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Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials (HYPOT)

Primary Purpose

Neuropathy;Peripheral

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnorelaxation
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuropathy;Peripheral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient aged ≥ 18 years
  • Patient who was prescribed PES
  • French speaking patient
  • Patient affiliated to a social security scheme
  • Patient having given oral, free, informed and express consent

Exclusion Criteria:

  • Patient with severe pathologies of the peripheral nerve
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Pregnant woman
  • Patient denies
  • Psychotic patient

Sites / Locations

  • Groupe Hospitalier Paris Saint-Joseph

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Somatosensory evoked potentials without hypnorelaxation

Somatosensory evoked potentials with hypnorelaxation

Arm Description

As part of this research, the patient must complete a pain scale and a Spielberger Stay-A anxiety self-assessment questionnaire before the PES examination. Somatosensory evoked potentials are carried out according to the usual management.

As part of this research, the patient must complete a pain scale and a Spielberger Stay-A anxiety self-assessment questionnaire before the PES examination. Hypno-relaxation is induced by following VAKOG: external sensory identification, fixation of attention, bodily sensation, breathing, sensory perceptions, closing of the eyes. The work phase follows induction and allows deepening of the hypnotic trance. It corresponds to a metaphorical narrative associated with post-hypnotic suggestions and is fueled by the construction of suggestions and metaphors. The protocol is adapted to each patient. The investigator who remains present throughout the duration of the examination, maintains a hypnotic, empathetic, attentive attitude, and makes it possible to recover this material. The investigator, thanks to hypnosis, allows the development of a creative imagination which allows a modification of the relation to space and time.

Outcomes

Primary Outcome Measures

duration of the somatosensory evoked potentials
This correspond to the duration of the somatosensory evoked potentials exam in minuts, between the 2 groups.

Secondary Outcome Measures

Quality of the somatosensory evoked potentials
This outcome corresponds to the number of averages used to realize the somatosensory evoked potentials exam.

Full Information

First Posted
December 30, 2019
Last Updated
April 26, 2023
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT04218448
Brief Title
Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials
Acronym
HYPOT
Official Title
Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
PI's decision
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
April 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Somatosensory evoked potentials corresponds to a neurophysiological exam that studies the functioning of the sensitivity pathways. It is often complementary to the imaging examination (MRI or scanner) and the electroneuromyogram which studies only the peripheral part of the sensory and motor pathways while the somatosensory evoked potentials are interested in their central and peripheral component. The studied information are the potentials generated in the nervous system by the presentation of sensory stimulation. The examination makes it possible to study conduction times which will be defined as normal or pathological according to standards established on control subjects. Their indication is multiple: study of the repercussions of cervical osteoarthritis, specify the diagnosis of certain neuropathies, study of the conduction pathways at the medullary level in the event of trauma or inflammatory or other lesion. In our study, the investigators will only be interested in the somatosensory evoked Potentials. A study has shown that hypnotic suggestions to reduce the unpleasantness of pain triggered by thermal stimulation lead to a selective reduction of activity in the anterior cingulate cortex without modifying the activation of the somesthetic cortex. Pain is, like all sensory stimulation, subject to the influences of attention, anticipation, mental imagery, previous conditioning. The fronto-cingular areas, activated by analgesics such as morphine, or by cortical stimulation are the same as those used by non-drug techniques such as hypnosis. Therapeutic hypnosis is "a relational experience bringing into play physiological and psychological mechanisms allowing the individual to live better, reduce or eliminate an acute or chronic painful pathology" (Definition of Doctor Jean Marc Benhaiem). The study of somatosensory evoked Potentials is a long examination (90 to 120 minutes), which can be uncomfortable for the patient (patient lying down, immobile and relaxed), not having to contract his muscles, especially if he is already painful due to his pathology or if it is difficult for him to remain motionless in the supine position. It is indeed necessary to average around 600 to 1000 responses (number of averages) to a small electrical simulation on each member studied. The muscular contractions of an anxious and/or painful patient prolong the duration of the examination or even disturb the results, to the point of making it impossible to interpret the examination. To our knowledge, hypnosis has already been used to improve muscle relaxation and reduce anxiety and pain during electromyograms, but hypnosis has never been used to improve the outcome of somatosensory evoked Potentials. Furthermore, if hypnosis modifies certain late cortical waves, it does not cause modification of the early waves and therefore does not disturb the results expected in our clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy;Peripheral

