Skip to main content
OpenTrials
Completed

NCT Number: NCT06130267

The Impact of an Immersive Digital Therapeutic Tool on Pain Perception

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche de l'institut universitaire de santé mentale de Montréal

Montreal, Quebec, H1N 3V2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endocare

Other

Virtual paradigm (calming environnement)

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Stéphane Potvin

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2023
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.