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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
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2025 to Oct 21, 2025 · Completion date: Jun 2027 to Jun 2029 · Eligibility criteria shortened, about 20 words · 2 morev2 Show 5 more changesShow less
    • Start date changed from estimate of Jun 2025 to Oct 21, 2025
    • Completion date: Jun 2027 to Jun 2029
    • Eligibility criteria shortened, about 20 words
    • Secondary endpoints revised (11)
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06928740
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Conditions Low Back Pain, Anxiety
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov