<?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>IRCT20200107046040N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-14</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of  the first skin contact father with their  preterm infants admitted to Neonatal Intensive Care Unit (NICU) ward of Shohada Kargar Hospital on  their anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of  the first skin contact father with their  preterm infants admitted to Neonatal Intensive Care Unit (NICU) ward</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52040</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples were divided into test and control groups in pairs and individually (one in between), so that the first infant was divided into the experimental group and the second infant into the control group, and so on, Blinding description: In this study, a trained research colleague was used to make skin contact and the researcher did not know about it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Skin-to-skin contact.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After introducing and presenting the necessary explanations about the goals and methods of research and ensuring the confidentiality of information, written and informed consent was received in two copies. . Then, before starting the intervention, the individuals completed the Spielberger STAI form of the situational anxiety-trait questionnaire and the demographic profile form (the infant profile was completed by the researcher from the patient file). ). For 30 minutes (based on similar studies) they were exposed to skin-to-skin contact with infants who had stable conditions according to inclusion criteria. In this way, the naked baby was placed on the skin of the father's abdomen, which in this type of contact, no face-to-face communication was established between the father and the baby and only brought the benefits of skin-to-skin contact. The time of sampling and intervention was between 11 and 17 o'clock. During the skin contact of the baby, the nurse was present to control the baby's symptoms by observation. The parameters of blood oxygen saturation, heart rate, respiration rate are monitored by the nurse. Immediately after skin-to-skin contact, the questionnaire was completed again by individuals. Intervention 2: Control group: Control group: After introducing and presenting the necessary explanations about the goals and methods of the research and ensuring the confidentiality of the information, written and informed consent was received in two copies. Then, before beginning the intervention, individuals completed the Spielberger STAI Formal-Characteristic Anxiety Questionnaire and the Demographic Characteristics Form (the infant profile was completed by the researcher from the patient's record). Minutes in this group, no skin contact with fathers. Immediately after leaving, the questionnaire was completed again by individuals.</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:
...

When:
Access period starts from 1399

To whom:
It will be available to researchers working in academic and scientific institutions and to people working in industry.

Conditions:
...

Where to obtain:
...

How to obtain:
...

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>khadijeh dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd - Safaieh - Timsar Fallahi St. - Bouali Alley School of Midwifery Nursing</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>dehghanish@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>khadijeh dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd - Safaieh - Timsar Fallahi St. - Bouali Alley School of Midwifery Nursing</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877443</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>dehghanish@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Calendar age (2 to 5 days)
The baby has physiologically stable conditions
Fetal age under 37 weeks
Absence of nicotine or caffeine by the father one hour before enrollment (due to the possible effect of these substances on anxiety)</inclusion_criteria>
      <agemin>2 days</agemin>
      <agemax>5 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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: After introducing and presenting the necessary explanations about the goals and methods of research and ensuring the confidentiality of information, written and informed consent was received in two copies. . Then, before starting the intervention, the individuals completed the Spielberger STAI form of the situational anxiety-trait questionnaire and the demographic profile form (the infant profile was completed by the researcher from the patient file). ). For 30 minutes (based on similar studies) they were exposed to skin-to-skin contact with infants who had stable conditions according to inclusion criteria. In this way, the naked baby was placed on the skin of the father's abdomen, which in this type of contact, no face-to-face communication was established between the father and the baby and only brought the benefits of skin-to-skin contact. The time of sampling and intervention was between 11 and 17 o'clock. During the skin contact of the baby, the nurse was present to control the baby's symptoms by observation. The parameters of blood oxygen saturation, heart rate, respiration rate are monitored by the nurse. Immediately after skin-to-skin contact, the questionnaire was completed again by individuals.</i_keyword>
      <i_keyword>Control group: Control group: After introducing and presenting the necessary explanations about the goals and methods of the research and ensuring the confidentiality of the information, written and informed consent was received in two copies. Then, before beginning the intervention, individuals completed the Spielberger STAI Formal-Characteristic Anxiety Questionnaire and the Demographic Characteristics Form (the infant profile was completed by the researcher from the patient's record). Minutes in this group, no skin contact with fathers. Immediately after leaving, the questionnaire was completed again by individuals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fathers Anxiety Level. Timepoint: At the beginning of the study before the intervention and immediately after the intervention in both groups. Method of measurement: The level of anxiety in the experimental and control groups before and after the intervention was determined using the Spielberger Anxiety 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-26</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Yazd Imam Shahr Kargar Blvd. North Sajjad St. Alley 16 corner of Ayatollah Sadr Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
