The Impact of an Immersive Digital Therapeutic Tool on Pain Perception

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-24

Study Completion Date

2023-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling

NCT05601713

Hyperthermia Weather; Heat Heat Stress +2 more

COMPLETED NA

Heat Therapy to Reduce Pain and Improve Walking Tolerance

NCT03435835

Peripheral Arterial Disease

COMPLETED NA

Establishing Evidence-based Indoor Temperature Thresholds to Protect Health

NCT04348630

Aging Heat Stress Physiological Stress

COMPLETED NA

Validity of Humidity Ramp Protocols for Identifying Limits of Survivability in Heat-exposed Persons

NCT05963529

Heat Stress Heat Exposure Temperature Change, Body +1 more

COMPLETED NA

Impact of Thermal Stress on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents

NCT02659410

Heat

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Perception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control condition

same paradigm without the active agent

Group Type PLACEBO_COMPARATOR

Endocare

Intervention Type OTHER

Virtual paradigm (calming environnement)

Virtual Reality condition

calming VR environment

Group Type EXPERIMENTAL

Endocare

Intervention Type OTHER

Virtual paradigm (calming environnement)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endocare

Virtual paradigm (calming environnement)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes