RAdiology Consultation Effectiveness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
Performing a consultation with the radiologist before a spinal invasive procedure serves to foster a trusting physician-patient relationship. It also provides an opportunity for the comprehensive explanation of the procedure, its aftermath, and any patient inquiries. We believe that this proactive approach has the potential to alleviate pre-procedure anxiety, thereby contributing to an enhanced overall experience of the intervention and its outcomes. Despite these potential benefits, it is noteworthy that such consultations are not systematically implemented, and their impact on the intervention effictness remains unexplored in existing literature.
The hypothesis is grounded in the belief that patients who perform a consultation preceding their spinal intervention are likely to witness improvements in both the overall experience of the procedure and its effectiveness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient 18 years of age or older
Referred to the imaging department for a peri-spinal injection under CT guidance.
Low back pain, dorsal pain, or neck pain with an average pain intensity of ≥ 5/10 on NPRS.
Disqualifiers
Patient unable to read and/or write French
Patient unable to condut a teleconsultation (no phone, no internet connection)
Current pregnancy, breastfeeding, or lack of effective contraception for women of childbearing age
Lack of consent
Trial design
Design model
Parallel
Treatments tested in this trial
Spinal injection
Procedure/SurgeryPatients underwent a spinal injection procedure under CT scan
pre-operative consultation
Other interventionPre-operative consultation, in person or by teleconsultation, consists of an interview about the patient's history and symptoms. This is followed by a clinical examination and consultation of the patient's imaging file, to confirm the request for paraspinal infiltration and its location. In addition, the radiologist explains the procedure to the patient, supplementing the explanatory documents already provided at the time of the appointment, and outlines the results that may be expected and any complications.
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: Physical Consultation (PC)Active comparator 2 interventions
Group B: Teleconsultation (TC)Active comparator 2 interventions
Group C: No Consultation (NC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups
Measuring pain on a numerical scale is a common method used to assess and communicate the intensity of a person's pain. The Numeric Pain Rating Scale (NPRS) is a numerical scale ranging from 0 to 10, where 0 represents no pain, and 10 represents the worst imaginable pain. Patients are asked to rate their pain by choosing a number that best reflects their current level of pain. Interpretation: 0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
Time frame
30 days after the surgical procedureSecondary outcomes
1
Patient satisfaction with care
Satisfaction survey for healthcare is crucial to understanding the experiences of patients : The patient will be asked if he is satisfied: his medical care ( yes/no) If no : why and the arm to which he would have liked to belong
Time frame
30 days after the surgical procedure2
Assessment of Intervention Anxiety
The level of patient anxiety measured using a standardized anxiety scale (State-Trait Anxiety Inventory) The questionnaire includes 2 separate scales to assess state anxiety (how subjects feel now) and trait anxiety (how subjects usually feel). Each scale comprises 20 items. each item is rated from 0 to 3, so each scale is rated from 0 to 60, the higher the score, the greater the anxiety
Time frame
Patient anxiety will be assessed at Day 0, just before the invervention3
Assessment of Medication Consumption
The total quantity and frequency of analgesic, anti-inflammatory (NSAIDs), corticosteroid, and anxiolytic medications consumed by patients, recorded through patient self-reports and medical records.
Time frame
The Medication Consumption will be recorded throughout the study (120 days)4
Assessment of Procedure-Symptom Adequacy Improvement
The percentage of procedures deemed fully adequate for the patient's symptoms and imaging, as determined by the radiologist's evaluation.
Time frame
before the procedureSponsors and contacts
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Source ClinicalTrials.gov