<?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>IRCT20190311043004N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-14</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of counseling (positive psychology based intervention) on happiness and labor pain coping behaviors of  pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of midwifery counseling (positive psychology based intervention) on happiness and labor pain coping behaviors of  pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38505</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The blocking method (quadrilateral blocks) is used for random assignment. in this method Block list is written and numbers assigned to them. Finally, the allocation of treatment is based on random numbers.To do this, the random blocked website is used. A random sequence of blocking is given to a specific person outside the research team who is responsible for random assignment, Blinding description: Both groups participate in the 8 sessions of the class with the content of childbirth preparedness sessions and the intervention group will participate in positive psychological sessions in addition to participating in these 8 sessions (preparedness of childbirth). The scheduling of the sessions is planned in such a way that the control and intervention groups do not interact and the content of each meeting is not known. The analyst is also unaware of the person's ability to control the group or intervention. Exposure assessment is also provided by the trained person who does not know the allocation of people to the control and intervention teams. However, due to the fact that the consultation is carried out by the researcher himself, the researcher will not be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Happiness. Condition 2: Coping behaviors with labor pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A group of interventions is a group of pregnant women who participate in positive psychological counseling sessions in addition to participating in childbirth classes, who participate in 8 sessions of 90 minutes in 8 weeks. The intervention is based on Frederick Ben Nin's positive cognitive-behavioral therapy. The general objectives of the sessions are: the first session (familiarity with the concept of positivism), the second session (social happiness and awareness), the third week (the introduction of the exemption process model), the fourth week (introducing the appreciation concept), the fifth week (explanation of optimism) Sixth Week (The Concept of Hope and Hope), Seventh Week (Explaining Self-esteem and Valuable Feeling), Eighth Week (The Importance of Life and Trust in God). Intervention 2: Control group: The control group only participates in classes with the content of the classes of childbirth preparation (8 sessions) and do not receive any other 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:
puplishable data include thesis interpreted results and papers and protocol if needed

When:
Access from 2020

To whom:
Data are access for all researchers in scientific institutes

Conditions:
In case of Author's permission

Where to obtain:
To corresponding author or executive author

How to obtain:
By contact with the departmant or send an email to authors

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Keyvanloo shahrestanaky</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 plaqu ,No 1, Sarcheshme Ave</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613675955</zip>
        <telephone>+98 51 4429 4209</telephone>
        <email>Azam.k1looshah@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>azam keyvanloo shahrestanaky</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 plaqu ,No 1, Sarcheshme Ave</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613675955</zip>
        <telephone>+98 51 4429 4209</telephone>
        <email>Azam.k1looshah@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age (18 -35)
Being primiparous
Literacy reading and writing
Having a low-grade risk pregnancy
Tendency to normal delivery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>had experienced grief or death of a loved one until past year
Suffering from addiction and drug abuse
having Mental or medical illness
have indication for cesarean section
Having verbal and hearing problems as a communication barrier to the researcher</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_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: A group of interventions is a group of pregnant women who participate in positive psychological counseling sessions in addition to participating in childbirth classes, who participate in 8 sessions of 90 minutes in 8 weeks. The intervention is based on Frederick Ben Nin's positive cognitive-behavioral therapy. The general objectives of the sessions are: the first session (familiarity with the concept of positivism), the second session (social happiness and awareness), the third week (the introduction of the exemption process model), the fourth week (introducing the appreciation concept), the fifth week (explanation of optimism) Sixth Week (The Concept of Hope and Hope), Seventh Week (Explaining Self-esteem and Valuable Feeling), Eighth Week (The Importance of Life and Trust in God).</i_keyword>
      <i_keyword>Control group: The control group only participates in classes with the content of the classes of childbirth preparation (8 sessions) and do not receive any other intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Happiness refers to the judgment of the individual about the desirability of the quality of life as a whole, which is scored by the Oxford Happiness Questionnaire. The Oxford Happiness Questionnaire (OHI) has 29 sentences, each containing 4 sentences, the first term is zero, the second is the score 1 , The third phrase marks 2 and the fourth expression takes the score of 3. Finally, a person earns a score between 0 and 87.Higher scores mean more happiness. Timepoint: Beginning of the study (before intervention) and after intervention. Method of measurement: Oxford Happiness questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Coping behaviors with labor pain. Timepoint: After the intervention (the onset of the active phase of labor). Method of measurement: Coping behaviors with labor pain 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-16</approval_date>
        <contact_name>Ethics committee of Shahrood University of Medical Sciences</contact_name>
        <contact_address>7th tir square, shahrood University of Medical Sciences shahroud Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
