UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049585 |
|---|---|
| Receipt number | R000056477 |
| Scientific Title | Analysis the relation of acupuncture effects between respiration and heart rate variability in healthy men ; A randomized controlled trial |
| Date of disclosure of the study information | 2022/11/30 |
| Last modified on | 2024/11/26 17:05:30 |
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Basic information
Public title
Analysis the relation of acupuncture effects between respiration and heart rate variability in healthy men ; A randomized controlled trial
Acronym
Analysis the relation of acupuncture effects between respiration and heart rate variability in healthy men
Scientific Title
Analysis the relation of acupuncture effects between respiration and heart rate variability in healthy men ; A randomized controlled trial
Scientific Title:Acronym
Analysis the relation of acupuncture effects between respiration and heart rate variability in healthy men
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In experiments in which acupuncture needles are inserted, if subjects stop breathing slightly or become tachypneic, this will also affect the results of HRV analysis.
Therefore, we will measure the variation in breathing patterns caused by acupuncture stimulation and evaluate the effect on HRV analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Instantaneous heart rate is calculated from the R-R interval of the recorded ECG. In addition, HRV analysis is performed as an indicator of cardiac autonomic function.
Key secondary outcomes
A breathing pickup is attached to the upper abdomen and the breathing pattern is measured from the movement associated with respiratory motion.
The intensity of "pain" or "de qi" associated with acupuncture stimulation is measured using a visual analogue scale (VAS) of 10 cm in width.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Control group (no treatment) :
After 20 minutes of rest, including the electrode device, the patient will begin respiration and electrocardiogram measurements. A total of 11.5 minutes of measurement is performed.
Interventions/Control_2
Intervention group (acupuncture stimulation) :
After 20 minutes of rest, including the electrode device, respiration and ECG measurements will begin. Measurements will be taken for a total of 11.5 minutes: 5 minutes of rest before stimulation, 90 seconds during stimulation, and 5 minutes of rest after stimulation. After the experiment, a questionnaire regarding the type and severity of pain will be filled out.
Using disposable stainless-steel needles (40 mm long and 0.20 mm thick), stimulate LI4 (lateral to the midpoint of the second metacarpal bone) for 90 seconds.
The acupuncture simulation is applied by the sparrow pecking method; that is, acupuncture needle is inserted and moved vertically at the frequency of 1Hz at depth of 15-20mm.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
A healthy male between the ages of 18 and 30
Key exclusion criteria
(1) Those who are in the hospital or receiving medication due to an underlying disease
(2) Those with circulatory system abnormalities
(3) Those who have poor physical condition due to sleep disorder
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Imai |
Organization
Teikyo Heisei University
Division name
Graduate School of Health Sciences
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
k.imai@thu.ac.jp
Public contact
Name of contact person
| 1st name | Toshimi |
| Middle name | |
| Last name | Hiroi |
Organization
Teikyo Heisei University
Division name
Graduate School of Health Sciences
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
Homepage URL
hiroi-t@takasaki-u.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee,Teikyo Heisei University
Address
2-51-4 Higashi-Ikebukuro, Toshima-ku, Tokyo
Tel
03-5843-3111
rec@thu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In order to expand the group of subjects to be recruited, an application for amendment was submitted to the Ethics Committee.
The application for amendment was approved on June 1, 2024.
Teikyo Heisei University Ethics Committee Approval Number: 2022-111-1
Management information
Registered date
| 2022 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056477
