<?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>IRCT20150119020719N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-01</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of led psycho-education in distress, postnatal depression,parental eligibility of women with high risk pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of midwifery led psycho-education in distress, postnatal depression,parental eligibility of women with high risk pregnancy that referred to Kamali hospital 1396-1397</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31428</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Use the quadruple random block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: postpartum depression. Condition 2: parenthood stress.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group consists of nuliparous women with high-risk pregnancy diagnosis and gestational age of 34 week and more,who are hospitalised in prenatal section in kamali hispital.intervention group will receive midwifery led psycho_education about increasing parental eligibility,reducing parental distress and preventing postnatal depression.Midwifery led psycho_education,is a brief counseling education provided by a midwife and 4 sessions.contents of these session is as follows:First session lasts 60-90 minutes and is attended as group and in person during hispitalisation in high-risk pregnant women section.In this session,the goals of the study are explained and some information about infant necessary cares,how child is growing,childs gender and postnatal depression signs is provided.In the end,information about strategies for mothers to face with stress is provided.Second session is also while being hospitalised in high_risk pregnant women section,immediately after first session is done,and lasts for 60-90 minutes.In this session, information about extending and improving social support,identifying and confronting personal conflicts hs provided,and problem solving skills and skills to improve relationship with spouse after the birth of the newborn child is educated.In the end,this session includes respiratory techniques postnatal exercises,mind focus and stress reduction trainings.Third session is right after childbirth,and is attended as personal training.In this sessions before is reviewed,and respiratory techniques,postnatal exercises,mind focous and stress reduction approaches are practised,and how to make use of other mothers experiences and problems the patient has had after childbirth is spoken.Forth session is done,as personal training trough phone call, in one month after childbirth.in this session,educations provided are followed, suggestions about problems faced with after childbirth is offered,worries associated with maternal role is spoken and family support is emphasised. Intervention 2: The Control group will receive routine care.</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 participants data can be shared after being unidentified

When:
Start the access period after publishing the results

To whom:
Public

Conditions:
For use in studies

Where to obtain:
LEILA CHAHARRAHY FARD.09127681698،Leila.chf@yahoo.com

How to obtain:
he application will be sent to the project implementer by email and within 24 hours will receive the necessary items

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Esmaelzadeh Saeieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing Midwifery, Golestan_i, Baghestan, Alborz, Iran</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098</zip>
        <telephone>+98 912 623 2569</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Esmaelzadeh Saieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing Midwifery, Golestan_i, Baghestan, Alborz, Iran</address>
        <city>Alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0098</zip>
        <telephone>+98 912 623 2569</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>nulliparous
with diagnosed of  high risk pregnancy
admit at least one week on perinatal section at kamali hospital
gestational age 34 weeks or more
At least the reading and writing skills
Iranian nationality
have a satisfaction on research participation
access on phone</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>having psychologic  disorder or on treatment with psychologist expert and history of hospitalization on  psychiatry or tretment by sedative
having child with mental or physical malformation
mothers with child under 34 weeks
reject phone call for pursuit training
not have a satisfaction on research participation
not participate on one training class</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53.0</hc_code>
      <hc_code>53.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild mental and behavioral disorders associated with puerperium, not elsewhere classified</hc_keyword>
      <hc_keyword>Mild mental and behavioral disorders associated with puerperium, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group consists of nuliparous women with high-risk pregnancy diagnosis and gestational age of 34 week and more,who are hospitalised in prenatal section in kamali hispital.intervention group will receive midwifery led psycho_education about increasing parental eligibility,reducing parental distress and preventing postnatal depression.Midwifery led psycho_education,is a brief counseling education provided by a midwife and 4 sessions.contents of these session is as follows:First session lasts 60-90 minutes and is attended as group and in person during hispitalisation in high-risk pregnant women section.In this session,the goals of the study are explained and some information about infant necessary cares,how child is growing,childs gender and postnatal depression signs is provided.In the end,information about strategies for mothers to face with stress is provided.Second session is also while being hospitalised in high_risk pregnant women section,immediately after first session is done,and lasts for 60-90 minutes.In this session, information about extending and improving social support,identifying and confronting personal conflicts hs provided,and problem solving skills and skills to improve relationship with spouse after the birth of the newborn child is educated.In the end,this session includes respiratory techniques postnatal exercises,mind focus and stress reduction trainings.Third session is right after childbirth,and is attended as personal training.In this sessions before is reviewed,and respiratory techniques,postnatal exercises,mind focous and stress reduction approaches are practised,and how to make use of other mothers experiences and problems the patient has had after childbirth is spoken.Forth session is done,as personal training trough phone call, in one month after childbirth.in this session,educations provided are followed, suggestions about problems faced with after childbirth is offered,worries associated with maternal role is spoken and family support is emphasised.</i_keyword>
      <i_keyword>The Control group will receive routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Distress. Timepoint: Before intervention, After intervention and one month after delivery. Method of measurement: distress Questionnaire.</prim_outcome>
      <prim_outcome>Postnatal depression. Timepoint: Before intervention, After intervention and one month after delivery. Method of measurement: edinburgh postnatal depression scale.</prim_outcome>
      <prim_outcome>Parental eligibility. Timepoint: Before intervention, After intervention and one month after delivery. Method of measurement: parental eligibility 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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-10</approval_date>
        <contact_name>Ethics Committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Alborz University of Medical Sciences, Azimieh, Alborz, Iran Alborz Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
