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/NCT06013280</url>
    </required_header>
    <id_info>
      <org_study_id>IstanbulMUH-FTR-SIS-01</org_study_id>
      <nct_id>NCT06013280</nct_id>
    </id_info>
    <brief_title>The Effect of Relaxation Techniques on Earthquake Survivors</brief_title>
    <official_title>The Effect of Relaxation and Breathing Exercise on Post-Earthquake Stress Related Symptoms</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medipol University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medipol University Hospital</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>
        The aim of this study is to investigate the effect of relaxation and breathing exercises on&#xD;
        individuals experiencing post-earthquake stress-related symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Earthquakes negatively affect survivors both physically and psychologically. Early&#xD;
        psychological symptoms after disasters are considered normal responses to an abnormal event.&#xD;
        Therefore, it is not unexpected to feel very intense negative emotions after such traumas.&#xD;
        However, the chronicity of these negative emotions puts the lives of individuals at risk.&#xD;
        Mental problems such as stress, depression, posttraumatic stress disorder and anxiety are&#xD;
        seen at high levels among earthquake survivors. In this study, it was aimed to investigate&#xD;
        the effect of relaxation and breathing exercises applied to earthquake survivors who&#xD;
        experienced post-earthquake stress-related symptoms.&#xD;
  &#xD;
        There are two gropus: relaxing exercise group and control group. Relaxing and breathing&#xD;
        exercise protocol is only for relaxing exercise group. A protocol consisting of 40 minutes of&#xD;
        progressive muscle relaxation exercise and breathing exercises, 3 times a week for 4 weeks,&#xD;
        was planned. Control group participants were asked to continue their daily lives. Evaluations&#xD;
        were made before and 4 weeks after the intervention and stress-related symptoms were&#xD;
        measured.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 20, 2023</start_date>
    <completion_date type="Actual">June 25, 2023</completion_date>
    <primary_completion_date type="Actual">June 25, 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>Two groups with a control group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Beck Anxiety (BAI)</measure>
      <time_frame>four weeks</time_frame>
      <description>Beck Anxiety Inventory is a brief measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. It is a self-report scale consisting of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score ranges from 0-63. The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Posttraumatic Stress Diagnostic Scale (PDS)</measure>
      <time_frame>four weeks</time_frame>
      <description>The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report questionnaire designed to measure the severity of PTSD symptoms. A total score of 1-10 is considered as mild symptoms 11-20 moderate symptoms 21-35 as moderate to severe symptoms and 36 or over as is considered to reflect severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Beck Depression Inventory (BDI)</measure>
      <time_frame>four weeks</time_frame>
      <description>The Beck Depression Inventory Second is a 21-item self-report instrument measuring the existence and severity of symptoms of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale -10</measure>
      <time_frame>four weeks</time_frame>
      <description>The Perceived Stress Scale (PSS-10) is a widely used and well validated 10 item self report questionnaire designed to measure to what degree the respondent appraises his life situation over the past month. A higher score is associated with greater vulnerability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index</measure>
      <time_frame>four weeks</time_frame>
      <description>This scale contains seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efciency, sleep disturbances, use of sleep medication, and daytime dysfunction. There are 19 questions in this questionnaire, with a total score ranging from 0-21. A higher score indicates worse sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SF-12</measure>
      <time_frame>four weeks</time_frame>
      <description>SF-12 evaluates health - related quality of life.It was developed to shorten the SF-36 using a regression method. As per the dimensionality of the SF-36, SF-12 encompasses 12 items that have to be scored in two 0-100 components: the physical component summary (PCS12) and the mental component summary (MCS12). SF-12 items are referred to as physical restrictions, physical functioning, bodily pain, general health compared with others, vitality, social functioning, role limitations due to emotional issues, and mental health (MH). Higher scores indicates higher quality of life.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">46</enrollment>
    <condition>Earthquake</condition>
    <condition>Mental Health Issue</condition>
    <arm_group>
      <arm_group_label>Relaxing Exercise Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Relaxing exercise group participants applied 40 minutes of progressive muscle relaxation and breathing exercises, 3 times a week for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group received no intervention, continued their daily life as usual.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Progresive Muscle Relaxation and Breathing Exercise</intervention_name>
      <description>Intervention protocol contains 40 minuntes sessions, which involved tensing and relaxing the body along with deep breathing.&#xD;
  Protocol consisted with; Warm-up (5 minutes breathing exercise) Progressive Muscle Relaxation Exercises (The participants performed PMR for each body part in a particular order, beginning with the face muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet. This muscle tensing and relaxing procedures were performed in accompaniment with deep breathing.) Cool-down (5 minutes breathing exercise)</description>
      <arm_group_label>Relaxing Exercise Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals with a Beck anxiety inventory score greater than 8 and anxiety experience&#xD;
               for more than 1 month&#xD;
  &#xD;
            -  Individuals who experienced the earthquake of February 6, 2023 Kahramanmaraş / Türkiye&#xD;
               and agreed to participate in the study&#xD;
  &#xD;
            -  Individuals without cognitive impairment&#xD;
  &#xD;
            -  Individuals who can understand and apply verbal commands in Turkish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any history of psychiatric medication support for the last 6 months&#xD;
  &#xD;
            -  Any history of psychological problems before the earthquake&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sabiha Irem Sancaktar, M.Sc.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istanbul Medipol Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Istanbul Medipol University</name>
        <address>
          <city>Istanbul</city>
          <state>Beykoz</state>
          <zip>34820</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
      <investigator_full_name>sabiha sancaktar</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>earthquake</keyword>
    <keyword>physiotherapy</keyword>
    <keyword>breathing exercise</keyword>
    <keyword>relaxing exercise</keyword>
    <keyword>stress</keyword>
    <keyword>mental health</keyword>
    <!-- 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/NCT06013280
  org study id: IstanbulMUH-FTR-SIS-01
  nct id: NCT06013280
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate the effect of relaxation and breathing exercises on
        individuals experiencing post-earthquake stress-related symptoms.
