Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06920524

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

Led by University Hospital, Clermont-Ferrand · Updated on 2025-05-23

80

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients, male or female, with spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) eligible for botulinum toxin injections
  • Patients with known pain and/or anxiety
  • Able to give informed consent to participate in research
  • Enrolled in a French Social Security system
Not Eligible

You will not qualify if you...

  • Contraindication to musical intervention such as severe hearing impairment, unstabilized psychotic disorders, or history of auditory trauma
  • Major cognitive impairment
  • Any medical condition deemed incompatible with the research by the investigator
  • Need for MEOPA sedation during botulinum toxin injection sessions
  • Use of medications or medical conditions affecting heart rate variability, including beta-blockers, anti-arrhythmics, anxiolytics, benzodiazepines, anti-hypertensives, and calcium antagonists
  • Pregnant or breastfeeding women
  • Refusal to participate

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU de Clermont-Ferrand

Clermont-Ferrand, France, 63000

Actively Recruiting

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Research Team

L

Lise Laclautre

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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