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Somatosensory evoked potentials without hypnorelaxation
Arm Type
No Intervention
Arm Description
As part of this research, the patient must complete a pain scale and a Spielberger Stay-A anxiety self-assessment questionnaire before the PES examination. Somatosensory evoked potentials are carried out according to the usual management.
Arm Title
Somatosensory evoked potentials with hypnorelaxation
Arm Type
Experimental
Arm Description
As part of this research, the patient must complete a pain scale and a Spielberger Stay-A anxiety self-assessment questionnaire before the PES examination. Hypno-relaxation is induced by following VAKOG: external sensory identification, fixation of attention, bodily sensation, breathing, sensory perceptions, closing of the eyes. The work phase follows induction and allows deepening of the hypnotic trance. It corresponds to a metaphorical narrative associated with post-hypnotic suggestions and is fueled by the construction of suggestions and metaphors. The protocol is adapted to each patient. The investigator who remains present throughout the duration of the examination, maintains a hypnotic, empathetic, attentive attitude, and makes it possible to recover this material. The investigator, thanks to hypnosis, allows the development of a creative imagination which allows a modification of the relation to space and time.
Intervention Type
Other
Intervention Name(s)
Hypnorelaxation
Intervention Description
Hypno-relaxation is induced by following VAKOG: external sensory identification, fixation of attention, bodily sensation, breathing, sensory perceptions, closing of the eyes. The work phase follows induction and allows deepening of the hypnotic trance. It corresponds to a metaphorical narrative associated with post-hypnotic suggestions and is fueled by the construction of adapted suggestions and metaphors, adapted to each patient. The investigator who remains present throughout the duration of the examination, maintains a hypnotic, empathetic, attentive attitude, and makes it possible to recover this material. Using the elements previously supplied by the patient, the investigator tells a story which allows the patient to focus his attention on something other than the performance of the somatosensory evoked potentials examination. The investigator, thanks to hypnosis, allows the development
Primary Outcome Measure Information:
Title
duration of the somatosensory evoked potentials
Description
This correspond to the duration of the somatosensory evoked potentials exam in minuts, between the 2 groups.
Time Frame
one day
Secondary Outcome Measure Information:
Title
Quality of the somatosensory evoked potentials
Description
This outcome corresponds to the number of averages used to realize the somatosensory evoked potentials exam.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged ≥ 18 years Patient who was prescribed PES French speaking patient Patient affiliated to a social security scheme Patient having given oral, free, informed and express consent Exclusion Criteria: Patient with severe pathologies of the peripheral nerve Patient under guardianship or curatorship Patient deprived of liberty Pregnant woman Patient denies Psychotic patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronique MARCAUD, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23623560
Citation
Del Percio C, Triggiani AI, Marzano N, De Rosas M, Valenzano A, Petito A, Bellomo A, Soricelli A, Cibelli G, Babiloni C. Subjects' hypnotizability level affects somatosensory evoked potentials to non-painful and painful stimuli. Clin Neurophysiol. 2013 Jul;124(7):1448-55. doi: 10.1016/j.clinph.2013.02.008. Epub 2013 Apr 25.
Results Reference
background
PubMed Identifier
24291728
Citation
Fiorio M, Recchia S, Corra F, Tinazzi M. Behavioral and neurophysiological investigation of the influence of verbal suggestion on tactile perception. Neuroscience. 2014 Jan 31;258:332-9. doi: 10.1016/j.neuroscience.2013.11.033. Epub 2013 Nov 27.
Results Reference
result
PubMed Identifier
9252330
Citation
Rainville P, Duncan GH, Price DD, Carrier B, Bushnell MC. Pain affect encoded in human anterior cingulate but not somatosensory cortex. Science. 1997 Aug 15;277(5328):968-71. doi: 10.1126/science.277.5328.968.
Results Reference
result
PubMed Identifier
10781270
Citation
Faymonville ME, Laureys S, Degueldre C, DelFiore G, Luxen A, Franck G, Lamy M, Maquet P. Neural mechanisms of antinociceptive effects of hypnosis. Anesthesiology. 2000 May;92(5):1257-67. doi: 10.1097/00000542-200005000-00013.
Results Reference
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PubMed Identifier
10801169
Citation
Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.
Results Reference
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PubMed Identifier
20161034
Citation
Stoelb BL, Molton IR, Jensen MP, Patterson DR. THE EFFICACY OF HYPNOTIC ANALGESIA IN ADULTS: A REVIEW OF THE LITERATURE. Contemp Hypn. 2009 Mar 1;26(1):24-39. doi: 10.1002/ch.370.
Results Reference
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PubMed Identifier
18669215
Citation
Vanhaudenhuyse A, Boveroux P, Boly M, Schnakers C, Bruno MA, Kirsch M, Demertzi A, Lamy M, Maquet P, Laureys S, Faymonville ME. [Hypnosis and pain perception]. Rev Med Liege. 2008 May-Jun;63(5-6):424-8. French.
Results Reference
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PubMed Identifier
18971768
Citation
Slack D, Nelson L, Patterson D, Burns S, Hakimi K, Robinson L. The feasibility of hypnotic analgesia in ameliorating pain and anxiety among adults undergoing needle electromyography. Am J Phys Med Rehabil. 2009 Jan;88(1):21-9. doi: 10.1097/PHM.0b013e31818e00bd.
Results Reference
result
PubMed Identifier
10568858
Citation
De Pascalis V, Magurano MR, Bellusci A. Pain perception, somatosensory event-related potentials and skin conductance responses to painful stimuli in high, mid, and low hypnotizable subjects: effects of differential pain reduction strategies. Pain. 1999 Dec;83(3):499-508. doi: 10.1016/S0304-3959(99)00157-8.
Results Reference
result

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Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials

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