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

Not Applicable

Active, not recruiting

• Conditions: Central Neurogical Impairment
• Interventions: Device: DEEPSEN virtual reality mask

• Registration Number: NCT05364203
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Study Start: 2022-05-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14
• Primary Completion: 2024-06-22
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Comparator	DEEPSEN virtual reality mask	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.
Intervention	DEEPSEN virtual reality mask	Injections are made as in standard practice. We add the virtual reality mask with the image and the sound.

Primary Outcome Measures

Name	Time	Method
Heart rate variability (HRV) before injection and during the injections	during the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Effect on the pain induced by the injection	during the procedure	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.
Quality of the conditions for performing botulinum toxin injections	during the procedure	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 \[on a 5-point Likert type scale points (conditions extremely bad/poor/neither bad nor good/good/extremely good)\]

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France