Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Decrease in anxiety in group 1compared to the other groups
研究概览
简要总结
Infusion tests are now the gold standard for the diagnosis of chronic adult hydrocephalus (CAH), also known as normal pressure hydrocephalus. It is an invasive procedure using the same approach as a lumbar puncture. Once the intrathecal puncture is performed, the intracranial pressure is measured in lateral decubitus via a pressure head. Dynamic tests (injection of 0.9% NaCl at a constant flow rate) are performed after recording the basal pressure. This type of test lasts 30 to 45 minutes in lateral decubitus. Patients with CAH have cognitive-behavioral disorders that can alter the gesture and its interpretation in case of movements or contractures. Movement artefacts lead to a longer recording time. The longer the test, the more the patients' tolerance tends to decrease. Moreover, the patient's feeling towards this test is important because it may have to be repeated. Pain, anxiety and patient comfort are essential parameters to consider. Non-medicinal techniques (hypnosis, music therapy) have shown a tendency to reduce anxiety in pediatric and adult populations with an impact on instantaneous anxiety but also on personality-related anxiety. Most studies are focused on specific pathologies, primarily in palliative care, or on pediatric application. The use of these techniques in an elderly population with mild cognitive-behavioral disorders has not been explored.
The objective is to evaluate the impact of hypnosis on anxiety, pain and comfort during the lumbar infusion test.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 65 years old undergoing assessment for suspected CAH in day hospitalization for a lumbar infusion test
- •No major cognitive impairment (MMSE>20)
排除标准
- •Patient less than 65 years old
- •Major cognitive impairment (MMSE<20)
- •History of lumbar surgery
- •Contraindication to lumbar puncture or infusion test
- •Hearing impairment
研究组 & 干预措施
hypnosis
In group 1, the patient benefits from a dedicated nurse consultation. During this consultation, the nurse will explain the highlights of the hospitalization, the procedure and anticipate the hypnosis technique to be used. The technique chosen during the consultation will be applied during the test. The nurse is positioned at the head of the patient and with physical contact.
干预措施: hypnosis (Other)
comfort
In group 2, the patient benefits from a nurse consultation. Non-medicinal techniques are not offered. During the infusion test, the nurse will be positioned at the patient's head allowing proximity but without oral or physical intervention.
干预措施: comfort (Other)
standard
In group 3, the IDE consultation is performed according to the same modalities as in group 2. During the procedure, the nurse will be out of the patient's field of vision and will assist the surgeon in the installation behind the patient. Only the surgeon will interact with the patient.
结局指标
主要结局
Decrease in anxiety in group 1compared to the other groups
时间窗: 2 years
Decrease in anxiety in group 1 compared to the other groups
次要结局
- Decrease in pain in group 1(2 years)
- Better overall patient impression in group 1 versus other groups(2 years)
- Increase in comfort in group 1(2 years)
- Less heart rate variation in group 1 versus other groups(2 years)
- Decreased puncture time required in group 1 versus other groups(2 years)
- fewer position changes required in group 1 versus other groups(2 years)