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

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Recruiting
CT.gov ID
NCT04218448
Collaborator
(none)
44
1
2
42.5
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hypnorelaxation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials
Actual Study Start Date :
Jan 13, 2020
Anticipated Primary Completion Date :
Jan 16, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Somatosensory evoked potentials without hypnorelaxation

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.

Experimental: Somatosensory evoked potentials with hypnorelaxation

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.

Other: Hypnorelaxation
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

Outcome Measures

Primary Outcome Measures

  1. duration of the somatosensory evoked potentials [one day]

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

Secondary Outcome Measures

  1. Quality of the somatosensory evoked potentials [one day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

Sponsors and Collaborators

  • Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Veronique MARCAUD, MD, Groupe Hospitalier Paris Saint Joseph

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT04218448
Other Study ID Numbers:
  • HYPOT
First Posted:
Jan 6, 2020
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2022