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/NCT05962853</url>
    </required_header>
    <id_info>
      <org_study_id>CU-SBF-CB-02</org_study_id>
      <nct_id>NCT05962853</nct_id>
    </id_info>
    <brief_title>Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study</brief_title>
    <acronym>TENS</acronym>
    <official_title>Effect of TENS on Patient Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cukurova University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cukurova 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 aim of this study is to evaluate the effect of TENS (Transcutaneous Electrical Nerve&#xD;
        Stimulation) on patient outcomes after laparoscopic cholecystectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Laparoscopic cholecystectomy is the standard treatment for symptomatic gallstones, acute&#xD;
        cholecystitis and gallstone pancreatitis.Many complications can be seen after laparoscopic&#xD;
        cholecystectomy.&#xD;
  &#xD;
        The most common complication after laparoscopic cholecystectomy is pain. Pain appears as&#xD;
        incisional, visceral and shoulder pain after laparoscopic cholecystectomy.After laparoscopic&#xD;
        surgery, increased intra-abdominal pressure, stretching of the peritoneum, inability to take&#xD;
        air given carbon dioxide (CO2), shoulder pain due to tension of muscle fibers due to&#xD;
        diaphragm irritation, and visceral pain due to the interference of trocars on the abdominal&#xD;
        wall as a result of intra-abdominal intervention are seen. After laparoscopic&#xD;
        cholecystectomy, the effect of general anesthesia and the proximity of the incision area to&#xD;
        the diaphragm may also cause pulmonary complications. Pneumoperiteneum developed by the&#xD;
        administration of CO2 gas after laparoscopic cholecystectomy; Diaphragmatic irritation,&#xD;
        increased intra-abdominal pressure, stretching of the peritoneum, and consequently the&#xD;
        tension in the muscle fibers in the diaphragm can cause pain.&#xD;
  &#xD;
        Inability to control pain can lead to many undesirable conditions in the patient, such as&#xD;
        reluctance to mobilize, increased oxygen consumption, and delayed wound healing. This&#xD;
        situation is also associated with increased hospital stay and financial burdens.In order to&#xD;
        provide effective pain control, the combined use of pharmacological and non-pharmacological&#xD;
        methods is important.Non-pharmacological methods are easy to learn, safe, have no definite&#xD;
        contraindications, and provide pain management with non-drug applications. In a&#xD;
        meta-analysis, it was determined that Transcutaneous Electrical Nerve Stimulation (TENS) is&#xD;
        an effective, safe non-pharmacological method for symptomatic relief of pain and discomfort&#xD;
        and no serious side effects were observed.&#xD;
  &#xD;
        Studies have shown that TENS application reduces postoperative pain level and analgesia&#xD;
        consumption. In addition, TENS application after laparoscopic cholecystectomy was found to be&#xD;
        associated with a decrease in postoperative pain severity and complaints of nausea and&#xD;
        vomiting. It is seen that there are not enough resources in the literature regarding the&#xD;
        application of TENS after laparoscopic cholecystectomy.&#xD;
  &#xD;
        The aim of this study is to evaluate the effect of TENS on patient outcomes after&#xD;
        laparoscopic cholecystectomy.&#xD;
  &#xD;
        .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">June 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 15, 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>Application of the experimental group: 2 hours after the surgery, TENS will be applied for 30 minutes and then TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). In order to protect sleep integrity, TENS application hours will be arranged according to the patient.&#xD;
  Application of the control group: TENS will not be applied to this group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Application will be made by the researcher and the outcome will be assessements will be performed by a investigator who is blinded to group allocation</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The Numerical Rating Scale (NRS)</measure>
      <time_frame>24 hours</time_frame>
      <description>The scale ranges from 0 to 10. It is numbered from 0 to 10 according to the severity of the pain. 0 means no pain and 10 means the most severe pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>APS-POQ-R - American Pain Society Patient Outcome</measure>
      <time_frame>24 hours</time_frame>
      <description>American Pain Society Patient Outcome Questionnaire-Revised to measure pain management and patient satisfaction developed.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Cholecystitis; Gallstone</condition>
    <condition>Cholecystolithiasis</condition>
    <arm_group>
      <arm_group_label>Experimental group ( TENS will be applied )</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After 30 minutes of TENS application 2 hours after the surgery, TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). TENS application hours will be arranged according to the patient in order to protect sleep integrity.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group ( TENS will not be applied )</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Application of the control group: TENS will not be applied to this group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Experimental group (Transcutaneous Electrical Nerve Stimulation)</intervention_name>
      <description>The application will be applied at 8 hour intervals in the first 24 hours after the surgery.</description>
      <arm_group_label>Experimental group ( TENS will be applied )</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over 18 years old,&#xD;
  &#xD;
            -  Without pacemaker and arrhythmia,&#xD;
  &#xD;
            -  No previous history of chronic pain, alcohol or drug addiction,&#xD;
  &#xD;
            -  Not using TENS/opioids before surgery,&#xD;
  &#xD;
            -  Epidural analgesia is not applied in the postoperative period, without cognitive&#xD;
               impairment,&#xD;
  &#xD;
            -  No thoracic incision other than cholecystectomy,&#xD;
  &#xD;
            -  Having at least 1 drain&#xD;
  &#xD;
            -  No metastatic disease&#xD;
  &#xD;
            -  No need for mechanical ventilation&#xD;
  &#xD;
            -  As a result of the evaluation by the physician, there is no objection to the&#xD;
               application of TENS,&#xD;
  &#xD;
            -  Who agree to participate in the study,&#xD;
  &#xD;
            -  No postoperative complications&#xD;
  &#xD;
            -  Patients with American Society of Anesthesiology (ASA) evaluation I, II, III will be&#xD;
               included in the sample group.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  refuse to participate in the study&#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>Cansel Bozer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cukurova University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cansel Bozer</last_name>
      <phone>+905434332624</phone>
      <email>cansel9815@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ceylan Kişial</last_name>
      <phone>+905068010561</phone>
      <email>cylnksl@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Adana City Training and Research Hospital</name>
        <address>
          <city>Adana</city>
          <state>Yüreğir / Adana</state>
          <zip>01220</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cansel Bozer</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cukurova University</investigator_affiliation>
      <investigator_full_name>Cansel Bozer</investigator_full_name>
      <investigator_title>doctorate student</investigator_title>
    </responsible_party>
    <keyword>Pain</keyword>
    <keyword>Cholecystectomy</keyword>
    <keyword>Nurse</keyword>
    <keyword>TENS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholecystitis</mesh_term>
      <mesh_term>Gallstones</mesh_term>
      <mesh_term>Cholelithiasis</mesh_term>
      <mesh_term>Cholecystolithiasis</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/NCT05962853
  org study id: CU-SBF-CB-02
  nct id: NCT05962853
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the effect of TENS (Transcutaneous Electrical Nerve
        Stimulation) on patient outcomes after laparoscopic cholecystectomy.
  Laparoscopic cholecystectomy is the standard treatment for symptomatic gallstones, acute
        cholecystitis and gallstone pancreatitis.Many complications can be seen after laparoscopic
        cholecystectomy.
  
