Impact of Hypnosis for Performing Lumbar Infusion Tests

Pain Clinical Trial

— HYPNINF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06419842
• Other study ID #: PI2023_843_0149
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Laurence JANIAK, APRN
• Phone: 0322088943
• Email: janiak.laurence[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Hydrocephalus
• Hypnosis
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in anxiety in group 1compared to the other groups	Decrease in anxiety in group 1 compared to the other groups	2 years
Secondary	Decrease in pain in group 1	Decrease in pain on the numerical scale in group 1 versus other groups	2 years
Secondary	Increase in comfort in group 1	Increase in comfort on the numerical scale in group 1 versus the other groups	2 years
Secondary	Better overall patient impression in group 1 versus other groups	Better overall patient impression (Likert scale) in group 1 versus other groups	2 years
Secondary	Less heart rate variation in group 1 versus other groups	Less heart rate variation in group 1 versus other groups	2 years
Secondary	Decreased puncture time required in group 1 versus other groups	Decreased puncture time required in group 1 versus other groups	2 years
Secondary	fewer position changes required in group 1 versus other groups	fewer position changes required in group 1 versus other groups	2 years