The Impact of an Immersive Digital Therapeutic Tool on Pain Perception

Sponsor

Stéphane Potvin (Other)

Overall Status

Completed

CT.gov ID

NCT06130267

Collaborator

(none)

Enrollment

Location

Arms

9.7

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Perception	Other: Endocare	N/A

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

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 24, 2022

Actual Primary Completion Date :

Apr 15, 2023

Actual Study Completion Date :

Apr 15, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Thermal heat pain induced with a Peltier thermode [Immediately before, during and immediately after VR exposure]
Pain intensity and unpleasantness, on a COVAS scale from 0 (no pain) to 100 (worse pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de recherche de l'institut universitaire de santé mentale de Montréal	Montréal	Quebec	Canada	H1N 3V2

Sponsors and Collaborators

Stéphane Potvin

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stéphane Potvin, Full-time professor, Ciusss de L'Est de l'Île de Montréal

ClinicalTrials.gov Identifier:

NCT06130267

Other Study ID Numbers:

2022-2849

First Posted:

Nov 14, 2023

Last Update Posted:

Nov 14, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Stéphane Potvin, Full-time professor, Ciusss de L'Est de l'Île de Montréal

Pain

Emotions

virtual reality

within-subject design

Study Results

No Results Posted as of Nov 14, 2023