Status:
NOT_YET_RECRUITING
Efficacy on Anxiety of the Digital Music Application Versus Equimolar Mixture of Oxygen and Nitrous Oxide in Patients Receiving CT-guided Lumbar Infiltration
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Low Back Pain
Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06928740
Start Date
June 1 2025
End Date
June 1 2027
Last Update
April 15 2025
Active Locations (1)
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1
CHU de Nimes
Nîmes, France