Clinical trial NCT06130267: The Impact of an Immersive Digital Therapeutic Tool on Pain Perception
Official title: The Impact of an Immersive Digital Therapeutic Tool on Pain Perception: An Experimental Study With an Active Control Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Perception
Keywords: Pain
Emotions
virtual reality
within-subject design
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thermal heat pain induced with a Peltier thermode
timeFrame: Immediately before, during and immediately after VR exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre de recherche de l'institut universitaire de santé mentale de Montréal
state: Quebec
Study officials:
affiliation: University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de montréal
name: Stéphane Potvin, PhD
role: STUDY_DIRECTOR
References: