Efficacy of Hypnosis on Pain and Anxiety During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
- Conditions
- Alzheimer's DiseaseCognitive Impairment
- Interventions
- Behavioral: Hypnosis
- Registration Number
- NCT04368572
- Lead Sponsor
- Gérond'if
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lumbar puncture without hypnosis Hypnosis Lumbar puncture is performed by a physician assisted by a nurse or a psychologist who reassure the patient during the installation and the procedure. lumbar puncture under hypnosis Hypnosis Hypnosis is the only act added by protocol to patients receiving a lumbar puncture as part of the etiological assessment of cognitive disorders
- Primary Outcome Measures
Name Time Method Self-reported pain during the lumbar puncture 1 day Pain is assessed by visual analogue scale, a self-reported pain rating scale (0 "no pain" to 10 "worst pain")
- Secondary Outcome Measures
Name Time Method Pain assessed by the physician during the lumbar puncture using Algoplus© score 1 day Algoplus© score is an acute pain-behaviour scale for older people with inability to communicate verbally (0 "No pain" to 30 "worst pain")
Assessment of anxiety during the lumbar puncture according a visual analogue scale 1 day Anxiety is evaluated by the patient with a visual analogue scale (0 "No anxiety" to 10 "Worst anxiety)
Assessment of anxiety during the lumbar puncture according a numeric scale 1 day Anxiety is evaluated by the physician with a numeric scale (0 "No anxiety" to 10 "Worst anxiety)
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
Trial Locations
- Locations (1)
Geriatric Department, Bichat hospital
🇫🇷Paris, Ile-de-France, France