Actively Recruiting
Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2024-05-22
90
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the impact of hypnosis on anxiety, pain, and comfort during lumbar infusion tests in adults over 65 years old suspected of having chronic adult hydrocephalus (CAH), also known as normal pressure hydrocephalus. CAH patients often have cognitive-behavioral issues that can affect test interpretation, and current infusion tests are invasive and may cause discomfort. Non-medicinal techniques like hypnosis have shown promise in reducing anxiety in other populations, but their use in elderly patients with mild cognitive impairments has not been explored. Participants are randomly assigned to one of three groups. Group 1 receives a dedicated nurse consultation where hypnosis techniques are explained and applied during the lumbar infusion test, with the nurse physically present at the patient's head. Group 2 has a nurse consultation without hypnosis, and during the test, the nurse stays close but does not interact physically or verbally. Group 3 also receives consultation without hypnosis, but the nurse stays out of the patient's view during the test, with only the surgeon interacting with the patient. During the study, researchers will measure anxiety reduction as the primary outcome over two years, along with secondary outcomes such as pain levels, patient comfort, overall impression, heart rate variation, puncture time, and number of position changes. The lumbar infusion test involves measuring intracranial pressure and injecting saline at a constant rate, lasting 30 to 45 minutes. Participants will be monitored throughout the test to assess these outcomes and the impact of hypnosis on patient experience.
CONDITIONS
Brief Title
Impact of Hypnosis for Performing Lumbar Infusion Tests
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 65 years old undergoing assessment for suspected chronic adult hydrocephalus in day hospitalization for a lumbar infusion test
- No major cognitive impairment with MMSE above 20
You will not qualify if you...
- Patient younger than 65 years old
- Major cognitive impairment with MMSE below 20
- History of lumbar surgery
- Contraindication to lumbar puncture or infusion test
- Hearing impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day hospitalization
Participants receive a nurse consultation followed by a lumbar infusion test with varying levels of nurse interaction depending on group assignment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Actively Recruiting
Research Team
L
Laurence JANIAK, APRN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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