Impact of Hypnosis for Performing Lumbar Infusion Tests

NCT06419842 | Recruiting

• 1 other identifier: PI2023_843_0149
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Hypnosis; Hydrocephalus; Anxiety; Pain

Keywords

hypnosis; infusion study; Hydrocephalus; Anxiety; Pain

Outcome Measures

Primary Outcomes (1)

• Decrease in anxiety in group 1compared to the other groups

  Decrease in anxiety in group 1 compared to the other groups

  2 years

Secondary Outcomes (6)

• Decrease in pain in group 1

  2 years

• Increase in comfort in group 1

  2 years

• Better overall patient impression in group 1 versus other groups

  2 years

• Less heart rate variation in group 1 versus other groups

  2 years

• Decreased puncture time required in group 1 versus other groups

  2 years

Study Arms (3)

hypnosis

EXPERIMENTAL

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

comfort

SHAM COMPARATOR

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

standard

NO INTERVENTION

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.

Interventions

hypnosis OTHER

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.

hypnosis

comfort OTHER

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.

comfort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Hydrocephalus; Anxiety Disorders; Pain

Interventions

Hypnosis; methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Laurence JANIAK, APRN

CONTACT

0322088943; janiak.laurence@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 14, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)