Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001172897
Ethics application status
Approved
Date submitted
31/10/2012
Date registered
6/11/2012
Date last updated
6/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of Transcutaneous electrical nerve stimulation on simulator sickness in healthy adults
Scientific title
The effects of application of Transcutaneous electrical nerve stimulation (TENS) on posterior neck and the Zusanli acupoint on simulator sickness (SS) symptoms and sleepiness in healthy adults
Secondary ID [1] 281482 0
Nil
Universal Trial Number (UTN)
U1111-1136-5906
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
motion/simulator sickness 287746 0
Condition category
Condition code
Alternative and Complementary Medicine 288086 288086 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcutaneous electrical nerve stimulation (TENS) used in a within-subject crossover design wherein each subject will complete 4 test sessions (control, SS, TENS, and TENS + SS) in a randomized order.
[control session: no simulator exposure and no TENS stimulation]
[SS session: simulator Sickness; exposure to flight simulator for 30 minutes to induce simulator sickness]
[TENS session: transcutaneous electrical stimulation: electrical stimulation at midline posterior nuchal region and right Zusanli acupoint for 30 minutes using a self-contained, battery-operated, dual channel transcutaneous electrical nerve stimulator at a pulse rate of 100 Hz and the level of intensity (1 through 10) at the highest comfortable setting, per the manufacturer’s instructions]
[TENS + SS session: treat with TENS for 30 minutes then exposure the subject in flight simulator to induce simulator sickness. Purpose: to observe the effect of the TENS (the intervention)]
To prevent the carryover of intervention, sessions were spaced at least 2 days apart. (The wash out period between sessions is at least 2 days apart).

Each session consisted of 4 phases: phase 1 (10 minutes), consisting of preparation and recording of baseline physiologic parameters; phase 2 (10 minutes), electrical stimulation (for TENS and TENS + SS sessions); phase 3 (20 minutes), SS stimulation (for SS and TENS + SS sessions) and electrical stimulation (only in TENS + SS sessions); and phase 4 (30 minutes), the post-test period.
TENS treatment will last 30 minutes (complete duration of phases 2 and 3) at two sites: (1) the midline posterior nuchal region and (2) the Zusanli acupoint, located 1 finger breadth lateral to the tibial anterior crest, about 4 finger widths below the knee.
Intervention code [1] 285988 0
Treatment: Devices
Intervention code [2] 285989 0
Treatment: Other
Comparator / control treatment
Active treatment (no treatment given).

In this crossover design, subject act as their own control. The SS session is considered control treatment to the SS + TENS session. (TENS is considered the intervention)
Control group
Active

Outcomes
Primary outcome [1] 288292 0
Simulator sickness symptoms including sleepiness were evaluated with the Simulator Sickness Questionnaire (SSQ) and Visual Analogue Scales for evaluating Sleepiness Symptoms (VAS-SS)
Timepoint [1] 288292 0
before phase 1 and after phase 3 of the experiment
Primary outcome [2] 288294 0
The d2 test, a standardized paper-and-pencil test, will be utilized to assess cognitive function, more specifically the visual attention
Timepoint [2] 288294 0
The d2 test will be tested before (during phase 1) and after simulator sickness induction (after phase 3) in each session
Secondary outcome [1] 299774 0
Salivary stress biomarkers' level (salivary alpha amylase activity and salivary cortisol concentrations) were evaluated.
Timepoint [1] 299774 0
before (during phase 1) and after simulator sickness induction (15 min and 30 min after phase 3) in each session.
Secondary outcome [2] 299837 0
heart rate and derived heart rate variability (HRV) were recorded and analyzed.
Timepoint [2] 299837 0
before (during phase 1) and after simulator sickness induction in each session.

Eligibility
Key inclusion criteria
healthy, non-smoking, young male participants (age 20-40)
Minimum age
20 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
vestibular, visual, cardiovascular, respiratory, and gastrointestinal tract disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Healthy volunteers will be recruited through advertisements. The allocation sequence will be generated prior to the recruitment of participants by the Research Randomizer Program and concealed in sequentially numbered and sealed opaque envelops, which will be opened when participants are ready for allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomization will be determined using a computer program (Research Randomizer), which generates a list of random numbers. For every block of persons, a balanced block (equal numbers of persons are assigned to each session) is used. Randomization will be conducted by a separate researcher.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4663 0
Taiwan, Province Of China
State/province [1] 4663 0

Funding & Sponsors
Funding source category [1] 286254 0
University
Name [1] 286254 0
National Defense Medical Center
Country [1] 286254 0
Taiwan, Province Of China
Primary sponsor type
University
Name
Institute of Aerospace and Undersea medicine
Address
No. 161, Section 6, Min-Chuan East Road, Taipei, 114 Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 285055 0
Individual
Name [1] 285055 0
Hsin Chu
Address [1] 285055 0
No. 161, Section 6, Min-Chuan East Road, Taipei, 114 Taiwan, R.O.C.
Country [1] 285055 0
Taiwan, Province Of China
Other collaborator category [1] 277148 0
Hospital
Name [1] 277148 0
GanShan Armed Force Hospital
Address [1] 277148 0
1, Dayi 2nd road, GangShan
Kaohsiung 820
Taiwan, R.O.C.
Country [1] 277148 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288333 0
Institutional Review Board in aviation medicine research of Gangshan Armed Force Hospital
Ethics committee address [1] 288333 0
Ethics committee country [1] 288333 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 288333 0
01/05/2009
Approval date [1] 288333 0
25/06/2009
Ethics approval number [1] 288333 0
098-007

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34905 0
Address 34905 0
Country 34905 0
Phone 34905 0
Fax 34905 0
Email 34905 0
Contact person for public queries
Name 18152 0
Hsin Chu
Address 18152 0
No. 161, Section 6, Min-Chuan East Road, Taipei, 114 Taiwan, R.O.C.
Country 18152 0
Taiwan, Province Of China
Phone 18152 0
+886-287923100 ext 18390
Fax 18152 0
Email 18152 0
[email protected]
Contact person for scientific queries
Name 9080 0
Hsin Chu
Address 9080 0
No. 161, Section 6, Min-Chuan East Road, Taipei, 114 Taiwan, R.O.C.
Country 9080 0
Taiwan, Province Of China
Phone 9080 0
+886-287923100 ext 18390
Fax 9080 0
Email 9080 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AISimultaneous transcutaneous electrical nerve stimulation mitigates simulator sickness symptoms in healthy adults: a crossover study2013https://doi.org/10.1186/1472-6882-13-84
N.B. These documents automatically identified may not have been verified by the study sponsor.