UMIN-CTR Clinical Trial

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

Nausea

Classification by specialty

Gastroenterology	Cardiology	Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Teikyo Heisei University

Institute

Department

Personal name

Organization

Teikyo Heisei University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

ethical commitie,

Address

2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo

Tel

03-5843-3111

Email

rec@thu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

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 related information

Registered date

2019

Year

08

Month

21

Day

Last modified on

2022

Year

04

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042797