NCT06928740

Efficacy on Anxiety of the Digital Music Application Versus Equimolar Mixture of Oxygen and Nitrous Oxide in Patients Receiving CT-guided Lumbar Infiltration

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Since the Covid-19 crisis, patients appear more stressed, with increasing fear of exams and the hospital environment, in particular for CT scan teams, which require injections. Currently, an equimolar mixture of oxygen and nitrous oxide (EMONO) is used to calm patients. However, the patient's prone position complicates its use, with patients sometimes in painful position and the discomfort of gas inhalation (nausea, dizziness, etc.), as well as reduced lung capacity. Greater patient anxiety increases the risk of complications, or even failure, (unexpected movement, stiffness, refusal to complete the procedure, etc.). In this study, music therapy using Music Care® tablets, was tested to replace EMONO. The study authors hypothesize that the use of the Music Care® device will have a comparable efficacy to that of EMONO (non-inferiority) in reducing patient anxiety during CT-guided lumbar infiltration. Furthermore, the study authors hypothesize that this simple, non-invasive method, with no contraindications for the patient, will be better tolerated and appreciated by both the patient and the paramedical team in charge of the treatment.

Conditions

• Low Back Pain
• Anxiety

Interventions

Type	Name	Description
OTHER	Music Care® device	Installation of the Music Care® device, selection of the sequence based on the patient's musical taste, listening to at least 20-minute sequence in the preparation room. Once placed on the scanner table, the patient listens to the same sequence as in the preparation room.
OTHER	EMONO	Equimolar mixture of oxygen and nitrous oxide given as usual care

Timeline

• Start date: 2025-10-21
• Primary completion: 2027-06-01
• Completion: 2029-06-01
• First posted: 2025-04-15
• Last updated: 2026-02-20

Locations

1 site across 1 country: France