NCT04860271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

April 23, 2021

Last Update Submit

February 20, 2022

Conditions

Anxiety

Keywords

acupuncturepress needleanxiety

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Heart Rate Variability

    two weeks

Study Arms (2)

Filiform Needle

ACTIVE COMPARATOR

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

Press Needle

ACTIVE COMPARATOR

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

Interventions

Manual AcupuncturePROCEDURE

Manual acupuncture treatment using different types of needle

Filiform NeedlePress Needle

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, Jakarta Pusat, 10430, Indonesia

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Irma Nareswari, dr. Sp.Ak

    Faculty of Medicine, University of Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medical Acupuncture Study Programme University of Indonesia

Study Record Dates

First Submitted

April 23, 2021

First Posted

April 26, 2021

Study Start

March 9, 2021

Primary Completion

April 30, 2021

Study Completion

May 31, 2021

Last Updated

March 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)