Evaluation de l'efficacité Sur l'anxiété de l'Application numérique Musicale, Music Care® Versus MEOPA, Kalinox® Chez Des Patients bénéficiant d'Une Infiltration Lombaire scanoguidée. Etude Monocentrique contrôlée randomisée de Non infériorité en Ouvert.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Anxiety between groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •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
- •Patients with low back pain for whom scan-guided infiltration is indicated, whether at the foraminal level, posterior joints, pudendal, epidural, sacroiliac, or via the sacrococcygeal hiatus.
- •Patient with an anxiety score ≥ 35/100 based on the STAI-ETAT questionnaire
排除标准
- •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
- •Indication for epidural 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
研究组 & 干预措施
Music Care
干预措施: Music Care® device (Other)
Control
干预措施: EMONO (Other)
结局指标
主要结局
Anxiety between groups
时间窗: Day 0: before injection of corticosteroids
0-100 visual analog scale (VSA)
Anxiety between groups
时间窗: Baseline
0-100 visual analog scale (VSA)
Anxiety between groups
时间窗: Day 0: upon locating helix and a skin location
0-100 visual analog scale (VSA)
次要结局
- Patient satisfaction between groups(Day 0: Before discharge from imagery department)
- Patient comfort between groups(Day 0: After injection of corticosteroids)
- Patient-reported pain between groups(Day 0: After injection of corticosteroids)
- Satisfaction of radiographer between groups(Day 0)
- Rate of adverse events between groups(Day 0: immediately after procedure)
- Rate of complications between groups(Day 0: immediately after procedure)
- Patient-reported pain between groups(Day 0: Before injection of corticosteroids)
- Anxiety between groups according to type of injection (foraminal, pudendal or posterior articular)(Day 0: Before injection of corticosteroids)
- Anxiety between groups according to type of injection (foraminal, pudendal or posterior, articular, epidural, sacroiliac joints, and sacrococcygeal hiatus)(Day 0: After injection of corticosteroids)
- Rate of adverse events between groups(Day 0: During procedure)
- Rate of complications between groups(Day 0: During procedure)
