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

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ClinicalTrials.gov Identifier: NCT03352024
Recruitment Status : Withdrawn (internal organizational problem and dysfunction of study material)
First Posted : November 24, 2017
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Cognitive Impairment Alzheimer Disease Other: Relational care Other: Hypno-analgesia Not Applicable

Detailed Description:

The main objective was to assess whether the use of hypnoanalgesia technic during the LP procedure comparing to commun procedure reduce the pain of the patient evaluated by the hetero-evaluation ALGOPLUS scale.

Secondary objectives were to evaluate the differences between the hypno-analgesia and the helping relationship on:

  • pain assessed by the Simple Verbal Scale (EVS);
  • pain assessed by the Visual Analog Scale (EVA);
  • pain and stress measured by conductance analysis;
  • the anxiety score assessed by a STAI self-assessment questionnaire (State-Trait Anxiety Inventory, STAI-Y);
  • the rate of failure during the LP procedure.

Methodology :

A monocentric randomized controlled, open-label (with an evaluation of the blind randomization of the randomization arm) with two parallel arms:

  • the arm named "hypno-analgesia + EMLA patch" = cutaneous anesthesia associated with hypno-analgesia.
  • the arm called "helping relationship + EMLA patch" = cutaneous anesthesia associated with a helping relationship The estimated number of patients was 100. Analysis of the primary outcome measure: The score of the ALGOPLUS scale will compared between the two groups of patients using the Chi2 test after checking the validity conditions of the test.

The project will last 36 months and the duration of the inclusions 24 months. The LP will be carried out during one day of hospitalization as part of the diagnosis assessments. No specific follow-up is scheduled.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of Hypno-analgesia, Non-drugs Technique of Care, on Pain That May Inverve During a Lumbar Puncture for Diagnosis of Patient With Mild to Moderate Alzheimer's Dementia.
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 13, 2020


Arm Intervention/treatment
Standard Care
Relational care used to help the patient by reducing the fear and anxiety
Other: Relational care
Relational care is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))

Hypnosis
Hypno-analgesia is used to help the patient by reducing the fear and anxiety
Other: Hypno-analgesia
Hypno-analgesia is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))




Primary Outcome Measures :
  1. Algoplus score of pain during the LP procedure [ Time Frame: 1 day ]
    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


Secondary Outcome Measures :
  1. Rate of failure of the Lumbar Ponction [ Time Frame: 1 day ]
    This outcome is defined by the incapacity to perform the Lumbar Punction or by the incapacity to collect 12 ml of CSF (cererbrospinal fluid) therefore is defined by the number of the Lumbar Punction aborted

  2. Evaluation of the anxiety [ Time Frame: 1 day ]
    Assessed by an self-completed questionnaire STAI (State-Trait Anxiety Inventory, STAI-Y-A) done before and after the Lumbar Punction and oriented on the anxiety during the LP

  3. Evaluation of the pain [ Time Frame: 1 day ]
    assessed by the Pain monitorTM . The threshold is fixed in 0.2 pic/seconds over whom it is considered that pain is present

  4. Evaluation of the pain by the patient [ Time Frame: 1 day ]
    assessed by the scales EVA (Visual analog scale)

  5. Evaluation of the pain by the patient [ Time Frame: 1 day ]
    assessed by the scales EVS (Simple Verbal scale)



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352024


Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Audrey GABELLE, MD, PhD CHU de Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03352024    
Other Study ID Numbers: 9731
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
neuro degenerative diseases
Alzheimer's disease
lumbar puncture
CSF
hypno analgesia
no drug care
pain
anxiety
counseling
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders