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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Procedure: Auricular acupressure

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survey on heart rate variability during auricular acupressure at zero point on the left ear	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	During procedure

Collaborators and Investigators

• Sponsor: Bui Pham Minh Man

Publications and helpful links

Helpful Links

• Round R, Litscher G, Bahr F. Auricular acupuncture with laser. Evidence-Based Complementary and Alternative Medicine 2013;2013.
• 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.
• 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.
• 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.
• He W, Wang X, Shi H, et al. Auricular acupuncture and vagal regulation. Evidence-Based Complementary Alternative Medicine. 2012;2012.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Auricular Acupressure; Zero point
• Other Study ID Numbers: 675/HDDD-DHYD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic characteristic and outcome data will be shared
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No