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/NCT05988320</url>
    </required_header>
    <id_info>
      <org_study_id>SANKOU-HEM-ZD-02</org_study_id>
      <nct_id>NCT05988320</nct_id>
    </id_info>
    <brief_title>The Effect of Pranayama Breathing Exercise on Fatigue in Cancer Patient Caregivers</brief_title>
    <official_title>Comparison of the Effect on Fatigue of the Cancer Patient Caregiver Who Applied Pranayama Breathing Exercise and no Application</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanko University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sanko 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>
        This research is a randomized controlled experimental study to determine the effect of&#xD;
        pranayama breathing exercise applied to caregivers of cancer patients on fatigue.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        METHODST: The research will be carried out at Erciyes University Health Practice and Research&#xD;
        Center Mehmet Kemal Dedeman Hematology - Oncology Hospital located in Kayseri city center.&#xD;
  &#xD;
        Population and Sample of the Research: The population of the research will be the caregivers&#xD;
        of the patients hospitalized in the medical oncology clinic of Erciyes University Health&#xD;
        Practice and Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital. Cancer&#xD;
        patient caregivers who meet the inclusion criteria of the study and volunteer to participate&#xD;
        in the study will constitute the sample of the study.&#xD;
  &#xD;
        Sample of the Research: It was calculated by performing power analysis for the sample of the&#xD;
        research. In the article titled &quot;Evaluation of fatigue and sleep quality of caregivers of&#xD;
        advanced cancer patients&quot;, the minimum sample size per group was 22 when the calculation was&#xD;
        made as alpha=0.05 and power=0.80, taking into account the pretest-posttest fatigue score&#xD;
        averages of the caregivers. It is planned to take 30 people per group Data Collection Form&#xD;
        and Tools: The data of the study will be collected through the Caregiver Information Form,&#xD;
        Piper Fatigue Scale, Informed Voluntary Consent Form, Eastern Cooperative Oncology Group (for&#xD;
        the patient) Performance Scale forms.&#xD;
  &#xD;
        Data Collection: Ethics committee, institutional permission and scale usage permission were&#xD;
        obtained for the data of the study. Intervention and control group selection in the study&#xD;
        will be collected by minimization randomization. The data will be collected by the researcher&#xD;
        himself by face-to-face interview method. The intervention group will be given pranayama&#xD;
        training. The post-test will be done four weeks after both groups are pre-tested.&#xD;
  &#xD;
        Pre-Test: . After informing the caregivers of cancer patients in the Medical Oncology clinic&#xD;
        about the research and obtaining verbal and written consent from the researcher, the&#xD;
        caregiver introduction form and Piper fatigue scale will be applied to the experimental and&#xD;
        control groups, respectively.&#xD;
  &#xD;
        Post-Test: The piper fatigue scale will be re-administered to the individuals in both groups&#xD;
        by the same researcher four weeks after the pre-test, and one day after the pranayama&#xD;
        breathing exercise in the control group and experimental group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 20, 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>The caregivers of the patients hospitalized in the medical oncology clinic of the Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital will be formed. Cancer patient caregivers who meet the inclusion criteria of the study and volunteer to participate in the study will constitute the sample of the study.It is planned to take 30 people per group and 60 people in total.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>fatigue of cancer caregivers</measure>
      <time_frame>four weeks</time_frame>
      <description>Measuring the fatigue of cancer patient caregivers before and after four weeks of training</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Caregiver</condition>
    <condition>Fatigue</condition>
    <arm_group>
