Passive VS Active VR on HPT Using the Thermal Sensory Analyzer With a Peltier-Based Contact Thermode

Study Overview
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Brief Summary
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This is a prospective, crossover study of healthy participants evaluating the impact of passive vs. active virtual reality (VR) games on heat pain threshold (HPT).

Detailed Description
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Virtual reality (VR) is an emerging, non-pharmaceutical intervention used to reduce perceived pain and anxiety in patients. VR's effect on pain and anxiety on patients is well-studied as is how VR games improve recalled pain and anxiety in pediatric burn and bone-fracture patients undergoing painful medical procedures. However, how differences in VR application construction (such as passive play vs. active play) impact patient perception of pain and anxiety is not well understood. In this study, we will measure the impact of passive vs. active VR applications on heat pain threshold (HPT) and immediate vs. recalled pain and anxiety levels.

Official Title
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Impact of Passive VR Versus Active VR on Heat Pain Thresholds Using the Thermal Sensory Analyzer (TSA-II) With a Peltier-Based Contact Thermode

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Behavioral: Oculus Go headset without active intervention
* Behavioral: Oculus Go headset with active intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: greater than 18 years of age English speaking hearing intact Exclusion Criteria: a history of severe motion sickness currently have nausea history of seizures have hearing loss; are pregnant are currently taking beta blockers, chronotropic heart medications, or opioids or other prescription pain medications history of chronic pain or acute pain syndromes.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active VR then Passive VR<br>Participant will conduct the experiment using active VR first and then passive VR | Behavioral: Oculus Go headset without active intervention<br>* VR software with non-interactive content.<br>Behavioral: Oculus Go headset with active intervention<br>* Participant will engage with the game display on the VR headset. Engagement time depends on the HPT limits test.<br>|
| Experimental: Passive VR then Active VR<br>Participant will conduct the experiment using passive VR first and then active VR | Behavioral: Oculus Go headset without active intervention<br>* VR software with non-interactive content.<br>Behavioral: Oculus Go headset with active intervention<br>* Participant will engage with the game display on the VR headset. Engagement time depends on the HPT limits test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heat pain threshold | Heat pain threshold measured by the TSA Air II device. Temperature ranges from 32 degrees C to 50 degrees C, with higher temperatures indicating a higher heat pain threshold. | Duration of intervention, approximately 15 minutes | 
| Change in pressure pain threshold | Pressure pain threshold measured by a computerized pressure pain algometer. Pressure ranges from 0 kPa to 1000 kPa, with higher pressures indicating a higher pressure pain threshold. | Duration of intervention, approximately 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in recalled pain level | Recalled pain level measured by a numerical rating scale (NRS) from 0-10. Scale ranges from 0-10, with higher scores indicating higher pain levels. | 24 hours after the intervention | 
| Change in lower recalled fear/anxiety level | Lower recalled fear/anxiety level measure by the adapted Fear Questionnaire (FQ). This scale ranges from 0-8, 0 indicating participants would not avoid the situation in the future, and 8 meaning they would always avoid the situation in the future. | 24 hours after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Thermal Sensory Analyzer (TSA-II), Peltier-Based Contact Thermode