Cognitive ImpairmentPOESYNCT04368572
Efficacy of Hypnosis on Pain and Anxiety During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
A study testing Hypnosis in people with Cognitive Impairment and Alzheimer's Disease, run by Gérond'if at 1 site in France.
Trial summary
Lumbar puncture is a diagnostic procedure performed as part of the etiological assessment of cognitive disorders. Despite good tolerance and very rare complications, lumbar puncture is still perceived as being painful or anxiety-provoking by patients. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to Jun 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years old
- Indication for a lumbar puncture for etiological diagnosis of cognitive impairment
- Understanding French Language
- Written and informed consent for this study signed by the patient
- Affiliated to Health Insurance
Who cannot join
- MMS< 17 or cognitive impairment not allowing informed consent
- Contraindication to lumbar puncture
- Refusal to sign the written and informed consent
- Patient deprived of freedom by court or administrative order
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Geriatric Department, Bichat hospital
Paris, Île-de-France Region, 75018
Matthieu Lilamand, MD, +33(0) 140257369, matthieu.lilamand@aphp.fr
About this study
Official title: Comparison of the Efficacy of Hypnosis on Pain and Anxiety Versus Standard Care During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
Lumbar puncture is a diagnostic procedure performed as part of the etiological assessment of cognitive disorders. Despite good tolerance and very rare complications, lumbar puncture is still perceived as being painful or anxiety-provoking by patients. Hypnosis could improve pain and anxiety when performing lumbar puncture.
Read the detailed description
Lumbar puncture is an invasive procedure potentially inducing pain and anxiety indicated in elderly patients for cognitive assessment. Indeed, the measure of amyloid biomarkers and tau in the cerebrospinal fluid is useful in the etiological diagnosis of cognitive disorders. With the ageing of the population and the increase incidence of cognitive disorders, this diagnostic procedure will be more and more frequent. Many studies have shown the efficiency of hypnosis during invasive procedure, especially in young children. The absence of side-effect is a major asset in elderly patients at high iatrogenic risk. It represents an interesting alternative to anxiolytic or sedative treatments. Nevertheless, its effectiveness in the elderly during lumbar puncture remains to be demonstrated. Investigators hypothesized that hypnosis may decrease pain and anxiety during lumbar puncture associated to setting comfort situation (relational care, music, transcutaneous anesthesia).
- Conditions
- Cognitive Impairment, Alzheimer's Disease
- Being tested
- Hypnosis
- Keywords
- Hypnosis, Lumbar puncture, Cognitive impairment, Alzheimer's Disease, Cerebrospinal fluid
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
An interview assesses the patient's level of anxiety, interests and dissociative abilities. Hypnosis is done by following the steps:
First step: reception and installation of the patient Second step: induction phase Third step: hypnotic trance phase Fourth step: reorientation phase
| Study group | Role | What they receive |
|---|---|---|
| lumbar puncture under hypnosis | Experimental | Hypnosis is the only act added by protocol to patients receiving a lumbar puncture as part of the etiological assessment of cognitive disorders Receives: Behavioral: Hypnosis |
| lumbar puncture without hypnosis | Active comparator | Lumbar puncture is performed by a physician assisted by a nurse or a psychologist who reassure the patient during the installation and the procedure. Receives: Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain during the lumbar puncture
Pain is assessed by visual analogue scale, a self-reported pain rating scale (0 "no pain" to 10 "worst pain")
Measured: 1 day
Secondary outcomes (5)
Pain assessed by the physician during the lumbar puncture using Algoplus© score
Algoplus© score is an acute pain-behaviour scale for older people with inability to communicate verbally (0 "No pain" to 30 "worst pain")
Measured: 1 day
Assessment of anxiety during the lumbar puncture according a visual analogue scale
Anxiety is evaluated by the patient with a visual analogue scale (0 "No anxiety" to 10 "Worst anxiety)
Measured: 1 day
Assessment of anxiety during the lumbar puncture according a numeric scale
Anxiety is evaluated by the physician with a numeric scale (0 "No anxiety" to 10 "Worst anxiety)
Measured: 1 day
Assessment of anxiety during the lumbar puncture by monitoring the heart rate
Measured: 1 day
Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response
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 posted30 Apr 2020
- Study start1 Aug 2019
- Primary completionMay 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Lilamand, MD, Study chair, Geriatric Department, Bichat hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368572
- Sponsor's protocol ID
- 2019-A00447-50
- Acronym
- POESY
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Courtois-Amiot P, Cloppet-Fontaine A, Poissonnet A, Benit E, Dauzet M, Raynaud-Simon A, Paquet C, Lilamand M. Hypnosis for pain and anxiety management in cognitively impaired older adults undergoing scheduled lumbar punctures: a randomized controlled pilot study. Alzheimers Res Ther. 2022 Sep 2;14(1):120. doi: 10.1186/s13195-022-01065-w.
