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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04860271
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 13.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Procedure: Manual Acupuncture	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 9, 2021
• Actual Primary Completion Date: Apr 30, 2021
• Actual Study Completion Date: May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Manual Acupuncture; Manual acupuncture treatment using different types of needle
Active Comparator: 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.	Procedure: Manual Acupuncture; Manual acupuncture treatment using different types of needle

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Secondary Outcome Measures

1. Heart Rate Variability [two weeks]

   A measurement to know the balance of autonomic nerve system

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Hospital	Jakarta	Jakarta Pusat	Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

• Principal Investigator: Irma Nareswari, dr. Sp.Ak, Faculty of Medicine, University of Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Irma Nareswari, B.MedSc, Sp.Ak, Head of Medical Acupuncture Study Programme University of Indonesia, Indonesia University
• ClinicalTrials.gov Identifier: NCT04860271
• Other Study ID Numbers: 20-12-1513
• First Posted: Apr 26, 2021
• Last Update Posted: Mar 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Irma Nareswari, B.MedSc, Sp.Ak, Head of Medical Acupuncture Study Programme University of Indonesia, Indonesia University: acupuncture; press needle; anxiety
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Mar 8, 2022