Clinical trial NCT04368572: Efficacy of Hypnosis on Pain and Anxiety During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
Official title: Comparison of the Efficacy of Hypnosis on Pain and Anxiety Versus Standard Care During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Alzheimer's Disease
Keywords: Hypnosis
Lumbar puncture
Cognitive impairment
Alzheimer's Disease
Cerebrospinal fluid
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported pain during the lumbar puncture
timeFrame: 1 day
Secondary outcomes:
measure: Pain assessed by the physician during the lumbar puncture using Algoplus© score
timeFrame: 1 day
measure: Assessment of anxiety during the lumbar puncture according a visual analogue scale
timeFrame: 1 day
measure: Assessment of anxiety during the lumbar puncture according a numeric scale
timeFrame: 1 day
measure: Assessment of anxiety during the lumbar puncture by monitoring the heart rate
timeFrame: 1 day
measure: Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Geriatric Department, Bichat hospital
state: Ile-de-France
Study officials:
affiliation: Geriatric Department, Bichat hospital
name: Matthieu Lilamand, MD
role: STUDY_CHAIR
References:
citation: Courtois-Amiot P, Cloppet-Fontaine A, Poissonnet A, Benit E, Dauzet M, Raynaud-Simon A, Paquet C, Lilamand M. Hypnosis for pain and anxiety management in cognitively impaired older adults undergoing scheduled lumbar punctures: a randomized controlled pilot study. Alzheimers Res Ther. 2022 Sep 2;14(1):120. doi: 10.1186/s13195-022-01065-w.