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Completed

NCT Number: NCT05586698

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ho Chi Minh City, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

    Time frame: During procedure

Sponsors and collaborators

Lead sponsor

Bui Pham Minh Man

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2022
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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