NCT01389622Unknown2 期
Effect of Self-administered Auricular Acupressure on Smoking Cessation-a Pilot Study
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Spot 7-day cessation rate
研究概览
简要总结
Auricular acupressure has been practiced in China and Germany to help people in smoking cessation programs. The purpose of this clinical trial is to test for the clinical effectiveness of self-administered auricular acupressure as a non-invasive method for smoking cessation.
详细描述
Auricular acupressure has been practiced in China and Germany to help people in smoking cessation programs with varying degrees of success in different settings. The purpose of this clinical trial is to test for the clinical effectiveness of self-administered auricular acupressure as a non-invasive method for smoking cessation.
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
- 是
入选标准
- •Participants are included in the study if they satisfy the following criteria:
- •Male or female.
- •Between 18 and 75 years of age inclusive.
- •Able to provide informed consent to study.
- •History of tobacco cigarette smoking for at least 6 months.
- •Confirmed intention of smoking cessation with no more than 2 previous failed attempts in the last 3 year.
排除标准
- •Existing pharmacotherapy for smoking cessation.
- •History of major psychiatric disorder or chronic pain syndromes.
- •More than 2 failed attempts of smoking cessation in the previous 3 years.
- •History of other substance abuse.
- •History of atopy, or suspected/known allergy to plaster.
结局指标
主要结局
Spot 7-day cessation rate
时间窗: Weekly during the intervention period (weeks 1-6)
Efficacy of intervention for smoking cessation
次要结局
- End-expiratory carbon monoxide levels (CO)(Weekly during the intervention period (weeks 1-6) and week 13 and week 26)
- Adverse effects in terms of self-reported discomfort levels from auricular acupressure(Weekly during the intervention period (weeks 1-6))
- Stress level according to the Stress Check List (SCL)(Weekly during the intervention period (weeks 1-6) and week 13 and week 26)
- Continuous Cessation Rate (CAR)(Weekly during the intervention period (weeks 1-6) and week 13 and week 26)
- Nicotine withdrawal symptoms according to Minnesota Nicotine Withdrawal Scale (MNWS)(Weekly during the intervention period (weeks 1-6) and week 13 and week 26)
研究者
研究点 (2)
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