<?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>IRCT2013121515783N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-30</date_registration>
      <primary_sponsor>Post Graduate Research Grant University of Malaya</primary_sponsor>
      <public_title>The effectiveness of exposure to different sound levels in preserving hearing</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of applying different permissible exposure limits in preserving hearing threshold level among automobile industry workers: An intervention study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14945</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: The statistician was also blinded except the researchers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prevention of Noise-induced hearing loss.</hc_freetext>
      <i_freetext>Intervention 1: Intervention (as control arm)- On Factory 1,  Hearing protection devices were used to reduce noise exposure level between 85 and 90 dBA, based on noise reduction rate (currently adopted by the factory). Intervention 2: Second arm (Intervention)-  Hearing protection devices were used to reduce noise exposure level between 80 and 85 dBA.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Associate Prof. Dr. Tin Tin Su</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Social and Preventive Medicine, Faculty of Medicine Building, University of Malaya, 50603 Kuala Lumpur</address>
        <city>Kuala Lumpur</city>
        <country1>Malaysia</country1>
        <zip></zip>
        <telephone>0060379674756</telephone>
        <email>tstin@ummc.edu.my</email>
        <affiliation>University of Malaya</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Anselm Su Ting</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Community Medicine and Public Health, Faculty of Medicine and Health Sciences, University Malaysia Sarawak,Kuching, Sarawak, Malaysia</address>
        <city>Kuching</city>
        <country1>Malaysia</country1>
        <zip></zip>
        <telephone>006082416550</telephone>
        <email>anselmsuting@yahoo.com; anselmst@ummc.edu.my</email>
        <affiliation>University Malaysia Sarawak, Malaysia</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criterion is subjects exposed to noise levels above action level (85 dBA in one factory and 80 dBA in another factory).&#13;
&#13;
       Exclusion criteria are refused to participate, contract workers, who have diseases of ear, impacted wax, perforated tympanic membrane, physical trauma to ear, lorry drivers, who had undergone ear surgery and those have congenital hearing loss.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H83.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Noise-induced hearing loss</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention (as control arm)- On Factory 1,  Hearing protection devices were used to reduce noise exposure level between 85 and 90 dBA, based on noise reduction rate (currently adopted by the factory)</i_keyword>
      <i_keyword>Second arm (Intervention)-  Hearing protection devices were used to reduce noise exposure level between 80 and 85 dBA</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hearing threshold level. Timepoint: Six months. Method of measurement: Using manual audiometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Measuring knowledge, attitude and practice on noise-induced hearing loss. Timepoint: Six months. Method of measurement: Through questionnaire.</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>Post Graduate Research Grant University of Malaya</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Medical Ethics Committee, University Malaya Medical Centre</contact_name>
        <contact_address>University of Malaya, Jalan Universiti Kuala Lumpur Kuala Lumpur Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
