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/NCT06024044</url>
    </required_header>
    <id_info>
      <org_study_id>2022/P428</org_study_id>
      <nct_id>NCT06024044</nct_id>
    </id_info>
    <brief_title>Effect of Mobilization Training Given to Hysterectomy Operation on Bottom Functions and Pain</brief_title>
    <official_title>The Effect of Mobilization Training Given to Women Before the Hysterectomy Operation on Post-Operational Bottom Functions and Pain: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Trakya University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Trakya University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Objectives: Research on the effect of mobilization training given to women before the&#xD;
        hysterectomy operation on post-operational bottom functions and pain is a new and promising&#xD;
        feld of research. However, high-level evidence on whether mobilization and mobilization&#xD;
        training has an effect on bowel function and pain is insufficient. The present study&#xD;
        addresses this research question.&#xD;
  &#xD;
        Design: A two-arm randomized controlled trial was conducted in 82 women patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This two-arm randomized controlled trial (RCT) was conducted in the women patients undergoing&#xD;
        hysterectomy located in Edirne, between May 2022 and June 2023. During the intake, the women&#xD;
        patients undergoing hysterectomy were informed about the goals and setup of the study and&#xD;
        intervention, and assessed for eligibility by a brief standardized interview. The women&#xD;
        patients undergoing hysterectomy who fulfilled our criteria received an information letter&#xD;
        and informed consent form, as well as the baseline questionnaire. Those women patients&#xD;
        undergoing hysterectomy that provided written informed consent for participation were&#xD;
        included in the study. Assessments in both groups were performed before randomization (i.e.,&#xD;
        baseline) and directly after the intervention period.&#xD;
  &#xD;
        Randomization: The women patients undergoing hysterectomy were randomly assigned to an&#xD;
        education or control groups. A research assistant not actively involved in the design and&#xD;
        data analysis of the study created a random distribution sequence and assigned participants&#xD;
        to one of the two conditions (1:1 ratio).&#xD;
  &#xD;
        Intervention:&#xD;
  &#xD;
        Mobilization Training: A face-to-face &quot;Patient Information Form&quot; was applied to the training&#xD;
        group in the first interview before the hysterectomy operation. The participants in the&#xD;
        training group were given hysterectomy postoperative mobilization training by the researcher&#xD;
        (B.K) using presentation and verbal information technique. A &quot;Post-Operative Follow-up Chart&quot;&#xD;
        was given to the participants to fill in the 1st and 2nd postoperative days. The training&#xD;
        group participants were followed up by the researcher on the 0th and 1st days after the&#xD;
        operation in line with the mobilization training they received. The &quot;Post-Operative Follow-up&#xD;
        Chart&quot; questioning the patients' mobilization times, distances, bowel functions and pain&#xD;
        scores was filled in by the researcher in detail by face-to-face interview method.&#xD;
        Mobilization time (minutes) and distance (meters) were evaluated by the patients and their&#xD;
        relatives, and recorded on the chart, using the stopwatch and pedometer on the personal&#xD;
        mobile phones of the patients.&#xD;
  &#xD;
        Control Group: The women patients in the control group who underwent hysterectomy were&#xD;
        informed that mobilization training would be performed after a postoperative 2-day waiting&#xD;
        period. Meanwhile, no intervention was made except for any routine nursing care.&#xD;
  &#xD;
        Measures: &quot;Patient Information Form&quot; and &quot;Post-Operative Follow-up Chart&quot; were used in the&#xD;
        study. Patient Information Form: It was created by the researchers by scanning the literature&#xD;
        and consists of a total of 18 questions, including 6 questions about the personal&#xD;
        characteristics of the participants, 3 questions about the obstetric and surgical&#xD;
        characteristics, and 9 questions about the postoperative results. Postoperative Follow-up&#xD;
        Chart: It was created by the researchers by scanning the literature and consists of a 24-hour&#xD;
        chart including the 0 and 1 postoperative day mobilization time, mobilization distance, pain&#xD;
        score, gas and stool output time of the participants.&#xD;
  &#xD;
        Sample size calculation for the primary research question was performed based on a pilot&#xD;
        study. Tharwat et al. (2021), within the scope of the findings of their study named &quot;Impact&#xD;
        of Sugarless Chewing gum Versus Peppermint on First Bowel Movement after Cesarean Section:&#xD;
        Randomized Controlled Trial&quot;, sample calculation was made by predicting the effect size of&#xD;
        0.6307060, 95% confidence level, and 80% power. Power analysis of the study was performed&#xD;
        with G*POWER 3.1.9.7 (Power analysis statistical software) program (Faul et al., 2021). A&#xD;
        total of 82 women with hysterectomy (Training group: 41 women, Control group: 41 women)&#xD;
        constituted the sample.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 12, 2022</start_date>
    <completion_date type="Actual">June 15, 2023</completion_date>
    <primary_completion_date type="Actual">May 14, 2022</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain evaluated using the Visual Analog Scale</measure>
