<?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>IRCT20170501033751N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-02</date_registration>
      <primary_sponsor>Khomein Faculty of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Music Therapy on Anxiety and Pain in Burn Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Music Therapy with Nature Sounds on Anxiety and Pain of Change Dressings For Burn Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72453</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting the research samples, the patients will be divided into intervention and control groups using simple random method and random number table, Blinding description: In this study, the person who analyzes the study data after entering the data into the statistical software is not aware of the allocation of the study groups and the type of intervention allocated and does not know which individual in the test group each of the data is related to. or control.</study_design>
      <phase>2</phase>
      <hc_freetext>burn.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group:"Music therapy is performed using MP3 Player and headphones two days in a row at the time of dressing change, and they start 15 minutes before dressing change and listen to the sounds of nature for 30 minutes, which are birds singing, water and rain respectively. In addition, each type of music is presented for 5 minutes and this process is repeated for 30 minutes. Intervention 2: "Control group:" Dressing according to the doctor's order and in accordance with the usual treatment and without performing music therapy.</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:
All data can be shared after de-identifying individuals

When:
1403

To whom:
All researchers

Conditions:
To conduct related research

Where to obtain:
No. 20, Building of the Vice-Chancellor of the Faculty of Medical Sciences,Quds Boulevard,Khomein, Mr. Reza Biranvand, phone number: 08646221534, fax: 08646224142

How to obtain:
Submitting a written request via fax to receive documents to the Vice-Chancellor of Education and Research of Khomein Faculty of Medical Sciences and receiving information related to the research after a maximum of one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>rezvan ghafarzadegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 20, Building of the Vice-Chancellor of the Faculty of Medical Sciences,Quds Boulevard</address>
        <city>khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3881743364</zip>
        <telephone>+98 86 4622 1534</telephone>
        <email>rghafarzadegan@gmail.com</email>
        <affiliation>Khomein Faculty of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>reza beiranvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 20, Building of the Vice-Chancellor of the Faculty of Medical Sciences,Quds Boulevard</address>
        <city>khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3881743364</zip>
        <telephone>+98 86 4622 1534</telephone>
        <email>beiranvandreza@ymail.com</email>
        <affiliation>Khomein Faculty of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 65 years, the patient's ability to answer questions (in terms of physical and mental condition), having a stable and stable hemodynamic status,  2nd or 2nd and 3rd degree burns together with a range of 15 to 60% who have passed the resuscitation or urgent stage, written consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patient's neurological and mental disease
addiction to cigarettes and other narcotic drugs
Having comorbidity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M61.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calcification and ossification of muscles associated with burns</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group:"Music therapy is performed using MP3 Player and headphones two days in a row at the time of dressing change, and they start 15 minutes before dressing change and listen to the sounds of nature for 30 minutes, which are birds singing, water and rain respectively. In addition, each type of music is presented for 5 minutes and this process is repeated for 30 minutes.</i_keyword>
      <i_keyword>"Control group:" Dressing according to the doctor's order and in accordance with the usual treatment and without performing music therapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score according to pain intensity questionnaire(primary outcome). Timepoint: before the beginning of the stages and on the second day after the intervention. Method of measurement: Pain measurement questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score according to the Spielberger anxiety questionnaire(secondry outcome). Timepoint: before the beginning of the stages and on the second day after the intervention. Method of measurement: 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>Khomein Faculty of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-10</approval_date>
        <contact_name>Ethics Committee of Khomein Faculty of Medical Sciences</contact_name>
        <contact_address>No. 20, Building of the Vice-Chancellor of the Faculty of Medical SciencesKhomein,Quds Boulevard Khomein Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
