Protocol summary

Study aim
To increase refusal smoking self-efficacy with smoking prevention program in girl adolescents
Design
54 tenth grade girls in high school were chosen purposefully and a code was allocated to each one of them. Then, students were randomly divided into two control and intervention groups.
Settings and conduct
This experimental study is aimed to assess the effect of an educational program on refusal smoking self-efficacy in students. The target population includes 16-year-old students in the tenth grade in public senior high schools, Mashhad, Iran. Two schools with similar socioeconomic status (to be comparable) and from each, one class with at least 27 students will be selected. Then they will randomly be assigned to intervention and control groups. Then, for pre-test both groups will be asked to fill in the refusal smoking self-efficacy questionnaire. This pre-test is done to assess the comparability of the two groups and further adjustment if necessary. After that control group will continue having their ordinary educational program. However, the intervention group will take part in five 90 minute smoking preventive educational sessions, held in their schools and within five consecutive weeks. Instruction methods include lecture, group discussion, showing video, pamphlets, and role modelling with focus on short- and long-term harmful effect of smoking, as well as stress management, assertiveness, effective communication, and decision-making skills. The eight following activities are implemented in each session: (1) “Sharing experience/brainstorming” (discussion and brainstorm participant’s self-knowledge and self-experience about smoking), (2) “Knowledge about smoking” (ingredients of cigarettes, short-term effects of smoking on body and health, long-term effects of smoking on body and health, increasing awareness about consequence of smoking to passive smokers or second-hand smokers and understanding of myth and fact about smoking), (3) “Stress management for teenager” (stress management and lesson about stress, emotion experience, psychological stressor, strategies to handle stress situation, created positive mood and reduced stress in daily), (4) “Assertive communication and smoking refusal skill” (Training and role play to refuse cigarette offered by watching the video), enhancing awareness and motivate to refuse cigarette), (5) “Decision making skills” (Knowledge to make decision related to smoking behavior and practice decision making skill in group), .6)Role playing in situation that needs to say no.Four weeks after completion of intervention, both groups will be asked to fill in the refusal smoking self-efficacy questionnaire. The time frame of study was determined in accordance with the similar ones to increase the feasibility of the study. Data analysis will be done using Stata to see if there is a significant difference between two groups regarding the refusal smoking self-efficacy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- female students in grade 10 in governmental schools, exclusion criteria: 1- not having used smoke, 2- not having used psychiatric medicine
Intervention groups
the intervention group will take part in five 90 minute smoking preventive educational sessions, held in their schools and within five consecutive weeks. Instruction methods include lecture, group discussion, showing video, pamphlets, and role modelling with focus on short- and long-term harmful effect of smoking, as well as stress management, assertiveness, effective communication, and decision-making skills. The eight following activities are implemented in each session: (1) “Sharing experience/brainstorming” (discussion and brainstorm participant’s self-knowledge and self-experience about smoking), (2) “Knowledge about smoking” (ingredients of cigarettes, short-term effects of smoking on body and health, long-term effects of smoking on body and health, increasing awareness about consequence of smoking to passive smokers or second-hand smokers and understanding of myth and fact about smoking), (3) “Stress management for teenager” (stress management and lesson about stress, emotion experience, psychological stressor, strategies to handle stress situation, created positive mood and reduced stress in daily), (4) “Assertive communication and smoking refusal skill” (Training and role play to refuse cigarette offered by watching the video), enhancing awareness and motivate to refuse cigarette), (5) “Decision making skills” (Knowledge to make decision related to smoking behavior and practice decision making skill in group), .6)Role playing in situation that needs to say no.
Main outcome variables
Refusal smoking self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171016036814N1
Registration date: 2018-02-11, 1396/11/22
Registration timing: retrospective

Last update: 2018-02-11, 1396/11/22
Update count: 0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3006
Email address
rafieez2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-04-18, 1397/01/29
Actual recruitment start date
2017-11-01, 1396/08/10
Actual recruitment end date
2017-12-11, 1396/09/20
Trial completion date
empty
Scientific title
Study of The effect of educational smoking prevention program on smoking refusal self-efficacy of senior high school females
Public title
The effect of smoking prevention program on smoking refusal self-efficacy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female Had willingness to participate Had permission from the parents or guardians to join in the program Non-smoker
Exclusion criteria:
smoker Students with depression condition
Age
From 16 years old to 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 27
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: simple, unit of randomization: school, method: of the two schools that are randomly selected, one will assigned to intervention and the other will be taken as control. this procedure will be done by Excel program. Concealment is not applicable to the present study.
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 Mashhad University of Medical Sciences
Street address
No. 18, university Ave., mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9188615381
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
R.MUMS.REC.1396.167

Health conditions studied

1

Description of health condition studied
prevention of smoking in adolescents
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
smoking refusal self-efficacy
Timepoint
At the beginning of study, Four weeks after completion of intervention
Method of measurement
The self-efficacy scale for adolescents smoking by lawrence

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
The intervention group: the intervention group will take part in five 90 minute smoking preventive educational sessions, held in their schools and within five consecutive weeks. Instruction methods include lecture, group discussion, showing video, pamphlets, and role modelling with focus on short- and long-term harmful effect of smoking, as well as stress management, assertiveness, effective communication, and decision-making skills. The eight following activities are implemented in each session: (1) “Sharing experience/brainstorming” (discussion and brainstorm participant’s self-knowledge and self-experience about smoking), (2) “Knowledge about smoking” (ingredients of cigarettes, short-term effects of smoking on body and health, long-term effects of smoking on body and health, increasing awareness about consequence of smoking to passive smokers or second-hand smokers and understanding of myth and fact about smoking), (3) “Stress management for teenager” (stress management and lesson about stress, emotion experience, psychological stressor, strategies to handle stress situation, created positive mood and reduced stress in daily), (4) “Assertive communication and smoking refusal skill” (Training and role play to refuse cigarette offered by watching the video), enhancing awareness and motivate to refuse cigarette), (5) “Decision making skills” (Knowledge to make decision related to smoking behavior and practice decision making skill in group), .6)Role playing in situation that needs to say no.
Category
Prevention

2

Description
Control group: the control group receive no intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rahrovan Zienab high school
Full name of responsible person
Dr fatemeh heshmati nabavi
Street address
No. 25, Emamt Ave., mashhad Town
City
mashhad
Province
Razavi Khorasan
Postal code
9188615381
Phone
+98 51 3607 3783
Email
rafieez2@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
No. 18, univercity Ave., mashhad Town
City
mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3882 3255
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
zienab Rafiee
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO. 98 ,emamat Ave,
City
mashhad
Province
Razavi Khorasan
Postal code
9188615381
Phone
+98 51 3608 3416
Email
rafieez2@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
fatemeh heshmati nabavi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebn sina Ave.nursig and midwifery univercity
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1511
Email
HeshmatiNf2@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zeinab rafiee
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
hor ameli Ave.,Ebn sina Hospital.,mashhad town
City
mashhad
Province
Razavi Khorasan
Postal code
9188615381
Phone
+98 51 3711 2704
Email
rafieez2@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data except for identity information could be available to researchers
When the data will become available and for how long
six months after publishing the research paper
To whom data/document is available
Researchers
Under which criteria data/document could be used
research affairs
From where data/document is obtainable
Dr Fatemeh Heshmati Nabavi, Scientific responsible of the research project
What processes are involved for a request to access data/document
A research proposal which is approved by a formal organization and is confirmed by Mashhad University of Medical Sciences and then correspondence with Dr Fatemeh Heshmati Nabavi, Scientific responsible of the research project
Comments
Loading...