Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity (RVTOX)

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2024-12-02

Brief Summary

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The main objective of the study is to investigate the effect of exposure to a virtual reality session during botulinum toxin injections on injection-induced stress.

The secondary objectives are to study the effect of exposure to a virtual reality session during botulinum toxin injections, on the pain induced by the injection. And study the evolution of the effects of virtual reality with the repetition of the sessions.

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Detailed Description

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Botulinum toxin injections is very frequently used in the treatment of spasticity after central neurological damage (stroke, multiple sclerosis, spinal cord injury, head trauma). The injections may be painful and the tolerance of the injections varies from one patient to another. The pain felt during the injection causes in most patients great stress during the injection.

Virtual reality is a video technique with 360 ° vision simulating the physical presence of the patient in an "existing" environment outside the hospital setting. This technique has been used in painful procedures but only one publication, in pediatrics, has shown a decrease in pain and agitation during botulinum toxin injections.

The hypothesis of this research is that an immersive virtual reality system can, in adults, reduce stress and the painful experience of botulinum toxin injections.

Conditions

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Central Neurogical Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Patients will be selected during the physical medicine and rehabilitation consultation of the MPR department. They will be given the protocol newsletter. After their agreement to participate in the study, the following data will then be collected: age, sex, pathology, date of the first botulinum toxin injection. Randomization can then take place. The injections will be performed in day hospitalization. During the 1st injection, no particular device will be used. The following injections will be performed with the mask off or with virtual reality will be the randomization scheme.

The stress before, during and after the 1st and the last injection will be measured at each session by collecting the frequency variability by a heart rate monitor or equivalent, in four stages, at rest, before the procedure, during the procedure and after the procedure), during the 1st and last injection at each session. Pain during injection will be assessed using a vertical visual analogue scale.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

The processing of the heart rate data will be carried out blind from the device used. Indeed, the investigator must not be aware of the device used during the session so as not to have an influence and draw hasty conclusions.

Study Groups

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no intervention

Injections were done as usual without mask.

Group Type NO_INTERVENTION

No interventions assigned to this group

Comparator

Injections are made as in standard practice. The virtual reality headset is added to the patient. In this case, there is no image or sound. The mask is off.

Group Type ACTIVE_COMPARATOR

DEEPSEN virtual reality mask

Intervention Type DEVICE

DEEPSEN virtual reality mask with 360 ° vision. The audio-visual content will be chosen by the patient.

Intervention

Injections are made as in standard practice. We add the virtual reality mask with the image and the sound.

Group Type EXPERIMENTAL

DEEPSEN virtual reality mask

Intervention Type DEVICE

DEEPSEN virtual reality mask with 360 ° vision. The audio-visual content will be chosen by the patient.

Interventions

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DEEPSEN virtual reality mask

DEEPSEN virtual reality mask with 360 ° vision. The audio-visual content will be chosen by the patient.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patient, male or female, suffering from spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) and eligible for treatment by botulinum toxin injection
* Able to give an informed consent to participate in research
* Affiliation to Social Security.

Exclusion Criteria

* Contraindication to virtual reality (epilepsy, schizophrenia, strabismus, amblyopia, anisometropia, local contraindication to wearing a helmet (lesion of the face or the skull)
* Major cognitive disorders
* Any medical condition deemed by the investigator to be incompatible with the research.
* Indication of sedation by MEOPA during botulinum toxin injection sessions.
* Patients who have already experienced virtual reality
* Drug treatment or medical condition that may affect heart rate variability
* Pregnant or breastfeeding women
* Patients under safeguard of justice
* Refusal of participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No