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

NCT05586698 | Completed

• 1 other identifier: 675/HDDD-DHYD
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Auricular Acupressure; Zero point

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Procedure: Auricular acupressure

Interventions

Auricular acupressure PROCEDURE

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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bui Pham Minh Man: lead

Study Sites (1)

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

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 39309627 DERIVED

Related 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Model Details: A single-blinded pilot study

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 19, 2022
• Study Start: October 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

VN (1)