<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/NCT04466319</url>
  </required_header>
  <id_info>
    <org_study_id>80558721-050.99-E.25047</org_study_id>
    <nct_id>NCT04466319</nct_id>
  </id_info>
  <brief_title>The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery</brief_title>
  <official_title>The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With Gastrointestinal System Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eskisehir Osmangazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eskisehir Osmangazi 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 Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With&#xD;
      Gastrointestinal System Surgery&#xD;
&#xD;
      The research will be carried out as a randomized controlled experimental study in patients&#xD;
      with open gastrointestinal tract surgery in order to evaluate the effect of rocking chair&#xD;
      movement to be given in addition to standard care in the initiation of postoperative bowel&#xD;
      functions (post-operative first time gas, first time defecation).Ethics committee and&#xD;
      institution permissions and written consents of individuals were obtained prior to the&#xD;
      study.The universe of the study was composed of patients with open gastrointestinal surgery&#xD;
      lying in the general surgery service of a hospital in Eskisehir. With the error margin of&#xD;
      0.05, 90% test power, 30 people in intervention and control groups, 60 patients in total will&#xD;
      be included in the research.Appointment of patients to intervention and control groups was&#xD;
      done by stratification and block randomization method according to gastric and intestinal&#xD;
      surgery.The draw method was used to assign stratified patients to blind technique&#xD;
      intervention and control groups in order to avoid side-holding, and an equal number&#xD;
      (blocking) patients were assigned to each group. The individuals in the intervention group in&#xD;
      the rocking chair three times a day, 20 minutes, a total of 60 minutes after the first day&#xD;
      after surgery. The individuals in the control group will sit in a standard chair in the same&#xD;
      time as the intervention group in the non-rocking chair. The data will be collected using the&#xD;
      &quot;Descriptive characteristics determination form&quot;, &quot;Intervention Group Intestinal Functions&#xD;
      Evaluation Form&quot; and &quot;Control Group Intestinal Functions Evaluation Form&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion Criteria&#xD;
&#xD;
        -  Accepting to participate in the research&#xD;
&#xD;
        -  Being 18 or over&#xD;
&#xD;
        -  Having gastrointestinal surgery&#xD;
&#xD;
        -  No communication problems&#xD;
&#xD;
        -  No symptoms or disease (dizziness, Vertigo, Meniere.) That rocking chair movement will&#xD;
           adversely affect the patient&#xD;
&#xD;
        -  With or without a stoma in the postoperative period;&#xD;
&#xD;
        -  Patients with ASA (American Society of Anesthesiology) classification I or II&#xD;
&#xD;
      Exclusion Criteria&#xD;
&#xD;
        -  Not agreeing to participate in the research&#xD;
&#xD;
        -  Being 18 or under&#xD;
&#xD;
        -  Being a communication problem&#xD;
&#xD;
        -  The symptoms or disease (dizziness, Vertigo, Meniere.) That the rocking chair movement&#xD;
           will adversely affect the patient.&#xD;
&#xD;
        -  Having a history of ileus after surgery&#xD;
&#xD;
        -  Any complication after surgery&#xD;
&#xD;
        -  With inflammatory and irritable bowel disease&#xD;
&#xD;
        -  Using drugs that will affect intestinal motility before or after surgery.&#xD;
&#xD;
        -  Surgical intervention is laparoscopic&#xD;
&#xD;
        -  ASA classification is III, IV or V&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2019</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>A randomized controlled experimental study in patients with open gastrointestinal tract surgery to evaluate the effect of rocking chair movement to be given in addition to standard care at the start of postoperative bowel functions (post-operative first gas, initial defecation</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time to report of first flatus</measure>
    <time_frame>Defined as the first time hear the bowel sound after surgery1-5 days</time_frame>
    <description>Defined as the first time flatus happens</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time to report of first defecation</measure>
    <time_frame>End of surgery to the first defecation 1-7 days</time_frame>
    <description>Defined as the first time defecation happens.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of postoperative hospitalization</measure>
    <time_frame>End of surgery to hospital discharge 5-7 days</time_frame>
    <description>Defined as the length hospitalization after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Ileus</condition>
  <arm_group>
    <arm_group_label>intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The individuals in the intervention group in the rocking chair three times a day, 20 minutes, a total of 60 minutes after the first day after surgery.They did this intervention until they first defecation .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The individuals in the control group sat in a standard chair in the same time as the intervention group in the non-rocking chair.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rocking Chair</intervention_name>
    <description>Patients in the experimental group were sat rocking chair three times a day in a rocking wooden chair in addition to their postoperative routine care by their nurses. After providing the rocking chair to the patients' room, the researcher gave the data collection form to be filled by the patient himself. It was the researcher's supervision that the patient sat in the rocking chair for the first time. The rocking chair movement continued to intervene until the patient released gas. After emitting gas, he continued to swing in the rocking chair until he made his first stools. The patient was visited every day until he was discharged. No special clothing or materials were required for the patients to sit in the rocking chair.</description>
    <arm_group_label>intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Agree to participate in the research&#xD;
&#xD;
          -  Being 18 or over&#xD;
&#xD;
          -  Having gastrointestinal surgery&#xD;
&#xD;
          -  No communication problems&#xD;
&#xD;
          -  No symptoms or disease (dizziness, Vertigo, Meniere.) That rocking chair movement will&#xD;
             adversely affect the patient With or without a stoma in the postoperative period;&#xD;
&#xD;
          -  Patients with American Society of Anesthesiology (ASA) classification I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not agreeing to participate in the research&#xD;
&#xD;
          -  being 18 or under&#xD;
&#xD;
          -  Being a communication problem&#xD;
&#xD;
          -  The symptoms or disease (dizziness, Vertigo, Meniere.) That the rocking chair movement&#xD;
             will adversely affect the patient.&#xD;
&#xD;
          -  Having a history of ileus after surgery&#xD;
&#xD;
          -  Any complication after surgery&#xD;
&#xD;
          -  With inflammatory and irritable bowel disease&#xD;
&#xD;
          -  Using drugs that will affect intestinal motility before or after surgery.&#xD;
&#xD;
          -  Surgical intervention is laparoscopic&#xD;
&#xD;
          -  ASA classification is III, IV or V&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nedime Köşgeroğlu, Prof</last_name>
    <role>Study Director</role>
    <affiliation>T.C. İstanbul Rumeli University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dean of the Faculty of Medicine Ground Floor Meşelik Campus</name>
      <address>
        <city>Eskişehir</city>
        <state>Odunpazarı</state>
        <zip>26040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eskisehir Osmangazi University</investigator_affiliation>
    <investigator_full_name>Yasemin Şara</investigator_full_name>
    <investigator_title>research assistant</investigator_title>
  </responsible_party>
  <keyword>Ileus</keyword>
  <keyword>Gastrointestinal Diseases</keyword>
  <keyword>Gastrointestinal Motility</keyword>
  <keyword>Postoperative Complications</keyword>
  <keyword>Nurses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ileus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04466319
org study id: 80558721-050.99-E.25047
nct id: NCT04466319
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Effect of Rocking Chair Movement on the Start of Bowel Functions in Patients With
      Gastrointestinal System Surgery

      The research will be carried out as a randomized controlled experimental study in patients
      with open gastrointestinal tract surgery in order to evaluate the effect of rocking chair
      movement to be given in addition to standard care in the initiation of postoperative bowel
      functions (post-operative first time gas, first time defecation).Ethics committee and
      institution permissions and written consents of individuals were obtained prior to the
      study.The universe of the study was composed of patients with open gastrointestinal surgery
      lying in the general surgery service of a hospital in Eskisehir. With the error margin of
      0.05, 90% test power, 30 people in intervention and control groups, 60 patients in total will
      be included in the research.Appointment of patients to intervention and control groups was
      done by stratification and block randomization method according to gastric and intestinal
      surgery.The draw method was used to assign stratified patients to blind technique
      intervention and control groups in order to avoid side-holding, and an equal number
      (blocking) patients were assigned to each group. The individuals in the intervention group in
      the rocking chair three times a day, 20 minutes, a total of 60 minutes after the first day
      after surgery. The individuals in the control group will sit in a standard chair in the same
      time as the intervention group in the non-rocking chair. The data will be collected using the
      "Descriptive characteristics determination form", "Intervention Group Intestinal Functions
      Evaluation Form" and "Control Group Intestinal Functions Evaluation Form".
Inclusion Criteria

        -  Accepting to participate in the research

        -  Being 18 or over

        -  Having gastrointestinal surgery

        -  No communication problems

        -  No symptoms or disease (dizziness, Vertigo, Meniere.) That rocking chair movement will
           adversely affect the patient

        -  With or without a stoma in the postoperative period;

        -  Patients with ASA (American Society of Anesthesiology) classification I or II

      Exclusion Criteria

        -  Not agreeing to participate in the research

        -  Being 18 or under

        -  Being a communication problem

        -  The symptoms or disease (dizziness, Vertigo, Meniere.) That the rocking chair movement
           will adversely affect the patient.

        -  Having a history of ileus after surgery

        -  Any complication after surgery

        -  With inflammatory and irritable bowel disease

        -  Using drugs that will affect intestinal motility before or after surgery.

        -  Surgical intervention is laparoscopic

        -  ASA classification is III, IV or V
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized controlled experimental study in patients with open gastrointestinal tract surgery to evaluate the effect of rocking chair movement to be given in addition to standard care at the start of postoperative bowel functions (post-operative first gas, initial defecation
primary purpose: Other
masking: None (Open Label)
measure: time to report of first flatus
time frame: Defined as the first time hear the bowel sound after surgery1-5 days
description: Defined as the first time flatus happens
measure: time to report of first defecation
time frame: End of surgery to the first defecation 1-7 days
description: Defined as the first time defecation happens.
measure: length of postoperative hospitalization
time frame: End of surgery to hospital discharge 5-7 days
description: Defined as the length hospitalization after surgery
arm group label: intervention arm
arm group type: Experimental
description: The individuals in the intervention group in the rocking chair three times a day, 20 minutes, a total of 60 minutes after the first day after surgery.They did this intervention until they first defecation .
arm group label: Control arm
arm group type: No Intervention
description: The individuals in the control group sat in a standard chair in the same time as the intervention group in the non-rocking chair.
intervention type: Other
intervention name: Rocking Chair
description: Patients in the experimental group were sat rocking chair three times a day in a rocking wooden chair in addition to their postoperative routine care by their nurses. After providing the rocking chair to the patients' room, the researcher gave the data collection form to be filled by the patient himself. It was the researcher's supervision that the patient sat in the rocking chair for the first time. The rocking chair movement continued to intervene until the patient released gas. After emitting gas, he continued to swing in the rocking chair until he made his first stools. The patient was visited every day until he was discharged. No special clothing or materials were required for the patients to sit in the rocking chair.
arm group label: intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nedime Köşgeroğlu, Prof
role: Study Director
affiliation: T.C. İstanbul Rumeli University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Eskisehir Osmangazi University
investigator full name: Yasemin Şara
investigator title: research assistant
mesh term: Ileus
sharing ipd: No