<?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>IRCT20250101064239N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-28</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The comparative effect of pressure acupressure and low-level laser acupressure on P6 point to the control of postoperative nausea and vomiting after abdominal laparoscopic surgery.</public_title>
      <acronym></acronym>
      <scientific_title>The comparative effect of pressure acupressure and low-level laser acupressure on P6 point to the control of postoperative nausea and vomiting after abdominal laparoscopic surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>118</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81062</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: This is done using the block permutation method.
Based on this method, the organizer of the operating room, who is not the same person for data collection, before sending patients to the operating room, will categorize patients into two groups of A and B in the recursive following order "AABB, ABAB, ABBA, BBAA, BABA".  
For example: (AABB), the first and second patients in group A, the third and fourth patients in group B; (ABAB), the fifth and seventh patients in group A, the sixth and eighth patients in group B, and so on.
The person responsible for data collection in the recovery room is not informed of the patient categories, Blinding description: The operating room organizer will divide the patients into A and B groups just before entering the operating room.
Pressure acupressure and laser acupressure are performed by the anesthesiologist in the operating room.
Since the patients and the person responsible for data collection and analysis are unaware of the group categorization, this study is a double-blind clinical trial.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postoperative nausea and vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 20 minutes before induction of general anesthesia, laser acupressure is applied to the P6 point of both hands for 15 minutes using a diode laser with a wavelength of 808 nm and a power of 20 mw. In order to blind the patients, pressure cuffs without effective pressure are also applied to the same P6 point on both hands. Intervention 2: Intervention group: 20 minutes before induction of general anesthesia, pressure acupressure is applied to the P6 point of both hands for 15 minutes using pressure cuffs at a pressure level that does not affect venous return. To blind the patients, a diode laser with a wavelength of 808 nm and a power of 20 mw without effective radiation is also applied to the same P6 point on both hands.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can be shared after hiding identities

When:
Upon completion of the study and submission of the final report

To whom:
Researchers at academic institutions

Conditions:
It can be used with a reference to the source used (forthcoming study).

Where to obtain:
Researchers (Reza Namdari - Reza.namdari78@gmail.com)
                     (Dr. Alireza Susan Abadi - Dr.susanabadi@arakmu.ac.ir)

How to obtain:
Once the request is submitted and approved by the researchers, the data can be obtained.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Susan Abadi Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3313 3147</telephone>
        <email>Dr.susanabadi@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Susan Abadi Farahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3383 8268</telephone>
        <email>Dr.susanabadi@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between the ages of 18 and 75 years old
Patients who are candidates for elective laparoscopic abdominal surgery
Patients with American society of anesthesiologists (ASA) class 1 and 2
Patients with no history of motion sickness or chemotherapy
Patients with informed consent
Patients who have not taken antiemetics in the past 48 hours
Patient alertness and cooperation in completing the Nausea and Vomiting Severity Questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue study participation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 20 minutes before induction of general anesthesia, laser acupressure is applied to the P6 point of both hands for 15 minutes using a diode laser with a wavelength of 808 nm and a power of 20 mw. In order to blind the patients, pressure cuffs without effective pressure are also applied to the same P6 point on both hands.</i_keyword>
      <i_keyword>Intervention group: 20 minutes before induction of general anesthesia, pressure acupressure is applied to the P6 point of both hands for 15 minutes using pressure cuffs at a pressure level that does not affect venous return. To blind the patients, a diode laser with a wavelength of 808 nm and a power of 20 mw without effective radiation is also applied to the same P6 point on both hands.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of nausea and vomiting. Timepoint: Measuring the severity of nausea and vomiting in hours 0-2-4-12-24 after surgery. Method of measurement: Vomiting score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of ondansetron required. Timepoint: 0, 2, 4, 12, 24 hours after surgery. Method of measurement: Amount of intravenous ondansetron needed (milligram).</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-31</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Third floor, No. 24, Golestan 12 street, Mostafa Khomeini Ave, Qods Blvd, Arak, Iran Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