      <arm_group_label>Experimental: Applications to the Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pranayama breathing will be performed by the caregivers of cancer patients in the Medical Oncology clinic for a total of 4 weeks, covering 15-20 minutes every day, for a total of 4 weeks. information will be given about the benefits and benefits, and any questions will be answered. The application steps will be repeated both by explaining and showing, until the caregiver learns, and if there are any points that they cannot do, they will be corrected. When the caregivers are observed to perform the application fully, they will be asked to do the pranayama breathing exercise every day for 4 weeks and will provide the effectiveness and continuity of the application by providing the same researcher 3 days a week (Tuesday, Thursday, Saturday) with a smartphone WhatsApp video call.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Applications to the Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Only the pre-test will be applied to the caregivers of cancer patients in the Medical Oncology clinic in the control group. After the caregiver introduction form and Piper fatigue scale application, no breathing exercises will be performed. Individuals will continue their daily lives. Four weeks later the Piper fatigue scale will be administered again. After the Piper fatigue scale is applied, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Pranayama breathing exercise</intervention_name>
      <description>Pranayama is an important step in yoga, way of life, and is translated as &quot;the science of breathing, breath control, willful breathing&quot;. This alternating breathing-out action also balances the sympathetic and parasympathetic nervous systems, giving the person a state of calm, providing relaxation and positively affecting fatigue. Application steps; Right hand Nasika mudra is performed. Nasika mudra is the mudra where the second and third fingers of the right hand are folded into the palm and the other fingers are exposed. Then the right nostril is closed with the first finger of the right hand. Start by breathing through the left nostril. Then the left nostril is closed with the fourth finger and the breath is held. While the left nostril is closed, the right nostril is opened and inhaled. Breathe again through</description>
      <arm_group_label>Experimental: Applications to the Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Above 18 years old 2. Able to read and write 3. Having sufficient communication&#xD;
               skills 4. Does not have any ailment that will reduce the ability to grasp and&#xD;
               understand 5. Giving active care to inpatients in the clinic 6. Able to use smart&#xD;
               mobile phone 7. Caregivers who agree to participate in the study will be included in&#xD;
               the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - 1. Having a chronic disease 2. Caregivers using opioids or sedating drugs will not be&#xD;
          included in the study.&#xD;
  &#xD;
          3. Using integrated health practices in the treatment process 4. Patients who exercise&#xD;
          regularly will not be included in the study.&#xD;
  &#xD;
          Research Termination Criteria&#xD;
  &#xD;
          Intervention Group&#xD;
  &#xD;
            1. Developing health problems&#xD;
  &#xD;
            2. Unwilling to continue Pranayama practice&#xD;
  &#xD;
            3. Not practicing pranayama as recommended or unable to do it effectively,&#xD;
  &#xD;
            4. The study will be terminated with patients who want to withdraw from the study.&#xD;
  &#xD;
          Control Group&#xD;
  &#xD;
            1. Developing health problems&#xD;
  &#xD;
            2. The study will be terminated with patients who want to withdraw from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zeynep DOĞAN, Master</last_name>
      <phone>+90507 427 49 85</phone>
      <email>zeynep.dogan@sanko.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sevil GÜLER</last_name>
      <phone>+90536 426 38 72</phone>
      <email>sevilbicer@erciyes.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Erciyes University</name>
        <address>
          <city>Kayseri</city>
          <state>Talas</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zeynep DOĞAN</last_name>
        <phone>+905074274985</phone>
        <email>zeynep.dogan@sanko.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sanko University</investigator_affiliation>
      <investigator_full_name>Zeynep Doğan</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>1. cancer patient caregiver 2. pranayama 3. Fatigue</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>We plan to share it after it is ready for publication.</ipd_description>
    </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/NCT05988320
  org study id: SANKOU-HEM-ZD-02
  nct id: NCT05988320
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research is a randomized controlled experimental study to determine the effect of
        pranayama breathing exercise applied to caregivers of cancer patients on fatigue.
  METHODST: The research will be carried out at Erciyes University Health Practice and Research
        Center Mehmet Kemal Dedeman Hematology - Oncology Hospital located in Kayseri city center.
  
