<?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>IRCT20171014036764N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Impact of Spiritual Care on Depression of Mothers of Premature Infant</public_title>
      <acronym></acronym>
      <scientific_title>The Impact of Spiritual Care on Depression of Mothers of Premature Infant in Neonatal Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30435</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Music Therapy and Beautification unit.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: According to the needs assessment and interview with the mothers, audiobooks, educational books, and worship objects will be placed in a dressing room designed for relaxation and, in accordance with the mother's request, the materials provided by the researcher through the telegram, CD, Flash and mobile transfer will be provided to the mother. The posters for space maternity and maternity rooms will be provided. The 9 spiritual actions proposed in this study included: Spiritual Action 1: Facilitate spiritual care including prayer ceremony and facilitate the organization of religious ceremonies appropriate to the culture and the family. Spiritual Action 2: Spiritual protection involves providing worship objects and encouraging participation in ceremonies. Spiritual Action 3: Presence includes physical presence and availability. Spiritual Action 4: Active listening involves listening without judgments to mothers' speeches, providing memos to moms for writing and expressing their concerns and religious care. Spiritual Action 5: Goodness and goodwill, including familiarizing the staff with spiritual care and how to deal with mothers. Spiritual Action 6: Touch involves hugging mother and baby with the parent's permission and facilitating and encouraging the presence of the father alongside the mother and helping to establish Correct relationship with the baby. Spiritual Action 7: Increasing self-awareness involves increasing knowledge about how to care for the baby with CDs and educational books and raising awareness about the course of the baby's disease. Spiritual Action 8: Voice Therapy featuring indifferent music and religious sound therapy. Spiritual Action 9: Instilling hope, including the beauty of the section and placing the contents of the hope and tranquility of the room of the mothers based on the requirements of the needs assessment. The intervention group of your choice and as required in the need assessment stage, one or more cases They will receive the mentioned spiritual care in their approved forms. Intervention 2: Control group: The mothers of the control group did not receive any intervention, and at the beginning they would complete the questionnaire of spiritual well being and demographic anxiety. At the time of discharge, they will complete the Beck Spiritual Intelligence and Beck Anxiety Inventory.</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:
Results of the data and method are published in the article

When:
Start the access period 3 months after printing the results

To whom:
All people who make a request

Conditions:
Use in scientific research is allowed.

Where to obtain:
Seyed Maryam Mousavi smmousavi@khuisf.ac.ir 00989158529689

How to obtain:
The person requesting the application should send e-mail. Reply will be provided within 2 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Maryam Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Khorasgan Branch, University Blvd, Arqavanieh, Jey Street</address>
        <city>Isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9139898653</zip>
        <telephone>+98 512121001</telephone>
        <email>smmousavi@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Khorasgan Branch, University Blvd, Arqavanieh, Jey Street</address>
        <city>Isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4058</telephone>
        <email>n45sadeghi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To be satisfied with the study
Mothers of premature infants hospitalizedAt the start of the study, at least one day and a maximum of one week from the time the infant is admitted
Do not use drugs (or any psychoactive substances such as cigarettes, opium, glass, hashish, heroin, cocaine)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participate in spiritual care classes
Have a history of mental illness According to family
More than one week after admission of the infant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other depressive episodes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: According to the needs assessment and interview with the mothers, audiobooks, educational books, and worship objects will be placed in a dressing room designed for relaxation and, in accordance with the mother's request, the materials provided by the researcher through the telegram, CD, Flash and mobile transfer will be provided to the mother. The posters for space maternity and maternity rooms will be provided. The 9 spiritual actions proposed in this study included: Spiritual Action 1: Facilitate spiritual care including prayer ceremony and facilitate the organization of religious ceremonies appropriate to the culture and the family. Spiritual Action 2: Spiritual protection involves providing worship objects and encouraging participation in ceremonies. Spiritual Action 3: Presence includes physical presence and availability. Spiritual Action 4: Active listening involves listening without judgments to mothers' speeches, providing memos to moms for writing and expressing their concerns and religious care. Spiritual Action 5: Goodness and goodwill, including familiarizing the staff with spiritual care and how to deal with mothers. Spiritual Action 6: Touch involves hugging mother and baby with the parent's permission and facilitating and encouraging the presence of the father alongside the mother and helping to establish Correct relationship with the baby. Spiritual Action 7: Increasing self-awareness involves increasing knowledge about how to care for the baby with CDs and educational books and raising awareness about the course of the baby's disease. Spiritual Action 8: Voice Therapy featuring indifferent music and religious sound therapy. Spiritual Action 9: Instilling hope, including the beauty of the section and placing the contents of the hope and tranquility of the room of the mothers based on the requirements of the needs assessment. The intervention group of your choice and as required in the need assessment stage, one or more cases They will receive the mentioned spiritual care in their approved forms.</i_keyword>
      <i_keyword>Control group: The mothers of the control group did not receive any intervention, and at the beginning they would complete the questionnaire of spiritual well being and demographic anxiety. At the time of discharge, they will complete the Beck Spiritual Intelligence and Beck Anxiety Inventory.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Admit/ Discharge time. Method of measurement: Beck Depression 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-04</approval_date>
        <contact_name>Ethics Committee Islamic Azad University, Najaf Abad Branch</contact_name>
        <contact_address>Blvd daneshgah, Najaf Abad, Islamic Azad University, Najaf Abad Branch Isfehan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