        The most common complication after laparoscopic cholecystectomy is pain. Pain appears as
        incisional, visceral and shoulder pain after laparoscopic cholecystectomy.After laparoscopic
        surgery, increased intra-abdominal pressure, stretching of the peritoneum, inability to take
        air given carbon dioxide (CO2), shoulder pain due to tension of muscle fibers due to
        diaphragm irritation, and visceral pain due to the interference of trocars on the abdominal
        wall as a result of intra-abdominal intervention are seen. After laparoscopic
        cholecystectomy, the effect of general anesthesia and the proximity of the incision area to
        the diaphragm may also cause pulmonary complications. Pneumoperiteneum developed by the
        administration of CO2 gas after laparoscopic cholecystectomy; Diaphragmatic irritation,
        increased intra-abdominal pressure, stretching of the peritoneum, and consequently the
        tension in the muscle fibers in the diaphragm can cause pain.
  
        Inability to control pain can lead to many undesirable conditions in the patient, such as
        reluctance to mobilize, increased oxygen consumption, and delayed wound healing. This
        situation is also associated with increased hospital stay and financial burdens.In order to
        provide effective pain control, the combined use of pharmacological and non-pharmacological
        methods is important.Non-pharmacological methods are easy to learn, safe, have no definite
        contraindications, and provide pain management with non-drug applications. In a
        meta-analysis, it was determined that Transcutaneous Electrical Nerve Stimulation (TENS) is
        an effective, safe non-pharmacological method for symptomatic relief of pain and discomfort
        and no serious side effects were observed.
  
        Studies have shown that TENS application reduces postoperative pain level and analgesia
        consumption. In addition, TENS application after laparoscopic cholecystectomy was found to be
        associated with a decrease in postoperative pain severity and complaints of nausea and
        vomiting. It is seen that there are not enough resources in the literature regarding the
        application of TENS after laparoscopic cholecystectomy.
  
        The aim of this study is to evaluate the effect of TENS on patient outcomes after
        laparoscopic cholecystectomy.
  
        .
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Application of the experimental group: 2 hours after the surgery, TENS will be applied for 30 minutes and then TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). In order to protect sleep integrity, TENS application hours will be arranged according to the patient.
  Application of the control group: TENS will not be applied to this group
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Application will be made by the researcher and the outcome will be assessements will be performed by a investigator who is blinded to group allocation
  measure: The Numerical Rating Scale (NRS)
  time frame: 24 hours
  description: The scale ranges from 0 to 10. It is numbered from 0 to 10 according to the severity of the pain. 0 means no pain and 10 means the most severe pain.
  measure: APS-POQ-R - American Pain Society Patient Outcome
  time frame: 24 hours
  description: American Pain Society Patient Outcome Questionnaire-Revised to measure pain management and patient satisfaction developed.
  arm group label: Experimental group ( TENS will be applied )
  arm group type: Experimental
  description: After 30 minutes of TENS application 2 hours after the surgery, TENS will be applied 3 times at 8 hour intervals. Postoperatively at the 2nd hour (just before TENS), at the 3rd hour (1 hour after the onset of TENS), at the 10th hour (just before the TENS), at the 11th hour (1 hour after the start of TENS), at the 18th hour ( Just before TENS) at the 19th Hour (1 hour after the start of TENS). TENS application hours will be arranged according to the patient in order to protect sleep integrity.
  arm group label: Control Group ( TENS will not be applied )
  arm group type: No Intervention
  description: Application of the control group: TENS will not be applied to this group.
  intervention type: Other
  intervention name: Experimental group (Transcutaneous Electrical Nerve Stimulation)
  description: The application will be applied at 8 hour intervals in the first 24 hours after the surgery.
  arm group label: Experimental group ( TENS will be applied )
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cansel Bozer
  role: Principal Investigator
  affiliation: Cukurova University
  last name: Cansel Bozer
  phone: +905434332624
  email: cansel9815@gmail.com
  last name: Ceylan Kişial
  phone: +905068010561
  email: cylnksl@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Cukurova University
  investigator full name: Cansel Bozer
  investigator title: doctorate student
  mesh term: Cholecystitis
  mesh term: Gallstones
  mesh term: Cholelithiasis
  mesh term: Cholecystolithiasis
  sharing ipd: No