<?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>IRCT20220407054443N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-24</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention based on the theory of planned behavior on Kangaroo mother care in mothers who have premature infants</public_title>
      <acronym>KMC</acronym>
      <scientific_title>Investigating the effect of educational intervention based on the theory of planned behavior on the intention and behavior of Kangaroo mother care  in the mothers who have  premature infants hospitalized in the intensive care units of premature infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62855</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: A pre-test will be performed through a questionnaire from both intervention and control groups. In the intervention group; an educational intervention will be conducted. Post-test will be done before discharging from hospital.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Kangaroo mother care. Condition 2: kangaroo mother care in mothers with premature infant.</hc_freetext>
      <i_freetext>Intervention group: The face-to-face educational intervention will be done based on the structures of the theory of planned behavior in three sessions at every two days. Training classes in groups of 3-4 people will be held  at the hospital. The educational content will be adjusted based on the needs assessment of the analysis of pre -test results. The educational content will be based on the structures of the theory of planned behavior. The duration of face-to-face training will be 45-60 minutes. content of the first session including: introduce and establish communication with the participants in the research, expression of purpose of the study, introduce kangaroo mother care, and readiness to do it. In the second session, prognosis related to premature infants, the consequences of kangaroo mother care, maternal and neonatal benefits of kangaroo mother care will be explained. In the third session, the father of the infant or one of relatives will be participate in secession, and barriers and facilitators of kangaroo mother care will be expressed. Lecture, question and answer strategy,  and group discussion will be used in these sessions.  Educational booklets, pamphlets, mobile phones, Whats App text messages, videos and pictures are used as teaching aid methods..</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:
Publication of research results in the form of publishing a scientific article

When:
The access period starts 6 months after the publication of the article.

To whom:
All people

Conditions:
To inform researchers and mothers with premature babies

Where to obtain:
Dr. Roghieh Bayrami, Assistant Professor, School of Nursing and Midwifery, Urmia Email :rozabayrami@yahoo.com

How to obtain:
Enter the site of Urmia University of Medical Sciences and search for thesis title

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeedeh Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 7,Elin Apartment, First 16 Meters St.,Sadi St.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5719819762</zip>
        <telephone>+98 44 3368 7875</telephone>
        <email>elnaznemati14@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roghaye Bayrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery ,Nazlu Campus , Urmia University of Medical Sciences</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>0098 44 327549614</telephone>
        <email>rozabayrami@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having informed consent to participate in the study
Having a infant under 37 weeks hospitalized in the neonatal ward or NICU neonatal intensive care unit
Having a minimum of basic literacy
The baby should be in a stable condition on the mechanical ventilation
The baby may receive oxygen through a breathing tube, mask, or nose while caring for the baby, but the amount of oxygen needed should be approximately constant
The baby shall be kept in an incubator or cutter</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>having a fifth minute Apgar score less than 5
having less than 1200 grams weight.
having less than 30 weeks Intrauterine age of infant
During the last 12 hours, there is no need to change the device setting by doctor and nurse.
having no congenital malformations such as cleft palate, myelomeningocele, hydrocephalus and any other problems that lead to surgery and prevent the mother from being able to perform the usual care of a premature baby.
Maternal infertility history
Pregnancy resulting from IVF</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The face-to-face educational intervention will be done based on the structures of the theory of planned behavior in three sessions at every two days. Training classes in groups of 3-4 people will be held  at the hospital. The educational content will be adjusted based on the needs assessment of the analysis of pre -test results. The educational content will be based on the structures of the theory of planned behavior. The duration of face-to-face training will be 45-60 minutes. content of the first session including: introduce and establish communication with the participants in the research, expression of purpose of the study, introduce kangaroo mother care, and readiness to do it. In the second session, prognosis related to premature infants, the consequences of kangaroo mother care, maternal and neonatal benefits of kangaroo mother care will be explained. In the third session, the father of the infant or one of relatives will be participate in secession, and barriers and facilitators of kangaroo mother care will be expressed. Lecture, question and answer strategy,  and group discussion will be used in these sessions.  Educational booklets, pamphlets, mobile phones, Whats App text messages, videos and pictures are used as teaching aid methods.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intention  of Kangaroo mother care in mothers  who have  premature infant. Timepoint: Before the intervention and when the baby is going to discharge. Method of measurement: Researcher-made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Kangaroo mother care performing in mothers who have premature infant. Timepoint: Before the intervention and when the baby is going to discharge. Method of measurement: Researcher-made 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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-09</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urzhans Ave , Resalat Blvd Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
