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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    114
  • sponsor
    Bui Pham Minh Man
Updated on 23 October 2022
Accepts healthy volunteers

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.

Details
Condition Healthy Volunteers
Treatment Auricular acupressure
Clinical Study IdentifierNCT05586698
SponsorBui Pham Minh Man
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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