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

Healthy Volunteers Clinical Trial

Official title:

Survey on Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586698
• Other study ID #: 675/HDDD-DHYD
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Vietnam	Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Bui Pham Minh Man

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survey on heart rate variability during auricular acupressure at zero point on the left ear		During procedure
Primary	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

External Links

•   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.
•   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.
•   Round R, Litscher G, Bahr F. Auricular acupuncture with laser. Evidence-Based Complementary and Alternative Medicine 2013;2013.
•   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.