Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes
Primary Purpose
Stress, Physiological, Sport Injury
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Auricular acupoints stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Physiological focused on measuring archery, Ryodoraku, heart rate variability, auricular acupoint
Eligibility Criteria
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
Sites / Locations
- Department of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Ear-Acupressure Group
Sham-Acupressure Group
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
The change of meridian activities
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.
The change of heart rate variability
Analyzed by continuous heart rate recording with heart rate monitor (Garmin, the U.S.)
The change of Checklist Individual Strength, CIS
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.
The change of Visual Display Terminals visual syndrome, VDTs fatigue scale
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.
Secondary Outcome Measures
The change of motion stabilization
Recorded and analyzed by the WIMU PRO (RealTrack Systems, Almería, Spain) The bluetooth data will be collected and analyzed to show the motion characteristics.
Full Information
NCT ID
NCT04637607
First Posted
November 4, 2020
Last Updated
August 6, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04637607
Brief Title
Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes
Official Title
Immediate Effect of Non-invasive Auricular Acupoint Stimulation on the Performance and Meridian Activities of Archery Athletes- a Protocol for Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Physiological, Sport Injury
Keywords
archery, Ryodoraku, heart rate variability, auricular acupoint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study recruited the archery players in school teams among junior high, senior high schools, and colleges.
Masking
ParticipantOutcomes Assessor
Masking Description
The participants were randomly assigned to the treatment group and the control group. The Ear-Acupressure group received the seeds attached by 3M tap to the auricular acupoints. The Sham-Acupressure group received sham acupoint stimulation, on the same points, but only with 3M tap. The procedure was then switched to perform cross-over study design.
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ear-Acupressure Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-Acupressure Group
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Auricular acupoints stimulation
Intervention Description
Noninvasive auricular acupoints stimulation with seeds
Primary Outcome Measure Information:
Title
The change of meridian activities
Description
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.
Time Frame
Baseline, one hour, two hours
Title
The change of heart rate variability
Description
Analyzed by continuous heart rate recording with heart rate monitor (Garmin, the U.S.)
Time Frame
Two and half hours, keep recording during the whole process
Title
The change of Checklist Individual Strength, CIS
Description
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.
Time Frame
Baseline, one hour, two hours
Title
The change of Visual Display Terminals visual syndrome, VDTs fatigue scale
Description
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.
Time Frame
Baseline, one hour, two hours
Secondary Outcome Measure Information:
Title
The change of motion stabilization
Description
Recorded and analyzed by the WIMU PRO (RealTrack Systems, Almería, Spain) The bluetooth data will be collected and analyzed to show the motion characteristics.
Time Frame
Two and half hours, keep recording during the whole process
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHUN EN KUO, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Chinese Medicine
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
3685234
Citation
Hatfield BD, Landers DM, Ray WJ. Cardiovascular-CNS interactions during a self-paced, intentional attentive state: elite marksmanship performance. Psychophysiology. 1987 Sep;24(5):542-9. doi: 10.1111/j.1469-8986.1987.tb00335.x. No abstract available.
Results Reference
result
PubMed Identifier
21547837
Citation
Carrillo AE, Christodoulou VX, Koutedakis Y, Flouris AD. Autonomic nervous system modulation during an archery competition in novice and experienced adolescent archers. J Sports Sci. 2011 Jun;29(9):913-7. doi: 10.1080/02640414.2011.568514.
Results Reference
result
PubMed Identifier
33663090
Citation
Tsai YH, Wu SY, Hu WL, Lai YR, Tsao Y, Yen KT, Lin CH, Kuo CA. Immediate effect of non-invasive auricular acupoint stimulation on the performance and meridian activities of archery athletes: A protocol for randomized controlled trial. Medicine (Baltimore). 2021 Feb 26;100(8):e24753. doi: 10.1097/MD.0000000000024753.
Results Reference
derived
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Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes
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