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

NCT ID: NCT04368572

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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).

Conditions

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Cognitive Impairment Alzheimer's Disease

Keywords

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Hypnosis Lumbar puncture Cognitive impairment Alzheimer's Disease Cerebrospinal fluid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
the investigator will blindly collect the subject's self-rated pain and anxiety scales.

Study Groups

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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

Group Type EXPERIMENTAL

Hypnosis

Intervention Type BEHAVIORAL

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 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.

Group Type ACTIVE_COMPARATOR

Hypnosis

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gérond'if

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu Lilamand, MD

Role: STUDY_CHAIR

Geriatric Department, Bichat hospital

Locations

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Geriatric Department, Bichat hospital

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Anaïs Cloppet-Fontaine, MD

Role: CONTACT

Phone: +33 (0) 185781010

Email: [email protected]

Facility Contacts

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Matthieu Lilamand, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36056417 (View on PubMed)

Other Identifiers

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2019-A00447-50

Identifier Type: -

Identifier Source: org_study_id