<?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>IRCT20151103024859N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-15</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating of the effect of education on workers' noise annoyance</public_title>
      <acronym>KAP</acronym>
      <scientific_title>Investigation of the effect of education on workers' noise annoyance</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>170</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33199</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: At first, for blinding,groups 1 and 2 were selected from two different shifts.  On both shifts, the names of the people were first sorted according to their staff numbers.
Then by using extant software in the internet which is used for random work, the first groups, on first shift workers including 103 people 85 ones are simply randomly selected without any alternatives.
Also, the second group, on second shift workers, which consist of 113 people, was randomly assigned to 85 individuals.
Then the numbers were matched with the staff numbers of the workers, and the samples were selected.
The intervention and control groups are chosen by tossing up.
The letters A and B were attributed to them.
in this way groups A, the first group ,is chosen as the intervention group and group B, the second group , is chosen as the control group, Blinding description: The two groups don’t interfere with each other. 85 of Shift 1 and 85 of Shift 2 are selected.
The control group is not informed about the existence of the training.</study_design>
      <phase>N/A</phase>
      <hc_freetext>noise annoyance due to occupational exposure to noise.</hc_freetext>
      <i_freetext>Intervention 1: intervention group :On first shift; those parts of the factory which are exposed to noise over 85 dB, 85 workers are randomly chosen by draw, based on the workers numbers.After describing the procedure and purpose of research, their consents are filled out. If the worker doesn’t want to participate in the study, sampling will continue until the sampling size is completed in the intervention group.After completing the questionnaires (the knowledge, attitude and practice questionnaire, noise annoyance questionnaire), audiometry is done by the researcher in the studied sampler.After performing a pretest, the data is entered into the statistical software.Based on pretest results, designing of educational intervention and media will be required.Educational intervention that is likely to be in the form of 3 to 4 sessions of group discussion and lectures.After the training classes for the intervention group workers, two months after the intervention, both groups are followed up, and questionnaires are completed again for them.In the same way, of the workers of the other shift (who do not usually contact each other), 85 people will be selected as a control group. Intervention 2: control group : Among other shift workers who are exposed to noise over 85 dB, 85 workers are randomly chosen by draw.The choice is based on their worker numbers.Similar to the intervention group, questionnaires (knowledge, attitude, practice questionnaire, noise annoyance questionnaire) are completed by selected workers. Audiometry is done by the researcher in the studied sampler.After the pretest, the information of both groups is entered into the statistical software for designing is entered into the statistical software for designing of the educational intervention and the required media. The control group doesn’t receive any training.Two months later, the control group will completed the relevant questionnaires, again.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The company information file is confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Irajhd alimohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hemmat highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 8860 7939</telephone>
        <email>irajrastin1@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Irajhd alimohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hemmat highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 8860 7939</telephone>
        <email>irajrastin1@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Work in Pinak manufacturing co.
Exposure to sound greater than 85 dB
Work experience at least 1 year
No hearing loss above 25 dB
Agree to enter the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of employment in Pinak manufacturing co.
Exposure to noise less than 85 dB
Work experience less than 1 year
Hearing loss greater than 25 dB
Unwillingness to enter the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z57.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Occupational exposure to noise</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group :On first shift; those parts of the factory which are exposed to noise over 85 dB, 85 workers are randomly chosen by draw, based on the workers numbers.After describing the procedure and purpose of research, their consents are filled out. If the worker doesn’t want to participate in the study, sampling will continue until the sampling size is completed in the intervention group.After completing the questionnaires (the knowledge, attitude and practice questionnaire, noise annoyance questionnaire), audiometry is done by the researcher in the studied sampler.After performing a pretest, the data is entered into the statistical software.Based on pretest results, designing of educational intervention and media will be required.Educational intervention that is likely to be in the form of 3 to 4 sessions of group discussion and lectures.After the training classes for the intervention group workers, two months after the intervention, both groups are followed up, and questionnaires are completed again for them.In the same way, of the workers of the other shift (who do not usually contact each other), 85 people will be selected as a control group.</i_keyword>
      <i_keyword>control group : Among other shift workers who are exposed to noise over 85 dB, 85 workers are randomly chosen by draw.The choice is based on their worker numbers.Similar to the intervention group, questionnaires (knowledge, attitude, practice questionnaire, noise annoyance questionnaire) are completed by selected workers. Audiometry is done by the researcher in the studied sampler.After the pretest, the information of both groups is entered into the statistical software for designing is entered into the statistical software for designing of the educational intervention and the required media. The control group doesn’t receive any training.Two months later, the control group will completed the relevant questionnaires, again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Noise annoyance, score of ISO 15666 questionnaire. Timepoint: Measuring the noise annoyance (Before intervention) and 2 months after the intervention. Method of measurement: ISO 15666 questionnaire.</prim_outcome>
      <prim_outcome>Knowledge, information and understanding about noise and hearing protection devices are used. Timepoint: Measuring knowledge (Before intervention) and 2 months after the intervention. Method of measurement: Researcher-made questionnaire Knowledge Attitude Practices study related to noise.</prim_outcome>
      <prim_outcome>Attitude - A more or less constant condition of the mental system that reflects a person's stimulating sensation of something like hearing loss. Timepoint: Measuring attitude (Before intervention) and 2 months after the intervention. Method of measurement: Researcher-made questionnaire Knowledge Attitude Practices study related to noise.</prim_outcome>
      <prim_outcome>Practice - The perception and understanding of the worker himself. Timepoint: Measuring practice (Before intervention) and 2 months after the intervention. Method of measurement: Researcher-made questionnaire Knowledge Attitude Practices study related to noise.</prim_outcome>
      <prim_outcome>Training - The purpose of education is an activity that aims to increase the Knowledge of individuals with a view to changing attitudes and practices. Timepoint: Measurement of knowledge ,attitude and practice (before intervention) and 2 months after intervention. Method of measurement: Researcher-made questionnaire Knowledge Attitude Practices study related to noise.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Noise annoyance, score of ISO 15666 questionnaire. Timepoint: Measuring the noise annoyance (Before intervention) and 2 months after the intervention. Method of measurement: ISO 15666 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-01</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemat Highway next to Milad Tower,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
