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

RecruitingNot a drug-phase studyMS (type not specified)NCT06920524

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Intervention group IM-IM

What it measured

Main measures

  • Stress

    Baseline

    Walking and mobility

Other measures (6)

  • Stress

    3 months

  • Intensity of pain

    Baseline and 3 months

    Pain
  • Variation of anxiety

    Baseline and 3 months

    Mood and sleep
  • Measurement of perception of session time

    Baseline and 3 months

  • Patient satisfaction with the procedure

    Baseline and 3 months

    Quality of life (reported by participants)
  • Quality of the conditions under which botulinum toxin injections

    Baseline and 3 months

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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).

Papers

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History

    1. Started

      Apr 2025

    2. Main results due

      Oct 2027

    3. Finished

      Oct 2027

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