<?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>IRCT20110906007494N31</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-20</date_registration>
      <primary_sponsor>Vice Chancellor for Research Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>acupressure in cardiac patient</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on the intestinal function of patients with acute myocardial infarction under primary angioplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43656</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: ۴۸۹/۵۰۰۰
Eligible patients were randomly assigned to three groups of 30 acupressure, sham, and control groups using random numbers provided with computer software and Randomization Permuted Block. 15 to 6 blocks so that there are 2 people in each block. Therefore, 90 envelopes are designed and embedded inside based on information obtained from the computer program of letters A of acupressure group, B of sham group and C of control group. Based on the patient's admission date, the priority of opening the envelope is executed on the order of the number.</study_design>
      <phase>N/A</phase>
      <hc_freetext>myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1 : The SJ6 - LI4 - ST25- SP6 points of both members are determined symmetrically by the researcher's fingers. Acupressure will be performed twice daily (10 am and 6 pm) from the beginning of the day for three days. Point ST25 (Tianshu) is located two fingers away from the navel . The LI4 (Hegu) point lies at the depth of the muscle bundle, resulting from the thumb and forefinger . The SJ6 (Zhigou) dot is located four inches above the transverse line of the wrist between Radius and Ulna . The SP6 (sanyinjiao) point is four fingers above the medial ankle behind the posterior edge of the tibia.  Apply acupressure on each spot symmetrically for two minutes. Apply a minute with your thumb pressed vertically, then rest for 5 seconds and then rotate for one minute. A total of 9 minutes of intervention will be administered to the patient each time. Nutrition training and routine nursing care are also provided. Intervention 2: Intervention group2: The sham group offers routine nursing education and care, and the procedure will be exactly the same as the intervention group, except that pressure is close to the acupressure points according to accredited acupressure specialists in the field, which is about half that. No special timber is applied. The order of the pressure, the type of pressure, the position of the patient, the time and the amount of pressure in the test and sham groups will be the same. The location of the pressure points is similar to that of the intervention group except that they are 1.5 cm apart. It should be noted that in both groups, the pressure procedure will be taught by one person (the researcher). Intestinal function and checklists will then be completed before the intervention and in the first to fourth days. Intervention 3: Control group: After introducing and expressing the aims of the study and obtaining written informed consent and patient's consent to participate in the study, these patients receive nutritional and routine heart disease training. The demographic and medical information questionnaire, symptom checklist, Rome scale and Bristol are completed. There is no intervention in this group. Intestinal function indicators will be completed before the intervention and in the first to fourth days.</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 No decision yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Masoumeh Bagheri Nasami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Assistant of Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48157-33971</zip>
        <telephone>+98 11 3379 5508</telephone>
        <email>Mbagheri@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Masoumeh Bagheri Nasami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Assistant of Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48157-33971</zip>
        <telephone>+98 11 3379 5508</telephone>
        <email>Mbagheri@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Acute myocardial infarction, which is confirmed by a laboratory positive blood troponin level and confirmed by a physician.
Written and verbal consent to participate in the study
Age over 18
Ability to communicate verbally</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No more than 12 hours of myocardial infarction
No chronic constipation based on RomeIV criteria
Lack of known mental illnesses under treatment
Absence of ulcers, organ failure, tenderness and fractures in acupressure points
Lack of simultaneous participation in other intervention studies
no thyroid disease, incurable, neuromuscular, congenital gastrointestinal malformations and renal failure, no gastrointestinal disorders (gastric ulcer, chronic constipation history, fisher, hemorrhoids, prolapse of the rectum, obstruction of the rectum, obstruction) , Biography and physical examination by a physician
No dependence or addiction to any drug</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ST elevation (STEMI) myocardial infarction of unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1 : The SJ6 - LI4 - ST25- SP6 points of both members are determined symmetrically by the researcher's fingers. Acupressure will be performed twice daily (10 am and 6 pm) from the beginning of the day for three days. Point ST25 (Tianshu) is located two fingers away from the navel . The LI4 (Hegu) point lies at the depth of the muscle bundle, resulting from the thumb and forefinger . The SJ6 (Zhigou) dot is located four inches above the transverse line of the wrist between Radius and Ulna . The SP6 (sanyinjiao) point is four fingers above the medial ankle behind the posterior edge of the tibia.  Apply acupressure on each spot symmetrically for two minutes. Apply a minute with your thumb pressed vertically, then rest for 5 seconds and then rotate for one minute. A total of 9 minutes of intervention will be administered to the patient each time. Nutrition training and routine nursing care are also provided.</i_keyword>
      <i_keyword>Intervention group2: The sham group offers routine nursing education and care, and the procedure will be exactly the same as the intervention group, except that pressure is close to the acupressure points according to accredited acupressure specialists in the field, which is about half that. No special timber is applied. The order of the pressure, the type of pressure, the position of the patient, the time and the amount of pressure in the test and sham groups will be the same. The location of the pressure points is similar to that of the intervention group except that they are 1.5 cm apart. It should be noted that in both groups, the pressure procedure will be taught by one person (the researcher). Intestinal function and checklists will then be completed before the intervention and in the first to fourth days.</i_keyword>
      <i_keyword>Control group: After introducing and expressing the aims of the study and obtaining written informed consent and patient's consent to participate in the study, these patients receive nutritional and routine heart disease training. The demographic and medical information questionnaire, symptom checklist, Rome scale and Bristol are completed. There is no intervention in this group. Intestinal function indicators will be completed before the intervention and in the first to fourth days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intestinal function. Timepoint: Before and the first day to 4th day of intervention. Method of measurement: Bristool scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>University researches Assistance</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for Research Mazandaran University of Medical Sciences</source_name>
      <source_name>University researches Assistance</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-04</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran. sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
