<?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>IRCT20230212057395N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-18</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of online positive psychology counseling on psychological well-being of nulliparous pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of online positive psychology counseling on psychological well-being of nulliparous pregnant women participant in  childbirth preparation classes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68940</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 74  nulliparous pregnant women  are selected based on the entry and exit criteria as convenience sampling method from the comprehensive health centers of Farsan city and the covered bases. Then they are divided into two   groups of 37 people, positive counseling + childbirth preparation training (intervention group) and childbirth preparation training alone (control group) by a biostatistics specialist using simple randomization method and random number sequence with online randomization software ( using the site www.random.org/sequences).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychological well- being.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Pregnant women in this group participate in 8 weekly 90-minute sessions of routine birth preparation classes, which are held face-to-face in groups of 8 to 10 people. These classes are conducted by trained midwives in health centers according to the protocol of the Ministry of Health. The contents of the sessions include anatomy of the  reproductive system, nutrition during pregnancy, mental health of pregnant women, danger signs in pregnancy, benefits of natural childbirth, non-pharmacological pain relief methods, stages of labor, postpartum care and newborn health care. In addition, exercises to strengthen the skeletal-muscular system, breathing exercises and relaxation methods are taught that mothers should practice at home. At the beginning of each session; mothers should report how much they did their homework in the previous week. Intervention 2: Intervention group: Pregnant women in this group, like the control group, participates in 8 weekly 90-minute sessions of face-to-face childbirth preparation classes that are established in health centers according to the protocol of the Ministry of Health. In addition, they also participate in online positive psychology training classes in groups of 12 to 15 people according to Seligman and Rashid's protocol in 8 weekly sessions of 90 minutes. These classes are conducted under the supervision of a  psychologist consultant and by a senior student of counseling in midwifery who has completed the above course The content of the sessions includes explaining positive psychology, identifying strengths, expressing the role of positive feelings and emotions in increasing well-being, gratitude and forgiveness, focusing on the topic of hope and optimism, positive relationships, fascination and meaning in life. Each session has home practices, mothers are asked to do their practice before the next session and report the amount of practice in a virtual way in private.</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 personal data of study participants can be shared after unidentifying.

When:
After results publication.

To whom:
The data will be available to researchers working in academia and academia, and people in the industry can apply for it.

Conditions:
Scientific usage.

Where to obtain:
azamkhoshbin@gmail.com

How to obtain:
One Week after receiving requested email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Khoshbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1754</telephone>
        <email>azamkhoshbin@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Khoshbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1754</telephone>
        <email>azamkhoshbin@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality
Age 18 - 40 years
Nulliparity
Gestational Age 16 - 24 week
Single fetus
Literacy for reading and writing.
Interested in participate in childbirth preparation classes
Having Smartphone with licensed virtual software
Internet access
Voluntary willingness to participate in  research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of infertility
High risk pregnancy( hypertension, vaginal bleeding, diabetes, thyroid disorders, placenta previa, fetal anomalies and...)
The occurrence of unfortunate events in the past six months, such as the death of loved ones, accidents, divorce and ...
Self-reported drug abuse by the pregnant woman or her husband
Having a history or being treated for psychiatric disorders</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>Control group: Pregnant women in this group participate in 8 weekly 90-minute sessions of routine birth preparation classes, which are held face-to-face in groups of 8 to 10 people. These classes are conducted by trained midwives in health centers according to the protocol of the Ministry of Health. The contents of the sessions include anatomy of the  reproductive system, nutrition during pregnancy, mental health of pregnant women, danger signs in pregnancy, benefits of natural childbirth, non-pharmacological pain relief methods, stages of labor, postpartum care and newborn health care. In addition, exercises to strengthen the skeletal-muscular system, breathing exercises and relaxation methods are taught that mothers should practice at home. At the beginning of each session; mothers should report how much they did their homework in the previous week.</i_keyword>
      <i_keyword>Intervention group: Pregnant women in this group, like the control group, participates in 8 weekly 90-minute sessions of face-to-face childbirth preparation classes that are established in health centers according to the protocol of the Ministry of Health. In addition, they also participate in online positive psychology training classes in groups of 12 to 15 people according to Seligman and Rashid's protocol in 8 weekly sessions of 90 minutes. These classes are conducted under the supervision of a  psychologist consultant and by a senior student of counseling in midwifery who has completed the above course The content of the sessions includes explaining positive psychology, identifying strengths, expressing the role of positive feelings and emotions in increasing well-being, gratitude and forgiveness, focusing on the topic of hope and optimism, positive relationships, fascination and meaning in life. Each session has home practices, mothers are asked to do their practice before the next session and report the amount of practice in a virtual way in private.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of mean score of psychological well- being in two groups. Timepoint: Measurement of the well-being variable at the beginning of the study (before the start of the intervention) and the eighth week (end of the  intervention) and the twelfth week (follow-up) from the start of the study in two groups. Method of measurement: Ryff's Scales of Psychological Well-being.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-01</approval_date>
        <contact_name>Ethics committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Bahonar Square, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