PubMed 36056417
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Hypnosis on Pain and Anxiety Versus Standard Care During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04368572
- Acronym / sponsor ID
- POESY / 2019-A00447-50
- Conditions
- Cognitive Impairment, Alzheimer's Disease
- Keywords
- Hypnosis, Lumbar puncture, Cognitive impairment, Alzheimer's Disease, Cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 30 Apr 2020 (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.
Lumbar puncture is a diagnostic procedure performed as part of the etiological assessment of cognitive disorders. Despite good tolerance and very rare complications, lumbar puncture is still perceived as being painful or anxiety-provoking by patients. Hypnosis could improve pain and anxiety when performing lumbar puncture.
Detailed description
Lumbar puncture is an invasive procedure potentially inducing pain and anxiety indicated in elderly patients for cognitive assessment. Indeed, the measure of amyloid biomarkers and tau in the cerebrospinal fluid is useful in the etiological diagnosis of cognitive disorders. With the ageing of the population and the increase incidence of cognitive disorders, this diagnostic procedure will be more and more frequent. Many studies have shown the efficiency of hypnosis during invasive procedure, especially in young children. The absence of side-effect is a major asset in elderly patients at high iatrogenic risk. It represents an interesting alternative to anxiolytic or sedative treatments. Nevertheless, its effectiveness in the elderly during lumbar puncture remains to be demonstrated. Investigators hypothesized that hypnosis may decrease pain and anxiety during lumbar puncture associated to setting comfort situation (relational care, music, transcutaneous anesthesia).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbar puncture under hypnosis | Experimental | Behavioral: HypnosisHypnosis is the only act added by protocol to patients receiving a lumbar puncture as part of the etiological assessment of cognitive disorders |
| lumbar puncture without hypnosis | Active comparator | Behavioral: HypnosisLumbar puncture is performed by a physician assisted by a nurse or a psychologist who reassure the patient during the installation and the procedure. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 70 years old
- Indication for a lumbar puncture for etiological diagnosis of cognitive impairment
- Understanding French Language
- Written and informed consent for this study signed by the patient
- Affiliated to Health Insurance
Key exclusion criteria (4 listed)
- MMS< 17 or cognitive impairment not allowing informed consent
- Contraindication to lumbar puncture
- Refusal to sign the written and informed consent
- Patient deprived of freedom by court or administrative order
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 |
|---|---|---|
| HypnosisAn interview assesses the patient's level of anxiety, interests and dissociative abilities. Hypnosis is done by following the steps: First step: reception and installation of the patient Second step: induction phase Third step: hypnotic trance phase Fourth step: reorientation phase | Behavioural | lumbar puncture under hypnosis, lumbar puncture without hypnosis |
Primary outcome
Self-reported pain during the lumbar puncture
Time frame: 1 day
Pain is assessed by visual analogue scale, a self-reported pain rating scale (0 "no pain" to 10 "worst pain")
5 secondary outcomes
Pain assessed by the physician during the lumbar puncture using Algoplus© score
Time frame: 1 day
Assessment of anxiety during the lumbar puncture according a visual analogue scale
Time frame: 1 day
Assessment of anxiety during the lumbar puncture according a numeric scale
Time frame: 1 day
Assessment of anxiety during the lumbar puncture by monitoring the heart rate
Time frame: 1 day
Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Derived from this study: PubMed 36056417Courtois-Amiot P, Cloppet-Fontaine A, Poissonnet A, Benit E, Dauzet M, Raynaud-Simon A, Paquet C, Lilamand M. Hypnosis for pain and anxiety management in cognitively impaired older adults undergoing scheduled lumbar punctures: a randomized controlled pilot study. Alzheimers Res Ther. 2022 Sep 2;14(1):120. doi: 10.1186/s13195-022-01065-w.
- Individual participant dataSharing planned: Undecided
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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.
Matthieu Lilamand, MD study chair
Geriatric Department, Bichat hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Cognitive Impairment and Alzheimer's Disease, run by Gérond'if at 1 site in France.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anaïs Cloppet-Fontaine, MD (+33 (0) 185781010, anais.cloppet@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported pain during the lumbar puncture (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368572, which also lists 1 linked publication.
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 30 Apr 2020.