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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Consultation (PC) | Active Comparator | These patients have a consultation with the radiologist prior to the intervention, including an interview about their medical history and symptoms, a clinical examination, a review of the imaging file, an explanation of the procedure, and the opportunity to ask questions. |
|
| Teleconsultation (TC) | Active Comparator | These patients have a teleconsultation with the radiologist prior to the intervention, including an interview about their medical history and symptoms, a review of the imaging file, an explanation of the procedure, and the opportunity to ask questions. |
|
| No Consultation (NC) | Active Comparator | These patients not have a consultation prior to the procedure: The radiologist reviews the imaging file remotely. The explanation of the procedure is provided through documents, and questions are answered only on the day of the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal injection | Procedure | Patients underwent a spinal injection procedure under CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days after the surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days after the surgical procedure |
| Assessment of Intervention Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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
Legally protected population:
Not affiliated with a social security scheme or not benefiting from such a scheme
Participation in another research study with an ongoing exclusion period
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxme PASTOR, MD | Contact | 06 72 32 79 83 | +33 | maxime-pastor@chu-montpellier.fr |
| Catherine CYTEVAL, MD PhD | Contact | c-cyteval@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Maxime PASTOR, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Montpellier | Recruiting | Montpellier | Occitnaie | 34295 | France |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| pre-operative consultation | Other | Pre-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. |
|
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 |
| Patient anxiety will be assessed at Day 0, just before the invervention |
| 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. | The Medication Consumption will be recorded throughout the study (120 days) |
| 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. | before the procedure |
| The Numeric Pain Rating Scale (NPRS) | 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 | To assess short-term pain 15 days after the surgical procedure |
| The Numeric Pain Rating Scale (NPRS) | 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 | To assess short-term pain 90 days after the surgical procedure |