<?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>IRCT2016111730936N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-27</date_registration>
      <primary_sponsor>Vice Chancellor for research and technology of Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of chewing sugar-free gum massage the abdomen and constipation</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of abdominal massage, chewing sugar-free gum and a combined method on the incidence and severity of constipation in patients who have undergone lower limb skeletal traction in Sanandaj in Year 1395</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24441</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>constipation.</hc_freetext>
      <i_freetext>Intervention 1: For patients (3) a combination of chewing sugar-free gum a number Barbd Mark van an hour-a-day eating meals (breakfast, lunch, dinner) for half an hour and massage the abdomen in a clockwise direction for 15 minutes on the clock in the direction transverse colon and descending colon in the left upper abdomen in the direction of the anterior superior iliac spine down the left Without prejudice to patient privacy for 7 days + care routine will be performed by the principal investigator. Intervention 2: To control (4) routine actions, such as recommendations to increase fluid intake, fiber intake, and active and passive movements in bed is recommended. Intervention 3: For patients (2) clockwise abdominal massage for 15 minutes per hour of 9 am and 9 pm with gentle constant pressure with two or three fingers in a clockwise direction to rotate the area of the anterior superior iliac spine straight day + care routine will be performed by the principal investigator. Intervention 4: For patients (1) chewing sugar-free gum a number Mark van (25-gram package containing xylitol) 3 times a day for 30 minutes after an hour of eating every meal + routine hospital for 7 days prescribed by Research Associate and monitored.</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>aram nezakati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besat Hospital, Keshavarz Street</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6619616776</zip>
        <telephone>+98 878733285910</telephone>
        <email>aramnezakati20@gmail.comjamal.seidi@yahoo.com jamal.seidi@muk.ac.ir</email>
        <affiliation>Kurdistan University of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jamal Siedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13446-66177</zip>
        <telephone>+98 87 3182 7464</telephone>
        <email>jamal.seidi@yahoo.com jamal.seidi@muk.ac.ir</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Not having normal bowel movements and constipation model to study femoral fractures in patients older than 18 years approved by skeletal traction Follow the instructions in the diet based on normal diet without affecting the underlying disease bowel movements(Diabetes, depression, hemorrhoids, Fisher, dementia, multiple sclerosis, Parkinson's disease, a history of abdominal surgery, rheumatoid arthritis, hypothyroidism, spinal cord injury).No special diet or weight loss obesity. Lack of skin inflammation or ulcers in the massage area treated with specific drugs affecting the gastrointestinal tract, bowel movements and not (antacids, anticholinergic and anti-Parkinson's medications are, calcium channel blockers, diuretics, iron supplements, anti-inflammatory drugs NSAIDs, and opioid consumption).Lack of inflammatory bowel disease. No smoking and drugs.Exclusion criteria from the study:Not wanting to continue cooperation.Before the patient is discharged 7 days.The use of drugs affecting bowel function such as lactulose, magnesium hydroxide syrup and ...Inability to chew gum</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K59.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>constipation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For patients (3) a combination of chewing sugar-free gum a number Barbd Mark van an hour-a-day eating meals (breakfast, lunch, dinner) for half an hour and massage the abdomen in a clockwise direction for 15 minutes on the clock in the direction transverse colon and descending colon in the left upper abdomen in the direction of the anterior superior iliac spine down the left Without prejudice to patient privacy for 7 days + care routine will be performed by the principal investigator.</i_keyword>
      <i_keyword>To control (4) routine actions, such as recommendations to increase fluid intake, fiber intake, and active and passive movements in bed is recommended.</i_keyword>
      <i_keyword>For patients (2) clockwise abdominal massage for 15 minutes per hour of 9 am and 9 pm with gentle constant pressure with two or three fingers in a clockwise direction to rotate the area of the anterior superior iliac spine straight day + care routine will be performed by the principal investigator.</i_keyword>
      <i_keyword>For patients (1) chewing sugar-free gum a number Mark van (25-gram package containing xylitol) 3 times a day for 30 minutes after an hour of eating every meal + routine hospital for 7 days prescribed by Research Associate and monitored.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Constipation severity. Timepoint: 7 days after the intervention. Method of measurement: questionnaire ROM III.</prim_outcome>
      <prim_outcome>The incidence of constipation. Timepoint: 7 days after the intervention. Method of measurement: questionnaire ROM III.</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 and technology of Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-16</approval_date>
        <contact_name>Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences, after Qods Hospital Sanandaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
