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

NCT03352024 | Withdrawn

• 1 other identifier: 9731
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Cognitive Impairment; Alzheimer Disease

Keywords

neuro degenerative diseases; Alzheimer's disease; lumbar puncture; CSF; hypno analgesia; no drug care; pain; anxiety; counseling

Outcome Measures

Primary Outcomes (1)

• Algoplus score of pain during the LP procedure

  Evaluation of the pain during the Lumbar Punction procedure using the ALGOPLUS (Scale of behavioral evaluation of the pain on 30 points, 30 points being the worst pain) Scale assessment on the patients of each group

  1 day

Secondary Outcomes (5)

• Rate of failure of the Lumbar Ponction

  1 day

• Evaluation of the anxiety

  1 day

• Evaluation of the pain

  1 day

• Evaluation of the pain by the patient

  1 day

• Evaluation of the pain by the patient

  1 day

Study Arms (2)

Standard Care

OTHER

Relational care used to help the patient by reducing the fear and anxiety

Other: Relational care

Hypnosis

OTHER

Hypno-analgesia is used to help the patient by reducing the fear and anxiety

Other: Hypno-analgesia

Interventions

Relational care OTHER

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

Standard Care

Hypno-analgesia OTHER

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

Hypnosis

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient presenting clinical symptoms that may reflect Alzheimer's disease according to the criteria of NIA 2011, with either an isolated hippocampal episodic deficit or associated with dys-executive, phasic or praxic disorders of memory disorder, of insidious progressive evolution with a documented cognitive decline
• Global cognitive score with Mini Mental State MMS between 22 and 27;
• Age between 50 and 90 years ;
• Written and informed consent for this study signed by the patient

You may not qualify if:

• Refusal to have a LP procedure in the diagnosis process ;
• Refusal to participate in a session of hypno-analgesia;
• Refusal to be filmed during the LP ;
• Patient having already had a session of hypno-analgesia for other diagnostic assessments;
• Patient that done yoga or quite different technique of relaxation ;
• Socio-educational level not allowing the understanding of the neuropsychological tests;
• Not able to follow the majority of the aspects of the study without accompanying ;
• Refusal to sign the written and informed consent ;
• Patient deprived of freedom by court or administrative order

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Audrey GABELLE, MD, PhD

  CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 24, 2017
• Study Start: January 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 13, 2020
• Last Updated: November 24, 2020

Record last verified: 2017-11