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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lumbar puncture under hypnosis | Experimental | Hypnosis is the only act added by protocol to patients receiving a lumbar puncture as part of the etiological assessment of cognitive disorders |
|
| lumbar puncture without hypnosis | Active Comparator | Lumbar puncture is performed by a physician assisted by a nurse or a psychologist who reassure the patient during the installation and the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis | Behavioral | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anaïs Cloppet-Fontaine, MD | Contact | +33 (0) 185781010 | anais.cloppet@gerondif.org |
| Name | Affiliation | Role |
|---|---|---|
| Matthieu Lilamand, MD | Geriatric Department, Bichat hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric Department, Bichat hospital | Recruiting | Paris | ÃŽle-de-France Region | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36056417 | Derived | 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. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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the investigator will blindly collect the subject's self-rated pain and anxiety scales.
|
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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D004191 |
| Behavioral Disciplines and Activities |