<?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>IRCT20230626058592N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-05</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Salutogenesis theory on the postpartum quality of life</public_title>
      <acronym></acronym>
      <scientific_title>Designing, implementation and evaluating an educational program to improve the postpartum quality of life among nulliparous women based on Salutogenesis theory: An exploratory sequential mixed methods study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70951</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, a list of nulliparous women who met the inclusion criteria will be extracted from all health centers of Ahvaz. The selected women will be contacted through their contact information to be informed briefly about the purpose and method of the research and then invited to participate in the study. Sampling will continue until the predetermined number of participants enter the study.
In order to carry out the intervention, nulliparous women will be divided into two parallel group of intervention group (ST based training program along with routine childbirth preparation classes) and control (routine childbirth preparation classes) by random allocation method using blocked randomization with blocks of 6.  For allocation concealment, the names of the control and intervention groups will be written and placed in numbered identical closed and opaque envelopes by a person who has no information about the research objectives and when choosing the envelopes, a person who was not involved in the study is asked to choose an envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postpartum quality of life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The educational content is prepared based on the determinants effective in improving the quality of life after childbirth in primiparous women, which will be obtained from the qualitative and review phase. Intervention 2: Control group: Participants in the control group will attend routine childbirth preparation classes.</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 demographic characteristics of participants are confidential, but information on other variables will be shareable.

When:
12 months after the publication of the final article

To whom:
Researchers in scientific and academic institutions, health education and health promotion unit of the Ministry of Health and family health unit of the Ministry of Health

Conditions:
Educational and research use is permitted with the permission of the Ethics Committee of Ahvaz University of Medical Sciences. The application should be sent through the Research Vice-Chancellor of Medical Sciences Universities.

Where to obtain:
Corresponding author: Mojgan Javadnoori
 javadnoori-m@ajums.ac.ir

How to obtain:
Up to three weeks after receiving the request by email to the corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Shami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Kolahdoz St, Koi Saidieh</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4519783597</zip>
        <telephone>+98 919 954 9600</telephone>
        <email>maryamshami1870@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Shami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Kolahdoz St, Koi Saidieh</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4519783597</zip>
        <telephone>+98 919 954 9600</telephone>
        <email>maryamshami1870@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Nulliparous women
Being at gestational age 28 weeks and above
Being over 18 years old
Singleton pregnancy
Ultrasound confirmation of fetus health
Having no history of depression or long-term medical illness in the past according to the mother's statement
Willingness to participation the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women with a history of infertility
Pregnancy following assisted reproductive treatment.
Refusing to complete questionnaires
Cannot be accessed for unpredictable reasons.
The presence of illness in the spouse</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The educational content is prepared based on the determinants effective in improving the quality of life after childbirth in primiparous women, which will be obtained from the qualitative and review phase.</i_keyword>
      <i_keyword>Control group: Participants in the control group will attend routine childbirth preparation classes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postpartum quality of life. Timepoint: Immediately after delivery, 4 weeks after delivery and 8 weeks after delivery. Method of measurement: Using the postpartum quality of life questionnaire.</prim_outcome>
      <prim_outcome>Type of delivery. Timepoint: After delivery. Method of measurement: Examination of maternity records.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sense of coherence. Timepoint: Before the intervention, immediately after delivery, 4 weeks after delivery and 8 weeks after delivery. Method of measurement: SOC-13 questionnaire.</sec_outcome>
      <sec_outcome>Maternal self-efficacy. Timepoint: Immediately after delivery, 4 weeks after delivery and 8 weeks after delivery. Method of measurement: Maternal self-efficacy questionnaire.</sec_outcome>
      <sec_outcome>Breastfeeding self-efficacy. Timepoint: Immediately after delivery, 4 weeks after delivery and 8 weeks after delivery. Method of measurement: Breastfeeding Self‑Efficacy Scale‑Short Form.</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>2023-06-03</approval_date>
        <contact_name>Research Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ground floor, Ahvaz Academic City Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
