Multi-method Pilot Study to Evaluate the Interest of Music Therapy Associated to Nicotine Replacement Therapy (NRT) Versus NRT Alone on Craving Related to Smoking Cessation in Students.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Assess if Music therapy associated to NRT decrease tobacco craving compared to NRT alone
研究概览
简要总结
The study is a randomized, controlled trial comparing music therapy associated to NRT versus NRT alone to evaluate the value of music therapy in improving the management of craving among 120 student smokers (18 to 25 years old). This pilot multi-method study will combine the methodology of clinical trials with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a young audience.
详细描述
The participants will be recruited at the Clinical Investigation Center (CIC) of the University Hospital of Poitiers. At baseline visit, they will be randomly 1:1 assigned to receive either music therapy and NRT or NRT alone for 3 months.
During the 3 months after TQD (Target Quit Date), 3 visits will be performed by practitioners at the CIC. Practitioners will register smoking status of the participant, exhaled carbon monoxide concentration, body weight and all adverse events. Participants will answer questionnaires (FTCQ-12, HAD, MNWS, UPPS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •students, age >=18 and <=25 years,
- •smoking more than 5 cigarettes per day for at least 6 months,
- •motivated to quit smoking,
- •without legal tutors or subordination,
- •affiliated to a health insurance system as required by the French law on biomedical research,
- •written informed consent for participation in the study.
排除标准
- •Roommates and couples,
- •NRT contraindication
- •with depression and/or psychosis and/or cognitive disorder and/or mental retardation,
- •substance misuse or alcohol dependence,
- •smoking-cessation medication (NRT, bupropion, varenicline) or undergoing cognitive-behavioral therapy or hypnotherapy in the last 3 months,
- •electronic cigarette for smoking cessation in the last 3 months,
- •Persons benefiting from enhanced protection, i.e. persons deprived of their liberty by a judicial or administrative decision, adults under legal and finally patients in a vital emergency situation.
研究组 & 干预措施
Music intervention and NRT
The rhythm of the music sessions will be 2 per week in the first month, 1 per week in the second month and 1 every 15 days in the third month. In this group, music intervention will be associated to NRT.
干预措施: Music Intervention (Other)
Music intervention and NRT
The rhythm of the music sessions will be 2 per week in the first month, 1 per week in the second month and 1 every 15 days in the third month. In this group, music intervention will be associated to NRT.
干预措施: Nicotine replacement (Drug)
NRT group
Nicotine Patch, Nicotine Gum As in the intervention group, the physician will adapt the type of NRT according to the patient's smoking profile.
干预措施: Nicotine replacement (Drug)
结局指标
主要结局
Assess if Music therapy associated to NRT decrease tobacco craving compared to NRT alone
时间窗: Month 1
Score of French Version of the Tabacco Craving Questionnaire-12 (FTCQ-12). It consist of 12 questions, each rated on a likert-type scale with 7 response options. Lower scores mean a better outcome.
次要结局
- Test the feasability of such a program in smoking cessation(Month 3)
- Evaluate the evolution of tobacco craving(Month [2; 3])
- Evaluate the evolution of Anxiety(Month [1;2; 3])
- Evaluate the evolution of nicotine withdrawal symptoms(Month [1;2; 3])
- Evaluate the evolution of impulsivity(Month [1;2; 3])
- Evaluate the efficacy of the intervention on smoking cessation(Month [1;2; 3])