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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Comparison of the Efficacy of Hypnosis on Pain and Anxiety Versus Standard Care During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment

Conditions
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Cognitive Impairment, Alzheimer's Disease

Intervention / Treatment
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* Behavioral: Hypnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lumbar puncture under hypnosis<br>Hypnosis is the only act added by protocol to patients receiving a lumbar puncture as part of the etiological assessment of cognitive disorders | Behavioral: Hypnosis<br>* An interview assesses the patient's level of anxiety, interests and dissociative abilities. Hypnosis is done by following the steps: First step: reception and installation of the patient Second step: induction phase Third step: hypnotic trance phase Fourth step: reorientation phase<br>|
| Active Comparator: lumbar puncture without hypnosis<br>Lumbar puncture is performed by a physician assisted by a nurse or a psychologist who reassure the patient during the installation and the procedure. | Behavioral: Hypnosis<br>* An interview assesses the patient's level of anxiety, interests and dissociative abilities. Hypnosis is done by following the steps: First step: reception and installation of the patient Second step: induction phase Third step: hypnotic trance phase Fourth step: reorientation phase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported pain during the lumbar puncture | Pain is assessed by visual analogue scale, a self-reported pain rating scale (0 no pain to 10 worst pain) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed by the physician during the lumbar puncture using Algoplus© score | Algoplus© score is an acute pain-behaviour scale for older people with inability to communicate verbally (0 No pain to 30 worst pain) | 1 day | 
| Assessment of anxiety during the lumbar puncture according a visual analogue scale | Anxiety is evaluated by the patient with a visual analogue scale (0 No anxiety to 10 Worst anxiety) | 1 day | 
| Assessment of anxiety during the lumbar puncture according a numeric scale | Anxiety is evaluated by the physician with a numeric scale (0 No anxiety to 10 Worst anxiety) | 1 day | 
| Assessment of anxiety during the lumbar puncture by monitoring the heart rate |  | 1 day | 
| Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnosis, Lumbar puncture, Cognitive impairment, Alzheimer's Disease, Cerebrospinal fluid