<?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>IRCT20220310054249N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-25</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Acupressure in Cholecystectomy</public_title>
      <acronym></acronym>
      <scientific_title>Compare the Effect of Acupressure and Auriculotherapy on Shoulder Pain in Patients subjected to Laparoscopic Cholecystectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62450</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: All sample subjects are divided into three equal groups by simple random methods. First, 93 cards (equal to the number of sample volumes) will be prepared. Then A, B or C will be written on each card (31 cards A, 31 cards B and 31 cards C). These cards will be placed inside a box so that no one can see the cards inside the box. After shuffling the cards by the researcher, patients are asked to randomly take a card from the box (selected cards will not be returned to the box after selection). Thus, people are divided into three groups of 31 people A, B and C. In this way, three cards are prepared and one of the numbers one (acupressure), 2 (auriculotherapy) and 3 (control) will be written on each card. These cards are placed in a box and after shuffling, the researcher will randomly select a card for each group (the selected cards will not be returned to the box after selection), Blinding description: In this study, the researcher assistance will be used to complete all questionnaires to blind and prevent bias in the results. This person will be unaware of the groupings and the type of interventions that are performed in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cholecystitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acupressure is performed on GB21 points in the most prominent part of shoulder muscle, ST38 in lateral tibial cortex and between the distance between external ankle and popliteal crease, TW15 in the middle of the hypothetical line between the lower end of the seventh cervical vertebra and the acromion head by the researcher's thumb pulp. The amount of pressure is 3 to 4 kg, which is calibrated by the pressure of the therapist's hand on a digital scale. Pressure time for each point is 3 minutes of pressure and 1 minute of rest to our patient between two points on one side of the body (the same side that hurts). Intervention 2: Intervention group: Auriculotherapy is performed on the shoulder, shoulder joint, and clavicle points by a special ear prop. The amount of prop pressure in the ear is 1 to 2 kg, which is calibrated on a digital scale. Pressure time for each point is 3 minutes of pressure and 1 minute of rest to the patient between two points in one ear (ear is the same part of the body that is in pain). Intervention 3: Control group: The control group will not receive any 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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Sadat Zohourparvaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghaffari St.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3238 1407</telephone>
        <email>monazparvaz@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Abolfazl Vagharseyyedin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghaffari St.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3238 1407</telephone>
        <email>Waghars@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients stay in the hospital for at least one day after surgery
Be able to provide informed written consent
No lesions or wounds in the areas where acupressure is to be applied
Have no history of chronic pain in the shoulder or neck
No need for simultaneous combination surgery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of any disease related to bleeding or abnormal blood clotting 
Pregnancy or breastfeeding 
History of seizures
Dementia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cholecystitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acupressure is performed on GB21 points in the most prominent part of shoulder muscle, ST38 in lateral tibial cortex and between the distance between external ankle and popliteal crease, TW15 in the middle of the hypothetical line between the lower end of the seventh cervical vertebra and the acromion head by the researcher's thumb pulp. The amount of pressure is 3 to 4 kg, which is calibrated by the pressure of the therapist's hand on a digital scale. Pressure time for each point is 3 minutes of pressure and 1 minute of rest to our patient between two points on one side of the body (the same side that hurts).</i_keyword>
      <i_keyword>Intervention group: Auriculotherapy is performed on the shoulder, shoulder joint, and clavicle points by a special ear prop. The amount of prop pressure in the ear is 1 to 2 kg, which is calibrated on a digital scale. Pressure time for each point is 3 minutes of pressure and 1 minute of rest to the patient between two points in one ear (ear is the same part of the body that is in pain).</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shoulder Pain after Laparoscopic Cholecystectomy. Timepoint: Pain is measured after surgery and immediately after entering the ward, 1 hour, 4 hours and 8 hours after the intervention. Method of measurement: VAS Scale (Visual Analog Scale).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comfort. Timepoint: Comfort is measured after surgery and immediately after entering the ward, 1 hour, 4 hours and 8 hours after the intervention. Method of measurement: Questionnaire.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-09</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Ghaffari St., Birjand University of Medical Sciences, Vice Chancellor for Research and Technology Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
