Protocol summary

Study aim
Determining the impact of multimedia educational intervention on the clinical ability of operating room personnel in the field of radiation protection principles in operating rooms under radiation
Design
The clinical trial has 2 control and intervention groups; The control group includes people who did not receive training. The experimental group includes people who receive radiation protection training in the operating room. Uniblind Randomization in a simple way The total sample size includes 100 individuals.
Settings and conduct
Data collection tool and process: Clinical ability is measured through a researcher questionnaire made by Mohebbi and colleagues in the field of radiation protection principles. The questionnaire contains 32 items that examine the knowledge, attitude, practice, professional obligations and overall clinical capability of Chamran and Rajaii educational hospitals operating room nurses in the field of radiation protection. The written educational program for the intervention group is made using the latest protocol texts of the World Health Organization and the International Atomic Energy Agency. The current study is uniblind that outcome assessor blinding
Participants/Inclusion and exclusion criteria
Operating room nurses and surgeons; Has activity in the field of surgeries requiring radiological intervention; No family history of malignancy and cancer; No history of radiotherapy or diagnostic scan with radionuclides, No history of contamination with radioactive substances in the previous job, No family history of blood diseases; With work experience of at least one year
Intervention groups
The experimental group includes people who receive radiation protection training in the operating room. The control group includes people who did not receive training.
Main outcome variables
Clinical capability include knowledge; attitude; practice; professional obligations

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211129053216N1
Registration date: 2024-03-19, 1402/12/29
Registration timing: retrospective

Last update: 2024-03-19, 1402/12/29
Update count: 0
Registration date
2024-03-19, 1402/12/29
Registrant information
Name
Roya Ershadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 4927
Email address
roya.ershadpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of educational multimedia intervention on the clinical capability of the operating room personnel in the field of radiation protection principles in the operating room
Public title
Investigation the effect of educational multimedia intervention on the clinical capability of the operating room personnel in the field of radiation protection principles in the operating room
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Operating room nurse, anesthetist nurse and surgeons working in the operating room Has activity in the field of surgeries requiring radiological intervention No genetic history of cancer and malignancy No history of radiotherapy or diagnostic scan with radionuclides No history of contamination with radioactive substances in the previous job (such as benzene, arsenic, lead, mercury) No family history of blood diseases Having at least one year of work experience in the field of surgeries requiring radiological interventions
Exclusion criteria:
Unwillingness to cooperate
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random number table: A table of random number is a collection of numbers that are generated completely randomly without a specific pattern or order and are presented as a table. In the present study, the researcher must first determine the direction of reading the table numbers (for example, up, down, left or right), the second assumption of the researcher is to consider the numbers for different groups (for example, even numbers for intervention A and odd numbers for intervention B, another way is to consider numbers 0-24 for intervention A, numbers 25-49 for intervention B) then the researcher puts his hand on one of the numbers and moves in one of the predetermined directions and It registers the numbers and assigns them to different groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor blinding
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
13, solh st.
City
shiraz
Province
Fars
Postal code
7177635665
Approval date
2022-04-30, 1401/02/10
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1401.017

Health conditions studied

1

Description of health condition studied
Clinical capability in the field of radiation protection in the operating room
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
1.Clinical capability in the field of radiation protection principles that shows the level of capability of a person in the field of radiation protection.
Timepoint
Before the intervention, one week after the intervention, 2 month after the intervention
Method of measurement
Data collection tool and process: Clinical capability is measured through a researcher questionnaire made by Mohebi et al. in the field of radiation protection principles. The item is related to measuring performance and 5 items are related to measuring professional obligations, and it examines the clinical ability of operating room nurses in the field of radiation protection. According to the mentioned research, Cronbach's alpha coefficient was 0.87.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, the intervention group receives training on the principles of radiation protection in the operating room.. The written educational program for the intervention group is made using the latest protocols of the World Health Organization and the International Atomic Energy Agency. Educational texts in the form of posters (protocols or instructions for protection against radiation), PowerPoint, videos and brochures and educational software, with the help of several professors of the nuclear medicine faculty from the guidelines of the World Health Organization, the International Nuclear Energy Agency and Iran's Nuclear Energy Organization will be extracted. The educational intervention is done in a combined manner, including the installation of the radiation protection instruction poster in the operating room, face-to-face training, non-face-to-face and virtual training for two weeks.
Category
N/A

2

Description
Control group: In this study, the control group does not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran and Rajaii Hospitals of Shiraz
Full name of responsible person
Roya Ershadpour
Street address
13, solh st.
City
shiraz
Province
Fars
Postal code
7177635665
Phone
+98 917 089 6109
Email
roya.ershadpour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Janghorban
Street address
Zand
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 71 3628 2700
Email
roya.ershadpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zand st, Hazrat Fatemeh Nursing and Midwifery College
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
zmohebi@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zand st. Hazrat Fateme Nursing and Midwifery College
City
ُُShiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
zmohebi@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zinat Mohebbi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zand St, Hazrat Fatemeh Nursing and Midwifery College
City
ُShiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
zmohebi@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the impact of secondary outcome on the primary outcome is published.
When the data will become available and for how long
one year after the results were published
To whom data/document is available
Researcher participants and hospitals
Under which criteria data/document could be used
To the participants if they remain in the research until the last stage.
From where data/document is obtainable
Phone 09177137573 or email zinat mohebi : zmohebi@sums.ac.ir
What processes are involved for a request to access data/document
Email to Zinat mohebi and want the result of the research.
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