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

Alzheimer's Disease Clinical Trial

— POESY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368572
• Other study ID #: 2019-A00447-50
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 2020

Study information

• Verified date: April 2020
• Source: Gérond'if
• Contact: Anaïs Cloppet-Fontaine, MD
• Phone: +33 (0) 185781010
• Email: anais.cloppet[@]gerondif.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Behavioral:
• Hypnosis
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

Locations

Country	Name	City	State
France	Geriatric Department, Bichat hospital	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Assessment of anxiety during the lumbar puncture by monitoring the heart rate		1 day
Secondary	Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response		1 day