<?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>IRCT20190915044770N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-25</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pressure bracelet and pressure sticker on nausea and vomiting</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of compression bracelet and compression sticker at p6 on patients’ physiological indices and postoperative nausea and vomiting prevention in laparascopic cholecystectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>175</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42125</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Blinding description: Patients in this study were blinded to pressure bracelet and pressure tag groups in the intervention and control groups. They are not aware of the type of bracelet (with or without a push button) and a push sticker (with or without a metal piece) that both instruments have a complete similarity to each other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cholecystectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group with pressure bracelet at point P6. After selecting the appropriate wristband, the researcher closed the patient's wrist one hour before starting anesthesia on the P6 point and held it for 6 hours after embedding and then removing it. It should be noted that the severity of nausea based on the VAS visual scale, the severity of pain based on the visual VAS scale, the frequency of vomiting based on the checklist, as well as vital symptoms including respiratory rate, heart rate, blood pressure and temperature They are measured at times immediately after full consciousness in recovery, one hour later, 6 hours later, and 24 hours after surgery. The checklist will also be assessed 24 hours after surgery. Intervention 2: Intervention group: group with pressure sticker at point P6.  After selecting the appropriate sticker, the researcher closed the patient's sticker one hour before starting anesthesia on the P6 point and held it for 6 hours after embedding and then removing it. It should be noted that the severity of nausea based on the VAS visual scale, the severity of pain based on the visual VAS scale, the frequency of vomiting based on the checklist, as well as vital symptoms including respiratory rate, heart rate, blood pressure and temperature They are measured at times immediately after full consciousness in recovery, one hour later, 6 hours later, and 24 hours after surgery. The checklist will also be assessed 24 hours after surgery. Intervention 3: Control group: No specific action is taken.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is I have no plans for publishing right now</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Khatiban</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh BLVD</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3838 0320</telephone>
        <email>mahnaz.khatiban@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>asghar Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh BLVD</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3822 4864</telephone>
        <email>asghar.farahani@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidate for Laparoscopic Cholecystectomy with General Anesthesia
Age over 18 years
Having skin health at P6
No nausea for any reason before entering the study
No visual impairment to diagnose VAS
No angiocut at point P6</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient is discharged before the end of the study
Patient dissatisfaction to continue the study
Sensitivity to acupuncture bracelet and acupressure sticker
Bleeding and any factors that lead to open surgery</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: Group with pressure bracelet at point P6. After selecting the appropriate wristband, the researcher closed the patient's wrist one hour before starting anesthesia on the P6 point and held it for 6 hours after embedding and then removing it. It should be noted that the severity of nausea based on the VAS visual scale, the severity of pain based on the visual VAS scale, the frequency of vomiting based on the checklist, as well as vital symptoms including respiratory rate, heart rate, blood pressure and temperature They are measured at times immediately after full consciousness in recovery, one hour later, 6 hours later, and 24 hours after surgery. The checklist will also be assessed 24 hours after surgery.</i_keyword>
      <i_keyword>Intervention group: group with pressure sticker at point P6.  After selecting the appropriate sticker, the researcher closed the patient's sticker one hour before starting anesthesia on the P6 point and held it for 6 hours after embedding and then removing it. It should be noted that the severity of nausea based on the VAS visual scale, the severity of pain based on the visual VAS scale, the frequency of vomiting based on the checklist, as well as vital symptoms including respiratory rate, heart rate, blood pressure and temperature They are measured at times immediately after full consciousness in recovery, one hour later, 6 hours later, and 24 hours after surgery. The checklist will also be assessed 24 hours after surgery.</i_keyword>
      <i_keyword>Control group: No specific action is taken</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Prevention of nausea. Timepoint: Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Beating. Timepoint: Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery. Method of measurement: Find abundance with checklists.</prim_outcome>
      <prim_outcome>Vomiting. Timepoint: Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery. Method of measurement: Find abundance with checklists.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>The amount of anti-nausea and vomiting medication. Timepoint: 24 hours after surgery. Method of measurement: Check list.</prim_outcome>
      <prim_outcome>Blood pressure measurement. Timepoint: Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery. Method of measurement: Handheld pressure gauge.</prim_outcome>
      <prim_outcome>The number of pulses per minute. Timepoint: Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery. Method of measurement: Cardiac monitoring device.</prim_outcome>
      <prim_outcome>Breath rate per minute. Timepoint: Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery. Method of measurement: Visual observation.</prim_outcome>
      <prim_outcome>Body temperature. Timepoint: Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery. Method of measurement: Mercury thermometer.</prim_outcome>
      <prim_outcome>Arterial Oxygen Saturation Percentage. Timepoint: Immediately after the patient is fully awake, 1, 6 and 24 hours after surgery. Method of measurement: Cardiovascular monitoring.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-10</approval_date>
        <contact_name>Ethics Committee of Hamadan university of medical sciences</contact_name>
        <contact_address>Shahid Fahmideh BLVD Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
