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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368572
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Alzheimer's Disease Behavioral: Hypnosis Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: the investigator will blindly collect the subject's self-rated pain and anxiety scales.
Primary Purpose: Supportive Care
Official Title: Comparison of the Efficacy of Hypnosis on Pain and Anxiety Versus Standard Care During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: lumbar puncture under hypnosis
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

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


Active Comparator: lumbar puncture without 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.
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





Primary Outcome Measures :
  1. Self-reported pain during the lumbar puncture [ Time Frame: 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 :
  1. Pain assessed by the physician during the lumbar puncture using Algoplus© score [ Time Frame: 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")

  2. Assessment of anxiety during the lumbar puncture according a visual analogue scale [ Time Frame: 1 day ]
    Anxiety is evaluated by the patient with a visual analogue scale (0 "No anxiety" to 10 "Worst anxiety)

  3. Assessment of anxiety during the lumbar puncture according a numeric scale [ Time Frame: 1 day ]
    Anxiety is evaluated by the physician with a numeric scale (0 "No anxiety" to 10 "Worst anxiety)

  4. Assessment of anxiety during the lumbar puncture by monitoring the heart rate [ Time Frame: 1 day ]
  5. Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368572


Contacts
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Contact: Anaïs Cloppet-Fontaine, MD +33 (0) 185781010 anais.cloppet@gerondif.org

Locations
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France
Geriatric Department, Bichat hospital Recruiting
Paris, Ile-de-France, France, 75018
Contact: Matthieu Lilamand, MD    +33(0) 140257369    matthieu.lilamand@aphp.fr   
Sponsors and Collaborators
Gérond'if
Investigators
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Study Chair: Matthieu Lilamand, MD Geriatric Department, Bichat hospital
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Responsible Party: Gérond'if
ClinicalTrials.gov Identifier: NCT04368572    
Other Study ID Numbers: 2019-A00447-50
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gérond'if:
Hypnosis
Lumbar puncture
Cognitive impairment
Alzheimer's Disease
Cerebrospinal fluid
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders