Impact of Interventional Radiology Consultation on the Spinal Infiltrations Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
- •Adults protected by law (guardianship, curatorship, or judicial protection)
- •Non-emancipated minors
- •Individuals unable to express consent (research conducted in emergency situations)
- •Individuals deprived of liberty (by judicial or administrative decision, or involuntary hospitalization)
- •Not affiliated with a social security scheme or not benefiting from such a scheme
- •Participation in another research study with an ongoing exclusion period
结局指标
主要结局
Comparison of the Numeric Pain Rating Scale (NPRS) between the 3 groups
时间窗: 30 days after the surgical procedure
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
次要结局
- The Numeric Pain Rating Scale (NPRS)(To assess short-term pain 90 days after the surgical procedure)
- Patient satisfaction with care(30 days after the surgical procedure)
- Assessment of Intervention Anxiety(Patient anxiety will be assessed at Day 0, just before the invervention)
- Assessment of Medication Consumption(The Medication Consumption will be recorded throughout the study (120 days))
- Assessment of Procedure-Symptom Adequacy Improvement(before the procedure)