AnxietyNCT04860271
Manual Acupuncture Using Acupuncture Needle vs Press Needle for COVID-19 Healthcare Anxiety
A study testing Manual Acupuncture in people with Anxiety, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Manual Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 9 Mar 2021to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Manual Acupuncture
- Keywords
- acupuncture, press needle, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual AcupunctureProcedure or surgery
Manual acupuncture treatment using different types of needle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Manual Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: two weeks
Secondary outcomes (1)
Heart Rate Variability
A measurement to know the balance of autonomic nerve system
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start9 Mar 2021
- Primary completion30 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Irma Nareswari, B.MedSc, Sp.Ak, Universitas Indonesia
- Investigators
- Irma Nareswari, dr. Sp.Ak, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860271
- Sponsor's protocol ID
- 20-12-1513
- Status last verified
- Feb 2022
- First submitted
- 23 Apr 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04860271
- Acronym / sponsor ID
- 20-12-1513
- Conditions
- Anxiety
- Keywords
- acupuncture, press needle, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filiform Needle | Active comparator | Procedure: Manual AcupunctureRespondent 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. |
| Press Needle | Active comparator | Procedure: Manual AcupunctureRespondent 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual AcupunctureManual acupuncture treatment using different types of needle | Procedure or surgery | Filiform Needle, Press Needle |
Primary outcome
Hamilton Anxiety Scale
Time frame: 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
Short-Form 36
Time frame: 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
1 secondary outcome
Heart Rate Variability
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irma Nareswari, dr. Sp.Ak principal investigator
Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Acupuncture in people with Anxiety, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Scale (time frame: two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.