Using music to reduce stress during botulinum toxin injections for spasticity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of a musical intervention on patients undergoing botulinum toxin injections for spasticity caused by neurological conditions such as stroke and multiple sclerosis. The intervention aims to alleviate pain and anxiety associated with the injections by employing a structured music therapy approach. Participants will be exposed to music during their injection sessions to assess its effectiveness in improving their overall experience and tolerance of the procedure. The study focuses on adult patients who are eligible for botulinum toxin treatments and have reported pain or anxiety.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting

Study contacts

• Principal investigator: Marina BADIN — University Hospital, Clermont-Ferrand
• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.