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/NCT05969509</url>
    </required_header>
    <id_info>
      <org_study_id>AtaturkU-SBF-SZ-01</org_study_id>
      <nct_id>NCT05969509</nct_id>
    </id_info>
    <brief_title>Investigation of the Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy</brief_title>
    <official_title>Investigation of the Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ataturk 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>
        The goal of this clinical trial is to compare in health conditions. The main questions it&#xD;
        aims to answer are:&#xD;
  &#xD;
        Does progressive relaxation exercises reduce pain in patients undergoing laparoscopic&#xD;
        cholecystectomy? Does progressive relaxation exercises increase bowel movements in patients&#xD;
        undergoing laparoscopic cholecystectomy?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of our experimentally randomized controlled study, which researchers conducted in&#xD;
        order to study the effect of progressive relaxation exercises on pain and bowel movements in&#xD;
        patients undergoing laparoscopic cholecystectomy, is to reduce pain by intermittent&#xD;
        application of progressive relaxation exercises to patients after surgery and to study the&#xD;
        effect of exercise on bowel movements at an early stage.&#xD;
  &#xD;
        after the necessary permissions have been obtained july- september dates, Van Yüzüncü yıl&#xD;
        university Dursun Odabaş medical center, in the general surgery clinic , patients who agree&#xD;
        to participate in the study and meet the sample selection criteria will be included in the&#xD;
        study. Patient presentation form, bowel movement monitoring form and Visual Analog Scale&#xD;
        (VAS) Pain Form will be used in the collection of research data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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 consisting of experimental and control groups performed cholecystectomy.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>the cholecystectomy group will be given exercise sessions and the result evaluations will be performed by a researcher who is blind to the group allocation</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale (VAS) Pain Form</measure>
      <time_frame>examination between 1-2 days until Decontamination from surgery</time_frame>
      <description>it is a scale with two ends named differently on the vertical or horizontal line with a length of 10 cm (0=no pain, 10=the most severe pain). Marking the point corresponding to the intensity of pain felt by the patient on this line</description>
    </primary_outcome>
    <primary_outcome>
      <measure>bowel movement monitoring form</measure>
      <time_frame>examination between 1-2 days until Decontamination from surgery</time_frame>
      <description>It is the form in which the intestinal sounds, gas extraction and defecation sounds of the patients are monitored by the researcher.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Pain, Postoperative</condition>
    <arm_group>
      <arm_group_label>the group that performed relaxation exercises</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients' postoperative pain and bowel movements will be evaluated by applying relaxation exercise intermittently</description>
    </arm_group>
    <arm_group>
      <arm_group_label>the group that did not do relaxation exercises</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>patients' postoperative pain and bowel movements will be evaluated</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>progressive relaxation exercise</intervention_name>
      <description>applying progressive relaxation exercise to the experimental group after postoperative cholecystectomy and observing the experimental-control groups</description>
      <arm_group_label>the group that performed relaxation exercises</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Who experienced laparoscopic cholecystectomy surgery as planned for the first time&#xD;
  &#xD;
            -  Who volunteered to participate in the research&#xD;
  &#xD;
            -  18 years and over&#xD;
  &#xD;
            -  Whose mental state is healthy&#xD;
  &#xD;
            -  Without vision, hearing and speech problems&#xD;
  &#xD;
            -  Patients who know Turkish were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Who have previously practiced progressive relaxation exercises&#xD;
  &#xD;
            -  Someone with communication problems&#xD;
  &#xD;
            -  Health problems that prevent the practice of progressive relaxation exercises&#xD;
               (Epilepsy, bipolar disorder, schizophrenia, fever, infection, etc. ) is&#xD;
  &#xD;
            -  Patients who were not willing to participate in the study were not included in the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>şuheda zorer</last_name>
      <role>Principal Investigator</role>
      <affiliation>van yüzüncü yıl university dursun odabaş medical center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>şuheda zorer</last_name>
      <phone>05427336700</phone>
      <email>zorersuheda@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Van Yüzüncü Yıl University Dursun Odabaş Medical Center</name>
        <address>
          <city>VAN</city>
          <zip>65000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Van Yüzüncü Yıl Üniversitesi Dursun Odabaş Tıp Merkezi</last_name>
        <phone>(0432) 215 04 70</phone>
        <email>hastane@yyu.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>Şuheda Zorer</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</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/NCT05969509
  org study id: AtaturkU-SBF-SZ-01
  nct id: NCT05969509
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare in health conditions. The main questions it
        aims to answer are:
  
        Does progressive relaxation exercises reduce pain in patients undergoing laparoscopic
        cholecystectomy? Does progressive relaxation exercises increase bowel movements in patients
        undergoing laparoscopic cholecystectomy?
  The purpose of our experimentally randomized controlled study, which researchers conducted in
        order to study the effect of progressive relaxation exercises on pain and bowel movements in
        patients undergoing laparoscopic cholecystectomy, is to reduce pain by intermittent
        application of progressive relaxation exercises to patients after surgery and to study the
        effect of exercise on bowel movements at an early stage.
  
        after the necessary permissions have been obtained july- september dates, Van Yüzüncü yıl
        university Dursun Odabaş medical center, in the general surgery clinic , patients who agree
        to participate in the study and meet the sample selection criteria will be included in the
        study. Patient presentation form, bowel movement monitoring form and Visual Analog Scale
        (VAS) Pain Form will be used in the collection of research data.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: two groups consisting of experimental and control groups performed cholecystectomy.
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  masking description: the cholecystectomy group will be given exercise sessions and the result evaluations will be performed by a researcher who is blind to the group allocation
  measure: Visual Analog Scale (VAS) Pain Form
  time frame: examination between 1-2 days until Decontamination from surgery
  description: it is a scale with two ends named differently on the vertical or horizontal line with a length of 10 cm (0=no pain, 10=the most severe pain). Marking the point corresponding to the intensity of pain felt by the patient on this line
  measure: bowel movement monitoring form
  time frame: examination between 1-2 days until Decontamination from surgery
  description: It is the form in which the intestinal sounds, gas extraction and defecation sounds of the patients are monitored by the researcher.
  arm group label: the group that performed relaxation exercises
  arm group type: Experimental
  description: patients' postoperative pain and bowel movements will be evaluated by applying relaxation exercise intermittently
  arm group label: the group that did not do relaxation exercises
  arm group type: No Intervention
  description: patients' postoperative pain and bowel movements will be evaluated
  intervention type: Other
  intervention name: progressive relaxation exercise
  description: applying progressive relaxation exercise to the experimental group after postoperative cholecystectomy and observing the experimental-control groups
  arm group label: the group that performed relaxation exercises
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: şuheda zorer
  role: Principal Investigator
  affiliation: van yüzüncü yıl university dursun odabaş medical center
  last name: şuheda zorer
  phone: 05427336700
  email: zorersuheda@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ataturk University
  investigator full name: Şuheda Zorer
  investigator title: principal investigator
  mesh term: Pain, Postoperative
  sharing ipd: No