Evaluation of Hypnosis Practice During a Semi-invasive and Painful Medical Examination in Neurology: the Electromyogram (HYPNOK)

Electromyogram is a current exam usually in neurological practices use for study peripheral nervous system. This is a semi-invasive examination causing pain. The aim of the study is to evaluate hypnosis practice in patients during an electromyogram. The investigator will evaluate pain with quantitative and qualitative evaluation in two groups with and without hypnosis in an open, quasi-randomised prospective therapeutic study in Pau hospital centre

Study Overview

• Status: Completed
• Conditions: Patients Requiring Electromyogram
• Intervention / Treatment: Other: Hypnosis

Detailed Description

Electromyogram is frequently use in neurological practices for neuropathies detection or others peripheral nervous system affection. There is two parts during this examination. The first is called sensory and motor nervous conduction study. It consists to apply cutaneous electrodes wich send electric current on arms and legs. The second is the detection with use needles in several muscles of the four limbs with muscle contraction. So, electromyogram is long (sometimes up to one hour) and painful assessment.

Hypnosis is an old not invasive easy practice using in some medical conditions like fibroscopy, anesthesia, surgery. The mechanisms are unclear but this is an effective practice particularly in pain management. Hypnosis in neurological examinations remains unusual. Only two studies report use of hypnosis during electromyogram. The first in 2009 is a randomised suty. On 26 patients, they study hypnosis impact on anxiety and pain. The conclusion is significant efficacity of hypnosis on pain during electromyogram with pain decrease of 31% compared with control group. The second is a French study with only poster. There was no significant difference between hypnosis group and control group during electromyogram for pain. But, there was significant difference for anxiety item. These two studies shown opposite results.

In this study, the sponsor propose to evaluate hypnosis during electromyogram. The main criteria is quantitative pain evaluation. A neurologist doctor will do electromyogram and specialized nurse will do hypnosis. This is a prospective open, quasi-randomised study with two groups of patients. One with hypnosis realised by expert practitioner during electromyogram realisation. One group without hypnosis. The investigator will note pain during examination with standardised quantitative (primary outcome) and qualitative (secondary outcome) evaluation. The investigator will use visual Analog Scale and Saint-Antoine Pain Questionary (QDSA) but also Beck Anxiety Inventory for psychological effect. The duration of study is one year in single centre. The Pau Hospital hope validate this practice of hypnosis in this indication and extend it to other hospital centers for improve the quality of patient care.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pau, France, 64000
    • CH de Pau
  • Pau, France, 64046
    • KRIM Elsa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult patient
• patient who must perform an electromyogram
• patient who have given their free and informed consent

Exclusion Criteria:

• Patient known to be not receptive to hypnosis
• Patient having a contraindication to hypnosis (Psychotic disorders, paranoid personality)
• Patient having cognitive disorders or comprehension problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis; hypnosis realised by expert practitioner during electromyogram realisation	Other: Hypnosis; hypnosis realised by expert practitioner, before and during the electromyogram procedure
No Intervention: control; standard electromyogram realisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative pain	Evaluation of Pain reduction during the electromyogram following the concomitant practice of hypnosis, assessed quantitatively using the Visual Analog Scale	Visual Analog Scale (0 = no pain to 10 = extreme pain) will be completed by the patient 5 minutes before and 5 minutes after the end of the electromyogram

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative pain	Evaluation of Pain reduction during the electromyogram following the concomitant practice of hypnosis, assessed qualitatively assessment, using the Saint-Antoine Pain Questionary	Saint-Antoine Pain Questionary will be completed by the patient 5 minutes before and 5 minutes after the end of the electromyogram
Anxiety	Evaluation of Anxiety assessment using the Beck Anxiety Inventory	Beck Anxiety Inventory (0 = no anxiety to 63 = severe anxiety) will be completed by the patient 5 minutes before and 5 minutes after the end of the electromyogram

Collaborators and Investigators

• Sponsor: Centre Hospitalier de PAU

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Actual): March 10, 2025
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CHPAU2023/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No