<?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>IRCT20210116050043N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-24</date_registration>
      <primary_sponsor>Universiti Putra Malaysia</primary_sponsor>
      <public_title>Effect of Radiation Protection Module on Knowledge, Attitude and Practice among Radiation Workers in Ministry of Health Facilities Negeri Sembilan and Malacca</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Radiation Protection Module on Knowledge, Attitude and Practice among Radiation Workers in Ministry of Health Facilities Negeri Sembilan and Malacca</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>184</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55604</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation of radiation worker to either intervention or control arms were conducted by dividing in opaque envelopes containing colour-coded cards (white for ‘controls’, red for ‘intervention’ groups). Both State Physicist in the Department of Health Negeri Sembilan and the Department of Health Malacca were randomly picked the envelopes which divided the respondents into intervention and control arms.  In each state, the radiation worker in the Participants’ Name List will be number coded by the researcher. Only the researcher had access to the radiation workers’ names and the codes and is solely responsible for the safekeeping and confidentiality of all the records. For concealment of allocation, both state physicist from the Department of Health, Negeri Sembilan and Department of Health, Malacca did not know their group allocation. After randomisation complete, the researcher has done systematic random sampling in each group to achieve 79 respondent in each arm. Then, State Physicist invited radiation worker in the intervention group to attend the intervention programme. Thus one of the states was the intervention arm and the remaining state was control arms, Blinding description: A single-blinded technique was employed where the participating radiation worker and the State Physicists were unaware of their group allocation. During the recruitment of radiation worker, prior to the randomisation, all participating radiation workers were informed that the intervention module was provided by the group and stage of study to all participating radiation worker. Thus, the radiation worker was unaware of the group allocation throughout the study. Blinding of the radiation worker was done because awareness of being in the control group might influence their answers in the questionnaires.</study_design>
      <phase>3</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : •	2-hour interactive PowerPoint slide presentation was developed base on the baseline results from previous research in Negeri Sembilan. Respondents were informed on the principle, fundamental, epidemiology, prevalence, causes, consequences and prevention of radiation hazard.•	Short videos related to radiation protection was attached to the PowerPoint slide presentation.•	Reading material for references (pamphlet). •	Collateral as reminder (WhatsApp broadcasting). Respondents were reminded to read the pamphlet every 4 weeks until intervention end. The role of the WhatsApp group is to share information, problems and address any misunderstanding regarding radiation protection. Intervention 2: Control group: The Control Group were received 2-hour interactive talk on radiation protection by their state physicist.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The data is private and confidential. Most respondent denied sharing their data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khairul Anuar Bin Abdullah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fakulti Perubatan dan Sains Kesihatan, Universiti Putra Malaysia</address>
        <city>Serdang</city>
        <country1>Malaysia</country1>
        <zip>43100</zip>
        <telephone>+60 3-9769 2300</telephone>
        <email>drkhairulanuar84@gmail.com</email>
        <affiliation>Universiti Putra Malaysia</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khairul Anuar Bin Abdullah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 16, Jalan SW 27, Taman Sutera Wangi,</address>
        <city>Melaka</city>
        <country1>Malaysia</country1>
        <zip>75150</zip>
        <telephone>+60 3-9769 2300</telephone>
        <email>drkhairulanuar84@gmail.com</email>
        <affiliation>Universiti Putra Malaysia</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A radiation worker, who are provide with dosimeter by the employer.
A radiation worker with minimum 1-year working experience in health services.
c)	A radiation worker, who are working in the radiology department under the Department of Health, Negeri Sembilan and Department of Health, Malacca facilities.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A radiation worker in the Department of Health, Negeri Sembilan and Department of Health, Malacca, who was absent during data collection for 3 times.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group : •	2-hour interactive PowerPoint slide presentation was developed base on the baseline results from previous research in Negeri Sembilan. Respondents were informed on the principle, fundamental, epidemiology, prevalence, causes, consequences and prevention of radiation hazard.•	Short videos related to radiation protection was attached to the PowerPoint slide presentation.•	Reading material for references (pamphlet). •	Collateral as reminder (WhatsApp broadcasting). Respondents were reminded to read the pamphlet every 4 weeks until intervention end. The role of the WhatsApp group is to share information, problems and address any misunderstanding regarding radiation protection.</i_keyword>
      <i_keyword>Control group: The Control Group were received 2-hour interactive talk on radiation protection by their state physicist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Practices of radiation protection. Timepoint: pre intervention, 1 month post intervention and 3 month post intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Attitude and knowledge of radiation protection. Timepoint: pre intervention, 1 month post intervention and 3 month post intervention. Method of measurement: 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>Universiti Putra Malaysia</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-18</approval_date>
        <contact_name>Medical Review &amp; Ethics Committee (MREC), Ministry of Health Malaysia</contact_name>
        <contact_address>Kompleks Institut Kesihatan Negara Blok A, No 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170 Shah Alam, Selangor. Shah Alam Selangor Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
