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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Procedure: Manual Acupuncture

• Registration Number: NCT04860271
• Lead Sponsor: Indonesia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-03-09
• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-26
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-20
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Press Needle	Manual Acupuncture	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.
Filiform Needle	Manual Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Short-Form 36	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	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

Secondary Outcome Measures

Name	Time	Method
Heart Rate Variability	two weeks	A measurement to know the balance of autonomic nerve system

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, Jakarta Pusat, Indonesia