<?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>IRCT20110906007494N39</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-01</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on intestinal function</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on intestinal function in patients undergoing coronary artery bypass  surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57088</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients are randomly assigned to three groups of 30: acupressure, sham, and control using random numbers provided by computer software and Randomization Permuted Block; In other words, 15 blocks of 6 will be considered in such a way that in each block there are two people from each group of pressure, sham, and control. Therefore, 90 envelopes are designed and inside it, based on the information obtained from the computer program, the letters A of the acupressure group, B group of the sham group and C group of the control group are embedded. Based on the patient's admission date, the priority of opening the envelope door is executed in the order of the number on it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Intestinal function.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Acupressure will be performed twice a day (10 am and 6 pm) for three days from 48 hours after surgery for three days. The ST25 point is two fingers away from the navel. The LI4 point is located deep in the muscle bulge, resulting from the close alignment of the thumb and forefinger. Acupressure is applied symmetrically to each point for two minutes. One minute as a push with the thumb vertically, then, 5 seconds of rest and then, one minute of circular motion; Due to the fact that the interventions are performed simultaneously with the two-handed technique, in total, a maximum of 3 minutes of intervention will be applied to the patient each time; Nutrition training and routine nursing care are also provided. It should be noted that the interventions will be performed within 48 hours after surgery. Intervention 2: Intervention group: In the sham group, nutrition education and routine nursing care are provided and the procedure will be exactly the same as the experimental group; With the difference that the pressure is applied in the points close to the points of acupressure according to the experts of acupuncture and acupressure of the authoritative books of this field, that this point is not located on a specific meridian. The order of pressure, the type of pressure, the patient's position, the time and the amount of pressure in the test and sham groups will be the same. The location of the pressure points is the same as the intervention group; With the difference that it is located at a distance of 1.5 cm from them. It should be noted that in both groups, the pressure procedure will be taught by one person (researcher). Intestinal function and checklists will be completed 24 hours after surgery (before intervention), 48, 72, 96 and 120 hours after surgery. Intervention 3: Only nutrition education and heart disease routines are given.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Reseach Assistant of Mazandaran University of Medical sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>+98 11 3379 5508</telephone>
        <email>mansoorehezaty1994@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari, Joybar three ways, Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3379 5508</telephone>
        <email>Anna3043@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent to participate in research
Individuals undergoing CABG
No chronic constipation according to RomeIV criteria
Ability to communicate verbally
Lack of known neurological and mental illnesses under treatment, absence of wounds, disability
Sensitivity and fractures in the desired points of acupressure
Lack of simultaneous participation in other intervention studies
No thyroid disease, incurable, neuromuscular, congenital gastrointestinal abnormalities and kidney failure, no gastrointestinal disorders (gastrointestinal ulcer, history of chronic constipation, Fischer, hemorrhoids, rectal prolapse, intestinal obstruction based on patient history
History and physical examination by a physician
No dependence or addiction to any drugs
Lack of pulmonary drainage and discharge more than 200 ml per hour
No need for balloon pump inside the aorta
No intubation for more than 24 hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients using combination therapies such as acupuncture, herbal remedies, hypnosis, or yoga
Patients need laxatives other than magnesium hydroxide from 96 hours after surgery
Patients undergoing emergency coronary artery bypass graft surgery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other functional intestinal disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Acupressure will be performed twice a day (10 am and 6 pm) for three days from 48 hours after surgery for three days. The ST25 point is two fingers away from the navel. The LI4 point is located deep in the muscle bulge, resulting from the close alignment of the thumb and forefinger. Acupressure is applied symmetrically to each point for two minutes. One minute as a push with the thumb vertically, then, 5 seconds of rest and then, one minute of circular motion; Due to the fact that the interventions are performed simultaneously with the two-handed technique, in total, a maximum of 3 minutes of intervention will be applied to the patient each time; Nutrition training and routine nursing care are also provided. It should be noted that the interventions will be performed within 48 hours after surgery.</i_keyword>
      <i_keyword>Intervention group: In the sham group, nutrition education and routine nursing care are provided and the procedure will be exactly the same as the experimental group; With the difference that the pressure is applied in the points close to the points of acupressure according to the experts of acupuncture and acupressure of the authoritative books of this field, that this point is not located on a specific meridian. The order of pressure, the type of pressure, the patient's position, the time and the amount of pressure in the test and sham groups will be the same. The location of the pressure points is the same as the intervention group; With the difference that it is located at a distance of 1.5 cm from them. It should be noted that in both groups, the pressure procedure will be taught by one person (researcher). Intestinal function and checklists will be completed 24 hours after surgery (before intervention), 48, 72, 96 and 120 hours after surgery.</i_keyword>
      <i_keyword>Only nutrition education and heart disease routines are given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Digestive disorders. Timepoint: Before the intervention and after the intervention. Method of measurement: RomeIV.</prim_outcome>
      <prim_outcome>Intestinal function. Timepoint: Before the intervention and after the intervention. Method of measurement: Bristol Scale, Intestinal function checklist.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-29</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 (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
