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

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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

Tracking Information
First Submitted Date  ICMJE April 17, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
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")
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • 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")
  • 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)
  • 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)
  • Assessment of anxiety during the lumbar puncture by monitoring the heart rate [ Time Frame: 1 day ]
  • Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Hypnosis on Pain and Anxiety During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
Official Title  ICMJE Comparison of the Efficacy of Hypnosis on Pain and Anxiety Versus Standard Care During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Cognitive Impairment
  • Alzheimer's Disease
Intervention  ICMJE 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

Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Hypnosis
  • 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.
    Intervention: Behavioral: Hypnosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anaïs Cloppet-Fontaine, MD +33 (0) 185781010 anais.cloppet@gerondif.org
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04368572
Other Study ID Numbers  ICMJE 2019-A00447-50
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gérond'if
Study Sponsor  ICMJE Gérond'if
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Matthieu Lilamand, MD Geriatric Department, Bichat hospital
PRS Account Gérond'if
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP