MedTrace Logo

Impact of Hypnosis for Performing Lumbar Infusion Tests

NCT06419842 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-22

No results posted yet for this study

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

OTHER

hypnosis

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.

OTHER

comfort

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2026-05-31
Completion
2026-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419842 on ClinicalTrials.gov