Investigating the effect of educational intervention based on the health belief model in the prevention and preparedness to deal with human monkeypox disease in the medical staff
Improving the level of awareness and attitude of the treatment staff about Human Monkeypox
Design
A clinical trial incorporating a control group, parallel groups, and without blinding, will be randomized using a randomization method sourced from reputable sites such as www.Randomization.com or www.sealedenvelope.com.
Settings and conduct
The samples will be carefully chosen and then assigned at random to two groups, namely the test group and the control group. Subsequently, a questionnaire comprising items aimed at validating the plan will be distributed among 128 individuals from the treatment staff of Baqiyatullah Hospital (AS), who have been randomly chosen to participate. Moving on to the second phase, the essential training plan for enhancing the awareness of the treatment staff in the intervention group will be executed through the distribution of instructional materials. The intervention will be based on the constructs of the health belief model. Lastly, in the third phase, the initial questionnaire will once again be distributed, this time to both the intervention and control groups, one to two months after the intervention. Upon collection, the results will be compared with the initial findings obtained prior to the intervention.
Participants/Inclusion and exclusion criteria
Medical staff, Medical students; Suffering from an underlying disease, Suffering from some skin diseases, Unwillingness to cooperate
Intervention groups
Intervention group: receive educational material. Control group: no educational material. Control group will receive the educational content after finishing the trial.
Main outcome variables
perceived sensitivity; perceived intensity; obstacles and benefits
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231011059688N1
Registration date:2023-11-07, 1402/08/16
Registration timing:prospective
Last update:2023-11-07, 1402/08/16
Update count:0
Registration date
2023-11-07, 1402/08/16
Registrant information
Name
Ali Aghabarari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4268 2975
Email address
fatemeh_rahmaty@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of educational intervention based on the health belief model in the prevention and preparedness to deal with human monkeypox disease in the medical staff
Public title
Investigating the effect of educational intervention based on the health belief model in the prevention and preparedness to deal with human monkeypox disease in the medical staff
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The treatment staff includes doctors and nurses
Medical students (interns and externs)
Exclusion criteria:
Having an acute underlying disease
HPV infection
Herpes disease
Chicken pox and Zona
Reluctance to cooperate
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Experiment with pre-test-post-test design with control group and blocked random assignment
Blocked randomization is employed to ensure that an equal number of participants are allocated to the intervention and control groups at consecutive but equal time intervals. The block size can range from 5 to 20 individuals, with increments of 5 or 10. This method allows for the administration of different intervention types to alternate blocks, ensuring a balanced distribution.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Vanak, South Sheikh Bahaeii Street, West Brazil Street, No. 150
City
Tehran
Province
Tehran
Postal code
1435814819
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.073
Health conditions studied
1
Description of health condition studied
Human Monkeypox
ICD-10 code
B04
ICD-10 code description
Monkeypox
Primary outcomes
1
Description
Knowledge about Human Monkey pox
Timepoint
1 to 2 months after distribution of educational content
Method of measurement
Knowledge section in distributed questionnaire
2
Description
Perceived susceptibility to Human Monkeypox
Timepoint
1 to 2 months after distribution of educational content
Method of measurement
Perceived sensitivity section in distributed questionnaire
3
Description
Perceived severity of Human Monkeypox
Timepoint
1 to 2 months after distribution of educational content
Method of measurement
Perceived severity section in distributed questionnaire
4
Description
Perceived benefits
Timepoint
1 to 2 months after distribution of educational content
Method of measurement
Perceived benefits section in distributed questionnaire
5
Description
Perceived barriers
Timepoint
1 to 2 months after distribution of educational content
Method of measurement
Perceived barriers section in distributed questionnaire
6
Description
Self-efficacy in dealing with Human Monkeypox
Timepoint
1 to 2 months after distribution of educational content
Method of measurement
Self-efficacy section in distributed questionnaire
7
Description
Action guide in dealing with human monkeypox
Timepoint
1 to 2 months after distribution of educational content
Method of measurement
Action guide section in distributed questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: There are 64 people who were given educational content after the distribution of the questionnaire and after 1 to 2 months the questionnaire is distributed again and the results of the educational intervention are compared with the collected data.
Category
Prevention
2
Description
Control group: There are 64 people who were given the questionnaire two times with an interval of 1 to 2 months and after the completion of the research, the educational content is also provided to them.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Ali Aghabarari
Street address
Vanak, South Sheikh bahaeii Street, West Brazil Street, No. 150
City
Tehran
Province
Tehran
Postal code
1435814819
Phone
+98 13 4268 2975
Email
aghabarari1998@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Nematullah Junaidi Jafari
Street address
Vanak, Mollasadra Street, Baqiyatullah Hospital
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 13 4268 2975
Email
aghabarari1998@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ali Aghabarari
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Vanak, South Sheikh Bahai Street, West Brazil Street, No. 150
City
Tehran
Province
Tehran
Postal code
1435814819
Phone
+98 13 4268 2975
Fax
Email
fatemeh_rahmaty@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyyedeh Hamideh Molaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vanak, South Sheikh Bahai Street, West Brazil Street, No. 150
City
Tehran
Province
Tehran
Postal code
1435814819
Phone
+98 13 4268 2975
Fax
Email
fatemeh_rahmaty@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ali Aghabarari
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Vanak, South Sheikh Bahai Street, West Brazil Street, No. 150
City
Tehran
Province
Tehran
Postal code
1435814819
Phone
+98 13 4268 2975
Fax
Email
fatemeh_rahmaty@yahoo.com
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
All potential data, encompassing individual data and details regarding the primary results, shall be made available subsequent to the de-identification of subjects and the culmination of the clinical trial.
When the data will become available and for how long
The commencement of the data access period occurs approximately six months subsequent to the publication of the results.
To whom data/document is available
The data shall be made accessible to researchers employed in academic and scientific establishments.
Under which criteria data/document could be used
After gaining access to the data, individuals who have been granted authorization have the ability to conduct any essential examination and utilization of the data, on the condition that proper acknowledgement of the source is made and the original researcher's entitlements as the proprietor of the work are upheld.
From where data/document is obtainable
In order to obtain the data, it is imperative to initiate communication by means of dispatching a message to the specified electronic mail address. Subsequently, one must articulate the request for data access, while also highlighting the fundamental attributes, as well as the scientific establishment that is pertinent to the matter at hand. Rest assured, the requested data shall be promptly dispatched to the aforementioned recipients within a time period of less than one week. The designated electronic mail for correspondence is aghabarari1998@gmail.com, and the individual responsible for responding is Ali Aghabarari.
What processes are involved for a request to access data/document
Upon receipt and validation of the individual's identity, as well as the verification of their affiliation with a reputable scientific institution, provided that they consent to the stipulation of proper source citation and upholding the researcher's rights, the requested data will be furnished to them within a period of one week.