Efficacy of Hypnosis on Pain and Anxiety During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment (POESY)

Gérond'if

Status: Unknown

Conditions: Alzheimer's Disease; Cognitive Impairment

Treatments: Behavioral: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04368572

2019-A00447-50

Details and patient eligibility

About

Lumbar puncture is a diagnostic procedure performed as part of the etiological assessment of cognitive disorders. Despite good tolerance and very rare complications, lumbar puncture is still perceived as being painful or anxiety-provoking by patients. Hypnosis could improve pain and anxiety when performing lumbar puncture.

Full description

Lumbar puncture is an invasive procedure potentially inducing pain and anxiety indicated in elderly patients for cognitive assessment. Indeed, the measure of amyloid biomarkers and tau in the cerebrospinal fluid is useful in the etiological diagnosis of cognitive disorders. With the ageing of the population and the increase incidence of cognitive disorders, this diagnostic procedure will be more and more frequent. Many studies have shown the efficiency of hypnosis during invasive procedure, especially in young children. The absence of side-effect is a major asset in elderly patients at high iatrogenic risk. It represents an interesting alternative to anxiolytic or sedative treatments. Nevertheless, its effectiveness in the elderly during lumbar puncture remains to be demonstrated. Investigators hypothesized that hypnosis may decrease pain and anxiety during lumbar puncture associated to setting comfort situation (relational care, music, transcutaneous anesthesia).

Enrollment: 60 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 70 years old
• Indication for a lumbar puncture for etiological diagnosis of cognitive impairment
• Understanding French Language
• Written and informed consent for this study signed by the patient
• Affiliated to Health Insurance

Exclusion criteria

• MMS< 17 or cognitive impairment not allowing informed consent
• Contraindication to lumbar puncture
• Refusal to sign the written and informed consent
• Patient deprived of freedom by court or administrative order

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

lumbar puncture under hypnosis

Experimental group

Description:

Hypnosis is the only act added by protocol to patients receiving a lumbar puncture as part of the etiological assessment of cognitive disorders

Treatment:

Behavioral: Hypnosis

lumbar puncture without hypnosis

Active Comparator group

Description:

Lumbar puncture is performed by a physician assisted by a nurse or a psychologist who reassure the patient during the installation and the procedure.

Treatment:

Behavioral: Hypnosis