Back to resultsManual Acupuncture Using Acupuncture Needle vs Press Needle for COVID-19 Healthcare Anxiety
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Manual Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring acupuncture, press needle, anxiety
Eligibility Criteria
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
Sites / Locations
- Cipto Mangunkusumo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Filiform Needle
Press Needle
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Heart Rate Variability
A measurement to know the balance of autonomic nerve system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04860271
Brief Title
Manual Acupuncture Using Acupuncture Needle vs Press Needle for COVID-19 Healthcare Anxiety
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
acupuncture, press needle, anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Filiform Needle
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Press Needle
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Manual Acupuncture
Intervention Description
Manual acupuncture treatment using different types of needle
Primary Outcome Measure Information:
Title
Hamilton Anxiety Scale
Description
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
Time Frame
two weeks
Title
Short-Form 36
Description
A questionnaire to access quality of life, higher score means better quality of life. ranged 1-100. higher scores means better quality of life
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Heart Rate Variability
Description
A measurement to know the balance of autonomic nerve system
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irma Nareswari, dr. Sp.Ak
Organizational Affiliation
Faculty of Medicine, University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta
State/Province
Jakarta Pusat
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Manual Acupuncture Using Acupuncture Needle vs Press Needle for COVID-19 Healthcare Anxiety
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