<?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>IRCT20200120046200N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-11</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of supportive program on the stress and anxiety of fathers</public_title>
      <acronym></acronym>
      <scientific_title>Effect of supportive program on the stress and anxiety of fathers in the first exposure to premature infant</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46722</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization using Quadratic Random Block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of supportive program on fathers' stress and anxiety in first exposure to preterm infant.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group two albums are shown to the father. One album includes photos of a premature baby from birth to about two years old, and another album includes photos of former premature babies and current and well-to-do children, all born of different weights and ages. By showing these photos, we aim to prepare the father to see our baby with the features of a premature infant (intelligence support), on the one hand, and to provide emotional support for the future on the other, with conversations that show Photographs will be attempted, with the father's beliefs emphasized on trust, resort, patience, and submission to divine fate (spiritual support), and then the mother's milk storage and transportation will be taught and taught. The device tries, while supporting information, with the hope that our premature infant will eat our milk. There will also be emotional support for the father, at which point the father will be advised to enter the ward and, as he enters, the staff will be introduced to him, followed by the father to the infant's bed, and to engage in sedentary interactions with him. The baby is encouraged and empowered through continuous gentle touch, gentle whispering in the ear, and eye contact. Alongside the baby, the characteristics of the premature baby and the equipment around the premature baby will be explained in a simple, understandable language and will answer any further questions the father has about the baby, the environment and the routine equipment. At the end of the illustrated booklet and DVD, information will be provided to the father on the conditions and characteristics of preterm infants, the needs and alternatives of indirect and indirect nutrition, the general conditions and common problems of preterm infants for the next 3 days and during hospitalization. Their infants can use it and revive it in their minds if they forget to read and observe some topics. The father will also be given a telephone number to answer any questions he may have during these 3 days. On the third day, the father's anxiety questionnaire for the second time and the stress questionnaire for the first time. Intervention 2: Control group: In the control group, the father goes to the infant's bed and the infant's nurse answers any questions he may have. On the third day, the control group fathers will be given a second anxiety and stress questionnaire for the second time after completing the anxiety questionnaire and educational DVD and a telephone number will be provided to the father with any possible questions. Respond after reading the book and watching the DVD.</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 It will be decided in the future</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh saeedeh Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1807</telephone>
        <email>mousavi.ss@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh saeedeh Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1807</telephone>
        <email>mousavi.ss@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fathers:
Over 18 years of age
Literacy
Lack of employment in health centers
Ability to communicate verbally
No stressful events in the past 6 months (such as divorce, separation from spouse, job loss)
Lack of any mental illness or history of mental illness, according to the research unit
No history of infertility
Visitors to the hospital eventually 12 hours after preterm delivery
Neonates:
Gestational age less than 37 weeks
Fifth minute apgar above 5
single pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Any congenital malformations
Any serious disabling conditions: such as grade 3 or 4 intraventricular hemorrhage</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group two albums are shown to the father. One album includes photos of a premature baby from birth to about two years old, and another album includes photos of former premature babies and current and well-to-do children, all born of different weights and ages. By showing these photos, we aim to prepare the father to see our baby with the features of a premature infant (intelligence support), on the one hand, and to provide emotional support for the future on the other, with conversations that show Photographs will be attempted, with the father's beliefs emphasized on trust, resort, patience, and submission to divine fate (spiritual support), and then the mother's milk storage and transportation will be taught and taught. The device tries, while supporting information, with the hope that our premature infant will eat our milk. There will also be emotional support for the father, at which point the father will be advised to enter the ward and, as he enters, the staff will be introduced to him, followed by the father to the infant's bed, and to engage in sedentary interactions with him. The baby is encouraged and empowered through continuous gentle touch, gentle whispering in the ear, and eye contact. Alongside the baby, the characteristics of the premature baby and the equipment around the premature baby will be explained in a simple, understandable language and will answer any further questions the father has about the baby, the environment and the routine equipment. At the end of the illustrated booklet and DVD, information will be provided to the father on the conditions and characteristics of preterm infants, the needs and alternatives of indirect and indirect nutrition, the general conditions and common problems of preterm infants for the next 3 days and during hospitalization. Their infants can use it and revive it in their minds if they forget to read and observe some topics. The father will also be given a telephone number to answer any questions he may have during these 3 days. On the third day, the father's anxiety questionnaire for the second time and the stress questionnaire for the first time.</i_keyword>
      <i_keyword>Control group: In the control group, the father goes to the infant's bed and the infant's nurse answers any questions he may have. On the third day, the control group fathers will be given a second anxiety and stress questionnaire for the second time after completing the anxiety questionnaire and educational DVD and a telephone number will be provided to the father with any possible questions. Respond after reading the book and watching the DVD.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Father's anxiety. Timepoint: Baseline, day three. Method of measurement: State Trait Anxiety Inventory(STAI).</prim_outcome>
      <prim_outcome>Stress. Timepoint: Day three. Method of measurement: Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-15</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>ّّFifth floor, Headquarters., Iran University of Medical Sciences., Hemmat Highway between Chamran and Sheikh Fazlullah Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
