<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200804048300N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-25</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of acupressure and electrical stimulation in acupressure points on postoperative complications</public_title>
      <acronym></acronym>
      <scientific_title>Compartive Study of the Effect of Acupressure and Transcutaneous Electric Acupoint Stimulation on Severity of Pain, Nausea and Vomiting, Hypothermia and Hemodynamic Status after Laparoscopic cholecystectomy patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50207</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Permutation block randomization will be used to assign groups. Patients participating in the study were divided into 3 groups of 38 using 6 blocks using the letters AA, CC, TT (for group parity). For permutation block randomization, the method of sealed envelopes, random sequence will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Laparoscopic cholecystectomy patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group 1: In the acupressure group, using a special acupressure bracelet with the brand name PsiBand with American design and made in China during the entire recovery period of the patient in the postoperative care ward, on pc6 point which is already located by the researcher It is marked to be closed, and by applying the necessary pressure by this bracelet, the necessary items are recorded at this point. Intervention 2: Intervention group 2: In the Acu-tens group of STIMULATOR 710P PULS with Frequency = 2-5 HZ and Duration = Wider Pulses (200-250ms) Pulse by placing electrodes at pc6 point on the forearm of both hands with the intensity that the patient feels Moore Moore It gets in the hand but it does not bother him, it is used for 30 to 45 minutes to stimulate this point. Intervention 3: Control group: 38 patients in the control group will routinely receive routine operating room care, including medication, during and after surgery and will not receive any special intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Lack of complete sampling</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.1,41 Alley, Kashani Ave</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8137946855</zip>
        <telephone>+98 31 3365 1645</telephone>
        <email>hrm6871@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Nasiri Formi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences, Farahabad Ave.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8137946855</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>Ebrahim.Nasiri.f@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient's willingness and satisfaction to participate in the intervention
The patient is fully conscious
The target organ should not have an anatomical problem in terms of performing acupressure and Acupressure-Trans cutaneous Electrical Nerve Stimulation(Acu-Tens) at PC6(One of the points in acupuncture) point
All patients underwent general anesthesia with the same medication
Patients are between 30-60 years old
Do not have neurological or psychiatric illnesses (according to the patient) or a specific illness
Be in ASA I, II category</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of acute and chronic nausea and vomiting (such as gastrointestinal and ear disorders)
Drug and alcohol addiction
History of using acupressure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K91.86</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Retained cholelithiasis following cholecystectomy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group 1: In the acupressure group, using a special acupressure bracelet with the brand name PsiBand with American design and made in China during the entire recovery period of the patient in the postoperative care ward, on pc6 point which is already located by the researcher It is marked to be closed, and by applying the necessary pressure by this bracelet, the necessary items are recorded at this point.</i_keyword>
      <i_keyword>Intervention group 2: In the Acu-tens group of STIMULATOR 710P PULS with Frequency = 2-5 HZ and Duration = Wider Pulses (200-250ms) Pulse by placing electrodes at pc6 point on the forearm of both hands with the intensity that the patient feels Moore Moore It gets in the hand but it does not bother him, it is used for 30 to 45 minutes to stimulate this point</i_keyword>
      <i_keyword>Control group: 38 patients in the control group will routinely receive routine operating room care, including medication, during and after surgery and will not receive any special intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: before surgery, at the beginning of recovery, 2, 4, 6, 24 and 48 hours after surgery. Method of measurement: based on visual analog scale.</prim_outcome>
      <prim_outcome>Nausea intensity. Timepoint: before surgery, at the beginning of recovery, 2, 4, 6, 24 and 48 hours after surgery. Method of measurement: based on visual analog scale.</prim_outcome>
      <prim_outcome>The rate of vomiting. Timepoint: before surgery, at the beginning of recovery, 2, 4, 6, 24 and 48 hours after surgery. Method of measurement: Based on the number of times according to previous studies.</prim_outcome>
      <prim_outcome>Hypothermia. Timepoint: before surgery, at the beginning of recovery, 2, 4, 6, 24 and 48 hours after surgery. Method of measurement: Measurement of central body temperature using tympanic thermometer (TH839).</prim_outcome>
      <prim_outcome>Number of breaths. Timepoint: before surgery, at the beginning of recovery, 2, 4, 6, 24 and 48 hours after surgery. Method of measurement: Using patient monitoring of vital signs.</prim_outcome>
      <prim_outcome>Pulse count. Timepoint: before surgery, at the beginning of recovery, 2, 4, 6, 24 and 48 hours after surgery. Method of measurement: Using patient monitoring of vital signs.</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: before surgery, at the beginning of recovery, 2, 4, 6, 24 and 48 hours after surgery. Method of measurement: Using patient monitoring of vital signs.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-29</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>No.1, 41َAlley, kashani Ave esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
