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

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

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.

Study Overview

• Status: Completed
• Conditions: Central Neurogical Impairment
• Intervention / Treatment: Device: DEEPSEN virtual reality mask

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • France
    • Clermont-Ferrand, France, France
      • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)]	during the procedure

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Lech DOBIJA, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• Bougeard M, Hauret I, Pelletier-Visa M, Plan-Paquet A, Givron P, Badin M, Pereira B, Lanhers C, Coudeyre E. Use of immersive virtual reality for stress reduction during botulinum toxin injection for spasticity (RVTOX): a study protocol of a randomised control trial. BMJ Open. 2023 Oct 30;13(10):e066726. doi: 10.1136/bmjopen-2022-066726.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): December 2, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: pain; stress; spasticity; central neurological impairment (stroke, multiple sclerosis); virtual reality mask; botulinum toxin injections
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Muscle Spasticity; Stroke; Multiple Sclerosis
• Other Study ID Numbers: RBHP 2021 PLAN PAQUET; 2021-A02631-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No