The Impact of an Immersive Digital Therapeutic Tool on Pain Perception

Study Overview
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Brief Summary
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The goal of this experimental study is to examine the impact of a virtual reality paradigm on heat pain perception in healthy volunteers. The main question it aims to answer is to determine if the virtual reality paradigm reduces pain intensity and unpleasantness evoked by tonic heat pain stimulation. Tonic heat pain stimulation is applied on the left forearm of participants using a Peltier thermode immediately before, during and immediately after virtual reality exposure. Using a with-subject design, participants are sequentially exposed to both the virtual reality condition and an active control condition. The order of administration of the virtual reality and control conditions is randomized.

Detailed Description
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Pain is a complex and multifaced sensory and emotional experience. Virtual reality has shown promise in reducing experimental pain and chronic pain. However, many previous trials in the field lacked proper control conditions. This experimental study examines an immersive virtual environment initially designed for the treatment of endometriosis patients, which demonstrated promising analgesic effects. The current study aims to determine the impact of the virtual reality paradigm on experimental pain perception both during and after virtual reality exposure, while using an active control condition. This study involves healthy individuals with no chronic pain and uses a within-subject design, comparing a virtual reality paradigm with an active control condition. Continuous heat pain stimulation is applied to the left forearm of participants with a Peltier thermode, before, during and immediately after virtual reality exposure. For each continuous heat pain stimulation, pain intensity and unpleasantness are measured using a scale from 0 (no pain) to 100 (worst pain). Using a with-subject design, participants are sequentially exposed to both the virtual reality condition and an active control condition. The order of administration of the virtual reality and control conditions is randomized. Both conditions are administered in a single experimental session at the laboratory.

Official Title
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The Impact of an Immersive Digital Therapeutic Tool on Pain Perception: An Experimental Study With an Active Control Condition

Conditions
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Pain Perception

Intervention / Treatment
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* Other: Endocare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy men and women between 18 and 50 years old willing to participate in the study able to sign the informed consent form Exclusion Criteria: neurological disorders substance use disorders severe mental health disorder chronic pain any acute and unstable medical condition taking medication that acts on the central nervous system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control condition<br>same paradigm without the active agent | Other: Endocare<br>* Virtual paradigm (calming environnement)<br>|
| Experimental: Virtual Reality condition<br>calming VR environment | Other: Endocare<br>* Virtual paradigm (calming environnement)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal heat pain induced with a Peltier thermode | Pain intensity and unpleasantness, on a COVAS scale from 0 (no pain) to 100 (worse pain) | Immediately before, during and immediately after VR exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Emotions, virtual reality, within-subject design