<?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>IRCT20100823004617N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-27</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effect of Two Educational Methods Booklet and Role-Playing on Mother’s Knowledge and Perception of Self-Efficacy Regarding Infant Pain Management</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Two Educational Methods Booklet and Role-Playing on Mother’s Knowledge and Perception of Self-Efficacy Regarding Infant Pain Management</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52502</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infants Pain Management.</hc_freetext>
      <i_freetext>Intervention 1: The control group will receive routine ward training. These exercises are oral and include generalizations about calming the baby, such as non-nutritious cuddling and sucking with the mother's finger. These trainings are usually given to the mother before performing a painful procedure such as blood sampling, venipuncture, etc., or the baby's pain following bloating. Intervention 2: In intervention second group , in addition to routine care, an educational booklet will be given to mothers. This booklet contains content on the definition of pain, pain symptoms in infants, management methods in infants and in particular common non-pharmacological methods in pain management (skin-to-skin care, non-nutritious sucking, sucrose and breast milk) . After reading the content by the mother, the researcher will discuss the contents of the booklet face to face with the mother in two one and a half hour sessions in order to answer any questions or ambiguities in the content of the booklet. With the coordination of the mother and according to her desire, it will be formed in the baby's bed. In this method, to ensure the mother's learning, scenarios will be prepared by the researcher and mothers will be asked to explain how to control and manage pain in the baby. For example, the mother is asked to 'explain the correct amount and method of giving sucrose to a baby weighing 3 kg'. During the intervention, the mother's strengths and weaknesses are fed to her by the researcher. Intervention 3: In the third intervention group, in addition to routine care, the educational content will be taught to the mother through role-playing in two sessions of one and a half hours. For this purpose, individual sessions will be held in coordination with the mother and according to her wishes in the baby's bed. The image will be used to better understand theoretical issues such as pain symptoms in the baby. Common non-pharmacological methods of pain management, such as skin-to-skin care, non-nutritious sucking, oral sucrose, and practical breastfeeding, will be taught to the mother. For this purpose, depending on the circumstances, the mannequin or the baby (if the baby is asleep from the mannequin) will be used to educate the mother. To ensure the mother's learning, scenarios will be developed by the researcher and mothers will be asked to demonstrate how to control and manage pain in the baby using the methods described on the baby / mannequin. For example, the mother is asked to 'determine the amount of sucrose received for a baby weighing 3 kg and show the correct way to give sucrose to the baby'. During the intervention, the mother's strengths and weaknesses are fed to her by the researcher.</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>Mahnaz Jabraeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery., Shariati Street., Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 3336 4658</telephone>
        <email>jabraeilim@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Jabraeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery.,Shariati Street.,Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614766</zip>
        <telephone>+98 41 3336 4658</telephone>
        <email>jabraeilim@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Their babies are full-term and are fed under the mother's breast
48 hours after the baby was admitted to the ward.
The mother resides with the baby.
The mother is physically and mentally healthy
The mother is literate.
The baby has no history of hospitalization.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The mother is an employee of the health care system
Mothers with a history of pain management education.
Discharge or death of the baby or transfer of the baby to other medical centers
Withdrawal from continuing to participate in the study
Changes in the baby's clinical condition and malaise</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group will receive routine ward training. These exercises are oral and include generalizations about calming the baby, such as non-nutritious cuddling and sucking with the mother's finger. These trainings are usually given to the mother before performing a painful procedure such as blood sampling, venipuncture, etc., or the baby's pain following bloating.</i_keyword>
      <i_keyword>In intervention second group , in addition to routine care, an educational booklet will be given to mothers. This booklet contains content on the definition of pain, pain symptoms in infants, management methods in infants and in particular common non-pharmacological methods in pain management (skin-to-skin care, non-nutritious sucking, sucrose and breast milk) . After reading the content by the mother, the researcher will discuss the contents of the booklet face to face with the mother in two one and a half hour sessions in order to answer any questions or ambiguities in the content of the booklet. With the coordination of the mother and according to her desire, it will be formed in the baby's bed. In this method, to ensure the mother's learning, scenarios will be prepared by the researcher and mothers will be asked to explain how to control and manage pain in the baby. For example, the mother is asked to 'explain the correct amount and method of giving sucrose to a baby weighing 3 kg'. During the intervention, the mother's strengths and weaknesses are fed to her by the researcher.</i_keyword>
      <i_keyword>In the third intervention group, in addition to routine care, the educational content will be taught to the mother through role-playing in two sessions of one and a half hours. For this purpose, individual sessions will be held in coordination with the mother and according to her wishes in the baby's bed. The image will be used to better understand theoretical issues such as pain symptoms in the baby. Common non-pharmacological methods of pain management, such as skin-to-skin care, non-nutritious sucking, oral sucrose, and practical breastfeeding, will be taught to the mother. For this purpose, depending on the circumstances, the mannequin or the baby (if the baby is asleep from the mannequin) will be used to educate the mother. To ensure the mother's learning, scenarios will be developed by the researcher and mothers will be asked to demonstrate how to control and manage pain in the baby using the methods described on the baby / mannequin. For example, the mother is asked to 'determine the amount of sucrose received for a baby weighing 3 kg and show the correct way to give sucrose to the baby'. During the intervention, the mother's strengths and weaknesses are fed to her by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mothers' knowledge about Infant Pain Management. Timepoint: Before the Intervention and 72  Hours after The Intervention. Method of measurement: Using a Researcher-Made Questionnaire.</prim_outcome>
      <prim_outcome>Understanding Mothers' Self-Efficacy in Infant Pain Management. Timepoint: Before the Intervention and 72  Hours after The Intervention. Method of measurement: Using a Researcher-Made 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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-02</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences.,Attar Neyshabouri St., Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
