An interventional study of Relational care and Hypno-analgesia in Cognitive Impairment and Alzheimer Disease, sponsored by University Hospital, Montpellier. Withdrawn. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Supportive care
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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.
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:
Methodology :
A monocentric randomized controlled, open-label (with an evaluation of the blind randomization of the randomization arm) with two parallel arms:
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.
3,875 studies on the registry are indexed under Cognitive Dysfunction; 1,121 are open to participants now.
Browse Cognitive Dysfunction studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relational care used to help the patient by reducing the fear and anxiety
Other: Relational care
Hypno-analgesia is used to help the patient by reducing the fear and anxiety
Other: Hypno-analgesia
Relational care is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))
Hypno-analgesia is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))
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
Time frame: 1 day
Rate of failure of the Lumbar Ponction
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
Time frame: 1 day
Evaluation of the anxiety
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
Time frame: 1 day
Evaluation of the pain
assessed by the Pain monitorTM . The threshold is fixed in 0.2 pic/seconds over whom it is considered that pain is present
Time frame: 1 day
Evaluation of the pain by the patient
assessed by the scales EVA (Visual analog scale)
Time frame: 1 day
Evaluation of the pain by the patient
assessed by the scales EVS (Simple Verbal scale)
Time frame: 1 day
No study locations are listed for this record.
Start is estimated for Jan 2018; primary completion for Nov 2020, 34 months later.
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This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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