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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Clermont-Ferrand
NCT06920524 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). Tolerance of injections varies from patient to patient. For most patients, the pain experienced during the injection is a major source of stress. Numerous clinical trials have demonstrated the role of music therapy in pain management. Music therapy uses a "U" shaped technique, allowing the patient to relax in different phases. This system has demonstrated beneficial effects on pain and anxiety in various fields, such as chronic and acute pain, Alzheimer's disease, fibromyalgia and neurological pain. Given the painful nature of spasticity and anxiety treatment, we aim to use a musical intervention to help patients cope better with injections. The primary objective of the study is to investigate th

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📋 Eligibility rules (as published)
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
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What it tests

  • Intervention group IM-IM
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Where

1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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