        Population and Sample of the Research: The population of the research will be the caregivers
        of the patients hospitalized in the medical oncology clinic of Erciyes University Health
        Practice and Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital. Cancer
        patient caregivers who meet the inclusion criteria of the study and volunteer to participate
        in the study will constitute the sample of the study.
  
        Sample of the Research: It was calculated by performing power analysis for the sample of the
        research. In the article titled "Evaluation of fatigue and sleep quality of caregivers of
        advanced cancer patients", the minimum sample size per group was 22 when the calculation was
        made as alpha=0.05 and power=0.80, taking into account the pretest-posttest fatigue score
        averages of the caregivers. It is planned to take 30 people per group Data Collection Form
        and Tools: The data of the study will be collected through the Caregiver Information Form,
        Piper Fatigue Scale, Informed Voluntary Consent Form, Eastern Cooperative Oncology Group (for
        the patient) Performance Scale forms.
  
        Data Collection: Ethics committee, institutional permission and scale usage permission were
        obtained for the data of the study. Intervention and control group selection in the study
        will be collected by minimization randomization. The data will be collected by the researcher
        himself by face-to-face interview method. The intervention group will be given pranayama
        training. The post-test will be done four weeks after both groups are pre-tested.
  
        Pre-Test: . After informing the caregivers of cancer patients in the Medical Oncology clinic
        about the research and obtaining verbal and written consent from the researcher, the
        caregiver introduction form and Piper fatigue scale will be applied to the experimental and
        control groups, respectively.
  
        Post-Test: The piper fatigue scale will be re-administered to the individuals in both groups
        by the same researcher four weeks after the pre-test, and one day after the pranayama
        breathing exercise in the control group and experimental group.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The caregivers of the patients hospitalized in the medical oncology clinic of the Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital will be formed. Cancer patient caregivers who meet the inclusion criteria of the study and volunteer to participate in the study will constitute the sample of the study.It is planned to take 30 people per group and 60 people in total.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: fatigue of cancer caregivers
  time frame: four weeks
  description: Measuring the fatigue of cancer patient caregivers before and after four weeks of training
  arm group label: Experimental: Applications to the Intervention Group
  arm group type: Experimental
  description: Pranayama breathing will be performed by the caregivers of cancer patients in the Medical Oncology clinic for a total of 4 weeks, covering 15-20 minutes every day, for a total of 4 weeks. information will be given about the benefits and benefits, and any questions will be answered. The application steps will be repeated both by explaining and showing, until the caregiver learns, and if there are any points that they cannot do, they will be corrected. When the caregivers are observed to perform the application fully, they will be asked to do the pranayama breathing exercise every day for 4 weeks and will provide the effectiveness and continuity of the application by providing the same researcher 3 days a week (Tuesday, Thursday, Saturday) with a smartphone WhatsApp video call.
  arm group label: Applications to the Control Group
  arm group type: No Intervention
  description: Only the pre-test will be applied to the caregivers of cancer patients in the Medical Oncology clinic in the control group. After the caregiver introduction form and Piper fatigue scale application, no breathing exercises will be performed. Individuals will continue their daily lives. Four weeks later the Piper fatigue scale will be administered again. After the Piper fatigue scale is applied, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions.
  intervention type: Procedure
  intervention name: Pranayama breathing exercise
  description: Pranayama is an important step in yoga, way of life, and is translated as "the science of breathing, breath control, willful breathing". This alternating breathing-out action also balances the sympathetic and parasympathetic nervous systems, giving the person a state of calm, providing relaxation and positively affecting fatigue. Application steps; Right hand Nasika mudra is performed. Nasika mudra is the mudra where the second and third fingers of the right hand are folded into the palm and the other fingers are exposed. Then the right nostril is closed with the first finger of the right hand. Start by breathing through the left nostril. Then the left nostril is closed with the fourth finger and the breath is held. While the left nostril is closed, the right nostril is opened and inhaled. Breathe again through
  arm group label: Experimental: Applications to the Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zeynep DOĞAN, Master
  phone: +90507 427 49 85
  email: zeynep.dogan@sanko.edu.tr
  last name: Sevil GÜLER
  phone: +90536 426 38 72
  email: sevilbicer@erciyes.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Sanko University
  investigator full name: Zeynep Doğan
  investigator title: Lecturer
  mesh term: Fatigue
  sharing ipd: No
  ipd description: We plan to share it after it is ready for publication.