Stress, PhysiologicalNCT04637607
Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes
A study testing Auricular acupoints stimulation in people with Stress, Physiological and Sport Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 13 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological, Sport Injury
- What is being tested?
- Auricular acupoints stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Oct 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Health volunteers, age between 13-26 years old
- Received training of archery for more than one year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stress, Physiological, Sport Injury
- Being tested
- Auricular acupoints stimulation
- Keywords
- archery, Ryodoraku, heart rate variability, auricular acupoint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupoints stimulationOther
Noninvasive auricular acupoints stimulation with seeds
| Study group | Role | What they receive |
|---|---|---|
| Ear-Acupressure Group | Experimental | 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. Receives: Other: Auricular acupoints stimulation |
| Sham-Acupressure Group | Sham comparator | 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) Receives: Other: Auricular acupoints stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, one hour, two hours
The change of heart rate variability
Analyzed by continuous heart rate recording with heart rate monitor (Garmin, the U.S.)
Measured: Two and half hours, keep recording during the whole process
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.
Measured: Baseline, one hour, two hours
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.
Measured: Baseline, one hour, two hours
Secondary outcomes (1)
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.
Measured: Two and half hours, keep recording during the whole process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start22 Oct 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study recruited the archery players in school teams among junior high, senior high schools, and colleges.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHUN EN KUO, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637607
- Sponsor's protocol ID
- CMRPG8J0941
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3685234Carrillo 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.
PubMed 21547837Tsai 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.
PubMed 33663090
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04637607
- Acronym / sponsor ID
- CMRPG8J0941
- Conditions
- Stress, Physiological, Sport Injury
- Keywords
- archery, Ryodoraku, heart rate variability, auricular acupoint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study recruited the archery players in school teams among junior high, senior high schools, and colleges.
| Arm | Type | Receives |
|---|---|---|
| Ear-Acupressure Group | Experimental | Other: Auricular acupoints stimulationThe 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. |
| Sham-Acupressure Group | Sham comparator | Other: Auricular acupoints stimulationThe 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) |
Who may qualify
- Ages
- 13 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Health volunteers, age between 13-26 years old
- Received training of archery for more than one year
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupoints stimulationNoninvasive auricular acupoints stimulation with seeds | Other | Ear-Acupressure Group, Sham-Acupressure Group |
Primary outcome
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.
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.)
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.
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.
1 secondary outcome
The change of motion stabilization
Time frame: Two and half hours, keep recording during the whole process
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Results publication: PubMed 3685234Hatfield 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 publication: PubMed 21547837Carrillo 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.
- Derived from this study: PubMed 33663090Tsai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHUN EN KUO, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupoints stimulation in people with Stress, Physiological and Sport Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of meridian activities (time frame: Baseline, one hour, two hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637607, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.