The Impact of an Immersive Digital Therapeutic Tool on Pain Perception

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Perception
• Intervention / Treatment: Other: Endocare

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1N 3V2
      • Centre de recherche de l'institut universitaire de santé mentale de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stéphane Potvin
• Investigators: Study Director: Stéphane Potvin, PhD, University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 11, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Emotions; virtual reality; within-subject design
• Other Study ID Numbers: 2022-2849

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No