Clinical trial NCT06920524: Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity (MUSIBOT)
Official title: Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Multiple Sclerosis
Spinal Cord Injury
Head Trauma Injury
Keywords: Musical intervention
Pain Management
stress
Botulinum toxin
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the first visit, consent will be obtained from the patient or guardian, followed by data collection (age, sex, pathology, date of first injection). Randomization will take place after this stage. All injections will follow the same protocol (tracking technique, MYOBOT 26G needle, ice analgesia on request). A Polar H10 heart rate monitor will measure the stress induced by the medical procedure. Before the injection, the patient will complete the STAI-Y1 anxiety questionnaire.The control group (CT-IM) will receive only the heart rate monitor, and will receive injections as usual. The intervention group (IM-IM) will be provided with a tablet and headphones to listen to selected music before the injection. At the end, all patients will rate their pain (VAS 0-10), anxiety (STAI-Y1) and satisfaction. Their perception of time will be compared with the actual duration of the medical procedure.At the second visit (M3±1 month), all patients will have access to music before the injection.
Primary purpose: OTHER

Brief 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 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

Primary outcomes:
measure: Stress
timeFrame: Baseline
measure: Stress
timeFrame: Baseline
Secondary outcomes:
measure: Stress
timeFrame: 3 months
measure: Intensity of pain
timeFrame: Baseline and 3 months
measure: Variation of anxiety
timeFrame: Baseline and 3 months
measure: Measurement of perception of session time
timeFrame: Baseline and 3 months
measure: Patient satisfaction with the procedure
timeFrame: Baseline and 3 months
measure: Quality of the conditions under which botulinum toxin injections
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Marina BADIN
role: PRINCIPAL_INVESTIGATOR
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