Comparison of Manual Acupuncture Effectivity Using Filiform Needles and Press Tack Needle for Healthcare Worker's Anxiety During COVID-19 Outbreak: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Short-Form 36
研究概览
简要总结
This study would like to compare manual acupunture treatment for anxiety in COVID Health workers population in Cipto Mangunkusumo Hospital using filiform needles and press needle.
详细描述
This study wanted to know would press needle be having better outcome for anxiety treatment, compared with filiform needles, because press needle taken home and could be manipulated as needed at home, unlike filiform needle where an acupuncturist must be available to do the treatment. Furthermore, the press needle needed to be changed once within 5 days, that is 2-3 times in week. So we hope to have better acupuncture option (in effectivity and timewise) for COVID healthcare workers anxiety treatment. There are no study to compare the usage of the two types of needles for anxiety treatment to date.
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 (Investigator, Outcomes Assessor)
盲法说明
Investigator did not know the respondent and did not come in contact. The outcome assessor consist of 4 person who are randomly assessing the respondent, so the assessor do not know the full data since the beginning of participation thus do not have any bias when assessing the respondent
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COVID-19 health workers.
- •Rapid test COVID-19 t or PCR swab non reactive within 7 days before intervention
- •HAM-A score below 25
- •Could still do daily activities
- •Willing to enroll this study and sign the informed consent
- •Willing to comply with the study procedure
排除标准
- •Contraindicated for acupuncture : having medical emergencies, pregnancy, blood clotting issue, uncontrolled diabetic mellitus, fever.
- •Having acupunture treatment within 7 days prior to study intervention
- •Having tumor or infection at the pucture site
- •Cognitive or consciouseness impairment
- •Having anxiety therapy with a psychiatrist
研究组 & 干预措施
Filiform Needle
Respondent are health workers that is having mild to moderate anxiety symptoms, with Hamilton Anxiety Scale less than 25. This arm will receive 6 acupuncture treatment within 2 weeks, and will be taken outcome measurements 4 times, that is before the first treatment, after the third treatment, after the sixth treatment and at 2 weeks after the sixth treatment.
干预措施: Manual Acupuncture (Procedure)
Press Needle
Respondent are health workers that is having mild to moderate anxiety symptoms, with Hamilton Anxiety Scale less than 25. This arm will receive 3 acupuncture treatment within 2 weeks, and will be taken outcome measurements 4 times, that is before the first needle placement, after replacing the first sets of needles, after removing the third sets of needles and at 2 weeks after removing the third sets of needle.
干预措施: Manual Acupuncture (Procedure)
结局指标
主要结局
Short-Form 36
时间窗: two weeks
A questionnaire to access quality of life, higher score means better quality of life. ranged 1-100. higher scores means better quality of life
Hamilton Anxiety Scale
时间窗: two weeks
A questionnaire to access anxiety level, higher score means higher anxiety symptoms, ranged 0-56, mild anxiety scored below 17, 17-24 moderate anxiety, more than 24 severe anxiety
次要结局
- Heart Rate Variability(two weeks)
研究者
Dr. Irma Nareswari, B.MedSc, Sp.Ak
Head of Medical Acupuncture Study Programme University of Indonesia
Indonesia University