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

  • STATUS
    Recruiting
  • End date
    Oct 30, 2024
  • participants needed
    42
  • sponsor
    University Hospital, Clermont-Ferrand
Updated on 5 June 2022

Summary

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.

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.

Details
Condition Central Neurogical Impairment
Treatment DEEPSEN virtual reality mask
Clinical Study IdentifierNCT05364203
SponsorUniversity Hospital, Clermont-Ferrand
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

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 guardianship or curatorship or safeguard of justice
Refusal of participation
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