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The Impact of an Immersive Digital Therapeutic Tool on Pain Perception

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06130267
Enrollment
21
Registered
2023-11-14
Start date
2022-06-24
Completion date
2023-04-15
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Perception

Keywords

Pain, Emotions, virtual reality, within-subject design

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.

Interventions

Virtual paradigm (calming environnement)

Sponsors

Stéphane Potvin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Thermal heat pain induced with a Peltier thermodeImmediately before, during and immediately after VR exposurePain intensity and unpleasantness, on a COVAS scale from 0 (no pain) to 100 (worse pain)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026