<?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>IRCT20170110031865N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-30</date_registration>
      <primary_sponsor>Vice Chancellor for research and technology of Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of early mouth feeding on the post-cesarean pain</public_title>
      <acronym></acronym>
      <scientific_title>The effects of early mouth feeding on the amount of pain in elective cesarean patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24962</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The sample patients will be chosen by using closed envelopes randomly, and they will be placed in either groups ( control or intervention with early liquid diet), Randomization description: When entering the department, research units will be placed in one of the control or intervention groups (early liquids) using a simple random method using closed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: Patients in the intervention group (early feeding with liquid diet) will be placed in sitting position 6 hours after surgery. Mouth feeding, Initially, 30 ml equals to half of a glass of tea and 4 cubes of dissolved sugar will be given to the mother. Then, in case of tolerance and lack of nausea and vomiting after an hour, this volume doubles and can drink 60 ml of the liquid. After this time, based on the dietary intake of the patients, patients will receive juice and yogurt in the form of a soup diet if they tolerate and do not have nausea and vomiting, so that the patient's minimum fluid intake will be 1500 ml for each person per 24 hours.(If the nausea and vomiting of the patient are in an extent that they are not eager to eat and the fluids are less than 200 ml in 4 hours, the infusion of fluids continues and the person leaves the study). After starting mouth feeding, the flow of the vein fluid will be stopped. Before starting feeding, the pain of the mothers will be measured and recorded. The amount of pain at the time of entering the department, 24,18,12,6 after surgery, is determined by the pain reliever and will be recorded by the researcher in the questionnaire. Intervention 2: Control group: Patients in the control group will be treated according to the routine care. Meaning they will lie down on the back  position for 12 hours without eating or drinking anything. The amount of pain at the time of entering the department, 24,18,12,6 after surgery, is determined by the pain reliever and will be recorded by the researcher in the questionnaire.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The main consequence of the study is shared.

When:
Six months after the publication of the article

To whom:
Researchers working in academic and academic institutions

Conditions:
Use results in related studies

Where to obtain:
E-mail address, contact number

How to obtain:
A maximum of one month from the first e-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zahra rashidei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam khomaini street</address>
        <city>Divvandareh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6641967397</zip>
        <telephone>+98 87 3872 2930</telephone>
        <email>zrashidei@yahoo.com</email>
        <affiliation>Kurdistan University of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ronak Shahoei</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>66177-13446</zip>
        <telephone>+98 87317464</telephone>
        <email>zrashidei@yahoo.com</email>
        <affiliation>Kurdistan University of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>women with singleton pregnancies
gestational age 38 to 42 weeks
elective cesarean  (History: at least another previous Cesarean)
surgery with a cross-section of the abdomen and spinal anesthesia
vital signs within normal

non-smoker and no addiction to drugs
lack of any history of abdominal surgery other than caesarean
Child alive
Willing to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>patients giving up for any reason
medical disorders and Midwifery (diabetes , anemia, high blood pressure, heart disease, cardiovascular, renal, pulmonary, gastrointestinal, thyroid, immune disorders, infectious, psychiatric, metabolic disorders, electrolyte and irritable bowel syndrome)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain and other conditions associated with female genital organs and menstrual cycle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: Patients in the intervention group (early feeding with liquid diet) will be placed in sitting position 6 hours after surgery. Mouth feeding, Initially, 30 ml equals to half of a glass of tea and 4 cubes of dissolved sugar will be given to the mother. Then, in case of tolerance and lack of nausea and vomiting after an hour, this volume doubles and can drink 60 ml of the liquid. After this time, based on the dietary intake of the patients, patients will receive juice and yogurt in the form of a soup diet if they tolerate and do not have nausea and vomiting, so that the patient's minimum fluid intake will be 1500 ml for each person per 24 hours.(If the nausea and vomiting of the patient are in an extent that they are not eager to eat and the fluids are less than 200 ml in 4 hours, the infusion of fluids continues and the person leaves the study). After starting mouth feeding, the flow of the vein fluid will be stopped. Before starting feeding, the pain of the mothers will be measured and recorded. The amount of pain at the time of entering the department, 24,18,12,6 after surgery, is determined by the pain reliever and will be recorded by the researcher in the questionnaire.</i_keyword>
      <i_keyword>Control group: Patients in the control group will be treated according to the routine care. Meaning they will lie down on the back  position for 12 hours without eating or drinking anything. The amount of pain at the time of entering the department, 24,18,12,6 after surgery, is determined by the pain reliever and will be recorded by the researcher in the questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Arrival, 6,12,18 and 24 hours after surgery. Method of measurement: Visual Analoge Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Sanandaj University of Medical Sciences</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_name>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-22</approval_date>
        <contact_name>Ethic committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences, after Qods Hospital, Pasdaran street, Sanandaj Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
