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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04860271
• Other study ID #: 20-12-1513
• Status: Completed
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: February 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Procedure:
• Manual Acupuncture
Manual acupuncture treatment using different types of needle

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Heart Rate Variability	A measurement to know the balance of autonomic nerve system	two weeks