<?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>IRCT20220313054270N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-01</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Vitamin D and Vitamin E on the severity of postpartum pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Vitamin D and Vitamin E on the severity of postpartum pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>43</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62820</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the days of the week, the research units will be divided into two groups A (intervention group) (Saturdays, Mondays, Wednesdays) and group B (control groups) (Sundays, Tuesdays, Thursdays).</study_design>
      <phase>4</phase>
      <hc_freetext>postpartum pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: each person receives a packet containing 8 vitamin E with a dose of 100 mg and 8 vitamin D with a dose of 400 mg.  and every 6 hours, they take one vitamin D and one vitamin E, and after every 6 hours, for 8 times. the pain level is measured by the McGill ruler. Intervention 2: Control group: It does not receive any interference. Routine hospital care.</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:
After the publication of the article, confidential information such as patient and hospital details will be removed and other information will be provided to the researchers

When:
After the publication of the article

To whom:
Medical experts

Conditions:
Medical professionals can access the data for research purposes

Where to obtain:
Refer to the email of the responsible author.

How to obtain:
Official and academic email to the corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Ghalenovi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nuclear Martyrs Ave, Sabzevar University of Medical Sciences</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613943491</zip>
        <telephone>+98 51 4422 6958</telephone>
        <email>Minaghalenovi@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Ghalenovi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nuclear Martyrs Ave, Sabzevar University of Medical Sciences</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613943491</zip>
        <telephone>+98 51 4422 6958</telephone>
        <email>Minaghalenovi@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mother must be literate.
The age of the mother should be between 18-35 years.
Their delivery is natural and the first or second delivery.
Pregnancy age is between 42-37 weeks.
The mother is breastfeeding.
The exit of the placenta and the curtains is done spontaneously.
The mother has moderate to severe back pain.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The mother has not suffered a grade 3 or 4 perineal rupture.
Epidural or spinal anesthesia is not used.
During or before delivery, the drug has not been used to relieve pain, or 4 hours or more have passed since its us
The mother should not be addicted to drugs.
The mother does not have known chronic diseases (hypertension, diabetes, heart disease, infectious disease, lung disease, asthma)
The mother has no history of abdominal and pelvic surgery
The mother should not have symptoms of vitamin D deficiency (including bone and muscle pain, headache, and constant fatigue
The patient has no history of vitamin D3 deficiency.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z39.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for routine postpartum follow-up</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: each person receives a packet containing 8 vitamin E with a dose of 100 mg and 8 vitamin D with a dose of 400 mg.  and every 6 hours, they take one vitamin D and one vitamin E, and after every 6 hours, for 8 times. the pain level is measured by the McGill ruler.</i_keyword>
      <i_keyword>Control group: It does not receive any interference. Routine hospital care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of postpartum pain. Timepoint: 2 hours after delivery and then every 6 hours up to eight times. Method of measurement: Through the McGill pain scale (to reach less than 4 after the intervention).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of painkillers used. Timepoint: 2 hours after delivery and then every 6 hours, the consumption of painkillers is checked. Method of measurement: patient file.</sec_outcome>
      <sec_outcome>The amount of pain. Timepoint: 2 hours after delivery and then every 6 hours up to 8 times. Method of measurement: Via McGill ruler.</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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-20</approval_date>
        <contact_name>Ethics committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Nuclear Martyrs Ave, Sabzevar University of Medical Sciences Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
