To assess the effect of Virtual Reality mediated visual and auditory lowering of electrical pain detection and tolerance thresholds
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Electrical Stair: PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC)
(mA*mm), and post-test VAS (mm).
* Electrical Stair (including virtual reality simulation without enhancement):
PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mA*mm), and post-test
VAS (mm).
* Electrical Stair (including virtual reality simulation with enhancement): PDT
(mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mA*mm), and post-test VAS
(mm).
Secondary outcome
Questionnaires on personal characteristics, stress, anxiety and the
relationship with electrial pain detection and tolerance thresholds.
Background summary
The VR simulation is added to a nociceptive pain measurement, the electrical
stair test from the PainCart®. This test has been proven sensitive in clinical
trials in detecting the pharmacodynamic effects of multiple analgesics. The
measurements are performed in a quiet room, each subject is assigned to a
separate room to minimize any distraction. The electrical stair test uses two
electrodes on the tibial bone to assess cutaneous electrical pain. Single
electrical stimuli are provided with a duration of 0.2 ms, increasing from 0 mA
to a maximum of 50 mA in steps of 0.5 mA. The maximum duration of the test is
120 seconds.
In this study a VR simulation is introduced aimed at enhancing the pain
perception. Two VR environments (VR-neutral and VR+) are developed, both
simulating a room with a PainCart setup. The environments include an avatar of
the subject, the chair, and equipment of the electrical stair pain test,
including electrodes on the leg and a VAS slider. The VR-neutral simulation has
no additional aspects; it shows a similar setup as the test without VR. During
the VR+ simulation, a wound appears simultaneously with the intensity of the
pain test. The visual enhancement is supported with accompanying sounds of
electrical sparks. The simulation of the wounds starts and stops simultaneously
with the stimulation, both controlled by the subject. After 40 seconds of
simulation the intensity of the audio-visual stimulation no longer increases.
The VAS slider is visible in the simulation and used to record the Pain
Detection Threshold (PDT) and Pain Tolerance Threshold (PTT).
Study objective
To assess the effect of Virtual Reality mediated visual and auditory lowering
of electrical pain detection and tolerance thresholds
Study design
A maximum of 24 subjects will experience in set order all three setups:
PainCart without VR (*normal*), VR-neutral and VR+.
Study burden and risks
not applicable
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
* Healthy male subjects aged 18-40 years, inclusive; healthy is defined as no
clinically relevant abnormalities identified.
* Able to participate and willing to give written informed consent and to
comply with the study restrictions.
Exclusion criteria
* History of symptoms or any significant including (but not limited to)
neurological or psychiatric disorder., if assessed by the Principal
Investigator as possibly interfering with the study objectives.
* High pain tolerance (80% or higher value for the pain tolerance of the
electrical stair test)
* Presence of Virtual Reality Sickness (simulator sickness).
* Smoker of more than 5 cigarettes per day prior to screening or who use
tobacco products equivalent to more than 5 cigarettes per day.
* Consume, on average, > 8 units/day of (methyl)-xanthines (e.g. coffee, tea,
cola, chocolate) or not able to refrain from use during each stay at the CHDR
clinic.
* Have a urine drug screen detecting illicit drug of abuse (morphine,
benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a
positive alcohol breath test;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL75934.056.20 |
| OMON | NL-OMON28178 |