Condition: Stroke · Multiple Sclerosis · Spinal Cord Injury · Sponsor: University Hospital, Clermont-Ferrand
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 the effect of exposure to a musical intervention session during botulinum toxin injections, on injection-induced stress (heart rate variability). Secondary objectives: To study the effect of exposure to a musical intervention session during botulinum toxin injections, during the visit to injections #1, in terms of: * Injection-induced stress for HRV parameters other than LF/HF * Injection-induced pain * Injection anxiety * Patient satisfaction * Effect of musical intervention on the medical procedure performed (botulinum toxin injections) expressed by the doctor at the end of the session. To…
This description comes directly from the study's public registry record.
Lise Laclautre · +33473754963 · promo_interne_drci@chu-clermontferrand.fr
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| CHU de Clermont-Ferrand | Clermont-Ferrand, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06920524