Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID06419842

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Intervention

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

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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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