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

University Hospital, Clermont-Ferrand

Status: Active, not recruiting

Conditions: Central Neurogical Impairment

Treatments: Device: DEEPSEN virtual reality mask

Study type: Interventional

Funder types: Other

Identifiers

NCT05364203

RBHP 2021 PLAN PAQUET

2021-A02631-40 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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42 participants in 3 patient groups

no intervention

No Intervention group

Description:

Injections were done as usual without mask.

Comparator

Active Comparator group

Description:

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.

Treatment:

Device: DEEPSEN virtual reality mask

Intervention

Experimental group

Description:

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

Treatment:

Device: DEEPSEN virtual reality mask