<?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>IRCT20231120060117N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-06</date_registration>
      <primary_sponsor>College of Nursing, University of Baghdad</primary_sponsor>
      <public_title>Music Intervention for Reducing Children’s Pain and Anxiety During Dressing Changes</public_title>
      <acronym></acronym>
      <scientific_title>Music Intervention Undergoing Dressing Changes: Its Effects on Children’s Pain and Anxiety</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78841</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Children are randomly divided into groups by using a simple random method, the researchers select a piece from a container with prepared papers containing the words control and intervene. Grouping the children will be done according to the paper selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Daily dressing changes for burn injuries as a part of routine care, which is a painful procedure. Different degrees of pain intensity and anxiety are associated with individuals during dressing changes. Condition 2: Alternative methods for relieving pain and anxiety, which are based on psychological techniques without pharmacotherapy, can support analgesic action and achieve the desired goal of treatment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After identifying the children in the intervention group, they will listen to prepared music lists for 10 minutes before the dressing procedure. Then they have to describe their anxiety state according to the specific tool. the children were free to stay and listen to music during the procedure. then after the dressing is finished their pain level will be measured. Intervention 2: Control group:  After identifying the children in this group, they describe their anxiety state before the routine dressing procedure without music listening. then after the dressing is finished their pain level will be measured.</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:
The researcher is acknowledging the scientific community to have verifiable findings of the study. The sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.

When:
once the process of data collection, analysis, and analysis is complete successful publishing of the manuscript, all the related files will become available for 6 months after publication

To whom:
All the related files will be shared with any scientific interested parties.

Conditions:
It may be used after seeking the author's permission.

Where to obtain:
The author's professional e-mail will be available.

How to obtain:
N\A

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Adraa Hussein Shawq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Baghdad</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>00479</zip>
        <telephone>+964 770 263 8810</telephone>
        <email>adraa.hussein@conursing.uobaghdad.edu.iq</email>
        <affiliation>College of Nursing, University of Baghdad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Adraa Hussein Shawq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Baghdad</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>00479</zip>
        <telephone>+964 770 263 8810</telephone>
        <email>adraa.hussein@conursing.uobaghdad.edu.iq</email>
        <affiliation>College of Nursing, University of Baghdad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>school-age children
children with burn surface area were less than 39%
accepted to participate in the study</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>children with hearing and cognitive impairments
has a previous experience with burn injuries
refuse to participate
children with face burns</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
      <hc_code>T25.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
      <hc_keyword>Burn of unspecified degree of ankle and foot</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After identifying the children in the intervention group, they will listen to prepared music lists for 10 minutes before the dressing procedure. Then they have to describe their anxiety state according to the specific tool. the children were free to stay and listen to music during the procedure. then after the dressing is finished their pain level will be measured.</i_keyword>
      <i_keyword>Control group:  After identifying the children in this group, they describe their anxiety state before the routine dressing procedure without music listening. then after the dressing is finished their pain level will be measured.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decrease children's levels of pain after exposure to music listening. Timepoint: children who listen to music during daily dressing changes will measure their pain and anxiety every day for seven days. Method of measurement: objective pain scale for children, which was observed by the researchers after the dressing change, was used to assess their responses.</prim_outcome>
      <prim_outcome>Decrease children's levels of anxiety levels before exposure to music listening. Timepoint: children who listen to music before and during daily dressing changes will measure their anxiety every day for seven days. Method of measurement: state anxiety trait inventory for children to describe their status before the procedure.</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>The author of the study is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-25</approval_date>
        <contact_name>Research Ethical Approval Committee at the College of Nursing</contact_name>
        <contact_address>Bab AL-Muadum Baghdad Baghdad Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
