiliation: yüksek İhtisas University
  last name: Goncagul ALDAN
  phone: 05448211224
  email: gonc.afa15@gmail.com
  last name: Leyla Özdemir, prof
  email: leylac@hacettepe.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Yuksek Ihtisas University
  investigator full name: Goncagul Aldan
  investigator title: lecturer
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  sharing ipd: No