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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037750
Receipt No. R000042797
Scientific Title Autonomic abnormalities have been controlled by acupuncture, under the VR stress.
Date of disclosure of the study information 2020/03/31
Last modified on 2020/11/10

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Basic information
Public title Causing the autonomic abnormality in electorogastrograms and heat rate induced the VR stress and its controlled by acupuncture stimulation.
Acronym Causing the autonomic abnormality in electorogastrograms and heat rate induced the VR stress and its controlled by acupuncture stimulation.
Scientific Title Autonomic abnormalities have been controlled by acupuncture, under the VR stress.
Scientific Title:Acronym Autonomic abnormalities have been controlled by acupuncture, under the VR stress.
Region
Japan

Condition
Condition Nausea
Classification by specialty
Gastroenterology Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Causing the nausea and autonomic abnormality with motion sikness in electorogastrograms and heat rate induced the VR stress and its controlled by acupuncture stimulation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes EGG recording and data analysis:Percutaneous EGG is applied to record gastric myoelectrical activity in sitting position. Disposable Ag-AgCl2 electrodes (Vitrode M, NIHON KODEN) are affixed to the abdominal wall. EGG recordings have performed with a portable EGG recorder (EGS2, Nipro Co., Japan) with low and high cutoff frequencies of 1 and 12 cpm. After completion of the recording, EGG data are digitized at a sampling rate of 1 Hz and transferred to a personal computer, then analyzed with a commercially available software program (EGS2, Version 1.31, Gram Corp., Tokyo, Japan). Using a fast Fourier transform (FFT), we compute an algorithm of a power spectra of every 256 s. Each EGG recording have divided into blocks of 60 s without overlapping. On the power spectrum of each 60 s, the dominant frequencies of EGG are defined under 9 cpm. The percentages of the normogastria range (2-4 cpm), the bradygastria range (0-2 cpm), and the tachygastria range (4-9 cpm) are calculated, respectively. The percentage of gastric dysrhythmia is defined as the percentage of time during which normogastria of 2-4 cpm slow waves are absent over the entire observation period. After placement of the EGG electrodes and virtual reality (VR) head set machine, the subjects have asked to sit and relax on the chair for a total of 45 min: 15 min baseline period, 15 min drum rotation with VR, and 15 min recovery period. EGG have continuously recorded before, during, and after the drum rotation.
Key secondary outcomes Electrodes are attached to the chest and amplified using a bio-amplifier (ML132, AD instruments). The filter settings are high cut filter 60 Hz and the time constant is 0.03 sec. The electrocardiogram is taken into a PC at a sampling rate of 1 kHz via an A / D converter (PowerLab 8sp, AD Instruments), and heart rate variability (HRV) analysis is performed every 5 minutes using the analysis software Chart5 (PowerLab, AD Instruments) and HRV module. In the power spectrum obtained by FFT analysis, the band of 0.05 to 0.15 Hz is used as the low frequency (LF) component as an index of sympathetic nerve function, and the band of 0.15 to 0.4 Hz is used as the high frequency (HF) component of parasympathetic nerve function. Find the ratio of LF to total power (LF normalized unit: LFnu) and the ratio of HF (HF normalized unit: HFnu).As an index of the relative balance between the sympathetic nerve and the parasympathetic nerve, LF / HF, which is the ratio of the LF component and the HF component, is calculated.

Evaluation of nausea: The evaluation of nausea is performed with 0 points for no symptoms and 100 points for the condition leading to vomiting, and the degree of nausea is listened to every 15 minutes from the start of the experiment.

Evaluation of motion sickness symptom: The subjective symptom of motion sickness (SSMS) is used to evaluate motion sickness. SSMS consists of 7 items associated with motion sickness: discomfort, heavy head, heat, sweating, drowsiness (drowsiness), hypersalivation, and nausea. Depending on the degree of each symptom, a 4-6 grade is given, with a maximum of 49 points. Listen to this SSMS every 3 minutes for 15 minutes, which corresponds to VR load, and check the transition of symptoms over time.

Base
Study type Interventional

Study design
Basic design Parallel
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 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Procedures:
All subjects are asked to fast for at least for 4 h before the experiment. After placement of the EGG electrodes and VR head set machine, the subjects are asked to sit and relax on the chair for a total of 45 min: 15 min baseline period, 15 min drum rotation with VR, and 15 min recovery period. EGG is continuously recorded before, during, and after the drum rotation. After the 15 min baseline, the drum was rotated around the subject at a speed of 60 degree/sec. The subject has told to look straight ahead at the black and white stripes in the movie of optokinetic drum. To quantify the severity of nausea induced by the drum rotation, the visual analogue scale (VAS) is recorded before, immediately after, and 15 min after the cessation of drum rotation.
The optokinetic stimulus is not applied to control group that is shown the just the picture of black and white stripes that is not rotating movie.
Interventions/Control_2 VR stress:
All subjects are asked to fast for at least for 4 h before the experiment. After placement of the EGG electrodes and VR head set machine, the subjects are asked to sit and relax on the chair for a total of 45 min: 15 min baseline period, 15 min drum rotation with VR, and 15 min recovery period. EGG is continuously recorded before, during, and after the drum rotation. After the 15 min baseline, the drum was rotated around the subject at a speed of 60 degree/sec. The subject has told to look straight ahead at the black and white stripes in the movie of optokinetic drum. To quantify the severity of nausea induced by the drum rotation, the visual analogue scale (VAS) is recorded before, immediately after, and 15 min after the cessation of drum rotation.
The VR stress group does not perform acupuncture stimulation only with movie stimulation.
Interventions/Control_3 Acupuncture stimulation for 30 minutes before VR stress:
All subjects are asked to fast for at least for 4 h before the experiment. After placement of the EGG electrodes and VR head set machine, the subjects are asked to sit and relax on the chair for a total of 45 min: 15 min baseline period, 15 min drum rotation with VR, and 15 min recovery period. EGG is continuously recorded before, during, and after the drum rotation. After the 15 min baseline, the drum was rotated around the subject at a speed of 60 degree/sec. The subject has told to look straight ahead at the black and white stripes in the movie of optokinetic drum. To quantify the severity of nausea induced by the drum rotation, the visual analogue scale (VAS) is recorded before, immediately after, and 15 min after the cessation of drum rotation.
Acupuncture stimulation for 30 minutes to the acupoint (P6) located of the between the long palmar tendon and the carpal flexor tendon approximately 60mm down from the wrist is perform in after the start of the experiment.
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 1) Male aged 16 and under 30
2) Those who can attend the research site within the research period
3) Persons who can get written consent for participation in this study
Key exclusion criteria 1) Patients who are hospitalized or taking medication for basic diseases (diabetes, heart disease, kidney disease, liver disease, hyponatremia, difficult to treat hypertension, etc.)
2) Persons receiving medication
3) Persons with extremely short sleep (less than 5 hours per day) and those with long sleep (over 10 hours per day)
4) Those who have a reverse life day and night due to work or part-time job
5) Persons receiving treatment for autoimmune diseases, chronic inflammatory diseases, allergic diseases, cancer
6) People who have a habit of excessive smoking * 1 and excessive alcohol consumption * 2 or who are extremely irregular in their diet
7) Persons with significant abnormalities in blood pressure, blood tests, urine tests, etc.
8) Persons suspected of acute infections such as influenza
9) Those who have undergone major surgery in the digestive system such as gastrectomy, gastrointestinal suture, and intestinal resection
10) 400ml blood donation within 12 weeks before the experiment, 200ml blood donation within 4 weeks, ingredient blood donation within 2 weeks
11) Participants in other clinical trials
<Note>
* 1 Excessive smoking refers to more than 21 smoking per day.
* 2 Excessive alcohol consumption is more than 2 gos per day in terms of sake (500ml x 2 bottles of beer, 60ml x 2 whiskey doubles, 180ml mixed shochu, 60ml x 7 glasses of red wine glass) Refers to drinking alcohol.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Imai
Organization Teikyo Heisei University
Division name Department of Acupuncture and Moxibustion, Graduate School of Health Sciences
Zip code 170-8445
Address 2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL 080-1527-1617
Email kenji.imai1@gmail.com

Public contact
Name of contact person
1st name Daiyu
Middle name
Last name Shinohara
Organization Teikyo Heisei University
Division name Department of Acupuncture and Moxibustion, Graduate School of Health Sciences
Zip code 170-8445
Address 2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL 080-5521-6516
Homepage URL
Email d.shinohara1@gmail.com

Sponsor
Institute Teikyo Heisei University
Institute
Department

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 ethical commitie,
Address 2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
Tel 03-5843-3111
Email 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
2020 Year 03 Month 31 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 30
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 No longer recruiting
Date of protocol fixation
2019 Year 07 Month 30 Day
Date of IRB
2019 Year 08 Month 01 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 08 Month 21 Day
Last modified on
2020 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042797

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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