NCT04700306终止不适用
Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84)
研究概览
简要总结
To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.
详细描述
Pilot study to evaluate the impact of sophrology on the intensity of craving and on certain determinants of cigarette consumption: number of cigarettes, anxiety, degree of dependence, motivation, confidence, fatigue, irritability, quality of sleep.
This pilot study could serve as a basis for the development of research on a larger cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First outpatient consultation in tobacco addiction department
- •Consumption greater than or equal to 35 cigarettes per week
- •Minimum age: 18 years old / Maximum age: 75 years old
- •Absence of co-addiction of alcohol, other products and behavioural addictions (except if withdrawal for more than 1 year)
- •Commitment by the patient not to practice hypnosis or mindfulness while participating in the study
- •Mastering reading and writing skills
- •Acceptance to participate in the protocol
- •Affiliated to a social security system
排除标准
- •Patient-reported psychosis
- •Pregnant women
- •Participation in other intervention research
- •Patient under guardianship or curatorship
- •Refusal to participate in the study
结局指标
主要结局
FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84)
时间窗: 6 months after the end of consultations
Comparison of the inte craving between the sophrology group and the control group at nsity of 6 months after the end of consultations, using the FTCQ-12 questionnaire.
次要结局
- Measuring Confidence in Withdrawal Success by numerical scale (0 to 5)(6 months after the end of consultations)
- Fatigue levels by numerical scale (0 to 5)(6 months after the end of consultations)
- CO (carbon monoxide) test(6 months after the end of consultations)
- Number of cigarettes smoked per day(6 months after the end of consultations)
- Motivation to Quit Smoking by Numerical Scale (0 to 5)(6 months after the end of consultations)
- Evaluation of sleep by numerical scale (0 to 5)(6 months after the end of consultations)
- Fagerström test (0 to 11)(6 months after the end of consultations)
- Evaluation of irritability by numerical scale (0 to 5)(6 months after the end of consultations)
研究者
研究点 (4)
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