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

NCT05364203

CompletedNA

Sponsor: University Hospital, Clermont-Ferrand

Conditions: Central Neurogical Impairment

Interventions: DEEPSEN virtual reality mask

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Clermont-Ferrand, France, France