NCT05364203Completed
Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity (RVTOX)
Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 27 Apr 2022
- Start date
- 10 May 2022
- Primary completion date
- 2 Dec 2024
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Stroke, Multiple sclerosis
- NCT number
- NCT05364203
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 10 May 2022 to the primary completion date, 2 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Drug treatment or medical condition that may affect heart rate variability
Other
- Indication of sedation by MEOPA during botulinum toxin injection sessions.
- Patients who have already experienced virtual reality
- Pregnant or breastfeeding women
- Patients under safeguard of justice
- Refusal of participation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.