<?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>IRCT20180429039464N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of the effect of applying video interaction guidance on the intensity of grief in mothers with premature infant</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the effect of applying video interaction guidance on the intensity of grief in mothers with premature infant</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68474</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Sampling of the intervention and control groups will be done at the same time, mothers will be randomly assigned to the intervention and control groups. After giving informed consent and completing the pre-test pre-maturity grief questionnaire, the mothers of the intervention group will have three sessions video interaction guide and feedback intervention during the first week of the newborn's hospitalization in the neonatal intensive care unit. After the end of the first week, the post-test questionnaire will be administered. After the first test and after the end of the second week, the second post-test questionnaire will be provided to the mothers. In the control group, after informed consent and collecting the pre-test questionnaire from the mothers, one week and two weeks after the admission of the newborn in the  neonatal intensive care unit, the first post-test and the second post-test will be provided to mothers and will be collected after completion. There will be no intervention on the mothers of the control group, but it should be noted that the mothers of the control group will receive the usual care during the intervention, Randomization description: Mothers with premature baby hospitalized in the neonatal intensive care unit will be selected by Convenience sampling method and will be assigned to the intervention and control groups by 4 block randomization method. Allocation of groups is based on randomization with 18 groups of 4 people (72 people in total) who will be randomly assigned to group A (control group) and group B (intervention group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Intensity of Grief in Mothers with Premature Infant.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before the start of the intervention, the informed consent form and the pre-maturity grief pre-test questionnaire will be completed after the first interaction with the baby in the neonatal intensive care unit, on the first day of the intervention, the first filming of mother-baby interactions will be done, on the second day of the intervention, the videos will be edited by the researcher and selected Better moments than usual will be done, on the third day of the intervention, the first video interaction guidance session (watching the golden moments of mother-baby interaction by the researcher and the mother, positive feedback to the mother by the researcher) + the second filming, on the fourth day of the editing intervention Videos by the researcher, on the fifth day of the intervention, the second session of the video interaction guidance + the third filming, on the sixth day of the intervention, editing of the videos by the researcher, on the seventh day of the intervention, the third session of the video interaction guidance + completion of the first post-test questionnaire, at the end of the second week The questionnaire will be completed. Intervention 2: Control group: Before starting the intervention, the informed consent form and the completion of the pre-test questionnaire of pre-maturity grief will be done by the mother after the first interaction with the baby in the neonatal intensive care unit, at the end of the first week, the completion of the post-test questionnaire and at the end of the second week The second will be done.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the filming of the baby and the mother, the parents may not have consent regarding the publication of the data, even with anonymity, so to respect the confidentiality of the information and the consent of the parents, we cannot comment on this yet, but we hope to be able to confirm the results. The study will be published in general and anonymously in the form of articles or abstracts in conferences</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Hasanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Dr. Mirkhani St. (Eastern Nosrat)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>m-hasanpour@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Hasanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Dr. Mirkhani St. (Eastern Nosrat)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>m-hasanpour@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Over the age of 18
Literate to read and write
Having a premature baby girl or boy born under 37 weeks of pregnancy and admitted to the neonatal intensive care unit
Absence of known physical and psychological diseases (cancer, chronic and acute diseases, depression, etc.) in the initial evaluation as self-reported by mothers
Absence of alcohol and drug addiction in the initial assessment and as self-reported by mothers
Not having a history of divorce and separation from spouse during pregnancy
Having relative familiarity with mass communication tools such as mobile phones and working with mass communication software and social networks to connect the researcher with mothers
Absence of anomalies at the time of birth in the baby due to the prolonged grief process in mothers</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The mother's unwillingness to continue participating in the study at any stage of the research
Sudden deterioration and infant death at every stage of research and intervention implementation
Early discharge (less than one week of intervention) of the baby from the neonatal intensive care unit</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>Intervention group: Before the start of the intervention, the informed consent form and the pre-maturity grief pre-test questionnaire will be completed after the first interaction with the baby in the neonatal intensive care unit, on the first day of the intervention, the first filming of mother-baby interactions will be done, on the second day of the intervention, the videos will be edited by the researcher and selected Better moments than usual will be done, on the third day of the intervention, the first video interaction guidance session (watching the golden moments of mother-baby interaction by the researcher and the mother, positive feedback to the mother by the researcher) + the second filming, on the fourth day of the editing intervention Videos by the researcher, on the fifth day of the intervention, the second session of the video interaction guidance + the third filming, on the sixth day of the intervention, editing of the videos by the researcher, on the seventh day of the intervention, the third session of the video interaction guidance + completion of the first post-test questionnaire, at the end of the second week The questionnaire will be completed.</i_keyword>
      <i_keyword>Control group: Before starting the intervention, the informed consent form and the completion of the pre-test questionnaire of pre-maturity grief will be done by the mother after the first interaction with the baby in the neonatal intensive care unit, at the end of the first week, the completion of the post-test questionnaire and at the end of the second week The second will be done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of Grief in Mothers with Premature Infant. Timepoint: The first assessment of the severity of grief of mothers with premature babies before the start of the intervention will be by Hasanpour, Zarezadeh's Pre-maturity Grief Questionnaire. The second measurement will be one week after the start of the intervention and the third measurement will be two weeks after the start of the intervention. Method of measurement: Hasanpour, Zarezadeh's Pre-maturity Grief 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-11</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery &amp; Rehabilitation - Tehran University o</contact_name>
        <contact_address>Room 604, 6th floor, central building of Tehran University of Medical Sciences, intersection of Qods St., Keshavarz Blvd., Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
