Tests music during botulinum toxin injections to ease stress in spasticity
Tests a musical intervention during botulinum toxin injections in adults with spasticity.
Key facts
- Who runs it
- University Hospital, Clermont-Ferrand
- Where
- Clermont-Ferrand, FranceSee the site
- Trial code
- Registry title
- Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity (MUSIBOT)
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 25 Apr 2025
- Expected to end
- 30 Oct 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Intervention group IM-IM
- Record updated
- 23 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with spasticity from a nerve condition, such as multiple sclerosis, stroke or head trauma. They must be getting botulinum toxin injections and have known pain or anxiety.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) that can be treated with botulinum toxin injections
- Earlier treatment
- Regular botulinum toxin injections for spasticity
Main reasons for not taking part
- Severe hearing impairment, unstabilized psychotic disorders or history of auditory trauma
- Major cognitive impairment
- Sedation with MEOPA needed during the injection sessions
- Taking beta-blockers, anti-arrhythmics, anxiolytics, benzodiazepines, anti-hypertensives or calcium antagonists
- Pregnant or breast-feeding women
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Indication for MEOPA sedation during botulinum toxin injection sessions
- Pregnant or breast-feeding women
- Refusal to participate
Where in France
- CHU de Clermont-FerrandClermont-Ferrand, FranceContact: Lise laclautreTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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).
The 2 groups in the trial
- Control group CT-IM : standard conditionNo study treatment, for comparison
The control group (CT-IM) will receive no special devices, apart from the Polar H10 heart rate monitor. This group will perform botulinum toxin injections as usual in the department, with the same assessments as the IM-IM group.
- Intervention group : IM-IMTreatment being tested
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity
- Plain-language title
- Tests music during botulinum toxin injections to ease stress in spasticityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Record updated
- 23 May 2025