      <time_frame>change from baseline implamentation patent and after 0 and 1 postoperative day of practice.</time_frame>
      <description>The intensity of pain is measured using the VAS, a valid and reliable tool for measuring experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bottom functions evaluated using the Postoperative Follow-up Chart</measure>
      <time_frame>change from baseline implamentation patent and after 0 and 1 postoperative day of practice.</time_frame>
      <description>It was created by the researchers by scanning the literature, and consists of a 24-hour chart including the 0 and 1 postoperative day mobilization time, mobilization distance, pain score, gas and stool output time of the participants.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">82</enrollment>
    <condition>Mobilization</condition>
    <condition>Training Group</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The women patients in the control group who underwent hysterectomy were informed that mobilization training would be performed after a postoperative 2-day waiting period. Meanwhile, no intervention was made except for any routine nursing care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mobilization Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A face-to-face &quot;Patient Information Form&quot; was applied to the training group in the first interview before the hysterectomy operation. The participants in the training group were given hysterectomy postoperative mobilization training by the researcher (B.K) using presentation and verbal information technique. A &quot;Post-Operative Follow-up Chart&quot; was given to the participants to fill in the 1st and 2nd postoperative days. The training group participants were followed up by the researcher on the 0th and 1st days after the operation in line with the mobilization training they received. The &quot;Post-Operative Follow-up Chart&quot; questioning the patients' mobilization times, distances, bowel functions and pain scores was filled in by the researcher in detail by face-to-face interview method. Mobilization time (minutes) and distance (meters) were evaluated by the patients and their relatives, and recorded on the chart, using the stopwatch and pedometer on the personal mobile phones of the patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mobilization Training</intervention_name>
      <description>The participants in the training group were given hysterectomy postoperative mobilization training by the researcher (B.K) using presentation and verbal information technique. A &quot;Post-Operative Follow-up Chart&quot; was given to the participants to fill in the 1st and 2nd postoperative days. The training group participants were followed up by the researcher on the 0th and 1st days after the operation in line with the mobilization training they received. The &quot;Post-Operative Follow-up Chart&quot; questioning the patients' mobilization times, distances, bowel functions and pain scores was filled in by the researcher in detail by face-to-face interview method. Mobilization time (minutes) and distance (meters) were evaluated by the patients and their relatives, and recorded on the chart, using the stopwatch and pedometer on the personal mobile phones of the patients.</description>
      <arm_group_label>Mobilization Training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having hysterectomy surgery,&#xD;
  &#xD;
            -  At least primary school graduate,&#xD;
  &#xD;
            -  With good mental functions,&#xD;
  &#xD;
            -  Not experiencing serious depression, anxiety and stress,&#xD;
  &#xD;
            -  No serious postoperative complications,&#xD;
  &#xD;
            -  No chronic pain,&#xD;
  &#xD;
            -  No sensory problems (vision loss, auditory loss, etc.),&#xD;
  &#xD;
            -  Women who volunteered to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with depression, anxiety and stress disorder,&#xD;
  &#xD;
            -  Diagnosed with chronic pain,&#xD;
  &#xD;
            -  Women who did not volunteer to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>The women patients undergoing hysterectomy</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Burcu Küçükkaya, Asst. Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bartın University, Faculty of Health Sciences, Nursing Department, Division of Gynecology and Obstetrics Nursing, Bartın, Turkiye</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Zeynep Kızılcık Özkan, Asst. Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Trakya University, Faculty of Health Sciences, Nursing Department, Division of Surgery Nursing, Edirne, Turkiye</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Trakya University</name>
        <address>
          <city>Edirne</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bartın Unıversity</investigator_affiliation>
      <investigator_full_name>Burcu KUCUKKAYA</investigator_full_name>
      <investigator_title>Assist. Prof</investigator_title>
    </responsible_party>
    <keyword>Hysterectomy</keyword>
    <keyword>Women</keyword>
    <keyword>Post-Operational</keyword>
    <keyword>Bottom Functions</keyword>
    <keyword>Pain</keyword>
    <keyword>Mobilization Training</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06024044
  org study id: 2022/P428
  nct id: NCT06024044
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Objectives: Research on the effect of mobilization training given to women before the
        hysterectomy operation on post-operational bottom functions and pain is a new and promising
        feld of research. However, high-level evidence on whether mobilization and mobilization
        training has an effect on bowel function and pain is insufficient. The present study
        addresses this research question.
  
