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

Primary Purpose

Cognitive Impairment, Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
Gérond'if
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Impairment focused on measuring Hypnosis, Lumbar puncture, Cognitive impairment, Alzheimer's Disease, Cerebrospinal fluid

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geriatric Department, Bichat hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lumbar puncture under hypnosis

lumbar puncture without hypnosis

Arm Description

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 is performed by a physician assisted by a nurse or a psychologist who reassure the patient during the installation and the procedure.

Outcomes

Primary Outcome Measures

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")

Secondary Outcome Measures

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")
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)
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)
Assessment of anxiety during the lumbar puncture by monitoring the heart rate
Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response

Full Information

First Posted
April 17, 2020
Last Updated
April 27, 2020
Sponsor
Gérond'if
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1. Study Identification

Unique Protocol Identification Number
NCT04368572
Brief Title
Efficacy of Hypnosis on Pain and Anxiety During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gérond'if

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Alzheimer's Disease
Keywords
Hypnosis, Lumbar puncture, Cognitive impairment, Alzheimer's Disease, Cerebrospinal fluid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
the investigator will blindly collect the subject's self-rated pain and anxiety scales.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lumbar puncture under hypnosis
Arm Type
Experimental
Arm Description
Hypnosis is the only act added by protocol to patients receiving a lumbar puncture as part of the etiological assessment of cognitive disorders
Arm Title
lumbar puncture without hypnosis
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
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 Measure Information:
Title
Self-reported pain during the lumbar puncture
Description
Pain is assessed by visual analogue scale, a self-reported pain rating scale (0 "no pain" to 10 "worst pain")
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Pain assessed by the physician during the lumbar puncture using Algoplus© score
Description
Algoplus© score is an acute pain-behaviour scale for older people with inability to communicate verbally (0 "No pain" to 30 "worst pain")
Time Frame
1 day
Title
Assessment of anxiety during the lumbar puncture according a visual analogue scale
Description
Anxiety is evaluated by the patient with a visual analogue scale (0 "No anxiety" to 10 "Worst anxiety)
Time Frame
1 day
Title
Assessment of anxiety during the lumbar puncture according a numeric scale
Description
Anxiety is evaluated by the physician with a numeric scale (0 "No anxiety" to 10 "Worst anxiety)
Time Frame
1 day
Title
Assessment of anxiety during the lumbar puncture by monitoring the heart rate
Time Frame
1 day
Title
Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anaïs Cloppet-Fontaine, MD
Phone
+33 (0) 185781010
Email
anais.cloppet@gerondif.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu Lilamand, MD
Organizational Affiliation
Geriatric Department, Bichat hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Geriatric Department, Bichat hospital
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu Lilamand, MD
Phone
+33(0) 140257369
Email
matthieu.lilamand@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36056417
Citation
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.
Results Reference
derived

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

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