<?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>IRCT20240318061331N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Mummy on Intensity of Episiotomy Pain and Wound Healing</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Mummy on the Intensity of Episiotomy Pain and Wound Healing in Primiparous Afghan Women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76074</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be conducted using a convenience sampling, with samples being allocated to two groups via random assignment facilitated by software. The random allocation of women into the cream and placebo groups will be achieved through random sequence generation by the website www.randomization .com and employing random blocking, Blinding description: Mummy cream and placebo will be poured into completely identical tubes. The creams will be similar in shape, color, and packaging. Both the mummy cream and placebo are assigned unique codes, which are determined through a random selection process and only the supervising pharmacist will be aware of the assigned codes to the creams.</study_design>
      <phase>3</phase>
      <hc_freetext>The Intensity of Episiotomy Pain and Wound Healing.</hc_freetext>
      <i_freetext>Intervention 1: After child birth, the researcher will measure the length and depth of the episiotomy incision by utilizing a sterile swab that was marked with ruler measurements to accurately measure and record its length and depth. The mother will receive personalized instructions on perennial care, which involved gently cleansing the perineum from front to back using warm water, followed by the use of a clean cloth before applying the cream. She is also instructed to wash and dry her hands with water and liquid soap before applying the cream. The mummy cream was then applied to the episiotomy, with a total of 2 to 3 cm applied twice daily (every 12 hours) for a duration of 10 days. Intervention 2: After child birth, the researcher will measure the length and depth of the episiotomy incision by utilizing a sterile swab that was marked with ruler measurements to accurately measure and record its length and depth. The mother will receive personalized instructions on perineal care, which involved gently cleansing the perineum from front to back using warm water, followed by the use of a clean cloth before applying the cream. She is also instructed to wash and dry her hands with water and liquid soap before applying the cream. The placebo cream was then applied to the episiotomy, with a total of 2 to 3 cm applied twice daily (every 12 hours) for a duration of 10 days.</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 This decision regarding sharing will be made subsequent to the conclusion of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Zahra Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square , Razavi Khorasan, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>karimifz@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Zahra Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square , Razavi Khorasan, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>karimifz@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Afghan women aged 18-45 residing in Mashhad
Reading and writing literacy
Primipara
Normal delivery
Single, full-term, and healthy baby
Body mass index 18.5 to 24.9
Mediolateral episiotomy without any instances of rupture, hematoma, and extension of the incision (incision size more than 6cm)
Baby weight between 2500-4000 g</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Using chemical or herbal medications effective in reducing pain or improving the healing of episiotomy wounds
Not using the cream in two or more sessions throughout the entire period
Persistent constipation
Developing metritis or infection at the episiotomy site
Reopening of episiotomy stitches (of course its amount is checked and recorded in two groups)
Intercourse during the study
Experiencing any complications during the postpartum period
Genital skin disease such as vestibulitis, vulval dystrophy
Diseases such as (chronic systemic diseases, heart disease, coagulation disorder, diabetes, kidney and lung disease, anemia, malnutrition, neurological and psychiatric disorders, etc.)
Using medications effective in wound healing such as anticoagulants, antidepressants, antiepileptic, immunosuppressant
Drug abuse, psychotropic drugs, alcohol, and tobacco addiction
Using analgesics to reduce labor pain, experiencing childbirth
Complications during labor stages
Experiencing neonatal complications during labor stages
Having a history of sensitivity to mummy according to the self-report of the mother
Having lesions such as genital warts and genital herpes in the perineum, vagina, and perineum</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O90.89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of the puerperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After child birth, the researcher will measure the length and depth of the episiotomy incision by utilizing a sterile swab that was marked with ruler measurements to accurately measure and record its length and depth. The mother will receive personalized instructions on perennial care, which involved gently cleansing the perineum from front to back using warm water, followed by the use of a clean cloth before applying the cream. She is also instructed to wash and dry her hands with water and liquid soap before applying the cream. The mummy cream was then applied to the episiotomy, with a total of 2 to 3 cm applied twice daily (every 12 hours) for a duration of 10 days.</i_keyword>
      <i_keyword>After child birth, the researcher will measure the length and depth of the episiotomy incision by utilizing a sterile swab that was marked with ruler measurements to accurately measure and record its length and depth. The mother will receive personalized instructions on perineal care, which involved gently cleansing the perineum from front to back using warm water, followed by the use of a clean cloth before applying the cream. She is also instructed to wash and dry her hands with water and liquid soap before applying the cream. The placebo cream was then applied to the episiotomy, with a total of 2 to 3 cm applied twice daily (every 12 hours) for a duration of 10 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Intensity of Episiotomy Pain. Timepoint: Assessment of pain intensity will be conducted prior to the initiation of the intervention, as well as on the first, fifth, and tenth days following the intervention. Method of measurement: Pain intensity evaluation will be carried out prior to the intervention, as well as on the first, fifth, and tenth day post-intervention, using the shortened McGill pain questionnaire while in a sitting position.</prim_outcome>
      <prim_outcome>Episiotomy wound healing. Timepoint: Evaluation of wound healing on the first, fifth, and tenth day following the intervention involving the application of mummy cream. Method of measurement: Wound healing assessment will be done on the first, fifth, and tenth day after delivery, utilizing the Rida scale while in the lithotomy position.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-04</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square, , Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
