<?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>IRCT20180901040916N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigate the impact of counseling on acceptance and commitment therapy to the fear, attitude and intention of choosing the type of delivery</public_title>
      <acronym></acronym>
      <scientific_title>Investigate the impact of counseling with an approach based on acceptance and commitment therapy to the fear, attitude and intention of choosing the type of delivery in primigravid women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33795</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomized method:  simple using random numbers. At first, the researcher selects a number from the table with a blind eye, and then the numbers are given in the order of the row, the first number is assigned to the control group, and the second number assigned to the intervention group and so on. 
Random unit: Individual
Randomization Tool:Random numbers
Hiding: no.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fear of delivery, Attitude of delivery , Intent to choose the type of delivery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receiving 4 consultation sessions with an approach base on acceptance and commitment therapy in group ,any week ,a meeting with a duration of 90 to 120 minute up to 4 weeks. Session content: First Session: Introduction , determination the escape and avoidance of client strategies and determination of specify the dumps and bugs, Forecasts and evaluation of client about fear of childbirth. Second session: Education of control is problem not solution, Separating the judgments of person experiences and see thoughts without judging them. Third session: Help to client for determination of judgments about himself such as be cowardly, be weakly and so on. The education of mindfulness and help to client for identification values of himself and their classification. Fourth session: Presentation of practical approach for action and commitment about decided. Intervention 2: Control group: Routine Care Pregnancy Classes which lasts from 23 to 38 weeks of pregnancy for 8 sessions of 90 minutes.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboobeh firoozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, west Fajr, Baharan Ave., Faramarzabbasi Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>firoozim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboobeh firoozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Plate 9-Fajr 14-Baharan-Faramar Abbasi Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Firoozim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Residence in Mashhad                                                                   2- Access to Telephone                                                                                     3- Having at least elementary education                                                                                                                       4- Do not have a mother's hearing and speech problems that can not communicate with a researcher                                                                         5- Age between 18 and 35                                                                          6- Gestational age between 28 weeks to 32 weeks                                                                                                                               7- Single and low-risk pregnancy                                                       8- Primigravid                                                                                       9- Willingness to cooperate                                                                                  10- The sample has no history of infertility                                              11- The sample does not have a medical cause for cesarean section (such as a transverse or transverse placement, an uterine surgeon, etc.).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1- Do not be staffed by a hospital
2- She has not had severe mental problems in the last 6 months
3- In the Vijma's fear questionnaire, she scored less than 85 points</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O75.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Maternal distress during labour and delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receiving 4 consultation sessions with an approach base on acceptance and commitment therapy in group ,any week ,a meeting with a duration of 90 to 120 minute up to 4 weeks. Session content: First Session: Introduction , determination the escape and avoidance of client strategies and determination of specify the dumps and bugs, Forecasts and evaluation of client about fear of childbirth. Second session: Education of control is problem not solution, Separating the judgments of person experiences and see thoughts without judging them. Third session: Help to client for determination of judgments about himself such as be cowardly, be weakly and so on. The education of mindfulness and help to client for identification values of himself and their classification. Fourth session: Presentation of practical approach for action and commitment about decided.</i_keyword>
      <i_keyword>Control group: Routine Care Pregnancy Classes which lasts from 23 to 38 weeks of pregnancy for 8 sessions of 90 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of delivery. Timepoint: At the beginning of the study, then immediately and one week after the intervention. Method of measurement: Vijma's fear of delivery  Questionnaire; Version A.</prim_outcome>
      <prim_outcome>Attitude towards  delivery. Timepoint: At the beginning of the study and then immediately and one week after the intervention. Method of measurement: Attitude  to the type of delivery questionnaire.</prim_outcome>
      <prim_outcome>Intent to choose the type of delivery. Timepoint: At the beginning of the study and then immediately and one week after the intervention. Method of measurement: Intent selection choose the type  of delivery checklist.</prim_outcome>
      <prim_outcome>Social support. Timepoint: At the beginning of the study. Method of measurement: Modified Cassidy Social Support Assessment Questionnaire.</prim_outcome>
      <prim_outcome>Decision Conflict. Timepoint: At the beginning of the study. Method of measurement: Decision Conflict Questionnaire.</prim_outcome>
      <prim_outcome>Self-efficacy of delivery. Timepoint: At the beginning of the study. Method of measurement: Maternal self-efficacy questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-31</approval_date>
        <contact_name>Ethics Committee on Environmental Research</contact_name>
        <contact_address>No.1, West Hijab Ave., Hijab1 Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
