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

NCT06193785 | Completed

• 1 other identifier: CHPAU2023/02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Patients Requiring Electromyogram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Qualitative pain

  Saint-Antoine Pain Questionary will be completed by the patient 5 minutes before and 5 minutes after the end of the electromyogram

• Anxiety

  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

Study Arms (2)

Hypnosis

EXPERIMENTAL

hypnosis realised by expert practitioner during electromyogram realisation

Other: Hypnosis

control

NO INTERVENTION

standard electromyogram realisation

Interventions

Hypnosis OTHER

hypnosis realised by expert practitioner, before and during the electromyogram procedure

Hypnosis

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de PAU: lead

Study Sites (2)

CH de Pau

Pau, 64000, France

Location

KRIM Elsa

Pau, 64046, France

Location

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

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

Model Details: Prospective therapeutic study comparing two groups, open, quasi-randomised, single-centre

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 5, 2024
• Study Start: March 25, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

FR (2)