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The effect of education in the regard of the secondhand smoke on smoker men on the exposure of their pregnant wives

Protocol summary

Study aim
Determine the effect of training on secondhand smoke in smoker men on the exposure of their pregnant wives
Design
140 smoker men who have a pregnant wife are divided randomly into two groups of intervention and control. In the pre-test stage, the questionnaires were completed, and the number of cigarettes that pregnant women encountered during a week have been questioned. Then the educational program is given to the members of the intervention group. After two months and in the post-test stage, the questionnaires were completed again and the number of cigarettes that pregnant women encountered for a week have been questioned. In addition, the sample of saliva in pregnant women is taken in order to measure the amount of cotinine in it.
Settings and conduct
Participants are smoker men who have a pregnant wife and are referred to health centers in Isfahan. The tool used is the researcher- made questionnaire on knowledge, attitude, and practice of smoker men. The number of cigarettes that women have been exposed to it and Salivary cotinine in pregnant women is measured.
Participants/Inclusion and exclusion criteria
Entry: Smoker men who have a pregnant wife, and have consumed at least one cigarette around the pregnant wife Non-arrival: 1. The smoker men who are not at home for more than one week, 2. Termination of the pregnancy
Intervention groups
Intervention group: smoker men who have a pregnant wife and receive the educational program, that includes an educational pamphlet on the regard of the secondhand smoke, as well as 8 short messages, which will be sent as a reminder via a mobile phone, and a photo of a fetus in smoke with one sentence that demands from his father to please do not smoke.
Main outcome variables
The knowledge, attitude and practice of smoker men, The number of cigarettes that women have been exposed to it, The Cotinine saliva in pregnant women;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180722040555N1
Registration date: 2018-09-18, 1397/06/27
Registration timing: registered_while_recruiting

Last update: 2018-09-18, 1397/06/27
Update count: 0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Zohreh Karimiankakolaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3336 1047
Email address
zohrehkarimian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education in the regard of the secondhand smoke on smoker men on the exposure of their pregnant wives
Public title
Design, implementation, and evaluation of the educational programs about secondhand smoke in smoker men on the exposure of their pregnant wives
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All smoker men who have a pregnant wife The men who smoke at least one cigarette daily beside their pregnant wives
Exclusion criteria:
The smoker men who are not with their pregnant wives for more than one week Termination of the pregnancy.
Age
From 15 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling based on the table of random numbers
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
School of Public Health, Daneshjou Blvd, Alem Square
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2017-12-20, 1396/09/29
Ethics committee reference number
IR.SSU.SPH.REC.1396.133

Health conditions studied

1

Description of health condition studied
Exposure to secondhand smoke in pregnant women
ICD-10 code
Z58.7
ICD-10 code description
Exposure to tobacco smoke

Primary outcomes

1

Description
The mean score of knowledge, attitude, and practice of smoker men toward the secondhand smoke
Timepoint
Before the intervention and two months after the end of intervention
Method of measurement
Researcher-made Questionnaire of Knowledge, Attitude and Practice of Smoker Men

2

Description
The number of cigarettes that pregnant women are exposed to it over a week
Timepoint
Before the intervention and two months after the end intervention
Method of measurement
question

3

Description
Saliva cotinine levels in pregnant women after the end intervention
Timepoint
two months after the end intervention
Method of measurement
kit Saliva cotinine

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: smoker men who have a pregnant wife and receive the educational program. The educational program includes an educational pamphlet on the regard of the secondhand smoke that will be given to the members of the intervention group as well as 8 short messages, which will be sent as a reminder via a mobile phone, and a photo of a fetus in smoke with one sentence that demands from his father to please do not smoke in order to be exposed to men.
Category
Behavior

2

Description
Control group: Smoking men have a pregnant wife who does not take the training program
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Ali Health Centers of Isfahan
Full name of responsible person
Zohreh Karimian Kakolaki
Street address
Ground floor, West Sheikh Tusi Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8489153645
Phone
+98 31 3555 1901
Email
zohrehkarimian68@yahoo.com

2

Recruitment center
Name of recruitment center
Shaheed Aval Health Center of Isfahan
Full name of responsible person
Zohreh Karimian kakolaki
Street address
Meraj Avenue, Fajr.2 Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8489153645
Phone
+98 31 3554 0040
Email
zohrehkarimian68@yahoo.com

3

Recruitment center
Name of recruitment center
Shaheed Navab Safavi Health Center
Full name of responsible person
Zohreh Karimian kakolaki
Street address
Bozorgmehr Street, Ahmedabad Sq., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8489153645
Phone
+98 31 5229 7040
Email
zohrehkarimian68@yahoo.com
Web page address
http://www.thewellproject.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masoud Mirzaei
Street address
School of Public Health, Alem Square, Daneshjou Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
t_takmili@ssu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zohreh Karimian kakolaki
Position
PhD Student of Health Education and Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Ehtemam Alley, Azadegan Blvd., Karkevand, Isfahan
City
Mobarekeh
Province
Isfehan
Postal code
8489153645
Phone
+98 31 5251 3067
Email
zohrehkarimian68@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zohreh Karimian kakolaki
Position
PhD Student of Health Education and Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Ehtemam Alley, Azadegan Blvd., Karkevand, Isfahan
City
Mobarekeh
Province
Isfehan
Postal code
8489153645
Phone
+98 31 5251 3067
Email
zohrehkarimian68@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zohreh Karimian kakolaki
Position
PhD Student of Health Education and Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Ehtemam Alley, Azadegan Blvd., Karkevand, Isfahan
City
Mobarekeh
Province
Isfehan
Postal code
8489153645
Phone
+98 31 5251 3067
Email
zohrehkarimian68@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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