Protocol summary

Summary
This study aims at investigating the effect of education based on Health Belief Model on the promotion of preventing behaviors exposure to polluted air among pregnant women. The sample of 120 pregnant women under 6 months referred to health centers - Care Arak city at 6-24 weeks of gestation are represented. multi-stage sampling was used to select sampls. also they were assigned into 2 Intervention and control groups randomly. The data are gathered via a researcher-made questionnaire whose validity and reliability are assured in advance. Inclusion criteria: Pregnant women with who can read and write; Pregnant women under than 6 months. Exclusion criteria: pregnancy complications; the absence of training sessions. The educational intervention for the intervention group is done via holding an interactive educational seminar, presenting an Educational booklet as a reminder. The control group receive their routine education. The primary outcome: The preventive behaviors of exposure to air pollution. The Secondary outcomes: Increase knowledge, change attitude, improve practice.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014090119005N1
Registration date: 2015-02-18, 1393/11/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-18, 1393/11/29
Registrant information
Name
Somayeh Pourmosayebi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 4615
Email address
pourmosayebi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-09-29, 1393/07/07
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of educational program based on the health belief model on the promotion of preventing behaviors exposure to polluted air among pregnant women
Public title
The effect of education on the prevention of exposure to polluted air among pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with who can read and write; singleton pregnancy; Pregnant women under 6 months; aged 18 to 35 years; No experience chronic disease known (heart disease, lung disease, kidney disease, diabetes, thyroid). Exclusion criteria: pregnancy complications (preeclampsia, gestational hypertension, diabetes and bleeding) ; The absence of more than one session of training sessions; absence of complete session of the questionnaire.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
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
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Sardashat, Arak
City
Arak
Postal code
Approval date
2014-09-08, 1393/06/17
Ethics committee reference number
93-167-17

Health conditions studied

1

Description of health condition studied
pregnancy
ICD-10 code
Z35
ICD-10 code description
Supervision of high-risk pregnancy

Primary outcomes

1

Description
Adopt behaviors to prevent of exposure to air pollution in pregnant women
Timepoint
Before and three months after intervention
Method of measurement
A researcher-made questionnaire

Secondary outcomes

1

Description
Knowledge, Perceived susceptibility, Perceived severity, Perceived benefits, Perceived barriers, Cues to action, Self-efficacy, practice
Timepoint
Three months after the intervention.
Method of measurement
A researcher-made questionnaire

Intervention groups

1

Description
The educational intervention for the intervention group is done via holding an interactive educational seminar, presenting an Educational booklet as a reminder.
Category
Prevention

2

Description
Control Group : Just providing routine Education .
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak
Full name of responsible person
Mohsen Shamsi
Street address
Arak University of Medical Sciences, Basij Sq, Sardashat, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
davood hekmatpou
Street address
Arak University of Medical Sciences, Basij Sq, Sardashat, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Somayeh Pourmosayebi
Position
MSc student in Health Education
Other areas of specialty/work
Street address
Department of Public Health, Golestan Alley, Mustafa Khomeini Settlements, Arak
City
Arak
Postal code
Phone
+98 86 3224 1411
Fax
Email
pourmosayebi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohsen Shamsi
Position
PHD
Other areas of specialty/work
Street address
Department of Public Health, Golestan Alley, Mustafa Khomeini Settlements, Arak
City
Arak
Postal code
Phone
+98 86 3368 4615
Fax
Email
dr.shamsi@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Somayeh Pourmosayebi
Position
MSc student in Health Education
Other areas of specialty/work
Street address
Department of Public Health, Golestan Alley, Mustafa Khomeini Settlements, Arak
City
Arak
Postal code
Phone
Fax
Email
Web page address

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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