<?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>IRCT20190805044438N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-16</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effect of abdominal massage on constipation in elderly patients with fracture</public_title>
      <acronym></acronym>
      <scientific_title>The effect of abdominal massage on constipation in elderly patients with fracture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43755</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, the patients were selected by applying the entry criteria. Then they were randomly assigned, based on Random allocation software, in two groups: massage therapy and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Constipation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Abdominal massage with baby oil produced by Firooz Health Group for 3 consecutive days, twice a day, morning and evening, abdominal massage for 15 minutes with 20 ml of Firooz baby oil (To make it easier to move the hand on the patient's abdomen and Failure to cause discomfort to him), according to the instructions of the  National Health Service (NHS) for the patient. This massage consists of 8 steps. 1. Three movements of the lower abdomen to the navel 2. Three movements from both sides of the pelvic to the pubic symphysis  In the upper part and the whole abdomen 6. Repeat steps 4 and 5 .7. The horizontal movement of the abdomen from left to right 8. Vibration movements in all these points. Intervention 2: Control group:No specific intervention by the researcher will be performed on patients in this group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The decision is made after the research is completed</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roya Mansour-ghanaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran</address>
        <city>Langeroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4477163485</zip>
        <telephone>+98 13 4256 5058</telephone>
        <email>r_ghanaei@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Mansour-ghanaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran</address>
        <city>Langeroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4477163485</zip>
        <telephone>+98 13 4256 5058</telephone>
        <email>r_ghanaei@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly men and women 60 years and older.
Informed consent to participate in the study.
Ability to respond to the questionnaire.
Hospitalization due to fracture of more than 48 hours in the orthopedic department of the hospital under study.
Determining the problem of constipation based on the constipation Assessment scale(CAS) [scoring above 5 on the constipation Assessment  scale].</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cognitive problems, A history of mental illness, abdominal hernia, colorectal cancer, inflammatory bowel disease (Crohn's disease, IBD), irritable bowel syndrome and laparotomy.
Skin lesions in the abdomen.</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>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Abdominal massage with baby oil produced by Firooz Health Group for 3 consecutive days, twice a day, morning and evening, abdominal massage for 15 minutes with 20 ml of Firooz baby oil (To make it easier to move the hand on the patient's abdomen and Failure to cause discomfort to him), according to the instructions of the  National Health Service (NHS) for the patient. This massage consists of 8 steps. 1. Three movements of the lower abdomen to the navel 2. Three movements from both sides of the pelvic to the pubic symphysis  In the upper part and the whole abdomen 6. Repeat steps 4 and 5 .7. The horizontal movement of the abdomen from left to right 8. Vibration movements in all these points.</i_keyword>
      <i_keyword>Control group:No specific intervention by the researcher will be performed on patients in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Constipation score in Constipation Assessment Scale (CAS). Timepoint: Before intervention and 3 days after intervention. Method of measurement: Constipation Assessment Scale (CAS).</prim_outcome>
      <prim_outcome>Gastrointestinal symptom rating. Timepoint: Before intervention and 3 days after intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS).</prim_outcome>
      <prim_outcome>Stool form. Timepoint: Before intervention and 3 days after intervention. Method of measurement: Bristol Stool Form Scale.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-22</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Deputy of university Research and Technology of the University, Old Bldg (building) School of Health, in front of 17 Shahrivar Hospital, Shahid Siadati Ave, Namjoo St, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
