The Efficacy of Auricular Acupressure Combined With Nicotine Replacement Therapy on Nicotine Craving, Withdrawal Symptoms and Anxiety Levels in Psychiatric Inpatients: A Pilot Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Chiao-Chiao Liao
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Craving scale
概览
简要总结
The goal of this clinical trial is to evaluate the feasibility and preliminary effectiveness of auricular acupressure (ear seeds) combined with nicotine replacement therapy (NRT) in psychiatric inpatients (both male and female, aged 18-65) who are forced to abstain from smoking due to the smoke-free environment of the inpatient ward. The main questions it aims to answer are:
- Does auricular acupressure significantly reduce the severity of nicotine withdrawal symptoms compared to standard care?
- Can auricular acupressure effectively lower nicotine craving and anxiety levels in patients during their mandatory abstinence? Researchers will compare the experimental group (NRT plus active auricular acupressure) to a control group (NRT plus sham auricular acupressure) to see if the addition of ear point stimulation provides better relief for withdrawal distress.
Participants will:
- Receive standard nicotine replacement therapy (NRT) as prescribed by their physician.
- Be randomly assigned to receive either Vaccaria segetalis seeds or sham materials on specific ear acupuncture points.
- Be instructed to press the beads 3 times daily to stimulate the points for a period of 4 weeks.
- Complete standardized assessments (MNWS, HAMA, and craving scales) at baseline and multiple time points during the intervention.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Psychiatric inpatients aged 18 to 65 years.
- •Diagnosed with a mental disorder according to ICD-10-CM criteria.
- •History of daily smoking within the past six months (Fagerström Test for Nicotine Dependence \[FTND\] score ≥ 2).
- •Experiencing nicotine withdrawal symptoms due to mandatory smoking cessation upon admission (Minnesota Tobacco Withdrawal Scale \[MNWS\] baseline score ≥ 5).
- •Agree to and comply with the standard-of-care Nicotine Replacement Therapy (NRT) provided by the hospital.
- •Capable of understanding the study procedures and providing written informed consent
排除标准
- •Presence of severe skin infection, open wounds, or lesions on the auricle (outer ear).
- •Severe coagulation disorders or currently taking high-dose anticoagulants (due to potential risk of bleeding or irritation).
- •Pregnant or breastfeeding women.
- •Significant language barriers or cognitive impairment that prevents completion of assessment scales or adherence to study protocols.
- •History of receiving auricular therapy for smoking cessation within the past three months.
研究组 & 干预措施
Auricular Acupressure Group
Participants in this group will receive standard Nicotine Replacement Therapy (NRT) combined with active auricular acupressure. Vaccaria seeds will be applied to specific acupuncture points (e.g., Shenmen, Lung, Subcortex).
干预措施: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) (Drug)
Sham Auricular Acupressure Group
Participants in this group will receive standard Nicotine Replacement Therapy (NRT) combined with sham auricular acupressure. Sham material with no active stimulation will be applied to specific acupuncture points.
干预措施: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) (Drug)
Sham Auricular Acupressure Group
Participants in this group will receive standard Nicotine Replacement Therapy (NRT) combined with sham auricular acupressure. Sham material with no active stimulation will be applied to specific acupuncture points.
干预措施: Sham Auricular Acupressure (Device)
Auricular Acupressure Group
Participants in this group will receive standard Nicotine Replacement Therapy (NRT) combined with active auricular acupressure. Vaccaria seeds will be applied to specific acupuncture points (e.g., Shenmen, Lung, Subcortex).
干预措施: Auricular acupressure (Device)
结局指标
主要结局
Craving scale
时间窗: Baseline, Day 14, Day 28
A 100-mm Visual Analogue Scale (VAS) used to measure the participant's subjective "urge to smoke" at the moment of evaluation. The scale ranges from 1 (no craving at all) to 100 (extreme craving). Participants mark a number on the line that represents their current craving level.
Minnesota Tobacco Withdrawal Scale (MNWS) Total Score
时间窗: Baseline, Day 14, Day 28
次要结局
- Hamilton Anxiety Rating Scale (HAMA) Total Score(Baseline, Day 14, and Day 28)
- Minnesota Nicotine Withdrawal Scale (MNWS) Total Score(Baseline, Day 14, and Day 28)
- Autonomic Nervous System Function as Measured by Heart Rate Variability(Baseline, Day28)
研究者
Chiao-Chiao Liao
Resident Physician and Principal Investigator
TsaoTun Psychiatric Center, Department of Health, Taiwan