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ID
Source
Brief title
Health condition
Pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Electrical Stair: PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mA*mm).
• Electrical Stair (including virtual reality simulation without enhancement): PDT (mA), PTT (mA), Area Under the VAS pain Curve
(AUC) (mA*mm).
• Electrical Stair (including virtual reality simulation with enhancement): PDT (mA), PTT (mA), Area Under the VAS pain Curve (AUC) (mA*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®. The PainCart® 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
Screening up to -90 days till EOS
Intervention
Virtual Reality images
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
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9398 |
| CCMO | NL75934.056.20 |
| OMON | NL-OMON50817 |