Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity (MUSIBOT)

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Apr 3, 2025

Keywords

ClinConnect Summary

The MUSIBOT clinical trial is exploring whether listening to music can help reduce stress and pain during botulinum toxin injections, which are often used to treat muscle stiffness caused by conditions like stroke, multiple sclerosis, and spinal cord injuries. Many patients find these injections painful and stressful, and the study aims to see if a musical intervention can make the experience more comfortable. Participants will be able to choose their favorite style of music to listen to during the injections, and the researchers will measure how this music affects their stress levels, pain, and overall satisfaction with the treatment.

To be eligible for this study, participants must be adults experiencing muscle stiffness from neurological conditions and must be receiving botulinum toxin injections. They should also be able to understand the study and agree to participate. However, individuals with certain conditions, such as severe hearing problems or significant cognitive impairment, may not qualify. This study will take place over a maximum of four months, allowing researchers to see if repeated exposure to music during injections leads to better outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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