Healthy VolunteersNCT05586698
Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers
A study testing Auricular acupressure in people with Healthy Volunteers, run by Bui Pham Minh Man at 1 site in Vietnam.
Trial summary
Heart rate variability (HRV) is used to noninvasively assess the activity of the autonomic nervous system, in particular, its parts help to evaluate the cardiac sympathetic and parasympathetic activities. Increasing HRV may contribute to improving autonomic nervous system dysfunctions. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Auricular acupressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2022to 30 Jun 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females were individuals aged between 20-29.
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
- Vital signs within normal range:
- Pulse, and regularly heart rate, go together.
- Resting heart rate: 60 - 100 beats/min.
- Resting blood pressure: 90/60 mmHg to ≤ 140/90 mmHg.
Show all 14Show fewer
- Breathing rate: 16 ± 3 times/minute.
- emperature: 36.6-37.50C.
- SpO2 ≥ 95%.
- Body mass index (BMI): 18.5 - 23 kg/m2 .
- Had no history of cardiovascular disease, diabetes, or thyroid.
- Had no psychiatric stress problem during acupuncture day (confirmed by answering the DASS 21 questionnaire with stress points less than 15 points).
- Not currently participating in other intervention studies.
- Have no acupuncture experience yet.
Who cannot join
- Used stimulants such as beer, alcohol, coffee, and tobacco within 24 hours before conducting the study.
- Played sports 2 hours before the study.
- Had skin injuries in the area of auricular acupressure.
- Women during menstruation period, pregnancy, or breastfeeding.
- People using drugs affecting blood pressure and heart rate within 1 month.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City
About this study
Official title: Survey on Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers: a Pilot Study
Heart rate variability (HRV) is used to noninvasively assess the activity of the autonomic nervous system, in particular, its parts help to evaluate the cardiac sympathetic and parasympathetic activities. Increasing HRV may contribute to improving autonomic nervous system dysfunctions. In traditional medicine, acupuncture in the region of the vagus nerve distribution in the ear could increase parasympathetic activity and cause changes in HRV. Zero point located on the vagus nerve distribution is scientifically proven to enhance parasympathetic activity, however, the number of studies examining the effect of auricular acupressure at zero point on HRV is limited while this method is highly effective and convenient. In our study, we want to survey heart rate variability during auricular acupressure at Zero point on the left ear in healthy volunteers.
Read the detailed description
Participants and Methods: A randomized controlled trial is conducted by comparing the changes in HRV and elements of HRV during the auricular acupressure process at zero point on the left ear in healthy volunteers. A total of 114 participants were randomly assigned to 2 groups by computer GraphPad software and the allocation was 1:1. Participants in the experimental group received auricular acupressure at the left zero point, while the control group received placebo auricular acupressure by removing the ear seed but keeping the sticker attached in the left zero point. The primary outcome was the change in heart rate variability during auricular acupressure at zero point on the left ear. This trial will be performed as randomized, controlled, and single- blinded.
- Conditions
- Healthy Volunteers
- Being tested
- Auricular acupressure
- Keywords
- Auricular Acupressure, Zero point
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressureProcedure or surgery
We conducted auricular acupressure at zero acupoints on the left ear with Vaccaria ear seed (Group A) or removed seed (Group B) in 20 minutes, with 2 times of auricular acupressure. The stimulation was performed for 30 seconds each time, with two pressure movements per second, resulting in a total of 60 pressure movements per stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 57 participant received auricular acupressure at Zero point on the left ear. Heart rate, HRV, and elements of HRV will be recorded every 5 minutes. Receives: Procedure: Auricular acupressure |
| Group B | Experimental | 57 participant received sham acupressure at Zero point on the left ear. Heart rate, HRV, and elements of HRV will be recorded every 5 minutes. Receives: Procedure: Auricular acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey on heart rate variability during auricular acupressure at zero point on the left ear
Measured: During procedure
Survey on frequency-domain components LF (low-frequency range) and HF (high-frequency band) during auricular acupressure at zero point on the left ear
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A single-blinded pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bui Pham Minh Man
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586698
- Sponsor's protocol ID
- 675/HDDD-DHYD
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic characteristic and outcome data will be shared
Publications
Trinh DT, Nguyen NC, Tran AH, Bui MP, Vuong NL. Enhancing Vagal Tone, Modulating Heart Rate Variability with Auricular Acupressure at Point Zero: A Randomized Controlled Trial. Med Acupunct. 2024 Aug 21;36(4):203-214. doi: 10.1089/acu.2024.0001. eCollection 2024 Aug.
PubMed 39309627
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers: a Pilot Study
- ClinicalTrials.gov ID
- NCT05586698
- Acronym / sponsor ID
- 675/HDDD-DHYD
- Conditions
- Healthy Volunteers
- Keywords
- Auricular Acupressure, Zero point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Bui Pham Minh ManUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Oct 2022 (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.
