Effects of Auricular Acupressure and Group Therapy on Smoking Cessation Tobacco Withdrawal Symptoms, Depressive Symptoms, Resilience, and Serum Serotonin Level
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- serum cotinine levels:Change from 6-week serum cotinine levels at 6 months, 1 year, 2 years
研究概览
简要总结
Objective The purpose of this study is to examine the effects of auricular acupressure and group counseling with positive psychology and motivational interviewing on smoking cessation and tobacco withdrawal symptoms.
Methods This study is a single blind randomized controlled trial. This study has been performed at a University in South Korea. 180 smokers and 60 non-smokers will be recruited. Smokers will be randomly assigned to three groups: group 1 (auricular acupressure + group counseling); group 2 (placebo acupressure + group counseling); and the control group (self-help smoking cessation). Group counseling is undertaken once per week for 6 weeks. Auricular acupressure using acupellets is performed for 6 weeks continuously.
详细描述
- Introduction South Korea takes second place for its smoking rate among 22 member countries in the Organization for Economic Co-operation and Development (OECD). The smoking rate in the U.S. is 16.8% among adults aged 18 years or older, while the smoking rate in South Korea is 42.6%. Medical costs spent on diseases caused by smoking are estimated to be 1.53 billion dollars, accounting for 3.7% of all health insurance medical costs spent in 2012 in South Korea. In 2010, 54.9% of smokers tried to quit smoking. Concerns about health accounted for 67.7% of the motivation for smoking cessation. Compared to non-smoking men, male smokers have a 6.5, 4.6, and 3.6 fold increased risk of getting cancer of the larynx, lungs, and esophagus, respectively. Of smokers who tried to quit smoking, 84.7% did not have any assistance. Smokers reported that main reasons for failing smoking cessation were stress and withdrawal symptoms.
To increase the success rate in smoking cessation, stress management and reduction of withdrawal symptoms are very important. Many methods have been used to assist smoking cessation. These methods include cognitive behavioral therapy, antidepressants, nicotine patches, nicotine gum, positive psychology, motivational interviewing, acupuncture, and acupressure. Traditional psychiatric approaches focus on what is wrong, while positive psychology focuses on strength and values that empower individuals. Positive psychology deals with stress management using gratitude, love, forgiveness, and hope. Motivational interviewing is a "directive client-centered counseling approach for initiating behavior change by helping clients to resolve ambivalence". Acupuncture uses needles to stimulate acupuncture points, while acupressure uses fingers, hands, beads, or pellets to stimulate acupuncture points. Stimulation of acupuncture points reduces withdrawal symptoms by reducing desire or changing tastes. The mechanism of acupuncture on smoking cessation has not examined well. Cabioglu and his colleagues suggested that acupuncture may increase the levels of several neurotransmitters such as dopamine and serotonin.
There is no consistent evidence that acupuncture is effective for smoking cessation. Tahiri and his colleagues reported the smoking rate of acupuncture was 3%-55% at 6-month follow-ups based on 6 randomized controlled trials. Authors have suggested more randomized controlled studies are needed. A few studies have examined the effect of positive group psychotherapy on smoking cessation. In addition, only a few studies have examined the mechanism of acupressure on smoking cessation.
The purpose of this study was to examine the effects of auricular acupressure and group counseling with positive psychology and motivational interviewing on smoking cessation and reduction, tobacco withdrawal symptoms, depressive symptoms, and serum serotonin levels. 2. Methods 2.1. Design and setting The design of this study is a single blind randomized controlled trial. This study will be conducted at a University in South Korea from July 2013 to July 2017.
2.2. Sample selection Smokers will be recruited by internet advertisement or face-to-face contacts. All smokers were informed about the study protocol, benefits and side effects of interventions, and the right to withdraw from the study at any time without penalty. Smokers who agree to participate in this study signed consent forms before data collection. Ethical approval was obtained from the institutional review board in Incheon, South Korea.
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
- Double (Participant, Investigator)
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
- •smokers who:
- •were more than 19 years
- •could complete questionnaires
- •have smoked longer than 6 months
- •wanted to quit smoking cigarettes
- •did not have an infection on the surface of the ears.
排除标准
- •smokers who
- •were using nicotine patches or medications for smoking cessation
- •had allergies to copper or aluminum
- •had used illegal drugs
- •were pregnant.
结局指标
主要结局
serum cotinine levels:Change from 6-week serum cotinine levels at 6 months, 1 year, 2 years
时间窗: 6 weeks, 6 months, 1 year, 2 years
Serum cotinine levels reflect recent exposure to nicotine in tobacco smoke. Nonsmoking is usually defined as a serum cotinine level of less than or equal to 10 ng/mL (Pirkle et al., 1996).
smoking cessation: Change from Baseline Smoking status at 3,6 months, 1 year, 2 years
时间窗: baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years
self-report
urine cotinine test:Change from 6-week urine cotinine at 6 months, 1 year, 2 years
时间窗: 6 weeks, 6 months, 1 year, 2 years
Cotinine is the first-stage metabolite of nicotine. The urine cotinine test using a fresh urine specimen was used to check smoking cessation. There was neither any benefit for smoking cessation in this study nor any legal problem to smoking cigarettes in South Korea. Therefore, participants were allowed to provide urine specimens without close monitoring. The urine cotinine test is a rapid, one-step, immunochromatographic assay for the qualitative detection of cotinine in human urine at 200 ng/ml cut-off concentration. Three drops of urine were transferred to the urine cotinine test apparatus (Brand name: Lungene one step rapid test, Company: Hangzhou Clongene Biotech Co., Ltd, made in China). Two lines indicated a negative result, while one line indicated a positive result. For participants who did not smoke for at least one week, negative test results were expected. Urine cotinine was checked at the 6-week post-test and 6-month follow-up.
Minnesota Tobacco Withdrawal Scale(MTWS):Change from Baseline tobacco withdrawal symptoms at 2,3,4,5,6 weeks
时间窗: baseline,2,3,4,5,6 weeks
The MTWS was developed to measure nicotine withdrawal symptoms \[22\]. The MTWS consists of nine items with a 4-point Likert scale. Higher scores indicate more severe withdrawal symptoms. Cronbach's alpha was .88 in 118 Korean Americans. Factor analysis showed two factors: mental difficulties and physical difficulties. These two factors explained 66% of the variance
multidimensional coping scale: Change from Baseline coping skills at 6 weeks, 6 months, 1 year, 2 years
时间窗: baseline, 6 weeks, 6 months, 1 year, 2 years
The multidimensional coping scale was developed by Jeon, KG(1994). It consists 50 items including personal, social, and religious coping. The multidimensional coping scale is composed of personal, social, and religious coping resources: (Personal Coping Resources), active coping, passive withdrawal, emotional expression, active forgetting, perseverance, positive interpretation, positive comparison, accommodation, fatalism, self-criticism, emotional pacification; (Social Coping Resources), problem-solving social support seeking, emotional social support seeking; (Religious Coping Resources), religious seeking.
次要结局
- Patient Health Questionnaire-9(6 weeks, 6 months, 1 year, 2 years)
- Resilience(6 weeks, 6 months, 1 year, 2 years)
- Eysenck Personality Inventory(baseline)
- Serum serotonin(6 weeks, 6 months, 1 year, 2 years)
研究者
EUN JIN LEE
Associate professor
Inha University Hospital
