Status:
RECRUITING
Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity (MUSIBOT)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Stroke
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Botulinum toxin (BT) injections are a painful treatment frequently used to treat spasticity following central neurological damage (stroke, multiple sclerosis, spinal cord injury, head trauma). Toleran...
Eligibility Criteria
Inclusion
- Adult patients, male or female, suffering from spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) and eligible for botulinum toxin injection treatments.
- Patients with known pain and/or anxiety
- Able to give informed consent to participate in research
- Enrolled in a French Social Security system
Exclusion
- Contraindication to musical intervention (severe hearing impairment, unstabilized psychotic disorders, history of auditory trauma)
- Major cognitive impairment
- Any medical condition deemed by the investigator to be incompatible with the research.
- Indication for MEOPA sedation during botulinum toxin injection sessions
- Medication or medical conditions likely to interfere with heart rate variability during the study: beta-blockers, anti-arrhythmics, anxiolytics, benzodiazepines, anti-hypertensives and calcium antagonists.
- Pregnant or breast-feeding women
- Refusal to participate
Key Trial Info
Start Date :
April 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06920524
Start Date
April 25 2025
End Date
October 30 2027
Last Update
May 23 2025
Active Locations (1)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000