Cognitive ImpairmentPLHYMANEDENCT03352024
Impact of Hypno-analgesia on Pain During a Lumbar Puncture for Diagnosis of Alzheimer's Disease
A study testing Relational care and Hypno-analgesia in people with Cognitive Impairment and Alzheimer Disease, run by University Hospital, Montpellier.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Relational care and Hypno-analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to 13 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
About this study
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.
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.
Read the 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.
- Conditions
- Cognitive Impairment, Alzheimer Disease
- Being tested
- Relational care, Hypno-analgesia
- Keywords
- neuro degenerative diseases, Alzheimer's disease, lumbar puncture, CSF, hypno analgesia, no drug care, pain, anxiety, counseling
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relational careOther
Relational care is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))
Hypno-analgesiaOther
Hypno-analgesia is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Other | Relational care used to help the patient by reducing the fear and anxiety Receives: Other: Relational care |
| Hypnosis | Other | Hypno-analgesia is used to help the patient by reducing the fear and anxiety Receives: Other: Hypno-analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 1 day
Evaluation of the pain by the patient
assessed by the scales EVA (Visual analog scale)
Measured: 1 day
Evaluation of the pain by the patient
assessed by the scales EVS (Simple Verbal scale)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionNov 2020 (estimated)
- Study completion13 Nov 2020 (estimated)
Why it stopped: internal organizational problem and dysfunction of study material
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey GABELLE, MD, PhD, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352024
- Sponsor's protocol ID
- 9731
- Acronym
- PLHYMANEDE
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03352024
- Acronym / sponsor ID
- PLHYMANEDE / 9731
- Conditions
- Cognitive Impairment, Alzheimer Disease
- Keywords
- neuro degenerative diseases, Alzheimer's disease, lumbar puncture, CSF, hypno analgesia, no drug care, pain, anxiety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: internal organizational problem and dysfunction of study material
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- 13 Nov 2020 (estimated)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Other | Other: Relational careRelational care used to help the patient by reducing the fear and anxiety |
| Hypnosis | Other | Other: Hypno-analgesiaHypno-analgesia is used to help the patient by reducing the fear and anxiety |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relational careRelational care is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®)) | Other | Standard Care |
| Hypno-analgesiaHypno-analgesia is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®)) | Other | Hypnosis |
Primary outcome
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
5 secondary outcomes
Rate of failure of the Lumbar Ponction
Time frame: 1 day
Evaluation of the anxiety
Time frame: 1 day
Evaluation of the pain
Time frame: 1 day
Evaluation of the pain by the patient
Time frame: 1 day
Evaluation of the pain by the patient
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey GABELLE, MD, PhD principal investigator
CHU de Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing Relational care and Hypno-analgesia in people with Cognitive Impairment and Alzheimer Disease, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algoplus score of pain during the LP procedure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.