Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419842
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-14
Brief Title:
Impact of Hypnosis for Performing Lumbar Infusion Tests
Sponsor:
Centre Hospitalier Universitaire Amiens
Organization:
Centre Hospitalier Universitaire Amiens
Study Overview
Official Title:
Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPNINF
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 09 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 patients 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
The objective is to evaluate the impact of hypnosis on anxiety pain and comfort during the lumbar infusion test
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None