The Impact of an Immersive Digital Therapeutic Tool on Pain Perception

NCT06130267 | Completed

• 1 other identifier: 2022-2849
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Perception

Keywords

Pain; Emotions; virtual reality; within-subject design

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control condition

PLACEBO COMPARATOR

same paradigm without the active agent

Other: Endocare

Virtual Reality condition

EXPERIMENTAL

calming VR environment

Other: Endocare

Interventions

Endocare OTHER

Virtual paradigm (calming environnement)

Virtual Reality condition; control condition

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy men and women
• between 18 and 50 years old
• willing to participate in the study
• able to sign the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Stéphane Potvin: lead

Study Sites (1)

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

Montreal, Quebec, H1N 3V2, Canada

Location

Related Publications (1)

• Diallo S, Marchand S, Dumais A, Potvin S. The impact of an immersive digital therapeutic tool on experimental pain: a pilot randomized within-subject experiment with an active control condition. Front Pain Res (Lausanne). 2024 Jun 6;5:1366892. doi: 10.3389/fpain.2024.1366892. eCollection 2024.

  PMID: 38903416 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphane Potvin, PhD

  University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de montréal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full-time professor

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 14, 2023
• Study Start: June 24, 2022
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

CA (1)