Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers

Sponsor
Bui Pham Minh Man (Other)
Overall Status
Recruiting
CT.gov ID
NCT05586698
Collaborator
(none)
114
1
2
8.9
12.8

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Auricular acupressure
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
A single-blinded pilot studyA single-blinded pilot study
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Survey on Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers: a Pilot Study
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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.

Procedure: Auricular acupressure
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.

Experimental: Group B

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.

Procedure: Auricular acupressure
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.

Outcome Measures

Primary Outcome Measures

  1. Survey on heart rate variability during auricular acupressure at zero point on the left ear [During procedure]

  2. Survey on frequency-domain components LF (low-frequency range) and HF (high-frequency band) during auricular acupressure at zero point on the left ear [During procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City Ho Chi Minh City Vietnam

Sponsors and Collaborators

  • Bui Pham Minh Man

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bui Pham Minh Man, Medical Doctor, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier:
NCT05586698
Other Study ID Numbers:
  • 675/HDDD-DHYD
First Posted:
Oct 19, 2022
Last Update Posted:
Oct 19, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bui Pham Minh Man, Medical Doctor, University of Medicine and Pharmacy at Ho Chi Minh City

Study Results

No Results Posted as of Oct 19, 2022