<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/NCT03762486</url>
  </required_header>
  <id_info>
    <org_study_id>YuksekIU</org_study_id>
    <nct_id>NCT03762486</nct_id>
  </id_info>
  <brief_title>The Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision</brief_title>
  <official_title>The Effects of Two Different Electrical Stimulation Methods on the Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision: Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuksek Ihtisas University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuksek Ihtisas 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>
      The purpose of this study is to determine the effects of transcutaneous electrical nerve&#xD;
      stimulation (TENS) and transcutaneous acupoint electrical stimulation (TAES) on pain and&#xD;
      analgesic drug consumption in patients who had undergone abdominal surgery with a midline&#xD;
      incision. Evidence for the effects of and transcutaneous electrical stimulation on pain and&#xD;
      analgesic consumption on patients undergoing abdominal surgery with severe pain experience&#xD;
      and high levels of neuroendocrine stress response is uncertain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research was conducted as a randomized controlled trial. 158 patients who had undergone&#xD;
      abdominal surgery with diagnosis of gastric and colorectal cancer were assessed for&#xD;
      eligibility. This research sample consisted of 48 patients who underwent abdominal surgery&#xD;
      with a midline incision. The patients were randomized into three groups, the first&#xD;
      intervention group, which used TENS (around the incision), the second intervention group,&#xD;
      which used TAES (ST25, P6, ST36, Lİ4 acupuncture points) and the control group, which did&#xD;
      not. Electric stimulation was performed at the 30th minute, second, 18th, 21st, 40th, and&#xD;
      45th hours after the operation. Pain scores and analgesic consumption were assessed in the&#xD;
      first 48 hours after surgical intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2015</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</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>Factorial Assignment</intervention_model>
    <intervention_model_description>TENS was applied to around the insicion: Transcutaneous electrical nerve stimulation was applied to around the incision.&#xD;
TAES was applied to acupuncture points: Transcutaneous electrical stimulation was applied to acupuncture points.&#xD;
No intervention: No stimulation was performed to the patients.&#xD;
A standard analgesia protocol for post-operative pain control was used in all patients included in the study. A standard antiemetic protocol was used for all patients after surgery.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain intensity</measure>
    <time_frame>The pain levels were evaluated and compared within postoperative first 48 hours.</time_frame>
    <description>First Intervention Group: Electrical stimulation was implemented at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.&#xD;
Second Intervention Group: Electrical stimulation was implemented at acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.&#xD;
Control Group: No intervention was performed to the patients in the control group.&#xD;
The pain intensity of each groups' patients were recorded and compred at the post-operative 2, 18, 22, 42, and 46th hours. Pain intensity was evaluated with VAS. VAS with a range of 1-10 points was used while evaluating the pain intensity of all patients .The increase of the scale score shows that the pain intensity increases.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nausea severity</measure>
    <time_frame>The nausea severity of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.</time_frame>
    <description>VAS with a range of 1-10 points was used while evaluating the nausea severity of all patients .The increase of the scale score shows that the nausea severity increases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiemetic drug consumption</measure>
    <time_frame>Antiemetic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.</time_frame>
    <description>The antiemetic drug amount administered to the patients was recorded in mg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function tests</measure>
    <time_frame>Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.</time_frame>
    <description>The pulmonary functions of the patients were evaluated with a portable spirometer. Peak expiratory flow (PEF) and forced vital capacity (FVC) values were recorded. The measurement of respiratory functions was performed with the patient wrapping the disposable mouthpiece well with the lips during the measurement. The patient was asked to breathe deeply and exhale suddenly and quickly. This process was repeated three times and the best performance was taken as the base value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vomiting</measure>
    <time_frame>Vomiting status of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.</time_frame>
    <description>Vomiting: The number of times the patients vomited was recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic drug consumption</measure>
    <time_frame>Analgesic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.</time_frame>
    <description>All patients were administered intravenous tramadol hydrochloride infusion with the Patient Controlled Analgesia for the first 48 hours. Dexketoprofen trometamol vial intravenous and/or 50 mg. Pethidine hydrochloride intramuscular was used as the rescue analgesic.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Transcutaneous Electric Nerve Stimulation</condition>
  <arm_group>
    <arm_group_label>TENS to around the incision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAES to the acupuncture points</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No stimulation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No stimulation was performed to the patients in the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TENS</intervention_name>
    <description>4 electrodes were placed 2-3 cm lateral to the incision of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min</description>
    <arm_group_label>TENS to around the incision</arm_group_label>
    <other_name>First Intervention Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TAES</intervention_name>
    <description>4 electrodes were placed at the ST25, P6, ST36, and LI4 acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min</description>
    <arm_group_label>TAES to the acupuncture points</arm_group_label>
    <other_name>Second Intervention Group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had an American Society of Anesthesiologists (ASA) score of I-II&#xD;
&#xD;
          -  Patients were aged over 18 years&#xD;
&#xD;
          -  Patients who could read and write Turkish&#xD;
&#xD;
          -  Patients who were scheduled to undergo elective abdominal surgery with a midline&#xD;
             incision for a diagnosis of stomach or colorectal cancer&#xD;
&#xD;
          -  Patients without any impairment of vision, hearing or speech&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had a pacemaker&#xD;
&#xD;
          -  Patients whose skin integrity around the incision was degraded&#xD;
&#xD;
          -  Patients had a cognitive disorder, had a history of chronic pain, or were suffering&#xD;
             from neurological, renal, cardiac or pulmonary disorders that could affect the test&#xD;
             results&#xD;
&#xD;
          -  Patients with an opioid addiction&#xD;
&#xD;
          -  Patients those who had previously undergone electrical stimulation treatment&#xD;
&#xD;
          -  Morbidly obese subjects&#xD;
&#xD;
          -  Patients using psychoactive drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emine Iyigun, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Turkish Nurses Society</affiliation>
  </overall_official>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/citmatch</url>
    <description>for access to resources</description>
  </link>
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  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 5, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuksek Ihtisas University</investigator_affiliation>
    <investigator_full_name>Bediye Oztas</investigator_full_name>
    <investigator_title>Teaching Staff</investigator_title>
  </responsible_party>
  <keyword>Postoperative pain</keyword>
  <keyword>Alternative therapy</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>TENS</keyword>
  <keyword>Surgical nursing</keyword>
  <keyword>Randomised controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.ncbi.nlm.nih.gov/pubmed/citmatch</doc_url>
    </study_doc>
  </study_docs>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03762486/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03762486
org study id: YuksekIU
nct id: NCT03762486
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the effects of transcutaneous electrical nerve
      stimulation (TENS) and transcutaneous acupoint electrical stimulation (TAES) on pain and
      analgesic drug consumption in patients who had undergone abdominal surgery with a midline
      incision. Evidence for the effects of and transcutaneous electrical stimulation on pain and
      analgesic consumption on patients undergoing abdominal surgery with severe pain experience
      and high levels of neuroendocrine stress response is uncertain.
