Medical Hypnosis Against Anxiety and Pain in Electro-neuro-myography

NCT04372537 | Completed

• 2 other identifiers: 2019_422020-A00092-37
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Electroneuromyography (ENMG) is a regular neurological investigation that might be painful or unpleasant. Medical hypnosis can avoid these sensations, and is more and more performed during other medico-technical procedures (radiology, biopsies for example). This study aims at evaluate the effect of medical hypnosis on pain and anxiety during ENMG, in patients presenting with anxiety. Our hypothesis is that the anxiety and pain during ENMG will be lower in patients with hypnosis compared to patients with standard care. This will allow us to help patients with this tool during most ENMG procedures, and extend it to other electrophysiological procedures in the future.

Conditions

Anxiety

Keywords

hypnosis; electro-neuro-myography; anxiety; pain; analgesia

Outcome Measures

Primary Outcomes (1)

• Pain score evaluated by analogue visual scale

  EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable)

  at the end of electro-neuro-myography exam

Secondary Outcomes (2)

• Anxiety score evaluated by analogue visual scale

  at the end of electro-neuro-myography exam

• anxiety score evolution evaluated by analogue visual scale

  between baseline and at the end of electro-neuro-myography exam

Study Arms (2)

Hypnosis

EXPERIMENTAL

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.

Behavioral: hypnosis

Standard procedure group.

ACTIVE COMPARATOR

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.

Behavioral: standard care

Interventions

hypnosis BEHAVIORAL

use of hypnosis.

Hypnosis

standard care BEHAVIORAL

standard clinical procedure

Standard procedure group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient admitted for ENMG manifesting: spontaneous verbal anxiety about taking the test/- a state of anxiety about the examination, as evidenced by a dark colour on a wellness scale used in the unit
• 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

You may not qualify if:

• algesic sensitivity disorders
• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Agnosia

Interventions

Hypnosis; Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Perrine Bocquillon, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: March 22, 2021
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)