RecruitingNot ApplicableNCT06920524

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

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


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

80 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

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). 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 study the effect of exposure to a musical intervention session, during injections visit n°2, in order to evaluate the effect of repeated exposure to a musical intervention session, 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 physician at the end of the session. The hypothesis of this research is that a responsive musical intervention can, in adults, reduce the stress induced by botulinum toxin injections. Patients will be selected from the cohort of patients regularly treated for botulinum toxin injections in the Physical and Rehabilitation Medicine (PRM) department at Clermont-Ferrand University Hospital. Botulinum toxin injections will take place in the PRM department. Each patient will participate in the study for a maximum of 4 months. This study will be carried out in patients receiving regular botulinum toxin injections to treat spasticity. The first injection will be given with (IM-IM) or without musical intervention (CT-IM), depending on the randomization group, followed by the next injection with musical intervention. Patients will be able to choose the style of music (Jazz, Classical, Electronic, R\&B, Ambient, Rock, etc.) that appeals to them in order to benefit from a minimum 20-minute session of musical intervention (duration varying according to the number of injections to be performed).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether listening to music during botulinum toxin (Botox) injections for muscle spasticity can reduce stress, pain, and anxiety. Spasticity is muscle stiffness caused by neurological conditions like MS, stroke, or brain injury, and the injections can be uncomfortable. **You may be eligible if...** - You are an adult (male or female) with spasticity caused by a neurological condition (such as MS, stroke, or head trauma) - You are scheduled to receive botulinum toxin injections - You experience pain and/or anxiety related to these injections - You are enrolled in French Social Security **You may NOT be eligible if...** - You have severe hearing impairment - You have an unstabilized psychotic disorder or history of hearing trauma - You have major cognitive impairment - You require sedation (MEOPA) during your injections - You take medications that may affect heart rate variability Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntervention group IM-IM

The intervention group (IM-IM) will receive a tablet and headphones to listen to music during the toxin injections. Then, during the waiting time, the patient, with or without assistance, will choose the music they wish to listen to, according to their musical tastes. The duration of the music can be modulated according to the duration of the medical procedure to follow.


Locations(1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

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NCT06920524


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