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Impact of Hypno-analgesia on Pain During a Lumbar Puncture for Diagnosis of Alzheimer's Disease

NCT03352024 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-11-24

No results posted yet for this study

Summary

One of the missions of the Memory of Resources and Research Center (CMRR) is to establish a diagnosis of expertise in patients with amestic, language or behavioral cognitive complaint. Thanks to the dosage of specific biomarkers in the cererbrospinal fluid (CSF), it is currently possible to determine the underlying process of the disease in vivo by assess the pathological amyloid and Tau profile. To obtain these very sensitive and specific biomarkers, clinicians need to perform lumbar puncture (LP). . This exam is easy and reproducible but the gesture image remained negative despite some advances in the materials and care..

Within the Department of Neurology of Montpellier, the recommendations of the Haute Autorité de Santé (HAS) about pain management in adults are applied. A transdermal device of lidocaine-pilocaine (type EMLA) is applied 120 minutes before the LP . In addition, an equimolar oxygen-nitrous oxide (MEOPA) mixture could be added. Then, patients benefit from a helping relationship before and during the gesture dedicated to reduce anxiety.

Until recently, non-medicinal techniques (relaxation, hypnosis ...) were not recommendedin cases of major anxiety or analgesia deemed insufficient. Many studies have shown the efficiency of hypnoalgia in invasive gestures in young children. The University Hospital of Montpellier have developed training about hypnoanalgesia and have been implemented for patients with neurological disorders in our unit. A reduction and even a suppression of pain and a limitation of the apprehension of the gesture have been judged satisfactory both for the patient, the practionner and the nurse practicing regularly the LP. However, this evalusation remained subjective and clinically-based. Thus, it seems relevantto analyse the effect of this technic in order th test the following hypothesis: hypno-analgesia (non-medicinal technique of care) associated with EMLA patch is more effective than the helping relationship associated with EMLA patch to reduce the pain that may inverse during the LP for diagnosis in patient with mild to moderate stage of Alzheimer's disease.

Conditions

Interventions

OTHER

Relational care

Relational care is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))

OTHER

Hypno-analgesia

Hypno-analgesia is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Audrey GABELLE, MD, PhD · CHU de Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2020-11-30
Completion
2020-11-13

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03352024 on ClinicalTrials.gov