Heart rate variability (HRV) is used to noninvasively assess the activity of the autonomic nervous system, in particular, its parts help to evaluate the cardiac sympathetic and parasympathetic activities. Increasing HRV may contribute to improving autonomic nervous system dysfunctions. In traditional medicine, acupuncture in the region of the vagus nerve distribution in the ear could increase parasympathetic activity and cause changes in HRV. Zero point located on the vagus nerve distribution is scientifically proven to enhance parasympathetic activity, however, the number of studies examining the effect of auricular acupressure at zero point on HRV is limited while this method is highly effective and convenient. In our study, we want to survey heart rate variability during auricular acupressure at Zero point on the left ear in healthy volunteers.
Detailed description
Participants and Methods: A randomized controlled trial is conducted by comparing the changes in HRV and elements of HRV during the auricular acupressure process at zero point on the left ear in healthy volunteers. A total of 114 participants were randomly assigned to 2 groups by computer GraphPad software and the allocation was 1:1. Participants in the experimental group received auricular acupressure at the left zero point, while the control group received placebo auricular acupressure by removing the ear seed but keeping the sticker attached in the left zero point. The primary outcome was the change in heart rate variability during auricular acupressure at zero point on the left ear. This trial will be performed as randomized, controlled, and single- blinded.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-blinded pilot study
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Auricular acupressure57 participant received auricular acupressure at Zero point on the left ear. Heart rate, HRV, and elements of HRV will be recorded every 5 minutes. |
| Group B | Experimental | Procedure: Auricular acupressure57 participant received sham acupressure at Zero point on the left ear. Heart rate, HRV, and elements of HRV will be recorded every 5 minutes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy males and females were individuals aged between 20-29.
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
- Vital signs within normal range:
- Body mass index (BMI): 18.5 - 23 kg/m2 .
- Had no history of cardiovascular disease, diabetes, or thyroid.
Key exclusion criteria (5 listed)
- Used stimulants such as beer, alcohol, coffee, and tobacco within 24 hours before conducting the study.
- Played sports 2 hours before the study.
- Had skin injuries in the area of auricular acupressure.
- Women during menstruation period, pregnancy, or breastfeeding.
- People using drugs affecting blood pressure and heart rate within 1 month.
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 |
|---|---|---|
| Auricular acupressureWe conducted auricular acupressure at zero acupoints on the left ear with Vaccaria ear seed (Group A) or removed seed (Group B) in 20 minutes, with 2 times of auricular acupressure. The stimulation was performed for 30 seconds each time, with two pressure movements per second, resulting in a total of 60 pressure movements per stimulation. | Procedure or surgery | Group A, Group B |
Primary outcome
Survey on heart rate variability during auricular acupressure at zero point on the left ear
Time frame: During procedure
Survey on frequency-domain components LF (low-frequency range) and HF (high-frequency band) during auricular acupressure at zero point on the left ear
Time frame: During procedure
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 23 Oct 2023.
- Derived from this study: PubMed 39309627Trinh DT, Nguyen NC, Tran AH, Bui MP, Vuong NL. Enhancing Vagal Tone, Modulating Heart Rate Variability with Auricular Acupressure at Point Zero: A Randomized Controlled Trial. Med Acupunct. 2024 Aug 21;36(4):203-214. doi: 10.1089/acu.2024.0001. eCollection 2024 Aug.
- Round R, Litscher G, Bahr F. Auricular acupuncture with laser. Evidence-Based Complementary and Alternative Medicine 2013;2013.Link provided by the sponsor.
- Rajendra Acharya U, Paul Joseph K, Kannathal N, Lim CM, Suri JS. Heart rate variability: a review. Medical \& Biological Engineering \& Computing. 2006;44(12):1031-1051.Link provided by the sponsor.
- Trinh D-TT, Nguyen Q-CT, Bui M-MP, Nguyen V-D, Thai K-M. Heart Rate Variability during Auricular Acupressure at Heart Point in Healthy Volunteers: A Pilot Study. Evidence-Based Complementary Alternative Medicine. 2022;2022.Link provided by the sponsor.
- Arai Y-CP, Sakakima Y, Kawanishi J, et al. Auricular acupuncture at the "shenmen" and "point zero" points induced parasympathetic activation. Evidence-Based Complementary Alternative Medicine,. 2013;2013.Link provided by the sponsor.
- He W, Wang X, Shi H, et al. Auricular acupuncture and vagal regulation. Evidence-Based Complementary Alternative Medicine. 2012;2012.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Demographic characteristic and outcome data will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupressure in people with Healthy Volunteers, run by Bui Pham Minh Man at 1 site in Vietnam.
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 14 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 23 Oct 2023. 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 Vietnam. 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?
Survey on heart rate variability during auricular acupressure at zero point on the left ear (time frame: During procedure). 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?
On the ClinicalTrials.gov record for NCT05586698, which also lists 1 linked publication.
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 23 Oct 2023.