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临床试验/NCT02298127
NCT02298127Unknown不适用

Acceptability and Potential Efficacy of a Randomised, Double-blinded, Sham-controlled Trial of Auricular Acupressure for Smoking Cessation: A Pilot Study

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Withdrawal symptoms

研究概览

简要总结

The purpose of this study is to evaluate the potential efficacy of auricular acupressure to stimulate specific acupoints in enhancing smoking cessation by reducing nicotine withdrawal symptoms among attendees in primary healthcare settings.

详细描述

Uncontrolled trials indicated that auricular acupressure is an effective treatment for addictive behaviors such as smoking cessation. However, some methodological limitations can be identified among clinical trials in this area, and it is not clear whether it is more efficacious to use the commonly-used acupoints or other points that are specifically for reducing the withdrawal symptoms of nicotine. The study addresses the identified methodological shortcomings of the previous similar studies. It consists of a total of three intervention groups, which allows comparisons between the commonly-used acupoints of acupressure, acupoints specific to smoking cessation, and a sham-controlled intervention. The study does not only focus on the efficacy of smoking cessation but also assesses the mediate effect of auricular acupressure on nicotine withdrawal by questionnaire and biomarkers.

This is the first study of its kind to yield information on the acceptability and effectiveness of a safe, available auricular acupressure technique on smoking cessation in Hong Kong. The findings could provide further information for the development of future tobacco-control activities targeting smokers in a wider population who would like to use acupressure as a treatment option.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years and over
  • Currently smoking at least one cigarette per day in the past 30 days
  • Are Hong Kong residents
  • Able to communicate in Cantonese
  • Currently reside in Hong Kong and expect to continue to do so for the next 6 months
  • Have access to a telephone

排除标准

  • Currently undergoing other smoking cessation or similar programme
  • With a known history of allergy to adhesive tapes or history of current otitis externa or other ear disease

结局指标

主要结局

Withdrawal symptoms

时间窗: 1.25 month after the initial contact

Measured by two biomarkers for nicotine dependence: the gene expression level of nicotinic acetylcholine receptors (nAChRs) and dopamine level

7-day point prevalence by self report

时间窗: 1.25 month after the initial contact

7-day point prevalence by self report, validated by biochemical measures

时间窗: 6 month

Obtaining CO measurement and testing urinary cotinine for those participants who report quitting smoking

次要结局

  • Acceptability: Subjective data on acceptability of auricular acupressure for smoking cessation(1 month)
  • Feasibility outcome assessed in terms of participant recruitment, acupressure session attendance, retention, preference for using TCM for smoking cessation, perceived usefulness and confidence of quitting smoking by acupressure(6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Yim Wah Mak

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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