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/NCT05997394</url>
    </required_header>
    <id_info>
      <org_study_id>SCU-SBF-GK-01</org_study_id>
      <nct_id>NCT05997394</nct_id>
    </id_info>
    <brief_title>The Effect of Prayer on Dyspnea Severity, Anxiety and Spiritual Well-Being in Individuals With COPD</brief_title>
    <acronym>COPD</acronym>
    <official_title>The Effect of Prayer on Dyspnea Severity, Anxiety and Spiritual Well-Being in Individuals With COPD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cumhuriyet University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cumhuriyet 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 study will be conducted in order to examine the effect of prayer to individuals with&#xD;
        COPD on the severity of dyspnea, anxiety and spiritual well-being experienced by patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be conducted on people with COPD. People with COPD disease will be divided&#xD;
        into two groups. The experimental group will be given a prayer lesson for a month. Prayer&#xD;
        listening will not be performed to the control group. At the end of one month, the severity&#xD;
        of dyspnea, anxiety and spiritual well-being levels of people in both groups will be&#xD;
        re-evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 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>
      <intervention_model_description>It is a semi-experimental type of study. It consists of two groups: experiment and control.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>The experimental and control groups will be determined by randomization method by a person other than the researcher. Participants will not know which group they are in.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>dyspnea 12 scale</measure>
      <time_frame>1 month</time_frame>
      <description>as a result of 1-month prayer listening, the severity of dyspnea of the participants in the experimental group decreased. A minimum of 0 and a maximum of 36 points are taken from the scale. The increase in scores indicates that the frequency of dyspnea of patients has increased.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck anxiety scale</measure>
      <time_frame>1 month</time_frame>
      <description>as a result of listening to prayer for 1 month, the anxiety severity of the participants in the experimental group decreased. A minimum of 0 and a maximum of 63 points are taken from the scale. The increase in scores indicates that the frequency of anxiety of patients has increased.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Spiritual Well-Being Scale</measure>
      <time_frame>1 month</time_frame>
      <description>as a result of listening to prayer for 1 month, the spiritual well-being levels of the participants in the experimental group increased. A minimum of 0 and a maximum of 48 points are taken from the scale. An increase in scores indicates an increase in the spiritual well-being of patients.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group will be given a prayer concert for a month. At the end of one month, the severity of dyspnea, anxiety and spiritual well-being levels experienced by the participants will be re-checked.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>There will be no prayer audience for participants in this group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>A prayer concert will be held for the participants.</intervention_name>
      <description>Participants who are in the experimental group will be given a prayer audience.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  90 individuals (45 experiments, 45 controls) who can be contacted, who have agreed to&#xD;
               participate in the study&#xD;
  &#xD;
            -  who are literate, can speak Turkish&#xD;
  &#xD;
            -  who have not participated in a similar application of this study before&#xD;
  &#xD;
            -  who have agreed to participate in the study after being informed about the research&#xD;
  &#xD;
            -  are 18 years old and over, with a COPD diagnosis will be taken&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with mental and hearing problems, who have lost a family member and&#xD;
               someone close to them in the last year&#xD;
  &#xD;
            -  who are using tranquilizers/antidepressants&#xD;
  &#xD;
            -  who have experienced a traumatic situation such as divorce will be excluded from the&#xD;
               sample.&#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>Gülden Kaygusuz Gülden Kaygusuz</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tokat Zile Devlet Hatanesi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gülden Kaygusuz Gülden Kaygusuz</last_name>
      <phone>guldenkay.48@gmail.com</phone>
      <phone_ext>+905382124060</phone_ext>
      <email>guldenkay.48@gmail.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 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>Cumhuriyet University</investigator_affiliation>
      <investigator_full_name>Gülden Kaygusuz</investigator_full_name>
      <investigator_title>Graduate Student</investigator_title>
    </responsible_party>
    <keyword>DYSPNEA</keyword>
    <keyword>SPIRITUAL GOODNESS</keyword>
    <keyword>ANXIETY</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyspnea</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>It is not intended to share the data of individual participants.</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/NCT05997394
  org study id: SCU-SBF-GK-01
  nct id: NCT05997394
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will be conducted in order to examine the effect of prayer to individuals with
        COPD on the severity of dyspnea, anxiety and spiritual well-being experienced by patients.
  This study will be conducted on people with COPD. People with COPD disease will be divided
        into two groups. The experimental group will be given a prayer lesson for a month. Prayer
        listening will not be performed to the control group. At the end of one month, the severity
        of dyspnea, anxiety and spiritual well-being levels of people in both groups will be
        re-evaluated.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: It is a semi-experimental type of study. It consists of two groups: experiment and control.
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: The experimental and control groups will be determined by randomization method by a person other than the researcher. Participants will not know which group they are in.
  measure: dyspnea 12 scale
  time frame: 1 month
  description: as a result of 1-month prayer listening, the severity of dyspnea of the participants in the experimental group decreased. A minimum of 0 and a maximum of 36 points are taken from the scale. The increase in scores indicates that the frequency of dyspnea of patients has increased.
  measure: Beck anxiety scale
  time frame: 1 month
  description: as a result of listening to prayer for 1 month, the anxiety severity of the participants in the experimental group decreased. A minimum of 0 and a maximum of 63 points are taken from the scale. The increase in scores indicates that the frequency of anxiety of patients has increased.
  measure: Spiritual Well-Being Scale
  time frame: 1 month
  description: as a result of listening to prayer for 1 month, the spiritual well-being levels of the participants in the experimental group increased. A minimum of 0 and a maximum of 48 points are taken from the scale. An increase in scores indicates an increase in the spiritual well-being of patients.
  arm group label: Experimental Group
  arm group type: Experimental
  description: Participants in this group will be given a prayer concert for a month. At the end of one month, the severity of dyspnea, anxiety and spiritual well-being levels experienced by the participants will be re-checked.
  arm group label: Control Group
  arm group type: No Intervention
  description: There will be no prayer audience for participants in this group.
  intervention type: Other
  intervention name: A prayer concert will be held for the participants.
  description: Participants who are in the experimental group will be given a prayer audience.
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Gülden Kaygusuz Gülden Kaygusuz
  role: Principal Investigator
  affiliation: Tokat Zile Devlet Hatanesi
  last name: Gülden Kaygusuz Gülden Kaygusuz
  phone: guldenkay.48@gmail.com
  phone ext: +905382124060
  email: guldenkay.48@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Cumhuriyet University
  investigator full name: Gülden Kaygusuz
  investigator title: Graduate Student
  mesh term: Dyspnea
  sharing ipd: No
  ipd description: It is not intended to share the data of individual participants.