Clinical Trial

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

Study acronym: MKI-TDM
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-08.
Status change: Not Yet Recruiting → Recruiting 2026-02-18
Trial Details
NCT Number NCT06928740
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions Low Back Pain, Anxiety
Enrollment 128 participants
Start Date 2025-10-21
Primary Completion 2027-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-20