<?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>IRCT2017062134641N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-26</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of abdominal massage on the gastric residual valume</public_title>
      <acronym></acronym>
      <scientific_title>The effect of abdominal massage on gastric residual volume and abdominal circumference of patients a</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Acute pulmonary edema. Condition 2: head trauma. Condition 3: Congestive heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: According to the studies, there are two types of abdominal massage, Classic abdominal massage and massage based on the tensegrity principle. The present study uses massage based on  the tensegrity principle. This massage technique consists of 5 steps. The massage started with brushing the skin in the abdominal area, second stage elastic deformation of the thoracolumbar fascia was performed in the form of displacement, third stage The abdominal integuments were elastically deformed by kneading, The fourth stage involves shock movements along the armpit from top to bottom and down to the top and The last stage contains Elastic deformation of the muscles in the intercostal spaces. The patient's position is asleep to the back while undergoing massage.  The angle between the bed and the patient's head is 30 to 45 degrees, and the patient's legs are placed on a pillow. This condition helps to relax the abdominal muscles. Massage is runs twice for each patient, Massage session lasts about 20 minutes in each day. This action runs over 3 consecutive days. every day, before and after the massage, gastric residual valuom and abdominal circumference Calculated and Compare. For abdominal circumference measurement, a 150-cm flexible measure   will be used. The beginning point for the measurement is the umbilicus. Intervention 2: Control group:  The control group will receive usual care contain; Change position, Lavage, Gavage and etc.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>alireza abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv.   Kermanshah</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00988338279394</zip>
        <telephone>+98 83 3835 8258</telephone>
        <email>arabdi@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>alireza abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv.</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00988338279394</zip>
        <telephone>+98 83 3835 8258</telephone>
        <email>arabdi@kums.ac.ir</email>
        <affiliation>Kermanshah School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Having a nasogastric tube, Loss of consciousness, had not received radiotherapy treatment on the abdominal region in the previous 6 weeks, without intestinal obstruction, abdominal surgery, or diarrhea, Lack of Deep Venus Thrombosis, Not having an aneurysm, Not having ascites, Not receiving any effective gastrointestinal medicine&#13;
&#13;
 Exclusion criteria: Transferring the patient to other wards, death, discharge, Take out the gastric tube, Patients have intra-abdominal pressure 12 mm Hg and patients with abdominal compartment syndrome</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>150.1</hc_code>
      <hc_code>s06.7</hc_code>
      <hc_code>150.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Left ventricular failure</hc_keyword>
      <hc_keyword>Intracranial injury with prolonged coma</hc_keyword>
      <hc_keyword>Congestive heart failure</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: According to the studies, there are two types of abdominal massage, Classic abdominal massage and massage based on the tensegrity principle. The present study uses massage based on  the tensegrity principle. This massage technique consists of 5 steps. The massage started with brushing the skin in the abdominal area, second stage elastic deformation of the thoracolumbar fascia was performed in the form of displacement, third stage The abdominal integuments were elastically deformed by kneading, The fourth stage involves shock movements along the armpit from top to bottom and down to the top and The last stage contains Elastic deformation of the muscles in the intercostal spaces. The patient's position is asleep to the back while undergoing massage.  The angle between the bed and the patient's head is 30 to 45 degrees, and the patient's legs are placed on a pillow. This condition helps to relax the abdominal muscles. Massage is runs twice for each patient, Massage session lasts about 20 minutes in each day. This action runs over 3 consecutive days. every day, before and after the massage, gastric residual valuom and abdominal circumference Calculated and Compare. For abdominal circumference measurement, a 150-cm flexible measure   will be used. The beginning point for the measurement is the umbilicus.</i_keyword>
      <i_keyword>Control group:  The control group will receive usual care contain; Change position, Lavage, Gavage and etc.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gastric residual valume. Timepoint: before anf after intervention. Method of measurement: Using a special syringe for gavage.</prim_outcome>
      <prim_outcome>Abdominal circumference. Timepoint: before and after intervention. Method of measurement: Using a special flexible meter.</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>Vice Chancellor for Research, Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-03</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
