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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04637607
Other study ID # CMRPG8J0941
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2019
Est. completion date December 31, 2020

Study information

Verified date November 2020
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 26 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Auricular acupoints stimulation
Noninvasive auricular acupoints stimulation with seeds

Locations

Country Name City State
Taiwan Department of Chinese Medicine Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, one hour, two hours
Primary The change of heart rate variability Analyzed by continuous heart rate recording with heart rate monitor (Garmin, the U.S.) Two and half hours, keep recording during the whole process
Primary 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. Baseline, one hour, two hours
Primary 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. Baseline, one hour, two hours
Secondary 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. Two and half hours, keep recording during the whole process
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