<?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>IRCT20230712058758N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-07</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of developmental care education using Teach-back method on perceived stress and self- esteem of mothers with hospitalized  premature newborn</public_title>
      <acronym></acronym>
      <scientific_title>The effect of developmental care education using Teach-back method on perceived stress and self- esteem of mothers with hospitalized  premature newborn</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72389</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation of blocks in such a way that blocks of size 2, 4 and 6 will be used. For example, in the case where the block size is 2, we will have two states AB and BA (A and B are the intervention and control groups). In order to create the sequence and concealment, the online software with the following address will be used and a special randomization code will be generated: Sealed Envelope Ltd. 2021. Create a blocked randomization list. [online] Available from: http://www.sealedenvelope.com/simple-randomizer/v1/lists [Accessed 16 July 2022].</study_design>
      <phase>N/A</phase>
      <hc_freetext>premature newborn.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, mothers individually, during the first 10 days of their newborns' stay in the neonatal intensive care unit, during 4 sessions lasting 45 to 60 minutes based on the same study, are exposed to developmental care education using Teach- back method will be done by the researcher. In this group, the teach-back method with the 5T model will be used. The 5T model is a standard and operational definition of teach-back method that includes 5 steps; triage, tools, take responsibility, tell me and try again. The triage, tool, and take responsibility steps focus on effective comprehension of information and the tell me and try again steps to assess whether the patient has received the information. The Take Responsibility and Tell Me steps are referred to as " Teach Back lead-in." The steps of the teach-back method will include such things; Step 1: The teacher will ensure that he has used simple language and explained the concepts or process to the care recipient. Medical words and terms will be avoided. Step 2: The teacher will ask the care recipient to repeat the content in his own language: How did he understand the concepts or process that the researcher explained? Step 3: The teacher will identify and correct the care recipient's misperception or incorrect performance. Step 4: The instructor will question the care recipient again about what was taught to ensure that the misunderstanding has been corrected. Step 5: The instructor will repeat steps 4 and 5 until he is convinced that the care recipient understands the concepts or has the ability to perform the procedure correctly and safely. In the teach-back method using the same study, after teaching new information, mothers will be asked to explain that information in their own language. Then the level of knowledge of mothers and the adequacy of their explanations will be determined. The mother will repeat the instructions in her own language. In this way, the researcher will be able to evaluate the mother's understanding of the information. If the mother does not repeat the information correctly, the training phase will be completed for that information and progress will be resumed for the new information. However, if there is a defect or error in it, the information will be corrected and repeated by the researcher, and the mother will be asked to express the information in her own language. After completing the cycle, the mother will be asked: "Do you have any other questions?" If possible, open questions will be asked and closed questions will be avoided. Intervention 2: Control group: non-intervention: this training group will not be given.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley 26, Haft Tir Blvd., Nurabad, Fars, Islamic Republic of Iran</address>
        <city>Nurabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7351794374</zip>
        <telephone>+98 71 7253 1080</telephone>
        <email>zaynabmokhtari792@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alley 26, Haft Tir Blvd., Nurabad, Fars, Islamic Republic of Iran</address>
        <city>Nurabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7351794374</zip>
        <telephone>+98 71 7253 1080</telephone>
        <email>zaynabmokhtari792@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The experience of the first premature newborn admitted to the neonatal intensive care unit
A mother with a premature newborn with a history of hospitalization in the neonatal intensive care unit
single newborn
Willingness and informed consent to participate in the study
Gestational age more than 25 and less than 35 weeks
Mothers with mild, moderate or severe perceived stress on the Cohen Perceived Stress Scale</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Newborn weight less than 800 grams at birth
Newborns suffering from birth defects
Previous participation in studies similar to the current research
Having a history of depression or other psychiatric disorders in the mother
Working in medical science</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm [premature] newborn [other]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, mothers individually, during the first 10 days of their newborns' stay in the neonatal intensive care unit, during 4 sessions lasting 45 to 60 minutes based on the same study, are exposed to developmental care education using Teach- back method will be done by the researcher. In this group, the teach-back method with the 5T model will be used. The 5T model is a standard and operational definition of teach-back method that includes 5 steps; triage, tools, take responsibility, tell me and try again. The triage, tool, and take responsibility steps focus on effective comprehension of information and the tell me and try again steps to assess whether the patient has received the information. The Take Responsibility and Tell Me steps are referred to as " Teach Back lead-in." The steps of the teach-back method will include such things; Step 1: The teacher will ensure that he has used simple language and explained the concepts or process to the care recipient. Medical words and terms will be avoided. Step 2: The teacher will ask the care recipient to repeat the content in his own language: How did he understand the concepts or process that the researcher explained? Step 3: The teacher will identify and correct the care recipient's misperception or incorrect performance. Step 4: The instructor will question the care recipient again about what was taught to ensure that the misunderstanding has been corrected. Step 5: The instructor will repeat steps 4 and 5 until he is convinced that the care recipient understands the concepts or has the ability to perform the procedure correctly and safely. In the teach-back method using the same study, after teaching new information, mothers will be asked to explain that information in their own language. Then the level of knowledge of mothers and the adequacy of their explanations will be determined. The mother will repeat the instructions in her own language. In this way, the researcher will be able to evaluate the mother's understanding of the information. If the mother does not repeat the information correctly, the training phase will be completed for that information and progress will be resumed for the new information. However, if there is a defect or error in it, the information will be corrected and repeated by the researcher, and the mother will be asked to express the information in her own language. After completing the cycle, the mother will be asked: "Do you have any other questions?" If possible, open questions will be asked and closed questions will be avoided.</i_keyword>
      <i_keyword>Control group: non-intervention: this training group will not be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived stress. Timepoint: The level of perceived stress by mothers at the beginning of the study (before the intervention) and immediately after the intervention. Method of measurement: The Perceived Stress Scale of Cohen et al.</prim_outcome>
      <prim_outcome>Self- esteem. Timepoint: The level of self- esteem by mothers at the beginning of the study (before the intervention) and immediately after the intervention. Method of measurement: Rosenberg Self-Esteem Scale.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-30</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
