Comparison of the Effect of Board Game and Tobacco Cessation Education on Nicotine Addiction in Adolescent Smokers: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Stages of Change Scale (SCS):
研究概览
简要总结
Adolescents are at risk for tobacco use due to factors such as impulsivity, poor perception, desire to prove themselves, and insufficient neurological development. The Center of Disease (CDC) warns that if smoking continues at the current rate among young people, young people younger than 18 will die prematurely from a smoking-related disease
The aim of this study was to comparison the effect of a board game and tobacco cessation education on reducing nicotine addiction in adolescents.
A single-blind randomized controlled trial was used to evaluation the effect s of the different interventions on tobacco cessation. The 12 week interventions included: 1) Board Game (BG) and 2) Tobacco Cessation Education (TCE) developed based on Transtheoretical Model and 3) combined use of these two interventions (Cİ). All interventions were compared to Control Group(CG). "Fagerström Test for Nicotine Dependence (FNTD)" were used to collect data at baseline, at 8.week and at 12.week the intervention. "Assessment Of Stage Of Change Form (ASCF)" were used to collect data at baseline and at the end of each intervention (every two weeks one).
Participants were consisted of students studying at a high school in Eskisehir in Turkey. In order to form the intervention groups, permission was obtained from the school principal and teacher of each class, and the students were informed about the purpose of the study and the participation criteria. It was done in information classes. Recruitment began in October 2018 and end in January 2019.
Students who wanted to participate in the study were asked to send a short message to the investigator's private phone number. An automated response with a hyperlink was sent to a web page where information about the study was presented and students were asked to give informed consent at the push of a button. Students who agreed to participate were enrolled in a web-based questionnaire for egilibility screening.
详细描述
Tobacco use is one of the leading preventable causes of death.Tobacco use is a major risk factor for cardiovascular and respiratory diseases, more than 20 different types or subtypes of cancer, and many other debilitating health conditions. The risk of morbidity and mortality increases with the increase of tobacco use. There are many methods such as smoking cessation pharmacotherapy, nicotine replacement therapy, cognitive behavioral therapies. One of them is the education aiming at behavior change organized according to the Transtheoretic Model (TTM) . The main purpose of the model is to prevent addiction by applying the change stages without any medical support. However, these techniques have been reported to be limited in quitting success. This situation necessitated the use of different techniques. One of these techniques is games. The game; It is a conscious activity that provides socialization, does not have a specific financial gain/profit purpose, is carried out in a certain time period, according to binding rules, has a special purpose and provides an extraordinary life.Since it is very easy to reach information thanks to technology in our age, teaching activities with traditional methods are boring and cannot provide motivation. Therefore, games can create learning environments that make education fun. While the use of games in health education exposes individuals to subjects, it aims to create an internal motivation, targeting protection and improvement of health.
The sample size of the study was Cohen's effect size calculation. The effect size is generally defined as the size of the difference between the null hypotheses and alternative hypotheses, which is an indicator of the practical significance of the research results. Cohen's effect size calculation varies according to the study design. For our study, the ANOVA effect formula was used which is the intergroup interaction (relationship) test in repeated measurements. For 4 groups and 3 repeated measurements, the total sample size of based on a power of 0.80, with an effect size of 0.175 and a Type I error rate of 0.05 was calculated 80.
Study inclusion criteria were studying at XXX High School, having at least one cigarette a day and volunteering to participate in the study. There were 106 students who smoked regularly every day and were willing to participate in the study. Therefore we calculated the power of study with Type I error rate of 0.05, effect size of 0.175 and 106 samples as 0.91.
For the randomization; after baseline assessment, eligible students was given an automatic number using Java's built-in random number generator and randomly assigned to four equally-probability groups. Randomization was done by a research blind person in the EXCEL program. Research personnel were blind to allocation at initial randomization but were informed after assignment to groups. Participants were informed about which group they were allocated to. There were 26 participants in the BG group, 25 in the TCE group, 26 in the Cİ group, and 26 in the CG.
For the measurements were used Socio-demographic feature identification form,Fagerstrom test for nicotine dependence,Stages of Change Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Studying at Odunpazarı Mustafa Kemal Atatürk Vocational and Technical Anatolian High School,
- •Having at least one cigarette a day,
- •Volunteering to participate in the research
排除标准
- •Not smoker
- •Not wanting to participate in research
- •Have a mental health disorder
结局指标
主要结局
Stages of Change Scale (SCS):
时间窗: Three month
There is no scoring in the scale. "Have you stopped smoking?" The stage of change is determined according to the answers given by the individual to the question. The response of the individual "I don't plan to quit in the next 6 months" to precontemplation stage , "I intend to quit within 6 months" to contemplation stage, "I intend to quit within 30 days" to preparation stage , "I quit less than 6 months ago" to action stage, "to longer than 6 months" I quit a while ago" indicates that it is in the maintenance stage
Fagerstrom test for nicotine dependence (FTND)
时间窗: Three month
The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the that played both the board game and received tobacco cessation education was more successful in education tobacco than the group that played only the board game and received only smoking cessation education.
次要结局
未报告次要终点
研究者
Remziye CAN
Principal Investigator
Ministry of National Education, Turkey