  Earthquakes negatively affect survivors both physically and psychologically. Early
        psychological symptoms after disasters are considered normal responses to an abnormal event.
        Therefore, it is not unexpected to feel very intense negative emotions after such traumas.
        However, the chronicity of these negative emotions puts the lives of individuals at risk.
        Mental problems such as stress, depression, posttraumatic stress disorder and anxiety are
        seen at high levels among earthquake survivors. In this study, it was aimed to investigate
        the effect of relaxation and breathing exercises applied to earthquake survivors who
        experienced post-earthquake stress-related symptoms.
  
        There are two gropus: relaxing exercise group and control group. Relaxing and breathing
        exercise protocol is only for relaxing exercise group. A protocol consisting of 40 minutes of
        progressive muscle relaxation exercise and breathing exercises, 3 times a week for 4 weeks,
        was planned. Control group participants were asked to continue their daily lives. Evaluations
        were made before and 4 weeks after the intervention and stress-related symptoms were
        measured.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two groups with a control group
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Beck Anxiety (BAI)
  time frame: four weeks
  description: Beck Anxiety Inventory is a brief measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. It is a self-report scale consisting of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score ranges from 0-63. The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.
  measure: The Posttraumatic Stress Diagnostic Scale (PDS)
  time frame: four weeks
  description: The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report questionnaire designed to measure the severity of PTSD symptoms. A total score of 1-10 is considered as mild symptoms 11-20 moderate symptoms 21-35 as moderate to severe symptoms and 36 or over as is considered to reflect severe symptoms.
  measure: Beck Depression Inventory (BDI)
  time frame: four weeks
  description: The Beck Depression Inventory Second is a 21-item self-report instrument measuring the existence and severity of symptoms of depression.
  measure: Perceived Stress Scale -10
  time frame: four weeks
  description: The Perceived Stress Scale (PSS-10) is a widely used and well validated 10 item self report questionnaire designed to measure to what degree the respondent appraises his life situation over the past month. A higher score is associated with greater vulnerability.
  measure: Pittsburgh Sleep Quality Index
  time frame: four weeks
  description: This scale contains seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efciency, sleep disturbances, use of sleep medication, and daytime dysfunction. There are 19 questions in this questionnaire, with a total score ranging from 0-21. A higher score indicates worse sleep quality.
  measure: SF-12
  time frame: four weeks
  description: SF-12 evaluates health - related quality of life.It was developed to shorten the SF-36 using a regression method. As per the dimensionality of the SF-36, SF-12 encompasses 12 items that have to be scored in two 0-100 components: the physical component summary (PCS12) and the mental component summary (MCS12). SF-12 items are referred to as physical restrictions, physical functioning, bodily pain, general health compared with others, vitality, social functioning, role limitations due to emotional issues, and mental health (MH). Higher scores indicates higher quality of life.
  arm group label: Relaxing Exercise Group
  arm group type: Experimental
  description: Relaxing exercise group participants applied 40 minutes of progressive muscle relaxation and breathing exercises, 3 times a week for 4 weeks
  arm group label: Control Group
  arm group type: No Intervention
  description: This group received no intervention, continued their daily life as usual.
  intervention type: Other
  intervention name: Progresive Muscle Relaxation and Breathing Exercise
  description: Intervention protocol contains 40 minuntes sessions, which involved tensing and relaxing the body along with deep breathing.
  Protocol consisted with; Warm-up (5 minutes breathing exercise) Progressive Muscle Relaxation Exercises (The participants performed PMR for each body part in a particular order, beginning with the face muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet. This muscle tensing and relaxing procedures were performed in accompaniment with deep breathing.) Cool-down (5 minutes breathing exercise)
  arm group label: Relaxing Exercise Group
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sabiha Irem Sancaktar, M.Sc.
  role: Principal Investigator
  affiliation: Istanbul Medipol Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medipol University Hospital
  investigator full name: sabiha sancaktar
  investigator title: Research Assistant