Tablet-based music vs oxygen–nitrous oxide gas to reduce anxiety during CT-guided lumbar injections

Evaluation de l'efficacité Sur l'anxiété de l'Application numérique Musicale, Music Care® Versus MEOPA, Kalinox® Chez Des Patients bénéficiant d'Une Infiltration Lombaire scanoguidée. Etude Monocentrique contrôlée randomisée de Non infériorité en Ouvert.

This test tries to see if a tablet music program can calm adults with low back pain and anxiety during CT-guided lumbar injections as well as the usual oxygen–nitrous oxide gas (EMONO).

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (other)
• Locations: 1 site (Nîmes)
• Trial ID: NCT06928740 on ClinicalTrials.gov

What this trial studies

Adults with low back pain who have elevated anxiety (STAI ≥35) and are scheduled for CT-guided lumbar infiltration will receive either a Music Care® tablet intervention or the standard equimolar oxygen–nitrous oxide gas (EMONO) during the procedure. The trial is designed as a head-to-head comparison with a non-inferiority hypothesis that the music intervention will reduce procedural anxiety to a similar extent as EMONO. Outcomes will include changes in anxiety scores around the procedure, procedural tolerance, and any adverse effects such as nausea or dizziness. The approach aims to test a simple, non-invasive alternative to inhaled gas for improving patient comfort during prone CT-guided injections.

Who should consider this trial

Good fit: Adults with low back pain scheduled for CT-guided lumbar infiltration who have an anxiety score of at least 35 on the STAI, can hear and wear headphones, can give informed consent, and are covered by health insurance.

Not a fit: Patients who are deaf or hard of hearing, require an epidural injection, have contraindications to EMONO or cannot use headphones or a nasofacial mask are unlikely to benefit from the music intervention as tested here.

Why it matters

Potential benefit: If successful, the music tablet could offer similar anxiety relief without gas-related side effects, making the procedure more comfortable and easier to deliver.

How similar studies have performed: Previous studies have shown music can reduce anxiety for medical procedures, but replacing inhaled EMONO gas specifically during CT-guided lumbar infiltrations is relatively novel.

Eligibility criteria

Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patients with low back pain for whom scan-guided infiltration is indicated, whether at the foraminal level, posterior joints, pudendal, epidural, sacroiliac, or via the sacrococcygeal hiatus.
* Patient with an anxiety score ≥ 35/100 based on the STAI-ETAT questionnaire

Exclusion Criteria:

* The subject is participating in another drug or category I interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Indication for epidural injection
* Patient who is deaf or hard of hearing
* Contraindications to EMONO
* Facial or head trauma making it impossible to wear a nasofacial mask or headphones

Where this trial is running

Nîmes

• CHU de Nimes — Nîmes, France (RECRUITING)

Study contacts

• Principal investigator: Florelle TERRA — Centre Hospitalier Universitaire de Nīmes
• Study coordinator: Florelle TERRA

Conditions: Low Back Pain, Anxiety, Music therapy, Computerized tomography scan, ENOMO, Radiographer