Trial of Treatment Protocol for Smoking Cessation: A Pragmatic Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Continuous Abstinence Rate
研究概览
简要总结
Background: As smoking regulatory policies, including the WHO FCTC (Framework Convention on Tobacco Control), are enforcing, demand for smoking cessation treatment is being increased.
According the trend, development and evaluation of the medical guideline, Induced participation of medical personnel and available in Korean medical clinic, is needed. Purpose: To evaluate the satisfaction and effect of traditional & complementary medicine (T&CM) tobacco control program Methods: Recruited subjects were divided into control and test groups. They treated two times a week during the first three weeks and once a week during the last week.
Program participation rates and drop rates, satisfaction, amount of smoking before and after programs
, smoking-related key variables, nicotine dependence test (Fagerstrom test), Expired CO amounts, urinary cotinine amount, withdrawal symptoms, the change in quality of life(EQ-5D) are measured.
详细描述
Subjects in control group are treated NRT and counselling. Nicotine Replacement Therapy is provided 7 patches and 30 gums once a week for 4 weeks. Using amounts are depend on each subject's cravings. (Investigator will check how much they used.) Doctor consults about 10-15 minutes per visit.
Subjects in intervention group are treated NRT, counselling and traditional & complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy). Body acupoints are HT7, LI4, ST36, LU7, LU6 on both sides. Ear acupoints are Shenmen, Lung, Pharynx, Trachea, Endocrine. Subjects are treated with acupuncture for 20 minutes per visit and put ear acupuncture like sticker for 1-2 days. Mixture oil of Lavender, peppermint, rosemary are used to massage behind the ears. It is used 2 times a day and they can adjust frequency depending on their cravings.(Investigator will check how much they used.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •having willing to stop smoking 2) currently smoking and applying one of the following
排除标准
- •suffering in the last 2 weeks cardiovascular disease or Severe arrhythmias, unstable angina 2) suffering from severe arrhythmia
研究组 & 干预措施
Intervention group
NRT, counselling, traditional & complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy).
干预措施: Traditional & Complementary Medicine treatment (Other)
Intervention group
NRT, counselling, traditional & complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy).
干预措施: NRT, counselling (Other)
Control group
NRT, counselling
干预措施: NRT, counselling (Other)
结局指标
主要结局
Continuous Abstinence Rate
时间窗: 4 week
endpoint of treatment
次要结局
- 7-day Point Prevalence Abstinence(6,8,12,16,24 week)
- Program participation rate(0,7,10,14,17 day, 3,4,6,8,12,16,24 week)
- Withdrawal symptoms(1,2,3,4 week)
- Tobacco craving(0,7,10,14,17 day, 3,4,6,8,12,16,24 week)
- Prolonged Abstinence Rate(3,6 month)
- Amount of smoking(0,7,10,14,17 day, 3,4,6,8,12,16,24 week)
- Exhaled Carbon monoxide monoxide(0,7,10,14,17 day, 3,4,6,8,12,16,24 week)
- Quality of life(0,4 week)
- Nicotine dependence test (Fagerstrom test)(10, 17 day, 4week)
研究者
Sunju Park
Medical Doctor, Professor
Daejeon University