Clinical trial NCT05364203: Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity (RVTOX)
Official title: Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Central Neurogical Impairment
Keywords: central neurological impairment (stroke, multiple sclerosis)
virtual reality mask
spasticity
botulinum toxin injections
stress
pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Heart rate variability (HRV) before injection and during the injections
timeFrame: during the procedure
Secondary outcomes:
measure: Effect on the pain induced by the injection
timeFrame: during the procedure
measure: Quality of the conditions for performing botulinum toxin injections
timeFrame: during the procedure
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Lech DOBIJA
role: PRINCIPAL_INVESTIGATOR
References: