<?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>IRCT20160521027994N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-29</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Postpartum Quality of Life</public_title>
      <acronym>ACT</acronym>
      <scientific_title>Comparison of Acceptance and Commitment Based Counseling (ACT) with routine care on postpartum quality of life of adolescent mothers Mallard and Shahriar counties</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, first, the easy sampling method will be used and then individuals with inclusion criteria will be divided into two groups of intervention and control using random block division. In this way, first, using 4 blocks, the arrangement of people next to each other in each block will be determined, and then a number will be assigned to each block, and 18 blocks will be determined to provide the required number of samples. Then, using the table of random numbers, the sequence of using the blocks will be determined. Entry to each group in each block will be done by the number of selected blocks and the arrangement inside the block, respectively. The number of people in each group will be 35.</study_design>
      <phase>N/A</phase>
      <hc_freetext>quality of life  in postnatal.</hc_freetext>
      <i_freetext>Intervention 1: Adolescent mothers participating in the intervention group from 14 to 15 days after delivery, in 10 sessions per week, for 90-60 minutes, will receive psychological counseling based on commitment and acceptance. In each session, first, topics related to psychological issues based on commitment and acceptance, such as cultivating a sense of awareness, self-observation, acceptance of emotions, value-based behavior, self-improvement will be presented, and at the end of session , assignments on that topic will be given to clients. In the next sessions, first the homework presented will be discussed and then another part of the content in the field of psychology based on commitment and acceptance will be presented. At the end of the sessions, the quality of life questionnaire will be completed again, and also after two months, the questionnaires will be completed again to follow up on the counseling effects. Intervention 2: The control group does not receive services related to the ACT counseling package, and only midwifery services and counseling are provided for them, but at the end of the research and data collection, in order to comply with ethical standards, educational pamphlet in the field of commitment-based psychology and Admission will be provided to mothers in the control group.</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 release schedule is not yet known

When:
The release schedule is not yet known

To whom:
The release schedule is not yet known

Conditions:
The release schedule is not yet known

Where to obtain:
The release schedule is not yet known

How to obtain:
The release schedule is not yet known

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Karami Dehbaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahriar-Andisheh Phase 3-Sadaf Town-Dr. Gharib Boulevard-Lahouti St.-No. 18-Unit 3</address>
        <city>Tehran, Andesheh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513665758</zip>
        <telephone>+98 24 3344 4280</telephone>
        <email>parisaaliali@gmail.com</email>
        <affiliation>Zanjan University Of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Taraneh Emamgholi Khooshehchin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karmandan boulevard, School of Nursing and Midwifery</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۵۱۳۹۵۶۱۱۳</zip>
        <telephone>+98 24 4133 8138</telephone>
        <email>Khoosheh@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers aged 15 to 19 who visit health care facilities on days 10-14 of postpartum
Having primary education (8th grade)
Absence of a history of known psychiatric disorders in the mother based on individual statements and documents in the file and using a questionnaire (K-SADS-PL)
No history of drug and psychotropic use
No stressful events during the research (accidents, death of a loved one, separation from a spouse, bankruptcy, severe disputes, immigration)
No complications of childbirth (Hematoma, metritis, wound opening, etc.)
Willingness to participate in the study
People who have low to medium quality of life according to the questionnaire (score between 0 and 60 in the questionnaire)
Having a mobile phone and internet access</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>19 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dropping out of research during the intervention
Absence in more than two sessions of intervention sessions
Incidence of maternal and neonatal complications such as postpartum hemorrhage, postpartum infection, etc, hospitalization of the infant in NICU
Incompatibility with group therapy such as severe social phobia, conduct disorder and ADHD</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>Adolescent mothers participating in the intervention group from 14 to 15 days after delivery, in 10 sessions per week, for 90-60 minutes, will receive psychological counseling based on commitment and acceptance. In each session, first, topics related to psychological issues based on commitment and acceptance, such as cultivating a sense of awareness, self-observation, acceptance of emotions, value-based behavior, self-improvement will be presented, and at the end of session , assignments on that topic will be given to clients. In the next sessions, first the homework presented will be discussed and then another part of the content in the field of psychology based on commitment and acceptance will be presented. At the end of the sessions, the quality of life questionnaire will be completed again, and also after two months, the questionnaires will be completed again to follow up on the counseling effects.</i_keyword>
      <i_keyword>The control group does not receive services related to the ACT counseling package, and only midwifery services and counseling are provided for them, but at the end of the research and data collection, in order to comply with ethical standards, educational pamphlet in the field of commitment-based psychology and Admission will be provided to mothers in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life in postnatal. Timepoint: Before the intervention, the last consultation session and 2 months after intervention. Method of measurement: World health organization quality of life in breif quastionnaire (26 questions).</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-13</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences, Azadi Square Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
