<?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>IRCT20210123050116N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-04</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of acceptance and commitment counseling on body image and breastfeeding self-efficacy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of midwifery counseling with the approach of acceptance and commitment on the mental image of the body and breastfeeding self-efficacy in pregnant mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53872</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the allocation sequence generated from the website www.sealedenvelope.com and based on the 4-volume block method, participants are randomly assigned to two groups. Because people enter the study over time and because This method was used over time to assign a proportion to the groups by accident, and also by assigning one person to a group, it is not possible to guess which group the next person will belong to.
After generating the allocation sequence, each sequence letter (A, B) corresponds to a group. Since the participants enter the study from different centers, the central concealment method is used. The allocation sequence is in the hands of someone outside the research team. For each eligible person, after registering and entering the study, the desired person will be contacted and thus entered in a central list and will receive an identification code and assigned to the desired group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effectiveness of midwifery counseling with acceptance and commitment approach on body image and breastfeeding self-efficacy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At separate times, 8 sessions of counseling based on acceptance and commitment (in case of outbreak of Covid disease 19 virtually) so that the first 4 sessions twice a week and the second 4 sessions once a week, 10 sessions in each session for They receive 90 minutes at the training hall of the same comprehensive health service center. The content of the meetings is based on the protocol of acceptance and commitment based on the six processes (acceptance, failure, self as a context, living in the present, recognizing values and committed action). These meetings will be held professionally by the project manager. Intervention 2: Control group:Receives only routine care, and at the end (a placebo intervention) is formed as a training session for the control group to maintain ethical standards that does not interfere with the counseling intervention.</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 data can be shared after identifying the names of individuals.

When:
Access period starts four months after the results are registered

To whom:
Researchers and students of medical universities

Conditions:
The use of documents in all scientific and research activities is allowed, and to send a request for access to data and documents must be a student or researcher in the country's medical universities.

Where to obtain:
To receive data, send an email to this address: hosinisadat370@gmail.com

How to obtain:
The student or researcher will send an email with the full content of the reason for requesting and using the data to the email mentioned, and it will be sent to them as soon as they see the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam sadat Hosini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Side Passage Votary, Banke Mellat, Department Central, Street Martyr Artistic</address>
        <city>Jajarm</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9431148348</zip>
        <telephone>+98 58 3250 6146</telephone>
        <email>hosinisadat370@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam sadat Hosini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Side Passage Votary, Banke Mellat, Department Central, Street Martyr Artistic</address>
        <city>Jajarm</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9431148348</zip>
        <telephone>+98 58 3250 6146</telephone>
        <email>hosinisadat370@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>First pregnancy
Single pregnancy
Gestational age 28 to 32 weeks
Decided to exclusive breastfeeding
Obtain a cut-off score on the Multidimensional Body-Self Relationships Questionnaire
At least literacy
Familiarity with cyberspace
No addiction to cigarettes, drugs and alcohol
No problems during pregnancy (including pre Aklamsya, placenta previa, diabetes, Dklman)
The lack of major psychiatric disease
Lack of breast abnormalities
Lack of medical prohibition on breastfeeding for mother and baby
Previous non-participation in courses similar to this course
Having the consent to enter the study
Resident of Jajarm city and its suburbs</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence for more than two sessions
Relocation and unavailability of pregnant mothers</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: At separate times, 8 sessions of counseling based on acceptance and commitment (in case of outbreak of Covid disease 19 virtually) so that the first 4 sessions twice a week and the second 4 sessions once a week, 10 sessions in each session for They receive 90 minutes at the training hall of the same comprehensive health service center. The content of the meetings is based on the protocol of acceptance and commitment based on the six processes (acceptance, failure, self as a context, living in the present, recognizing values and committed action). These meetings will be held professionally by the project manager.</i_keyword>
      <i_keyword>Control group:Receives only routine care, and at the end (a placebo intervention) is formed as a training session for the control group to maintain ethical standards that does not interfere with the counseling intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of the mental image of the body in the multidimensional body-self relations questionnaire. Timepoint: At the beginning of the study (before the intervention) and immediately after the intervention, one month and three months after delivery. Method of measurement: Based on the standard body-self multidimensional relationship questionnaire, which has 68 Likert-scale questions, each question is scored from 1 (completely dissatisfied) to 5 (completely satisfied), so the minimum total score of an individual 68 and the maximum total score of a person can be 340. The scoring of the questionnaire is such that people who have a more appropriate mental image of themselves get higher scores. The cut-off score in this questionnaire is 142.</prim_outcome>
      <prim_outcome>Breastfeeding self-efficacy score in the standard breastfeeding self-efficacy questionnaire. Timepoint: At the beginning of the study (before the intervention) and immediately after the intervention, one month and three months after delivery. Method of measurement: Based on the standard breastfeeding self-efficacy questionnaire, which has 33 options and is rated on a 5-point Likert scale from strongly agree (score 5) to strongly disagree (score 1). Scores range from 33 to 165, and higher scores indicate higher levels of breastfeeding self-efficacy. A score of 33 to 76 is considered low self-efficacy, a score of 77 to 120 is considered moderate self-efficacy and a score of 121 to 165 is considered high self-efficacy.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-07</approval_date>
        <contact_name>Research Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud, Haftam Tir Square, Shahroud University of Medical Sciences and Health Services Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
