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

CompletedNot a drug-phase studyMS (type not specified)NCT05364203

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • DEEPSEN virtual reality mask

What it measured

Main measures

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

    during the procedure

Other measures (2)

  • Effect on the pain induced by the injection

    during the procedure

    Pain
  • Quality of the conditions for performing botulinum toxin injections

    during the procedure

Who could take part

MS (type not specified) · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      May 2022

    2. Main results due

      Dec 2024

    3. Finished

      Dec 2024

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