Cardio-visual Stimulation in Augmented Reality for Pain Reduction
NCT ID: NCT05085821
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2021-04-20
2023-06-29
Brief Summary
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Detailed Description
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Chronic pain has previously been associated with a distorted body representation, in particular of the affected body parts. Virtual Reality (VR) studies using embodiment-, respiration-, and heart-beat related feedback have demonstrated positive effects for induced pain in healthy participants (e.g., increased pain thresholds) and chronic pain in patient populations (e.g., decreased subjective pain, improved functionality, improved physiological markers of pain). Based on these studies, the AR intervention evaluated here aims to alleviate subjective pain symptoms and improve physiological pain markers in chronic pain patients using heartbeat-related feedback.
This within-subject study will compare subjective pain ratings before, during, and after an AR intervention that provides visual feedback of participants' on-going heartbeat in relation to their affected limb. Primary outcomes include subjective reports from participants (perceived efficacy, acceptability, and demand) and the intervention's clinical feasibility, including reports from therapists. Secondary outcomes include changes in heart rate and variability.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Experimental 1: HEART - Placebo - HEART - Placebo
The patient receives visual feedback in an augmented reality environment in four session, over two weeks.
Week 1: HEART, Placebo (after \>24hour washout) Week 2: HEART, Placebo (after \>24hour washout)
HEART
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
Placebo
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Experimental 2: HEART - Placebo - Placebo - HEART
The patient receives visual feedback in an augmented reality environment in four session, over two weeks.
Week 1: HEART, Placebo (after \>24hour washout) Week 2: Placebo, HEART (after \>24hour washout)
HEART
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
Placebo
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Experimental 3: Placebo - HEART - Placebo - HEART
The patient receives visual feedback in an augmented reality environment in four session, over two weeks.
Week 1: Placebo, HEART (after \>24hour washout) Week 2: Placebo, HEART (after \>24hour washout)
HEART
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
Placebo
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Experimental 4: Placebo - HEART - HEART - Placebo
The patient receives visual feedback in an augmented reality environment in four session, over two weeks.
Week 1: HEART, Placebo (after \>24hour washout) Week 2: Placebo, HEART (after \>24hour washout)
HEART
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
Placebo
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Interventions
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HEART
In an augmented reality environment, the patient receives visual feedback in synchrony with their cardiac-cycle (HEART)
Placebo
In an augmented reality environment, the patient receives visual feedback out-of-synchrony with their cardiac cycle (Placebo)
Eligibility Criteria
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Inclusion Criteria
* Present permanent chronic pain (for more than 3 months), secondary to a peripheral pathology (traumatic, orthopedic or neurological), located in the hand or forearm.
Exclusion Criteria
* People in emergency situations
* Persons unable to give informed consent
* Persons who are mentally or linguistically unable to understand the research test instructions
* Individuals who are not available to complete the entire study protocol
* Cognitive impairments that prevent the use of the equipment
* Psychiatric disorders
* Patients with seizure disorders
* Patients with central hemineglect
* Pain secondary to central nervous system pathology
* Patients with arrhythmia
* Patients with head tremors or head shaking.
18 Years
ALL
No
Sponsors
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Mindmaze SA
INDUSTRY
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
OTHER
Responsible Party
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Amélie Touillet
Principal Investigator
Principal Investigators
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Jean Paysant, Pr
Role: PRINCIPAL_INVESTIGATOR
UGECAM Nord Est
Locations
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Institut Régional de Médecine Physique et de Réadaptation
Nancy, , France
Countries
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Other Identifiers
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IRR-CLP-2019-4
Identifier Type: -
Identifier Source: org_study_id
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