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RecruitingNCT06419842

Impact of Hypnosis for Performing Lumbar Infusion Tests

Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests.

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERhypnosisthe 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.
OTHERcomfortthe 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.

Timeline

Start date
2024-05-14
Primary completion
2026-05-01
Completion
2026-07-01
First posted
2024-05-17
Last updated
2024-05-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06419842. Inclusion in this directory is not an endorsement.