Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes

August 6, 2021 updated by: Chang Gung Memorial Hospital

Immediate Effect of Non-invasive Auricular Acupoint Stimulation on the Performance and Meridian Activities of Archery Athletes- a Protocol for Randomized Controlled Trial

In our hypothesis, auricular acupoint stimulation might improve the attention and heart rate variability in archery athletes. The meridian activities regarding the attention and action in Chinese medicine systems might be influenced.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the execution of archery, attention is the key of performance in elite players, especially in the initial period.

Auricular acupoint stimulation is one of the therapeutic methods of traditional Chinese medicine. It is widely applied in various diseases. Researches had concluded the use of auricular acupoint stimulation on amplifying the anesthesia effect, weight reduction and the cessation of substance abuse. This study aimed to investigate the immediate effect of non-invasive auricular acupoint stimulation on the performance and the meridian activities of archery athletes.

The investigators will collect the meridian activities and balance index with Ryodoraku device, the continuous heart rate record and the scores of the two sections as the performance. The participants will rate their attention and fatigue levels through filling the self-reported questionnaires.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Department of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health volunteers, age between 13-26 years old
  • Received training of archery for more than one year

Exclusion Criteria:

  • History of psychiatric disorders
  • History of cardiovascular diseases
  • Previous operation history of dominant hand
  • Unwilling or unable to sign the informed consent of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ear-Acupressure Group
The subjects will receive true auricular acupoints stimulation with the attachment of Vaccaria seeds during the first round of play. After finishing the first round, the subjects will receive sham auricular acupoints stimulation.
Other: Auricular acupoints stimulation
Noninvasive auricular acupoints stimulation with seeds
Sham Comparator: Sham-Acupressure Group
The subjects will receive sham auricular acupoints stimulation with the attachment of Vaccaria seeds during the first round of play. After finishing the first round, the subjects will receive true auricular acupoints stimulation. (Crossover)
Other: Auricular acupoints stimulation
Noninvasive auricular acupoints stimulation with seeds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of meridian activities
Time Frame: Baseline, one hour, two hours
The meridian activities and balance index were measured and calculated with Ryodoraku device. (Meridian Energy Analysis Device, MEAD, medpex, Taiwan) The activity will be shown by numbers which were calculated by the skin electric resistance. The higher the number is, the higher meridian activity is presented.
Baseline, one hour, two hours
The change of heart rate variability
Time Frame: Two and half hours, keep recording during the whole process
Analyzed by continuous heart rate recording with heart rate monitor (Garmin, the U.S.)
Two and half hours, keep recording during the whole process
The change of Checklist Individual Strength, CIS
Time Frame: Baseline, one hour, two hours
The self-reported attention and fatigue questionnaire which is composed with 30 items. Each item ranks from zero to five. Higher scores indicated higher distraction and fatigue levels.
Baseline, one hour, two hours
The change of Visual Display Terminals visual syndrome, VDTs fatigue scale
Time Frame: Baseline, one hour, two hours
The self-reported attention and fatigue questionnaire which focus at visual syndrome. VDTs fatigue scale is been applied and standarized by Japanese Ministry of Health, Labor and Welfare survey results, 2004. VDTs fatigue scale is composed with 13 items. Each item ranks from zero to five. Higher scores indicated higher distraction and fatigue levels.
Baseline, one hour, two hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of motion stabilization
Time Frame: Two and half hours, keep recording during the whole process
Recorded and analyzed by the WIMU PRO (RealTrack Systems, Almería, Spain) The bluetooth data will be collected and analyzed to show the motion characteristics.
Two and half hours, keep recording during the whole process

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: CHUN EN KUO, MD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8J0941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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