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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Recruiting

CT.gov ID

NCT05364203

Collaborator

(none)

Enrollment

Location

Arms

29.7

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Neurogical Impairment	Device: DEEPSEN virtual reality mask	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

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.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.

Masking:

Single (Investigator)

Masking Description:

The processing of the heart rate data will be carried out blind from the device used. Indeed, the investigator must not be aware of the device used during the session so as not to have an influence and draw hasty conclusions.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 10, 2022

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

Oct 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: no intervention Injections were done as usual without mask.
Active Comparator: Comparator 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.	Device: DEEPSEN virtual reality mask DEEPSEN virtual reality mask with 360 ° vision. The audio-visual content will be chosen by the patient.
Experimental: Intervention Injections are made as in standard practice. We add the virtual reality mask with the image and the sound.	Device: DEEPSEN virtual reality mask DEEPSEN virtual reality mask with 360 ° vision. The audio-visual content will be chosen by the patient.

Arm

Intervention/Treatment

No Intervention: no intervention

Injections were done as usual without mask.

Active Comparator: Comparator

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.

Device: DEEPSEN virtual reality mask

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

Experimental: Intervention

Injections are made as in standard practice. We add the virtual reality mask with the image and the sound.

Device: DEEPSEN virtual reality mask

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

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.