Around the Turn: A Feasibility Cluster Randomized Controlled Trial of Using Auricular Acupressure to Abstain From Drug Abuse Through Training Nursing Students
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Screening rate
研究概览
简要总结
Drug abuse is a serious public health issue. Despite the serious consequences of drug abuse, there are around 2000 new cases reported by drug abusers each year. There is growing evidence of the use of auricular acupressure (AA), a traditional Chinese medicine (TCM) treatment modality, in reducing withdrawal symptoms among drug abusers. This study aims to investigate the feasibility and effectiveness of training nursing students to deliver brief education on AA on drug abusers.
详细描述
A 2-arm feasibility cluster RCT will be conducted in the 80 drug abusers from 7 substance abuse clinics in Hong Kong Hospital Authority following the CONSORT statement. The intervention group will receive AA intervention individually from trained nursing students. The control group will individually receive a 5-minute seminar delivered by a research assistant.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or above
- •Have reported to abuse drugs within the past 30 days
- •Can communicate in Cantonese and read Chinese
排除标准
- •Unstable mental conditions that are not suitable for the intervention
- •Receiving acupuncture or acupressure treatment currently or in the previous 30 days
结局指标
主要结局
Screening rate
时间窗: at the 6-month follow-up
calculated as the number of abusers screened at participated clinics divided by number of abusers at participated clinics during the recruitment period.
Randomization rate
时间窗: at the 6-month follow-up
calculated by dividing the number of abusers who are randomized into intervention and control groups by those who provide consent.
Attendance rate
时间窗: at the 6-month follow-up
calculated by dividing the number of abusers who complete the intervention by those who are randomized.
Complete rate
时间窗: at the 6-month follow-up
calculated by dividing the number of abusers who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.
Eligibility rate
时间窗: at the 6-month follow-up
calculated by dividing the number of abusers who are eligible by the number who are screened.
Consent rate
时间窗: at the 6-month follow-up
calculated by dividing the number of abusers who consent to join the study by the number who are eligible.
Retention rate
时间窗: at the 6-month follow-up
: calculated by dividing the number of abusers who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.
Adherence to intervention protocol
时间窗: at the 6-month follow-up
calculated by dividing the number of abusers who follow the intervention protocol by those who are randomized.
Adverse events
时间窗: at the 6-month follow-up
defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study.
Missing data
时间窗: at the 6-month follow-up
calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
次要结局
- Self-reported abstinence(at the 6-month follow-up)
- Abstinence with urine testing(at the 6-month follow-up)
- Self-reported levels of craving(at the 6-month follow-up)
- Quality of life measures by short-Form Six-Dimension(at the 6-month follow-up)
- Anxiety(at the 6-month follow-up)
研究者
Dr Katherine Lam
Research Assistant Professor
The Hong Kong Polytechnic University