Impact of Hypnosis for Performing Lumbar Infusion Tests (HYPNINF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety; Hypnosis; Hydrocephalus
• Intervention / Treatment: Other: hypnosis; Other: comfort

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurence JANIAK, APRN; Phone Number: 0322088943; Email: janiak.laurence@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Contact: Laurence JANIAK, APRN; Phone Number: 0322088943; Email: janiak.laurence@chu-amiens.fr
      • Sub-Investigator: Cyril CAPEL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient over 65 years old undergoing assessment for suspected CAH in day hospitalization for a lumbar infusion test
• No major cognitive impairment (MMSE>20)

Exclusion Criteria:

• Patient less than 65 years old
• Major cognitive impairment (MMSE<20)
• History of lumbar surgery
• Contraindication to lumbar puncture or infusion test
• Hearing impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hypnosis; In group 1, 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: 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.
Sham Comparator: comfort; In group 2, 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.	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.
No Intervention: standard; In group 3, the IDE consultation is performed according to the same modalities as in group 2. During the procedure, the nurse will be out of the patient's field of vision and will assist the surgeon in the installation behind the patient. Only the surgeon will interact with the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in anxiety in group 1compared to the other groups	Decrease in anxiety in group 1 compared to the other groups	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in pain in group 1	Decrease in pain on the numerical scale in group 1 versus other groups	2 years
Increase in comfort in group 1	Increase in comfort on the numerical scale in group 1 versus the other groups	2 years
Better overall patient impression in group 1 versus other groups	Better overall patient impression (Likert scale) in group 1 versus other groups	2 years
Less heart rate variation in group 1 versus other groups	Less heart rate variation in group 1 versus other groups	2 years
Decreased puncture time required in group 1 versus other groups	Decreased puncture time required in group 1 versus other groups	2 years
fewer position changes required in group 1 versus other groups	fewer position changes required in group 1 versus other groups	2 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Anxiety; hypnosis; Hydrocephalus; infusion study
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: PI2023_843_0149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No