Clinical trial NCT05586698: Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers
Official title: Survey on Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Auricular Acupressure
Zero point
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A single-blinded pilot study
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survey on heart rate variability during auricular acupressure at zero point on the left ear
timeFrame: During procedure
measure: Survey on frequency-domain components LF (low-frequency range) and HF (high-frequency band) during auricular acupressure at zero point on the left ear
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
Study officials:
References: