Central Neurogical ImpairmentRVTOXNCT05364203
Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity (RVTOX)
A study testing DEEPSEN virtual reality mask in people with Central Neurogical Impairment, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Neurogical Impairment
- What is being tested?
- DEEPSEN virtual reality mask
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2022to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or breastfeeding women
- Patients under safeguard of justice
- Refusal of participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Central Neurogical Impairment
- Being tested
- DEEPSEN virtual reality mask
- Keywords
- central neurological impairment (stroke, multiple sclerosis), virtual reality mask, spasticity, botulinum toxin injections, stress, pain
- Medical subject headings
- Stroke, Multiple Sclerosis, Muscle Spasticity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEEPSEN virtual reality maskDevice
DEEPSEN virtual reality mask with 360 ° vision. The audio-visual content will be chosen by the patient.
| Study group | Role | What they receive |
|---|---|---|
| no intervention | No intervention | Injections were done as usual without mask. |
| Comparator | Active 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. Receives: Device: DEEPSEN virtual reality mask |
| Intervention | Experimental | Injections are made as in standard practice. We add the virtual reality mask with the image and the sound. Receives: Device: DEEPSEN virtual reality mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the procedure
Secondary outcomes (2)
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.
Measured: 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)]
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start10 May 2022
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Neurogical ImpairmentStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lech DOBIJA, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364203
- Sponsor's protocol ID
- RBHP 2021 PLAN PAQUET
- Other IDs
- 2021-A02631-40
- Acronym
- RVTOX
- Status last verified
- Oct 2024
- First submitted
- 27 Apr 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 37903608
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity
- ClinicalTrials.gov ID
- NCT05364203
- Acronym / sponsor ID
- RVTOX / RBHP 2021 PLAN PAQUET
- Conditions
- Central Neurogical Impairment
- Keywords
- central neurological impairment (stroke, multiple sclerosis), virtual reality mask, spasticity, botulinum toxin injections, stress, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| no intervention | No intervention | –Injections were done as usual without mask. |
| Comparator | Active comparator | Device: DEEPSEN virtual reality maskInjections 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 | Experimental | Device: DEEPSEN virtual reality maskInjections are made as in standard practice. We add the virtual reality mask with the image and the sound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEEPSEN virtual reality maskDEEPSEN virtual reality mask with 360 ° vision. The audio-visual content will be chosen by the patient. | Device | Comparator, Intervention |
Primary outcome
Heart rate variability (HRV) before injection and during the injections
Time frame: 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.
2 secondary outcomes
Effect on the pain induced by the injection
Time frame: during the procedure
Quality of the conditions for performing botulinum toxin injections
Time frame: during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 37903608Bougeard 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.
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lech DOBIJA principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEEPSEN virtual reality mask in people with Central Neurogical Impairment, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (HRV) before injection and during the injections (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05364203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.