<?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>IRCT20160427027633N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-15</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of effectiveness of a education program on the promoting of social support of mothers</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effectiveness of a education program for husbands on the promoting of social support of mothers in the postpartum period</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56451</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization of subjects is block randomization with blocks with size of 4. This will be done with WinPepi11.0 software. 
This software generates random groups. In each block, 2 subjects are from the control group and 2 subjects are from the intervention group, which is arranged randomly, Blinding description: In this study, blindness is not possible for the researcher and participant. Therefore, in this study data analyzer blindness (lack of knowledge of the subject code) will be used, so the study will be single blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  The educational content developed for the intervention group will be implemented after completing the questionnaire online by mothers on the 3rd day after delivery. The intervention will be as follows, first in the WhatsApp program, based on the sample size, several groups of 7 to 10 people will be formed to perform the education, then education program will be held in the form of 4 online sessions of 45 to 90 minutes in this software and in the form of PowerPoint, lectures and questions and answers in WhatsApp software and weekly (one session per week) by the researcher. If the members want, they will ask their questions and problems in the group, and if they do not want, they will solve these issues individually (private chat) with the consultant (assistant researcher). Meeting time will be held by agreement of the participants. Educational content at the first session of the importance of maternal health in the postpartum period and anatomical, physiological changes in the postpartum period (first week after delivery), second session of the effect of these changes on the mother's mental status, the importance of social support from the mother in the postpartum period and maternal care (second week after delivery), third session of the baby care and principles of breastfeeding and how to deal with its challenges (third week after delivery), fourth session of the role of the father in the postpartum period and his supportive role in helping mothers to adapt to change (fourth week after delivery). At the end of the intervention period and 4 weeks after that (in the fourth and eighth week after delivery), the questionnaire will be completed again online by mothers. Intervention 2: Control group: For this group no intervention will perform and they will receive routine care. The questionnaire will be completed online by mothers in the 3rd day and fourth and eighth week after delivery.</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 I will decide after the end of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Foruzan Sharifipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3333 5368</telephone>
        <email>sharifipour_fr91@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Abbaspoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3333 5368</telephone>
        <email>abbaspoor-z762@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>First pregnancy
Single and term pregnancy
Do not suffer from physical and mental illnesses
Do not consume alcohol and tobacco
Married and living together with his husband
Husband's desire to participate in the study
Failure to participate in similar training or counseling classes before studying
No stressful events during the past month
Having media literacy (acquaintance with how WhatsApp program)
Acquaintance with cyberspace
Having a smart phone and the possibility of accessing the WhatsApp social network
Internet access
Access to the participant within at least the next 8 weeks</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unwillingness of people
Infant hospitalization
Occurrence of any stressful event for couples or their first-degree family members such as death or incurable disease
Moderate to severe postpartum depression</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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:  The educational content developed for the intervention group will be implemented after completing the questionnaire online by mothers on the 3rd day after delivery. The intervention will be as follows, first in the WhatsApp program, based on the sample size, several groups of 7 to 10 people will be formed to perform the education, then education program will be held in the form of 4 online sessions of 45 to 90 minutes in this software and in the form of PowerPoint, lectures and questions and answers in WhatsApp software and weekly (one session per week) by the researcher. If the members want, they will ask their questions and problems in the group, and if they do not want, they will solve these issues individually (private chat) with the consultant (assistant researcher). Meeting time will be held by agreement of the participants. Educational content at the first session of the importance of maternal health in the postpartum period and anatomical, physiological changes in the postpartum period (first week after delivery), second session of the effect of these changes on the mother's mental status, the importance of social support from the mother in the postpartum period and maternal care (second week after delivery), third session of the baby care and principles of breastfeeding and how to deal with its challenges (third week after delivery), fourth session of the role of the father in the postpartum period and his supportive role in helping mothers to adapt to change (fourth week after delivery). At the end of the intervention period and 4 weeks after that (in the fourth and eighth week after delivery), the questionnaire will be completed again online by mothers.</i_keyword>
      <i_keyword>Control group: For this group no intervention will perform and they will receive routine care. The questionnaire will be completed online by mothers in the 3rd day and fourth and eighth week after delivery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social support. Timepoint: Before, after the end of the intervention period  and 4 weeks later. Method of measurement: Postpartum Partner Support Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Efficacy of mother. Timepoint: Before, after the end of the intervention and 4 weeks later. Method of measurement: Postpartum Parental Expectations Survey.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-14</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
