Protocol summary

Study aim
The aim of this study is to develop, implement and evaluate the effectiveness of an educational intervention module based on Protection Motivation Theory (PMT) on the level of knowledge, attitude, and practice of radiation protection among radiation worker in the Ministry of Health facilities Negeri Sembilan and Malacca.
Design
a two-armed, single-blinded, parallel, randomised, controlled field trial, with pre-intervention and post-intervention evaluation.
Settings and conduct
34 healthcare facilities in Negeri Sembilan and Malacca. responded and field supervisor is blinded
Participants/Inclusion and exclusion criteria
Inclusion Criteria: a) A radiation worker with a minimum of 1-year of working experience in health services. b) A radiation worker, who are provided with a dosimeter by the employer. c) A radiation worker, who is working in the radiology department under the Department of Health, Negeri Sembilan and Department of Health, Malacca facilities. Exclusion Criteria: a) A radiation worker in the Department of Health, Negeri Sembilan and Department of Health, Malacca, who was absent during data collection 3 times. b) A radiation worker in the Department of Health, Negeri Sembilan and Department of Health, Malacca, who was not complete answering self-administered questionnaire during data collection.
Intervention groups
The intervention group consisted of radiology staffs that will be trained on ; • 2-hour interactive talk session consist of the principle, fundamental, epidemiology, prevalence, causes, consequences and prevention of radiation hazard. • Short videos related to radiation protection • Pamphlet. • Collateral as a reminder (WhatsApp) The control group consisting of radiology staffs that will be trained on a 2-hour interactive talk on radiation protection by their state physicist.
Main outcome variables
Level of knowledge, attitude and practice of radiation protection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210116050043N1
Registration date: 2021-04-24, 1400/02/04
Registration timing: retrospective

Last update: 2021-04-24, 1400/02/04
Update count: 0
Registration date
2021-04-24, 1400/02/04
Registrant information
Name
KHAIRUL ANUAR ABDULLAH
Name of organization / entity
Universiti Putra Malaysia
Country
Malaysia
Phone
+60 6-954 0410
Email address
drkhairulanuar84@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-01, 1399/09/11
Expected recruitment end date
2021-02-28, 1399/12/10
Actual recruitment start date
2020-12-01, 1399/09/11
Actual recruitment end date
2021-02-28, 1399/12/10
Trial completion date
2021-04-01, 1400/01/12
Scientific 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
Effect of Radiation Protection Module on Knowledge, Attitude and Practice among Radiation Workers in Ministry of Health Facilities Negeri Sembilan and Malacca
Purpose
Education/Guidance
Inclusion/Exclusion 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.
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.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 184
Actual sample size reached: 158
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Review & Ethics Committee (MREC), Ministry of Health Malaysia
Street address
Kompleks Institut Kesihatan Negara Blok A, No 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170 Shah Alam, Selangor.
City
Shah Alam
Postal code
40170
Approval date
2019-11-18, 1398/08/27
Ethics committee reference number
NMRR-19-2860-49849

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
practices of radiation protection
Timepoint
pre intervention, 1 month post intervention and 3 month post intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
Attitude and knowledge of radiation protection
Timepoint
pre intervention, 1 month post intervention and 3 month post intervention
Method of measurement
questionnaire

Intervention groups

1

Description
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.
Category
Other

2

Description
Control group: The Control Group were received 2-hour interactive talk on radiation protection by their state physicist.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
UNIVERSITI PUTRA MALAYSIA
Full name of responsible person
Khairul Anuar Bin Abdullah
Street address
FAKULTI PERUBATAN DAN SAINS KESIHATAN, SERDANG, SELANGOR
City
SERDANG
Postal code
43100
Phone
+60 3-9769 2300
Email
drkhairulanuar84@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Associate Professor Dr Ahmad Azuhairi Ariffin
Street address
Fakulti Perubatan dan Sains Kesihatan, Universiti Putra Malaysia
City
Serdang
Postal code
43100
Phone
+60 3-9769 2300
Email
drkhairulanuar84@gmail.com
Grant name
Fundemental Research Grant Scheme
Grant code / Reference number
FRGS/1/2019/SKK01/UPM/02/4
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Universiti Putra Malaysia
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Khairul Anuar Bin Abdullah
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Occupational Medicine
Street address
Fakulti Perubatan dan Sains Kesihatan, Universiti Putra Malaysia
City
Serdang
Province
Selangor
Postal code
43100
Phone
+60 3-9769 2300
Email
drkhairulanuar84@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Khairul Anuar Bin Abdullah
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Occupational Medicine
Street address
No 16, Jalan SW 27, Taman Sutera Wangi,
City
Melaka
Province
Melaka
Postal code
75150
Phone
+60 3-9769 2300
Email
drkhairulanuar84@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Khairul Anuar Bin Abdullah
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Occupational Medicine
Street address
No 16, Jalan SW 27, Taman Sutera Wangi,
City
Melaka
Province
Melaka
Postal code
75150
Phone
+60 3-9769 2300
Email
drkhairulanuar84@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data is private and confidential. Most respondent denied sharing their data
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
When the data will become available and for how long
To whom data/document is available
Under which criteria data/document could be used
From where data/document is obtainable
What processes are involved for a request to access data/document
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