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

Primary Purpose

Central Neurogical Impairment

Status

Active

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

DEEPSEN virtual reality mask

About this trial

This is an interventional supportive care trial for Central Neurogical Impairment focused on measuring central neurological impairment (stroke, multiple sclerosis), virtual reality mask, spasticity, botulinum toxin injections, stress, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

no intervention

Comparator

Intervention

Arm Description

Injections were done as usual without 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)]

Full Information

NCT ID

NCT05364203

First Posted

April 27, 2022

Last Updated

August 9, 2023

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT05364203

Brief Title

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

Acronym

RVTOX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 10, 2022 (Actual)

Primary Completion Date

June 22, 2024 (Anticipated)

Study Completion Date

October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Neurogical Impairment

Keywords

central neurological impairment (stroke, multiple sclerosis), virtual reality mask, spasticity, botulinum toxin injections, stress, pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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.

Masking

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.

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

no intervention

Arm Type

No Intervention

Arm Description

Injections were done as usual without mask.

Arm Title

Comparator

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

DEEPSEN virtual reality mask

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Effect on the pain induced by the injection

Description

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

Title

Quality of the conditions for performing botulinum toxin injections

Description

Time Frame

during the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lech DOBIJA

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the provisions concerning data confidentiality that are available to those responsible for the quality control of biomedical research, all researchers with direct access to the data will take the necessary precautions to ensure the confidentiality of information (participant identification and results). All data collected will be anonymized. Our study will be continued by the investigator and a second article with the results will be published. Dissemination of the results of this study will be through peer-reviewed publications, and national and international conferences

Learn more about this trial

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

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