Medical Hypnosis Against Anxiety and Pain in Electro-neuro-myography
NCT ID: NCT04372537
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2021-03-22
2024-04-29
Brief Summary
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Detailed Description
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ENMG is a frequently performed procedure in neurology to explore neuromuscular functions. It implies electric stimulations, needle insertion and needs the patient cooperation and the patient's well-being. This is all the more necessary that this procedure may be repeated for a patient along his/her life.
Only one study evaluated the effect of hypnosis on pain and anxiety during ENMG (Slack and al., 2009). Despite a low statistical power due to a small sample, it showed a reduction of the maximal pain during the needle electromyography.
More proof is therefore needed to assess the efficacity of hypnosis against pain and anxiety during ENMG.
Several members of our nurse and medical team have an experience in hypnosis practice and this procedure is sometimes used in some patients, when specifically required, alone or with other analgesic procedures (like nitrous oxide), but not in the current standard practice. This is mainly useful in patients with anxiety.
This study's principal objective is then to evaluate the effect of an hypnosis procedure, compared to a standard clinical procedure alone, on pain consecutive to ENMG, in patients presenting with anxiety when attending an ENMG. The secondary objective is to assess the effect of hypnosis on anxiety consecutive to the ENMG.
This is a monocentric, controlled, randomized, open-labeled study, with two balanced arms. The study cannot be blind since the members of the staff will apply at the same time the hypnosis procedures and the ENMG investigations.
Patients who have to undergo an ENMG due to their standard care investigations will be consecutively included as long as they're taken care of by members of the staff with an hypnosis experience and express any anxiety.
48 patients in each group will have to be include to achieve a sufficient power.
Statistical analyses will be blindly performed by our methodology, biostatistics and data management unit. All tests will be bilateral with an alpha risk of 5%, with an intention-to-treat procedure.
Our hypothesis is a reduction of pain and anxiety in the hypnosis group compared to the standard care one.
If this is confirmed, it will be an argument to offer this procedure in a systematic way to any patient with anxiety who has to undergo an ENMG as well as developing its use in other electrophysiological investigations.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Hypnosis
Patients will benefit from formal hypnosis (trance induction, hypno analgesia, comfort suggestions) and/or conversational hypnosis (confusion, distraction, use of chosen words, goodwill using verbal and non verbal languages).
They will also get to be informed of the proceedings of the performed examination as the standard procedure group.
hypnosis
use of hypnosis.
Standard procedure group.
Patients will be informed of the proceedings of the performed examination, without using any hypnosis technique.
This corresponds to the standard clinical procedures used while performing an electroneuromyogram.
standard care
standard clinical procedure
Interventions
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hypnosis
use of hypnosis.
standard care
standard clinical procedure
Eligibility Criteria
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Inclusion Criteria
* with a good understanding of the French language
* able to complete self-questionnaires
* Patient who has given written consent to participate in the trial
* Socially insured patient
Exclusion Criteria
* known history of psychiatric illness or current known psychiatric illness: severe depression, psychosis
* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign the consent form
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Perrine Bocquillon, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hopital Roger Salengro, CHU Lille
Lille, , France
Countries
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Other Identifiers
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2020-A00092-37
Identifier Type: OTHER
Identifier Source: secondary_id
2019_42
Identifier Type: -
Identifier Source: org_study_id