Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06928740 | NOT YET RECRUITING | Low Back Pain

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

Nīmes University Hospital Center

Brief 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.

Condition or disease

Low Back Pain

Anxiety

Intervention/treatment

Music Care® device

EMONO

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 128 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Evaluation of efficiency on the anxiety of the digital musical application, Music Care® versus Meopa, Kalinox® in patients with a scanoguid lumbar infiltration. Randomized controlled monocentric study of open inferiority.
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
  • * Patient with low back pain and an indication for CT-guided foraminal, posterior joint, or pudendal injection
  • * 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
  • * Patient who has already received a CT-guided posterior articular, foraminal, epidural, or pudendal injection
  • * Indication for epidural or cervical 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
  • * Patient who has taken an anxiolytic medication within 24 hours prior to the injection
Efficacy on Anxiety of the Digital Music Application Versus Equimolar Mixture of Oxygen and Nitrous Oxide in Patients Receiving CT-guided Lumbar Infiltration

Location Details

NCT06928740

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

chu's NI MES

Nîmes, France,