        Design: A two-arm randomized controlled trial was conducted in 82 women patients.
  This two-arm randomized controlled trial (RCT) was conducted in the women patients undergoing
        hysterectomy located in Edirne, between May 2022 and June 2023. During the intake, the women
        patients undergoing hysterectomy were informed about the goals and setup of the study and
        intervention, and assessed for eligibility by a brief standardized interview. The women
        patients undergoing hysterectomy who fulfilled our criteria received an information letter
        and informed consent form, as well as the baseline questionnaire. Those women patients
        undergoing hysterectomy that provided written informed consent for participation were
        included in the study. Assessments in both groups were performed before randomization (i.e.,
        baseline) and directly after the intervention period.
  
        Randomization: The women patients undergoing hysterectomy were randomly assigned to an
        education or control groups. A research assistant not actively involved in the design and
        data analysis of the study created a random distribution sequence and assigned participants
        to one of the two conditions (1:1 ratio).
  
        Intervention:
  
        Mobilization Training: A face-to-face "Patient Information Form" was applied to the training
        group in the first interview before the hysterectomy operation. The participants in the
        training group were given hysterectomy postoperative mobilization training by the researcher
        (B.K) using presentation and verbal information technique. A "Post-Operative Follow-up Chart"
        was given to the participants to fill in the 1st and 2nd postoperative days. The training
        group participants were followed up by the researcher on the 0th and 1st days after the
        operation in line with the mobilization training they received. The "Post-Operative Follow-up
        Chart" questioning the patients' mobilization times, distances, bowel functions and pain
        scores was filled in by the researcher in detail by face-to-face interview method.
        Mobilization time (minutes) and distance (meters) were evaluated by the patients and their
        relatives, and recorded on the chart, using the stopwatch and pedometer on the personal
        mobile phones of the patients.
  
        Control Group: The women patients in the control group who underwent hysterectomy were
        informed that mobilization training would be performed after a postoperative 2-day waiting
        period. Meanwhile, no intervention was made except for any routine nursing care.
  
        Measures: "Patient Information Form" and "Post-Operative Follow-up Chart" were used in the
        study. Patient Information Form: It was created by the researchers by scanning the literature
        and consists of a total of 18 questions, including 6 questions about the personal
        characteristics of the participants, 3 questions about the obstetric and surgical
        characteristics, and 9 questions about the postoperative results. Postoperative Follow-up
        Chart: It was created by the researchers by scanning the literature and consists of a 24-hour
        chart including the 0 and 1 postoperative day mobilization time, mobilization distance, pain
        score, gas and stool output time of the participants.
  
        Sample size calculation for the primary research question was performed based on a pilot
        study. Tharwat et al. (2021), within the scope of the findings of their study named "Impact
        of Sugarless Chewing gum Versus Peppermint on First Bowel Movement after Cesarean Section:
        Randomized Controlled Trial", sample calculation was made by predicting the effect size of
        0.6307060, 95% confidence level, and 80% power. Power analysis of the study was performed
        with G*POWER 3.1.9.7 (Power analysis statistical software) program (Faul et al., 2021). A
        total of 82 women with hysterectomy (Training group: 41 women, Control group: 41 women)
        constituted the sample.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: Pain evaluated using the Visual Analog Scale
  time frame: change from baseline implamentation patent and after 0 and 1 postoperative day of practice.
  description: The intensity of pain is measured using the VAS, a valid and reliable tool for measuring experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain).
  measure: Bottom functions evaluated using the Postoperative Follow-up Chart
  time frame: change from baseline implamentation patent and after 0 and 1 postoperative day of practice.
  description: It was created by the researchers by scanning the literature, and consists of a 24-hour chart including the 0 and 1 postoperative day mobilization time, mobilization distance, pain score, gas and stool output time of the participants.
  arm group label: Control
  arm group type: No Intervention
  description: The women patients in the control group who underwent hysterectomy were informed that mobilization training would be performed after a postoperative 2-day waiting period. Meanwhile, no intervention was made except for any routine nursing care.
  arm group label: Mobilization Training
  arm group type: Experimental
  description: A face-to-face "Patient Information Form" was applied to the training group in the first interview before the hysterectomy operation. The participants in the training group were given hysterectomy postoperative mobilization training by the researcher (B.K) using presentation and verbal information technique. A "Post-Operative Follow-up Chart" was given to the participants to fill in the 1st and 2nd postoperative days. The training group participants were followed up by the researcher on the 0th and 1st days after the operation in line with the mobilization training they received. The "Post-Operative Follow-up Chart" questioning the patients' mobilization times, distances, bowel functions and pain scores was filled in by the researcher in detail by face-to-face interview method. Mobilization time (minutes) and distance (meters) were evaluated by the patients and their relatives, and recorded on the chart, using the stopwatch and pedometer on the personal mobile phones of the patients.
  intervention type: Behavioral
  intervention name: Mobilization Training
  description: The participants in the training group were given hysterectomy postoperative mobilization training by the researcher (B.K) using presentation and verbal information technique. A "Post-Operative Follow-up Chart" was given to the participants to fill in the 1st and 2nd postoperative days. The training group participants were followed up by the researcher on the 0th and 1st days after the operation in line with the mobilization training they received. The "Post-Operative Follow-up Chart" questioning the patients' mobilization times, distances, bowel functions and pain scores was filled in by the researcher in detail by face-to-face interview method. Mobilization time (minutes) and distance (meters) were evaluated by the patients and their relatives, and recorded on the chart, using the stopwatch and pedometer on the personal mobile phones of the patients.
  arm group label: Mobilization Training
  criteria: 
  gender: Female
  gender based: Yes
  gender description: The women patients undergoing hysterectomy
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Burcu Küçükkaya, Asst. Prof.
  role: Principal Investigator
  affiliation: Bartın University, Faculty of Health Sciences, Nursing Department, Division of Gynecology and Obstetrics Nursing, Bartın, Turkiye
  last name: Zeynep Kızılcık Özkan, Asst. Prof.
  role: Principal Investigator
  affiliation: Trakya University, Faculty of Health Sciences, Nursing Department, Division of Surgery Nursing, Edirne, Turkiye
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Bartın Unıversity
  investigator full name: Burcu KUCUKKAYA
  investigator title: Assist. Prof
  sharing ipd: Undecided