The Efficacy to Reduce Smoking Craving of Combining Music Intervention With Nicotine Replacement Therapy Among Healthcare Professionals Who Are Trying to Quit: a Pilot Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Compare the efficacy of a strategy combining music therapy with nicotine replacement therapy (NRT) with that of NRT alone in reducing tobacco craving.
研究概览
简要总结
Tobacco is the leading preventable cause of death and disease worldwide. The health benefits of quitting smoking are well-documented. Healthcare professionals play a key role in the fight against smoking. Nevertheless, they are also affected by smoking, with a prevalence ranging from 16% to 43%, depending on their profession. Furthermore, their smoking status impacts how they deliver smoking cessation treatments.
A randomised controlled pilot trial to compare the efficacy of combining music intervention with nicotine replacement therapy (NRT) with NRT alone in managing smoking craving among 50 healthcare professionals who smoke is proposed.
Furthermore, given that the risk of relapse exceeds 50% in the first 12 months after quitting smoking and that this has harmful consequences for patients, this study also aims to identify predictors of successful cessation. In an ancillary study, the MUSICAT-BIO project, the association between successful cessation and both the gut microbiota and epigenetic regulation of BDNF is evaluated. Due to the limited available literature, a group of non-smoking volunteers is included in this study to enable comparison of the gut microbiota and BDNF epigenetic regulation between: 1) smokers and non-smokers; 2) abstinent and active smokers; and 3) abstinent smokers and non-smokers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >=18 years old
- •To be a free subject, without guardianship, curatorship or subordination.
- •To be affiliated with a Social Security scheme, or benefit from it through a third party.
- •Written Informed consent signed by the subject after receiving clear and honest information about the study.
- •Healthcare professionals include administrative and technical professionals working in the healthcare sector in the private, public or independent sectors.
- •Smoking at least 6 cigarettes per day for at least 6 months.
- •Being motivated to quit smoking
排除标准
- •Unstabilized depression
- •Psychosis and/or cognitive impairment and/or mental retardation or chronic use of medication for these disorders,
- •Addictive comorbidity such as alcoholism or abuse of substances other than tobacco,
- •Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a health or social institution, and finally patients in emergency situations.
- •Roommates, spouses, or family members already included in the study (to avoid interference with treatment)
- •Contraindication to nicotine replacement therapy (NRT)
- •Use of medication to quit smoking (NRT, bupropion), cognitive behavioral therapy (CBT), hypnotherapy, acupuncture in the last 3 months
- •Use of an electronic cigarette to quit smoking in the last 3 months
- •Concurrent participation in another clinical research study until visit V4 of this study.
- •MUSICAT-BIO Exclusion Criteria (ancillary study, 30 healthy volunteers):
- •Not be a smoker or former smoker, nor a vaper or former vaper (including nicotine-free vaping),
- •Chronic diseases,
- •Systemic corticosteroid treatment,
- •Anti-infective treatment in the previous 3 weeks (antibiotics, antivirals, antifungals, etc.),
- •Concurrent participation in another interventional clinical research study.
研究组 & 干预措施
NRT Group
TSN alone for 3 months.
干预措施: Biological collection (Other)
Music intervention and NRT
Combines music sessions and TSN for 3 months.
干预措施: Music intervention (Procedure)
Music intervention and NRT
Combines music sessions and TSN for 3 months.
干预措施: Biological collection (Other)
NRT Group
TSN alone for 3 months.
干预措施: Nicotine Replacement Therapy (NRT, nicotine patch) (Drug)
Music intervention and NRT
Combines music sessions and TSN for 3 months.
干预措施: Nicotine Replacement Therapy (NRT, nicotine patch) (Drug)
Healthy volunteers
30 healthy volunteers for ancillary study MUSICAT-BIO
干预措施: Biological collection (Other)
结局指标
主要结局
Compare the efficacy of a strategy combining music therapy with nicotine replacement therapy (NRT) with that of NRT alone in reducing tobacco craving.
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
- Compare the evolution of craving between the two groups at 1, 2 and 3 months after the target date for smoking cessation(Month [1;2;3])
- Compare the evolution of anxiety between the two groups at 1, 2 and 3 months after the target date for smoking cessation.(Month [1;2;3])
- Compare the success of the treatment in reducing tobacco consumption between the two groups at 1, 2, 3, 6 and 12 months after the target date for smoking cessation(Month [1;2;3;6;12])
- Compare the evolution of nicotine withdrawl symptoms between the two groups at 1, 2 and 3 months after the target date for smoking cessation.(Month [1;2;3])
- Compare the evolution of impulsivity between the two groups at 1, 2 and 3 months after the target date for smoking cessation.(Month [1;2;3])
- Compare the evolution of anxiety between the two groups at 1, 2, 3 months after the target date for smoking cessation(Month [1;2;3])