<?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>IRCT20201113049377N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-06</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of counseling on childbirth satisfaction based on Fordyce's happiness model</public_title>
      <acronym></acronym>
      <scientific_title>The effect of counseling on childbirth satisfaction in primiparous women based on Fordyce's happiness model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65498</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling will be done by multi-stage random allocation. In the first stage, each urban area is considered as a cluster. There are a total of 22 comprehensive health centers and bases in Zanjan city, which are located in 4 urban areas. Then, from each cluster, two comprehensive health centers (one intervention center, one control center) will be selected by a simple random method through lottery. Based on this, we will have 8 comprehensive health centers, 4 centers for the intervention group and 4 centers for the group. will be controlled. In this way, the names of both centers are written on two separate sheets and placed in the lottery bag, then the first paper removed will be assigned to the intervention group and the remaining paper to the control group. In the next stage, in the selected centers, eligible pregnant women will be selected by a simple random method, and mothers who are in the twenty-ninth week of pregnancy and are willing to participate in the study and meet the inclusion criteria will be included in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Satisfaction with childbirth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the intervention group will receive 6 virtual group counseling sessions based on Fordyce's happiness model, weekly and consecutively through the WhatsApp application for 60 to 90 minutes. The duration of the course is three weeks, and the contents of the sessions include the necessity of happiness, teaching the technique of expressing emotions and showing them, the technique of increasing optimism and intimate relationships, avoiding worrying thoughts, coping with stress, planning and the technique of living in the present, The art of being real is to lower expectations and give priority to happiness. Intervention 2: Control group: The control group consists of 40 people who will receive routine pregnancy care that includes measuring vital signs, weight, uterine height, fetal heart rate, examining danger signs and health education, and requesting and reviewing the required para-clinical measures. and in order to comply with ethics, all educational videos prepared by me will be sent to the control group after the study is completed.</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 The possibility of dissatisfaction of the participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Bagheri Nia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Plot 2174, Golsar Street 3, Phase 2, Golshahr, Zanjan City, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4514198415</zip>
        <telephone>+98 24 3372 6794</telephone>
        <email>eli.midwife73@gail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3539, Badr Ave.</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4514913459</zip>
        <telephone>+98 24 3344 6258</telephone>
        <email>p.mohebbi11@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Age range 18 to 42
Having the facilities and literacy to use the internet network in virtual space
Obtaining a score lower than 12.5 in the Edinburgh Depression Questionnaire
A singleton fetus (because Multiple pregnancy are candidates cesarean births and will be excluded from the study)
Healthy fetus with no abnormalities
No history of serious illness (heart, vascular, chronic kidney disease)
Absence of psychological disorders
Absence of drug, alcohol and street drug use</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People who do not want to continue participating in the study
People who do not participate in more than one counseling session
Existence of mental disorders based on mothers' self-report
Occurrence of stressful events in the research process such as: death of loved person, accident, separation from spouse and migration
Elective and emergency cesarean sections such as bleeding, dystocia, meconium</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: Participants in the intervention group will receive 6 virtual group counseling sessions based on Fordyce's happiness model, weekly and consecutively through the WhatsApp application for 60 to 90 minutes. The duration of the course is three weeks, and the contents of the sessions include the necessity of happiness, teaching the technique of expressing emotions and showing them, the technique of increasing optimism and intimate relationships, avoiding worrying thoughts, coping with stress, planning and the technique of living in the present, The art of being real is to lower expectations and give priority to happiness</i_keyword>
      <i_keyword>Control group: The control group consists of 40 people who will receive routine pregnancy care that includes measuring vital signs, weight, uterine height, fetal heart rate, examining danger signs and health education, and requesting and reviewing the required para-clinical measures. and in order to comply with ethics, all educational videos prepared by me will be sent to the control group after the study is completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Satisfaction with childbirth. Timepoint: 24 hours after delivery. Method of measurement: McKay's childbirth satisfaction questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of Happiness. Timepoint: In the first face-to-face meeting before the consultation, in the 36th week of pregnancy and 24 hours after delivery. Method of measurement: Oxford Happiness Questionnaire.</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>2022-08-23</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی زنجان</contact_name>
        <contact_address>No. 3539, Badr 9 Ave, Zanjan city زنجان Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
