NCT04368572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

April 17, 2020

Last Update Submit

April 27, 2020

Conditions

Cognitive ImpairmentAlzheimer's Disease

Keywords

HypnosisLumbar punctureCognitive impairmentAlzheimer's DiseaseCerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pain assessed by the physician during the lumbar puncture using Algoplus© score

    1 day

  • Assessment of anxiety during the lumbar puncture according a visual analogue scale

    1 day

  • Assessment of anxiety during the lumbar puncture according a numeric scale

    1 day

  • 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

Study Arms (2)

lumbar puncture under hypnosis

EXPERIMENTAL

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

lumbar puncture without hypnosis

ACTIVE COMPARATOR

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

Interventions

HypnosisBEHAVIORAL

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

lumbar puncture under hypnosislumbar puncture without hypnosis

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Department, Bichat hospital

Paris, Île-de-France Region, 75018, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36056417DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Matthieu Lilamand, MD

    Geriatric Department, Bichat hospital

    STUDY CHAIR

Central Study Contacts

Anaïs Cloppet-Fontaine, MD

CONTACT

+33 (0) 185781010anais.cloppet@gerondif.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
the investigator will blindly collect the subject's self-rated pain and anxiety scales.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 30, 2020

Study Start

August 1, 2019

Primary Completion

May 1, 2020

Study Completion

June 1, 2020

Last Updated

April 30, 2020

Record last verified: 2020-04

Locations

FR(1)