The harmful effects of tobacco smoke exposure on health of mothers and fetuses are documented and the aim of this double blind experimental study is evaluation of the effect of education, based on health belief model, to men on smoker men's health belief and the level of pregnant women's tobacco smoke exposure. The target population is smoker men in Rafsanjan. Having pregnant wife is the inclusion criteria. After random sampling the sixty men allocate in intervention and control group. In the intervention group the face to face education based on health belief model about the harms of tobacco smoke on the health of mother and fetus will be offered. In the intervention group the education based on health belief model about the harms of tobacco smoke on the health of mother and fetus will be offered. In control group the education about the personal and social benefits of benefit of cigarette smoke quitting will be offered. the duration of education is 45 minute for each person. Before, immediately and 6 week after education the level of health belief constructs will be measured . Also, before education and 6 week after education the level of pregnant women's tobacco smoke exposure will be evaluated. during study all participants and questioner will be blinded about the name of groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706142857N5
Registration date:2017-06-30, 1396/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-30, 1396/04/09
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
2016-01-21, 1394/11/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on health belief model of men on pregnant women's tobacco smoke exposure level
Public title
The effect of education of men on pregnant women's tobacco smoke exposure
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: men; smoker
exclusion criteria: lack of contact with cigarette smoke among their wife
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Isfahan university of Medical Sciences
Street address
Isfahan university of Medical Sciences
City
Isfahan
Postal code
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IR.MUI.REC.1393.3.678
Health conditions studied
1
Description of health condition studied
tobacco smoke exposure
ICD-10 code
Z58.7
ICD-10 code description
Exposure to tobacco smoke
Primary outcomes
1
Description
Health belief constructs
Timepoint
before intervention
Method of measurement
filling questionnaire
2
Description
the level of pregnant women's tobacco smoke exposur
Timepoint
before intervention, 6 week afer intervention
Method of measurement
filling questionnaire
Secondary outcomes
1
Description
health belief constructs
Timepoint
imediatly and 6 week after intervention
Method of measurement
filling questionnair
2
Description
pregnant women's tobacco smoke exposure level
Timepoint
6 weeks after intervention
Method of measurement
filling questionnair
Intervention groups
1
Description
Control group:The education about personal and social health benefits of quitting smoking
Category
Lifestyle
2
Description
Intervention group: The education based on health belief mode about harmful effect of tobacco smoke exposure on health of mothers and fetuses
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center in Rafsanjan
Full name of responsible person
Street address
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical sciences
Full name of responsible person
Shahnaz Kohan
Street address
Isfahan University of Medical sciences.
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
PhD
Other areas of specialty/work
Street address
Isfahan University of medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7637
Fax
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
PhD
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7537
Fax
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
PhD
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
00
Fax
Email
kazemi@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)