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

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

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Nimes
  Nîmes, France Recruiting

Study contacts

• Principal investigator: Florelle TERRA — Centre Hospitalier Universitaire de Nīmes
• Study coordinator: Florelle TERRA
• Email: florelle.terra@chu-nimes.fr
• Phone: 06.37.59.77.34

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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.