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IRCT20210612051555N4 IRCT 2022-03-12 Damanhour University- Faculty of Nursing Effect of Smoking Educational Intervention Based on Trans-theoretical Model on Egyptian Male Smokers' Knowledge, and Smoking Behavior Effect of Smoking Educational Intervention Based on Trans-theoretical Model on Egyptian Male Smokers' Knowledge, and Smoking Behavior 2022-02-15 anticipated 170 Complete https://irct.ir/trial/61371 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Those who meet the study criteria, will be randomized between the study and control groups using the randomization block technique using five successive steps: 1) establishing a list of numbers (1-170) in advance, 2) these numbers were written in small papers and turned to be hidden then combined in a ball, 3) all the 170 papers were randomly split to 17 blocks/10 per each. 4) from each block, five papers were pulled out to be randomly allocated to the study group and the other five papers were allocated to the control group, 5) the word "study" or " control" was written by the researchers beside each number in the pre-prepared list based on to the randomization block results. This respective list was kept until the start of data collection with a total of (85) participants were allotted to each group. Masking of the participants’ allocation to the study group or the control group was not feasible. N/A Smoking behavior and nicotine dependence level. Intervention 1: For the study group: 85 male smokers employees in the main building of the ministry of health in El-Beheira Governorate. The educational intervention using TTM will be designed and implemented throughout five phases. -Ice-breaking phase: the researchers visit the participants in their workplace and introduce themselves to each other in a trial to establish a trustful relationship with them. This phase also aided in initiating the recruitment process-Assessment phase: it will assess the participants' basic and smoking-related data, knowledge, nicotine dependence level, and TTM constructs to specify the participants’ stages and process of change, decisional balance, and self-efficacy to quit smoking even if exposed to triggering situations (pre-test). -Planning phase: considering the recent and reliable literature, the researchers designed an educational intervention about smoking based on TTM (PPT, informational brochures, educational videos, and booklet). These materials were further evaluated and approved by external peer reviewers. -Implementation phase: the participants will split into groups according to their respective stages of change. Motivational interviews and counseling will be implemented initially and repeated after 3 and 6 months at the group level, then they will be conducted at the individual level on monthly basis using phone interviews. The educational activities will be tailored to the stage of change while considering the psychological constructs of the TTM model and applying the motivational interview principles to foster the behavioral change process. e.g., those who will be in the pre-contemplation stage will be instructed about the negative consequences of smoking in every life aspect (physical, psychological, and social) to enhance their readiness to quit smoking. Whereas those who are in other stages were offered the functionally feasible strategies to foster quitting of smoking and enhance their smoking resistant techniques and problem-solving skills. A weekly motivating message for quitting smoking was delivered on WhatsApp to boost motivation. Intervention 2: Control group: 85 male smokers employees in the main building of the ministry of health in El-Beheira Governorate. they will not receive any education but ethically, all the educational materials will be given for them at the end of the study to maximize the benefits and protect their health rights. Yes - There is a plan to make this available What will be shared: Published research report that contains all the findings of the study. When: within one year and will be available long life To whom: for public Conditions: for scientific use and public education Where to obtain: Scientific ranked health journal How to obtain: none Comments: none
public Samiha Hamdi Sayed Ramadan
Damanhour, ElBehira, Governorate, Egypt
Damahour Egypt 22511 +20 45 3311679 samihareda93@gmail.com Damanhour University- Faculty of Nursing scientific Samiha Hamdi Sayed Ramadan
Damanhour, El-Behira, Governorate, Egypt
Damahour Egypt 22511 +20 45 3311679 samihareda93@gmail.com Damanhour University- Faculty of Nursing Egypt -Regular smoke of minimally one cigarette daily Being in the stages of pre-contemplation, contemplation, and preparation based on TTM Aged at least 20 years Enthusiastic to take part in the study. 20 years 50 years Male -Smoke another type of nicotine than cigarettes Actively share in any other smoking programs quitting Diagnosed with psychological health problems Addict to any other drugs were excluded from the study F17.29 Nicotine dependence, other tobacco product Behavior Behavior For the study group: 85 male smokers employees in the main building of the ministry of health in El-Beheira Governorate. The educational intervention using TTM will be designed and implemented throughout five phases. -Ice-breaking phase: the researchers visit the participants in their workplace and introduce themselves to each other in a trial to establish a trustful relationship with them. This phase also aided in initiating the recruitment process-Assessment phase: it will assess the participants' basic and smoking-related data, knowledge, nicotine dependence level, and TTM constructs to specify the participants’ stages and process of change, decisional balance, and self-efficacy to quit smoking even if exposed to triggering situations (pre-test). -Planning phase: considering the recent and reliable literature, the researchers designed an educational intervention about smoking based on TTM (PPT, informational brochures, educational videos, and booklet). These materials were further evaluated and approved by external peer reviewers. -Implementation phase: the participants will split into groups according to their respective stages of change. Motivational interviews and counseling will be implemented initially and repeated after 3 and 6 months at the group level, then they will be conducted at the individual level on monthly basis using phone interviews. The educational activities will be tailored to the stage of change while considering the psychological constructs of the TTM model and applying the motivational interview principles to foster the behavioral change process. e.g., those who will be in the pre-contemplation stage will be instructed about the negative consequences of smoking in every life aspect (physical, psychological, and social) to enhance their readiness to quit smoking. Whereas those who are in other stages were offered the functionally feasible strategies to foster quitting of smoking and enhance their smoking resistant techniques and problem-solving skills. A weekly motivating message for quitting smoking was delivered on WhatsApp to boost motivation. Control group: 85 male smokers employees in the main building of the ministry of health in El-Beheira Governorate. they will not receive any education but ethically, all the educational materials will be given for them at the end of the study to maximize the benefits and protect their health rights. Knowledge about smoking. Timepoint: Before and 6 months after intervention. Method of measurement: Smoking Knowledge scale. Smoking behavior. Timepoint: Before and 6 months after intervention. Method of measurement: TTM constructs questionnaire---stage of change, processes of change, decisional balance, self efficacy. Nicotine dependence level. Timepoint: Before and 6 months after intervention. Method of measurement: Fagerstrom Tolerance Questionnaire (FTQ). Damanhour University- Faculty of Nursing Approved 2022-01-10 Ethic's committee of the Faculty of Nursing- Damanhour University Damanhour, Elbehira, Governorate, Egypt Damahour El Behira Egypt