<?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>IRCT201409164529N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-10-30</date_registration>
      <primary_sponsor>Vice Chancellor for research Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cooling gel pads and topical olive oil on the intensity of episiotomy pain and wound healing</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of cooling gel pads and topical olive oil on the intensity of episiotomy pain and wound healing in primiparous women referring to hospitals affiliated with the Gilan university of Medical Sciences in 2014</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-07-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4833</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study the randomization was based on the consultation with professor of statistics and determine the number of samples, Excel file was available to the researcher that groups code (1= cooling gel pad group, 2= olive oil group) had put it randomly. Consecutive samples were assigned to each group based on their order  in the Excel file.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>episiotomy.</hc_freetext>
      <i_freetext>Intervention 1: Olive oil group: Mothers who use the olive oil was asked after washing and drying the perineum, olive oil gently placed on the wound 2 times a day for 10 days and then were used the pad after 1-2 minutes. Intervention 2: Cooling gel pad group: Mothers who use the cooling pad was asked after washing and drying the perineum, covered pads with gauze and mothers used it for 20 minutes whenever they needed.</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>Dr Noralsadat Kariman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing And Midwifery, Valiasr St, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 218865536671</telephone>
        <email>sbnmf@sbmu.ac.ir</email>
        <affiliation>School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rahele Amani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Valiasr St, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 218865536671</telephone>
        <email>sbnmf@sbmu.ac.ir</email>
        <affiliation>School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: primiparous woman; aged 18 to 35 years; have a vaginal delivery with mediolateral episiotomy without instrumental delivery and without tears; singleton birth with cephalic presentation; was educated;  resident in  Gilan; gestational ages between 37 to 42 weeks; child weigh between 2500 to 4000 grams; the lack of diseases such as chronic systemic disorders, cardiovascular, respiratory, coagulation disorders and connective tissue, diabetes, anemia, immunosuppressant, hemophilia, malnutrition and psychological disorders;  no allergies to topical drugs; not eclampsia and pre-eclampsia; no rupture of membranes more than 24 hours; no addiction; BMI between 19.8-30 kg/m2; no manual removal of placenta; no fetal anomaly or bedfast  to the neonatal unit; not taking the first stage of labor (more than 14 hours) and the second stage of labor (more than 2 hours) and the third stage of labor (more than 30 minutes);  not problems with cold therapy such as poor circulation and lower pain sensitivity to cold.&#13;
Exclusion criteria: do not visit for care; do not use the cooling gel pads and olive oil properly and as directed;  not interested to continue to participate in the study;  allergic to use olive oil; have a sex in the first 5 days after birth; manipulation of the perineum after episiotomy repair; use drugs on wound healing (anticoagulant, antidepressants, antiepileptic, alcohol, immunosuppressant drugs, antibiotics, chemotherapy) during the study;  have a episiotomy hematoma in the first 24 hours after delivery.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O70.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Second degree perineal laceration during delivery Perineal laceration, rupture or tear as in O70.0, also involving: pelvic floor, perineal muscles, vaginal muscles during delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Olive oil group: Mothers who use the olive oil was asked after washing and drying the perineum, olive oil gently placed on the wound 2 times a day for 10 days and then were used the pad after 1-2 minutes.</i_keyword>
      <i_keyword>Cooling gel pad group: Mothers who use the cooling pad was asked after washing and drying the perineum, covered pads with gauze and mothers used it for 20 minutes whenever they needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of episiotomy pain. Timepoint: before intervention, 12 hours, 5 and 10 days postpartum. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Wound healing of episiotomy. Timepoint: before intervention, 12 hours, 5 and 10 days postpartum. Method of measurement: REEDA 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>Vice Chancellor for research Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-07</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Velenjak Street, Shahid Chamran Highway, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
