Clinical trial NCT06419842: Impact of Hypnosis for Performing Lumbar Infusion Tests
Official title: Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypnosis
Hydrocephalus
Anxiety
Pain
Keywords: hypnosis
infusion study
Hydrocephalus
Anxiety
Pain
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient over 65 years old undergoing assessment for suspected CAH in day hospitalization for a lumbar infusion test
* No major cognitive impairment (MMSE\>20)

Exclusion Criteria:

* Patient less than 65 years old
* Major cognitive impairment (MMSE\<20)
* History of lumbar surgery
* Contraindication to lumbar puncture or infusion test
* Hearing impairment

Primary outcomes:
measure: Decrease in anxiety in group 1compared to the other groups
timeFrame: 2 years
Secondary outcomes:
measure: Decrease in pain in group 1
timeFrame: 2 years
measure: Increase in comfort in group 1
timeFrame: 2 years
measure: Better overall patient impression in group 1 versus other groups
timeFrame: 2 years
measure: Less heart rate variation in group 1 versus other groups
timeFrame: 2 years
measure: Decreased puncture time required in group 1 versus other groups
timeFrame: 2 years
measure: fewer position changes required in group 1 versus other groups
timeFrame: 2 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References: