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Clinical Trials/NCT06130267
NCT06130267CompletedNot Applicable

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

Stéphane Potvin2 sites in 1 country21 target enrollmentStarted: June 24, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
2
Primary Endpoint
Thermal heat pain induced with a Peltier thermode

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Thermal heat pain induced with a Peltier thermode

Time Frame: Immediately before, during and immediately after VR exposure

Pain intensity and unpleasantness, on a COVAS scale from 0 (no pain) to 100 (worse pain)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Stéphane Potvin

Full-time professor

Ciusss de L'Est de l'Île de Montréal

Study Sites (2)

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