This research was conducted as a randomized controlled trial. 158 patients who had undergone
      abdominal surgery with diagnosis of gastric and colorectal cancer were assessed for
      eligibility. This research sample consisted of 48 patients who underwent abdominal surgery
      with a midline incision. The patients were randomized into three groups, the first
      intervention group, which used TENS (around the incision), the second intervention group,
      which used TAES (ST25, P6, ST36, Lİ4 acupuncture points) and the control group, which did
      not. Electric stimulation was performed at the 30th minute, second, 18th, 21st, 40th, and
      45th hours after the operation. Pain scores and analgesic consumption were assessed in the
      first 48 hours after surgical intervention.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: TENS was applied to around the insicion: Transcutaneous electrical nerve stimulation was applied to around the incision.
TAES was applied to acupuncture points: Transcutaneous electrical stimulation was applied to acupuncture points.
No intervention: No stimulation was performed to the patients.
A standard analgesia protocol for post-operative pain control was used in all patients included in the study. A standard antiemetic protocol was used for all patients after surgery.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Postoperative pain intensity
time frame: The pain levels were evaluated and compared within postoperative first 48 hours.
description: First Intervention Group: Electrical stimulation was implemented at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.
Second Intervention Group: Electrical stimulation was implemented at acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery.
Control Group: No intervention was performed to the patients in the control group.
The pain intensity of each groups' patients were recorded and compred at the post-operative 2, 18, 22, 42, and 46th hours. Pain intensity was evaluated with VAS. VAS with a range of 1-10 points was used while evaluating the pain intensity of all patients .The increase of the scale score shows that the pain intensity increases.
measure: Nausea severity
time frame: The nausea severity of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
description: VAS with a range of 1-10 points was used while evaluating the nausea severity of all patients .The increase of the scale score shows that the nausea severity increases.
measure: Antiemetic drug consumption
time frame: Antiemetic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.
description: The antiemetic drug amount administered to the patients was recorded in mg.
measure: Pulmonary function tests
time frame: Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.
description: The pulmonary functions of the patients were evaluated with a portable spirometer. Peak expiratory flow (PEF) and forced vital capacity (FVC) values were recorded. The measurement of respiratory functions was performed with the patient wrapping the disposable mouthpiece well with the lips during the measurement. The patient was asked to breathe deeply and exhale suddenly and quickly. This process was repeated three times and the best performance was taken as the base value.
measure: Vomiting
time frame: Vomiting status of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.
description: Vomiting: The number of times the patients vomited was recorded
measure: Analgesic drug consumption
time frame: Analgesic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.
description: All patients were administered intravenous tramadol hydrochloride infusion with the Patient Controlled Analgesia for the first 48 hours. Dexketoprofen trometamol vial intravenous and/or 50 mg. Pethidine hydrochloride intramuscular was used as the rescue analgesic.
arm group label: TENS to around the incision
arm group type: Active Comparator
description: The Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision.
arm group label: TAES to the acupuncture points
arm group type: Active Comparator
description: The Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points.
arm group label: No stimulation
arm group type: No Intervention
description: No stimulation was performed to the patients in the control group.
intervention type: Other
intervention name: TENS
description: 4 electrodes were placed 2-3 cm lateral to the incision of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
arm group label: TENS to around the incision
other name: First Intervention Group
intervention type: Other
intervention name: TAES
description: 4 electrodes were placed at the ST25, P6, ST36, and LI4 acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
arm group label: TAES to the acupuncture points
other name: Second Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Emine Iyigun, Professor
role: Study Director
affiliation: Turkish Nurses Society
url: https://www.ncbi.nlm.nih.gov/pubmed/citmatch
description: for access to resources
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responsible party type: Principal Investigator
investigator affiliation: Yuksek Ihtisas University
investigator full name: Bediye Oztas
investigator title: Teaching Staff
mesh term: Pain
sharing ipd: No
study doc: 
provided document: 