Trial of Treatment Protocol for Smoking Cessation
- Conditions
- Smoking Cessation
- Interventions
- Other: Traditional & Complementary Medicine treatmentOther: NRT, counselling
- Registration Number
- NCT02768025
- Lead Sponsor
- Daejeon University
- Brief Summary
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.
- Detailed Description
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.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
-
- having willing to stop smoking 2) currently smoking and applying one of the following
-
- suffering in the last 2 weeks cardiovascular disease or Severe arrhythmias, unstable angina 2) suffering from severe arrhythmia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Traditional & Complementary Medicine treatment NRT, counselling, traditional \& complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy). Intervention group NRT, counselling NRT, counselling, traditional \& complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy). Control group NRT, counselling NRT, counselling
- Primary Outcome Measures
Name Time Method Continuous Abstinence Rate 4 week endpoint of treatment
- Secondary Outcome Measures
Name Time Method 7-day Point Prevalence Abstinence 6,8,12,16,24 week follow-up measure
Program participation rate 0,7,10,14,17 day, 3,4,6,8,12,16,24 week each treatment and follow-up
Withdrawal symptoms 1,2,3,4 week Prolonged Abstinence Rate 3,6 month follow-up measure
Tobacco craving 0,7,10,14,17 day, 3,4,6,8,12,16,24 week each treatment and follow-up
Amount of smoking 0,7,10,14,17 day, 3,4,6,8,12,16,24 week each treatment and follow-up
Exhaled Carbon monoxide monoxide 0,7,10,14,17 day, 3,4,6,8,12,16,24 week each treatment and follow-up
Quality of life 0,4 week beginning and endpoint of treatment
Nicotine dependence test (Fagerstrom test) 10, 17 day, 4week
Trial Locations
- Locations (1)
Dunsan Korean Medicine Hospital of Daejeon University
🇰🇷Daejeon, Korea, Republic of