<?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>IRCT20171130037691N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-22</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The impact of spousal support education to fathers on stress and self-efficacy score of mothers</public_title>
      <acronym></acronym>
      <scientific_title>The impact of spousal support education to fathers on stress and self-efficacy score of mothers in care of premature neonates hospitalized in neonatal intensive care unit of Shiraz University of Medical Sciences  2017.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28739</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Other design features: In order to prevent transfer of the training content to the control proup, the two groups had to be sampled separately. On the other hand, in order for nurses not to be affected by the intervention and their behavior not to be changed, the control group in each hospital has been sampled, primarily. Thus, the allocation of parents to each group took place after complete sampling of the control group at first place, in each hospital. That is, after the coin toss, sampling was made in Hafez and Nemazee Hospitals on odd and even days, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stress.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the control group, the fathers will meet on a routine basis within the specified hours and will not be associated with the research team during the admission. Intervention 2: Intervention group:In intervention group, educational interventions will be conducted. This intervention will take place 2 days after the newborn is admitted to the intensive care unit. It includes two 60-minute face-to-face training sessions with fathers of premature infants about the environment, equipment, health care staff and therapeutic care such as vein therapy , Oxygen therapy and ..., and information on premature infants (physical behaviors and symptoms), the role of the father in the protection and care of the baby and the mother, physical and mental changes created in the mother after childbirth, by the researcher using PowerPont will be provided. And questions and answers will be made between the researcher and the fathers about the subjects presented. At the end of the first session, a color booklet with an educational CD containing the educational content provided by the researcher and approved by the professors will be given to the fathers and the method of their use will be taught to the fathers. At the end of the first session, the fathers will visit the section And getting acquainted with the equipment and personnel of the department will be given to the department and the necessary training will be given in the section as well. One day after the end of the educational intervention to provide support for the parent and to exchange ideas and information between parents, the parents have the opportunity to meet for 3 days per hour, other than an appointment (in coordination with the manager and the department manager). Find and take care of the baby.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Gasemloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dormitory of Shahid Dastgheib, Eram Square,Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194684695</zip>
        <telephone>+98 44 3366 4762</telephone>
        <email>hamedgasemloo@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Hadian Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing Hazrat Fatemeh, Namazi Square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119–71936</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>zhadian@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Parents with preterm infants born at gestational age of 32-37 weeks of gestation
Neonates not being Under the mechanical ventilation
The absence of congenital anomalies in the neonate
After two days of admission for neonates
No history of premature infants hospitalized earlier in pregnancy
Parental exposure to other stressful events in the last 6 months
Wanting to have a pregnancy
No history of taking medications affecting maternal mental health
Parents wanting to participate in the study
Having at least elementary education
Not being twin or upper
Dominance in Persian
Unemployment to medical group professions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The baby with major malformations
Baby connected to the ventilator
Use of anxiety drugs and drugs that affect the mental health of the mother before starting the study
The experience of admission of premature infants in the neonatal intensive care unit
Parents face a stressor in the last six months
Twin being
Parental inconvenience to participate in the study
mother is illiterate
Neonate with gestational age less than 32 weeks of gestation and over 37 weeks of gestation
Mother educated from medical science</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute stress reaction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In the control group, the fathers will meet on a routine basis within the specified hours and will not be associated with the research team during the admission.</i_keyword>
      <i_keyword>Intervention group:In intervention group, educational interventions will be conducted. This intervention will take place 2 days after the newborn is admitted to the intensive care unit. It includes two 60-minute face-to-face training sessions with fathers of premature infants about the environment, equipment, health care staff and therapeutic care such as vein therapy , Oxygen therapy and ..., and information on premature infants (physical behaviors and symptoms), the role of the father in the protection and care of the baby and the mother, physical and mental changes created in the mother after childbirth, by the researcher using PowerPont will be provided. And questions and answers will be made between the researcher and the fathers about the subjects presented. At the end of the first session, a color booklet with an educational CD containing the educational content provided by the researcher and approved by the professors will be given to the fathers and the method of their use will be taught to the fathers. At the end of the first session, the fathers will visit the section And getting acquainted with the equipment and personnel of the department will be given to the department and the necessary training will be given in the section as well. One day after the end of the educational intervention to provide support for the parent and to exchange ideas and information between parents, the parents have the opportunity to meet for 3 days per hour, other than an appointment (in coordination with the manager and the department manager). Find and take care of the baby.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress mothers of premature infants. Timepoint: Measuring maternal stress on the second day of admission and the seventh day of admission. Method of measurement: By PSS questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self-efficacy of mothers of premature infants. Timepoint: On the second day of admission, premature baby and the seventh day of admission. Method of measurement: By PMP-SE questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-18</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>the central building of Shiraz University of Medical Sciences , opposite the Palestine Street, Zand Avenue ,Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
