Using music to reduce stress during botulinum toxin injections for spasticity
Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity
This study tests if listening to music during botulinum toxin injections can help adults with spasticity feel less pain and anxiety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06920524 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with spasticity of neurological origin who are eligible for botulinum toxin injections and experience pain or anxiety.
Not a fit: Patients with severe hearing impairments, major cognitive impairments, or those requiring sedation during injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the comfort and emotional well-being of patients receiving botulinum toxin injections.
How similar studies have performed: Previous studies have shown that music therapy can effectively reduce pain and anxiety in various medical contexts, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.