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

NCT ID: NCT04368572

Last Updated: 2020-04-30

Basic Information

• 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

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).

Conditions

Cognitive Impairment; Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

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

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

Gérond'if

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu Lilamand, MD

Role: STUDY_CHAIR

Geriatric Department, Bichat hospital

Locations

Geriatric Department, Bichat hospital

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Anaïs Cloppet-Fontaine, MD

Role: CONTACT

anais.cloppet@gerondif.org

+33 (0) 185781010

Facility Contacts

Matthieu Lilamand, MD

Role: primary

matthieu.lilamand@aphp.fr

+33(0) 140257369

References

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

2019-A00447-50

Identifier Type: -

Identifier Source: org_study_id