Clinical Trial

Impact of Hypnosis for Performing Lumbar Infusion Tests

Study acronym: HYPNINF
Unknown
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Record status
This record was last updated May 22, 2024 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-09
Trial Details
NCT Number NCT06419842
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Conditions Hypnosis, Hydrocephalus, Anxiety, Pain
Enrollment 90 participants
Start Date 2024-05-14
Primary Completion 2026-05 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2024-05-22