Protocol summary

Summary
This is an interventional study conducted to investigate the effect of health belief model education on cigarette smoking exposure in women who are in the first trimester of pregnancy. For this purpose, 88 pregnant women were enrolled to assign randomly to the intervention or control group. The education based on the health belief model was done as two 15-minute sessions of face to face education in the intervention group. Perceived susceptibility, perceived severity, perceived barriers, perceived benefits, perceived efficacy, and motivation of action constructs will be assessed in second and fifth recourse of prenatal care. Number of cigarette exposure was also compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138809242857N1
Registration date: 2010-02-03, 1388/11/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-02-03, 1388/11/14
Registrant information
Name
Ashraf Kazemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2939
Email address
kazemi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2009-06-20, 1388/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education on reducing passive smoking in pregnant women.
Public title
The effect of education with health belief model (HBM) on reducing passive smoking in pregnant women.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian nationality, continue the antenatal care, and no active smoker. Exclusion criteria: women who their smoker husband is not with them for more than one week during the study period.
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
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
Ethic committee of Isfahan University of Medical Sciences
Street address
IIsfahan University of Medical Sciences, vice-chancellor for Research, Hezarjerib st.
City
Isfahan
Postal code
81745319
Approval date
2008-01-05, 1386/10/15
Ethics committee reference number
187054

Health conditions studied

1

Description of health condition studied
Smoke exposure in pregnant women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Knowledge about duty of smoke exposure
Timepoint
Every 6 weeks
Method of measurement
questionnaire

Secondary outcomes

1

Description
Smoke exposure
Timepoint
Every 6 weeks
Method of measurement
Questionnaire

Intervention groups

1

Description
Education on the harms of exposure to cigarette smoking, two times at the first and second recourse for taking prenatal care in the intervention group
Category
Prevention

2

Description
No education in control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Midwifery units of district health centers
Full name of responsible person
Street address
selected health centers Of Isfahan University of Medical University
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical sciences
Full name of responsible person
Ashraf Kazemi
Street address
Isfahan University of Medical sciences, nursing faculty, midwifery department
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical sciences
Full name of responsible person
Ashraf Kazemi
Position
Ph.d candidate and academic member of university
Other areas of specialty/work
Street address
Isfahan University of Medical sciences, nursing faculty
City
Isfahan
Postal code
81746-72461
Phone
+98 31 1792 2939
Fax
+98 31 1669 9398
Email
kazemi@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ashraf Kazemi
Position
Ph.D candidate and academic member
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, nursing faculty
City
Isfahan
Postal code
73461-81746
Phone
+98 31 1792 2939
Fax
+98 31 1669 9398
Email
kazemi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical sciences
Full name of responsible person
Ashraf Kazemi
Position
Ph.D candidate and academic member
Other areas of specialty/work
Street address
Isfahan University of Medical sciences, nursing faculty
City
Isfahan
Postal code
81746-73461
Phone
+98 31 1792 2939
Fax
+98 31 1669 9398
Email
kazemi@nm.mui.ac.ir
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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