<?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>IRCT20110912007529N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-17</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>The effect distraction on patients undergoing dressing change</public_title>
      <acronym></acronym>
      <scientific_title>Compare auditory distraction and visual distraction on pain, anxiety and vital sign undergoing dressing changes of burns in elderly people</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45775</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization which the patient was the randomization unit. Assignment of patients to the intervention and control group is carried out by a statistical expert by using blocks of 3 with with the help of statistical software minitab and using random numbers, Blinding description: Samplers and the statistical analyzer will be blind to patients ‘allocation of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Burn.</hc_freetext>
      <i_freetext>Intervention 1: In the auditory distraction intervention group, nature based sounds about nature will be done for 20 minutes. Dressing wound will be change.The intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change. Intervention 2: In the visual distraction intervention group, films about nature will be done for 20 minutes. Dressing wound will be change.The intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change. Intervention 3: Control group: before dressing no intervention will be done for the patients. The intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change.</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 statistical data is available after being unidentifiable

When:
The access period is up to one year after the publication
of the results

To whom:
The access period is up to one year after the publication
of the results

Conditions:
Use of information for academic research projects is
allowed

Where to obtain:
Corresponding author;
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran

How to obtain:
Requests for specific information should be sent by an
email to the responsible author along with an
explanation of why the data is needed

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 2150</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Rejeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran,  Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 2150</telephone>
        <email>nrejeh@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in the study
Age between 60-75 years old
Lack of addiction to drugs and alcohol
Lack of cognitive impairment
Lack of  vision or hearing problems
Lack of psychosocial disorders
No other injury except of burning lesion
No previous record of burns
Burn of less than 25%
Second-degree burns on the upper and lower extremities
Less than 72 hours from the burns happening
Absence of self-immolation</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>patient dissatisfaction to continue participation in the study
pain existence in the other parts of body</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Burns and </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>T20-- T25</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the auditory distraction intervention group, nature based sounds about nature will be done for 20 minutes. Dressing wound will be change.The intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change.</i_keyword>
      <i_keyword>In the visual distraction intervention group, films about nature will be done for 20 minutes. Dressing wound will be change.The intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change.</i_keyword>
      <i_keyword>Control group: before dressing no intervention will be done for the patients. The intensity of pain, anxiety, and vital signs will be evaluated before intervention, after intervention and finally after dressing change</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: The intensity of pain will be evaluated before intervention, after intervention and finally after dressing change. Method of measurement: Visual Pain Scale.</prim_outcome>
      <prim_outcome>Pain Anxiety. Timepoint: The intensity of pain will be evaluated before intervention, after intervention and finally after dressing change. Method of measurement: Burn Specific Pain Anxiety Scale (BSPAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: The blood pressure will be evaluated before intervention, after intervention and finally after dressing change. Method of measurement: Check list.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: The respiratory rate will be evaluated before intervention, after intervention and finally after dressing change. Method of measurement: Check list.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: The heart rate will be evaluated before intervention, after intervention and finally after dressing change. Method of measurement: Check list.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-30</approval_date>
        <contact_name>Ethics committee of Shaded University</contact_name>
        <contact_address>Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
