<?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>IRCT20150119020719N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-14</date_registration>
      <primary_sponsor>The Research choncellor Department Of Alborz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Consultation on Postpartum Quality of Life in Primiparous Women with Body image Concern</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Midwifery Counseling on postpartum Quality of Life of Primiparous Women With Body image Concerns</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29335</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Use the quadruple random block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Quality of life after childbirth. Condition 2: Body Image concern after delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The intervention group in 3 sessions (60-90) minutes will be advised. Session1:  explaining the purpose of the study, Introduction, deﬁnition of body image and the problems arising from body dissatisfaction and Quality of Life, group discussion about appearance changes related to pregnancy, delivery, and postpartum; body image self-assessment tests, recommendation for exercise. Session 2: Recognizing negative body image roots; training to write daily diary of body image;  training Postpartum exercise; Session 3: Reviewing Past meetings, remembering and practicing the techniques described, question and answer at the end of the session. Quality of Life Questionnaire, and Multidimensional Body- Self Relationship Questionnaire will be completed before and after the counseling sessions and two weeks later in both intervention and control groups. Intervention 2: Control group: Receive routine 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:
All participant data can be shared after being unidentified

When:
Start the access period after printing the results

To whom:
Public

Conditions:
For use in studies allowed.

Where to obtain:
Sedigheh Salehi, sadighehsalehi6@gmail.com

How to obtain:
The application will be sent to the project implementer by email and  within 24 hours will receive the necessary items.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Esmaelzadeh Saeieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, first Golestan,Alborz</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3186947535</zip>
        <telephone>+98 912 623 2569</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Esmaelzadeh saieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, first Golestan, Baghestan,Alborz, Iran</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3186947535</zip>
        <telephone>+98 912 623 2569</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a score lower than 138 from the body image questionnaire
Iranian nationality
The interval betwen 6-12 months after Delivery,
At least the reading and writing skills
no addiction, or smoking
Non-exclusive nutrition with powder milk,
fluent in Persian,
First pregnancy,
Full Term pregnancy,
Baby without anomaly,
single pregnancy and live birth fetus,
without pregnancy complications, (Diabetes, preeclampsia, etc.),
without known medical illness and mental problems according  to one's own words</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Non-participation in 1 Full Sessions of Weekly Counseling
Having hormonal problems
Use of drugs
Psychological problems
Having burning scar or lesion on the body
Body mass index more than 30</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_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 intervention group in 3 sessions (60-90) minutes will be advised. Session1:  explaining the purpose of the study, Introduction, deﬁnition of body image and the problems arising from body dissatisfaction and Quality of Life, group discussion about appearance changes related to pregnancy, delivery, and postpartum; body image self-assessment tests, recommendation for exercise. Session 2: Recognizing negative body image roots; training to write daily diary of body image;  training Postpartum exercise; Session 3: Reviewing Past meetings, remembering and practicing the techniques described, question and answer at the end of the session. Quality of Life Questionnaire, and Multidimensional Body- Self Relationship Questionnaire will be completed before and after the counseling sessions and two weeks later in both intervention and control groups.</i_keyword>
      <i_keyword>Control group: Receive routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life after childbirth. Timepoint: Before intervention, After intervention and two weeks After intervention. Method of measurement: Quality of Life Questionnaire (SF-36).</prim_outcome>
      <prim_outcome>Body Image concern after delivery. Timepoint: Before intervention, After intervention and two weeks After intervention. Method of measurement: Multidimensional Body- Self  Relationship Questionnaire (MBSRQ).</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>The Research choncellor Department Of Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-19</approval_date>
        <contact_name>Ethics Committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Alborz University of Medical Sciences, Azimieh, Alborz, Iran Alborz Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
