<?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>IRCT20231028059875N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-30</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of auricular acupressure on patient’s comfort</public_title>
      <acronym></acronym>
      <scientific_title>effect of auricular acupressure on patient’s comfort after coronary artery interventions</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73399</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use the method of punching envelopes to randomize the samples; In this way, there are two separate envelopes, in envelope number one, there are 42 papers related to the acupressure intervention group with the letter A, and in envelope number 2, there are 42 papers in which the letter B means the control group. We put the envelopes it in front of the patient. And we ask him to take a number of papers from inside one of the envelopes randomly without switching. Depending on which one he chooses, the patient will be placed in the same group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery interventions (angiography and angioplasty).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, the benefits of acupressure and sticky plant seeds are explained, and patients are asked to ask any questions they may have. It will be explained to them that pressure plant labels will be placed on TF2, SF5, AT2 and HX1 points of their right ear for 2 hours. Then, the comfort of the patient, the severity of the patient's pain, the average arterial pressure, the heart rate and the oxygen saturation of the arterial blood will be measured three times at zero minute, 60 minutes later and 120 minutes after zero with the help of the available tools. It should be noted that minute zero is the moment the patient enters the ward. Intervention 2: Control group: In relation to the control group, it should be noted that no specific intervention is performed and after that the research criteria include patient comfort, patient pain intensity, mean arterial pressure, heart rate and arterial blood oxygen saturation in three times at zero minutes. It will be checked 60 minutes later and 120 minutes after the zero minute. It is important to mention that both groups will not be deprived of the routine medical procedures that are performed in the department after coronary interventions.</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 After completing the research project and consulting with the professors, I will make a decision about this</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh St</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838736</zip>
        <telephone>+98 81 3838 0447</telephone>
        <email>asadifatemeh1379@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hiva Azami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh St</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3838 0447</telephone>
        <email>hiva64@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidate patients for non-emergency radial coronary artery interventions
Ability to recognize NRS scale
Consent of the attending physician to participate in the research
Not having mental disorders with doctor's approval</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Feeling comfortable and not having pain in the radial area
Presence of damage and malignancy in the ear</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z98.61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronary angioplasty status</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, the benefits of acupressure and sticky plant seeds are explained, and patients are asked to ask any questions they may have. It will be explained to them that pressure plant labels will be placed on TF2, SF5, AT2 and HX1 points of their right ear for 2 hours. Then, the comfort of the patient, the severity of the patient's pain, the average arterial pressure, the heart rate and the oxygen saturation of the arterial blood will be measured three times at zero minute, 60 minutes later and 120 minutes after zero with the help of the available tools. It should be noted that minute zero is the moment the patient enters the ward</i_keyword>
      <i_keyword>Control group: In relation to the control group, it should be noted that no specific intervention is performed and after that the research criteria include patient comfort, patient pain intensity, mean arterial pressure, heart rate and arterial blood oxygen saturation in three times at zero minutes. It will be checked 60 minutes later and 120 minutes after the zero minute. It is important to mention that both groups will not be deprived of the routine medical procedures that are performed in the department after coronary interventions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comfort. Timepoint: Before the intervention, 30 and 120 minutes after the intervention. Method of measurement: Numerical rating scale.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention, 30 and 120 minutes after the intervention. Method of measurement: Numerical rating scale.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before the intervention, 30 and 120 minutes after the intervention. Method of measurement: Number of beats per minute, pulse oximetry device.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: Before the intervention, 30 and 120 minutes after the intervention. Method of measurement: Sphygmomanometer.</prim_outcome>
      <prim_outcome>Oxygen saturation percentage of arterial blood. Timepoint: Before the intervention, 30 and 120 minutes after the intervention. Method of measurement: pulse oximetry device.</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>2024-01-21</approval_date>
        <contact_name>Ethics committee of Hamadan university of medical science</contact_name>
        <contact_address>Hamadan university of medical science, Shahid Fahmideh Blvd, Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
