Manual Acupuncture Using Acupuncture Needle vs Press Needle for COVID-19 Healthcare Anxiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Anxiety

Intervention / Treatment
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* Procedure: Manual Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filiform Needle<br>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. | Procedure: Manual Acupuncture<br>* Manual acupuncture treatment using different types of needle<br>|
| Active Comparator: Press Needle<br>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. | Procedure: Manual Acupuncture<br>* Manual acupuncture treatment using different types of needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Scale | 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 | two weeks | 
| Short-Form 36 | A questionnaire to access quality of life, higher score means better quality of life. ranged 1-100. higher scores means better quality of life | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability | A measurement to know the balance of autonomic nerve system | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, press needle, anxiety