<?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>IRCT20190123042471N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-29</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of a Mindfulness-Based Stress Reduction (MBSR) Program on Coping Behaviors, and Attachment of Mothers of Neonates with Congenital Diseases in the selected hospitals affiliated to Shahid Beheshti University of Medical Sciences. 2018.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a Mindfulness-Based Stress Reduction (MBSR) Program on Coping Behaviors, and Attachment of Mothers of Neonates with Congenital Diseases in the selected hospitals affiliated to Shahid Beheshti University of Medical Sciences. 2019.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37146</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Use Random Number Tables.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Congenital disorders of the nervous system. Condition 2: Stress. Condition 3: Congenital malformations of the digestive system. Condition 4: Cleft lip and palate cleft. Condition 5: Congenital malformations of the liver, gall bladder and bile ducts.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The purpose of the intervention in this study is to conduct four sessions with maternal mindfulness-focused mental retardation content. The content of the sessions, respectively, includes the first session, referring, expressing feelings and thoughts, body scanning meditation, the second session including body scan exercises, three-minute breathing, the third session involves repeating the previous sessions and performing yoga movements. Finally, the fourth session will review the exercises and complete the questionnaires. Meetings will be held once a week and will last for 45-120 minutes. Intervention 2: Control group: In the control group, mothers will not participate in mindfulness-related stress reduction sessions and will only complete the Health Alert Scale for parents and the attachment questionnaire for Candida and Corkindal's mother and infant.</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:
Information about the questionnaire and only part of the main outcome information.

When:
Six months

To whom:
Nurses and nursing students

Conditions:
Use in research related to knowledge of research subject.

Where to obtain:
nahid.naseri93@gmail.com
Nahid Naseri

How to obtain:
Ten days after receipt of the email, the data will be available.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Naseri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Nursing Midwifery Faculty, Intersection of Niayesh, Valiasr St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>sbnmf@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Naseri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing Midwifery, Intersection of Niayesh, Valiasr St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>sbnmf@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The mother has reading and writing skills.
The mother has ability to speak in Persian.
Having a Neonates under one week of congenital diseases that does not lead to a baby's death based on prediction and diagnosis.
The mother has no mental illness or anxiety disorders based on the documentation of the baby case.
The mother has no previous experience of having another child with congenital malformations, according to her mother's, and documentation of the case.
Mother has no education in psychology and medical sciences.
Be a biological mother.
The mother is not afflicted with sensory disorders such as deafness, blindness and .....
Mother has the desire and ability to attend a meeting.
Access to mobile phones and familiarity with Telegram software.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mother's reluctance to participate in research.
Likely death of the baby according to clinical evidence and medical documentation.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q05.0</hc_code>
      <hc_code>F40</hc_code>
      <hc_code>Q39.0</hc_code>
      <hc_code>Q35.5</hc_code>
      <hc_code>Q44.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervical spina bifida with hydrocephalus</hc_keyword>
      <hc_keyword>Phobic anxiety disorders</hc_keyword>
      <hc_keyword>Atresia of esophagus without fistula</hc_keyword>
      <hc_keyword>Cleft hard palate with cleft soft palate</hc_keyword>
      <hc_keyword>Atresia of bile ducts</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The purpose of the intervention in this study is to conduct four sessions with maternal mindfulness-focused mental retardation content. The content of the sessions, respectively, includes the first session, referring, expressing feelings and thoughts, body scanning meditation, the second session including body scan exercises, three-minute breathing, the third session involves repeating the previous sessions and performing yoga movements. Finally, the fourth session will review the exercises and complete the questionnaires. Meetings will be held once a week and will last for 45-120 minutes.</i_keyword>
      <i_keyword>Control group: In the control group, mothers will not participate in mindfulness-related stress reduction sessions and will only complete the Health Alert Scale for parents and the attachment questionnaire for Candida and Corkindal's mother and infant.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mother's coping behaviors. Timepoint: Measuring maternal coping behaviors before and after intervention (before the first session of mindfulness-based stress reduction program) and after intervention (four weeks after intervention, after four sessions of mindfulness-based stress reduction program face to face weekly). Method of measurement: The McCobin Coping Health Inventory for Parents (CHIP) tool for measuring compatibility behaviors.</prim_outcome>
      <prim_outcome>Maternal attachment to the infant. Timepoint: Measurement of maternal attachment to infant before and after intervention (before the first session of mindfulness-based stress reduction program) and after intervention (four weeks after intervention, after four sessions of mindfulness-based stress reduction program face to face weekly). Method of measurement: The maternal attachment questionnaire for Candundas and Corkindal is used to measure attachment.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-31</approval_date>
        <contact_name>Ethics Committee, Faculty of Pharmacy, Nursing and Midwifery, Shahid Beheshti University of Medical </contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Intersection of niyayesh ,Valiasr St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
