Protocol summary

Summary
Objectives: To investigate the effect of educational program based on Health Belief Model on the mother's beliefs and practices in order to prevent injury prevention among under five-year children Design: A before-after trial Setting and conduct: The mothers who refer to health centers will be included if they fulfill eligibility criteria. Participants including major eligibility criteria: The participants with the following criteria will be included in the study: having under five-year child; having an active medical recode in the health center; voluntarily participate in the study; regular participation in the educational sessions. The participants with each one of the following criteria will be excluded from the study: Having under five-year child with chronic disease; absence from educational session more than twice. Intervention: The volunteers will be divided into six groups of 20 people each. For each group, six educational sessions will be hold separately during three weeks using different educational programs such as speech, question and answer, group discussion, as well as using CDs, pouters, booklets and pamphlets. Main outcome measures: In each individual six outcome will be measured before and after intervention. The outcomes of interest that will be assessed are as follows: knowledge (15 questions), practice (20 questions), perceived sensitivity (5 questions), perceived severity (5 questions), perceived benefits (5 questions), perceived barriers (5 questions), queue to action (4 questions), and self-efficacy. These outcomes may be affected by the intervention. Thus, we will compare the mean score of each outcome before intervention with that of after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203309014N11
Registration date: 2012-04-14, 1391/01/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-04-14, 1391/01/26
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational program based on Health Belief Model on the mother's beliefs and practices in order to prevent injury prevention among under five-year children: a before-after trial
Public title
The effect of educational program based on Health Belief Model on the mother's beliefs and practices in order to prevent injury prevention among under five-year children
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria : having under five-year child; having an active medical recode in the health center; being volunteer to participate in the study; regular participation in the educational sessions. exclusion criteria: Having under five-year child with chronic disease; absence from educational session more than twice.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Local Human Subject Review board of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2012-03-04, 1390/12/14
Ethics committee reference number
D/P/16/35/9/4576

Health conditions studied

1

Description of health condition studied
Injury to under five-year children
ICD-10 code
T29
ICD-10 code description
Burns and corrosions of multiple body regions

2

Description of health condition studied
Injury to under five-year children
ICD-10 code
T30
ICD-10 code description
Burn and corrosion, body region unspecified

3

Description of health condition studied
Injury to under five-year children
ICD-10 code
T31
ICD-10 code description
Burns classified according to extent of body surface involved

4

Description of health condition studied
Injury to under five-year children
ICD-10 code
T32
ICD-10 code description
Corrosions classified according to extent of body surface involved

Primary outcomes

1

Description
Knowledge (15 questions)
Timepoint
Two months after educational intervention
Method of measurement
Questionnaire

2

Description
Practice (20 questions)
Timepoint
Two months after educational intervention
Method of measurement
Questionnaire

3

Description
Perceived sensitivity (5 questions)
Timepoint
Two months after educational intervention
Method of measurement
Questionnaire

4

Description
Perceived severity (5 questions)
Timepoint
Two months after educational intervention
Method of measurement
Questionnaire

5

Description
Perceived benefits (5 questions)
Timepoint
Two months after educational intervention
Method of measurement
Questionnaire

6

Description
Perceived barriers (5 questions)
Timepoint
Two months after educational intervention
Method of measurement
Questionnaire

7

Description
Queue to action (4 questions)
Timepoint
Two months after educational intervention
Method of measurement
Questionnaire

8

Description
Self-efficacy
Timepoint
Two months after educational intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing

Intervention groups

1

Description
Intervention group: Holding six educational sessions during three weeks using different educational programs such as speech, question and answer, group discussion, as well as using CDs, pouters, booklets and pamphlets.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Hamadan City
Full name of responsible person
Dr Forouzan Rezapur Shahkolai
Street address
Department of Public Health, School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Ahmad Tavilani
Street address
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Grant name
از محل يك درصد بودجه طرح‌هاي تحقيقاتي دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Research Center for Health Sciences and Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
MD, PhD, Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
+98 81 1838 0509
Email
poorolajal@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Public Health
Full name of responsible person
Dr Forouzan Rezapur Shahkolai
Position
PhD
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
+98 81 1838 0509
Email
forouzan.rezapour@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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