Pain PerceptionNCT06130267
The Impact of an Immersive Digital Therapeutic Tool on Pain Perception
A study testing Endocare in people with Pain Perception, run by Stéphane Potvin at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Perception
- What is being tested?
- Endocare
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jun 2022to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women
- between 18 and 50 years old
- willing to participate in the study
- able to sign the informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche de l'institut universitaire de santé mentale de Montréal
Montreal, Quebec, H1N 3V2
About this study
Official title: The Impact of an Immersive Digital Therapeutic Tool on Pain Perception: An Experimental Study With an Active Control Condition
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.
Read the 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.
- Conditions
- Pain Perception
- Being tested
- Endocare
- Keywords
- Pain, Emotions, virtual reality, within-subject design
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndocareOther
Virtual paradigm (calming environnement)
| Study group | Role | What they receive |
|---|---|---|
| control condition | Placebo comparator | same paradigm without the active agent Receives: Other: Endocare |
| Virtual Reality condition | Experimental | calming VR environment Receives: Other: Endocare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal heat pain induced with a Peltier thermode
Pain intensity and unpleasantness, on a COVAS scale from 0 (no pain) to 100 (worse pain)
Measured: Immediately before, during and immediately after VR exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start24 Jun 2022
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stéphane Potvin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stéphane Potvin, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Stéphane Potvin, PhD, Study director, University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130267
- Sponsor's protocol ID
- 2022-2849
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38903416
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Immersive Digital Therapeutic Tool on Pain Perception: An Experimental Study With an Active Control Condition
- ClinicalTrials.gov ID
- NCT06130267
- Acronym / sponsor ID
- 2022-2849
- Conditions
- Pain Perception
- Keywords
- Pain, Emotions, virtual reality, within-subject design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Stéphane PotvinUniversity, hospital or other
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control condition | Placebo comparator | Other: Endocaresame paradigm without the active agent |
| Virtual Reality condition | Experimental | Other: Endocarecalming VR environment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy men and women
- between 18 and 50 years old
- willing to participate in the study
- able to sign the informed consent form
Key exclusion criteria (6 listed)
- neurological disorders
- substance use disorders
- severe mental health disorder
- chronic pain
- any acute and unstable medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndocareVirtual paradigm (calming environnement) | Other | Virtual Reality condition, control condition |
Primary outcome
Thermal heat pain induced with a Peltier thermode
Time frame: Immediately before, during and immediately after VR exposure
Pain intensity and unpleasantness, on a COVAS scale from 0 (no pain) to 100 (worse pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 38903416Diallo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Potvin, PhD study director
University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocare in people with Pain Perception, run by Stéphane Potvin at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal heat pain induced with a Peltier thermode (time frame: Immediately before, during and immediately after VR exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.