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

University Hospital, Clermont-Ferrand42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Central Neurogical Impairment

Interventions

DEEPSEN virtual reality maskDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

CHU Clermont-Ferrand

Clermont-Ferrand, France, France

Outcomes

Primary Outcomes

Heart rate variability (HRV) before injection and during the injections

The stress measurement is carried out using a watch and a belt (heart rate monitor) which, thanks to several parameters, will allow us to carry out an HRV analysis on the KUBIOS software.

Time frame: during the procedure

Secondary Outcomes

Effect on the pain induced by the injection

At the end of the injections, the doctor asks the patient to give a score between 0 (no pain) and 10 (the worst pain), in order to give an idea of the pain felt during the botulinum toxin injections.

Time frame: during the procedure

Quality of the conditions for performing botulinum toxin injections

Estimate by the doctor immediately after the end of the session \[by a simple numerical scale (ENS) ranging from 0 ("extremely bad conditions") to 10 ("extremely good conditions")\] or \[on a 5-point Likert type scale points (conditions extremely bad/poor/neither bad nor good/good/extremely good)\]

Time frame: during the procedure

Data from ClinicalTrials.gov

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