The Impact of an Immersive Digital Therapeutic Tool on Pain Perception

Pain Perception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06130267
• Other study ID #: 2022-2849
• Status: Completed
• Phase: N/A
• Start date: June 24, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: November 2023
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Perception

Intervention

Other:
• Endocare
Virtual paradigm (calming environnement)

Locations

Country	Name	City	State
Canada	Centre de recherche de l'institut universitaire de santé mentale de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Stéphane Potvin

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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