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Medical Hypnosis Against Anxiety and Pain in Electro-neuro-myography (HYPNOMADE)

Primary Purpose

Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hypnosis
standard care
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring hypnosis, electro-neuro-myography, anxiety, pain, analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hopital Roger Salengro, CHU LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypnosis

Standard procedure group.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Anxiety score evaluated by analogue visual scale
EVA measures the intensity of anxiety on a scale of 0 (calm) to 10 (maximum anxiety)
anxiety score evolution evaluated by analogue visual scale
Anxiety evolution pre/post electro-neuro-myography exam (EVA measures the intensity of anxiety on a scale of 0 (calm) to 10 (maximum anxiety imaginable) will be compared between the two groups

Full Information

First Posted
April 29, 2020
Last Updated
April 21, 2021
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04372537
Brief Title
Medical Hypnosis Against Anxiety and Pain in Electro-neuro-myography
Acronym
HYPNOMADE
Official Title
Medical Hypnosis Against Anxiety and Pain in Electro-neuro-myography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Medical hypnosis is more and more used during some medico-technical investigational procedures, such as interventional radiology, dental procedures, baby deliveries. Using the modified conscious state induced by trance or by conversational hypnosis (thanks to verbal and nonverbal language) allows a better tolerance of these procedures. Only very few situations recommend against this approach. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
hypnosis, electro-neuro-myography, anxiety, pain, analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard procedure group.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
hypnosis
Intervention Description
use of hypnosis.
Intervention Type
Behavioral
Intervention Name(s)
standard care
Intervention Description
standard clinical procedure
Primary Outcome Measure Information:
Title
Pain score evaluated by analogue visual scale
Description
EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable)
Time Frame
at the end of electro-neuro-myography exam
Secondary Outcome Measure Information:
Title
Anxiety score evaluated by analogue visual scale
Description
EVA measures the intensity of anxiety on a scale of 0 (calm) to 10 (maximum anxiety)
Time Frame
at the end of electro-neuro-myography exam
Title
anxiety score evolution evaluated by analogue visual scale
Description
Anxiety evolution pre/post electro-neuro-myography exam (EVA measures the intensity of anxiety on a scale of 0 (calm) to 10 (maximum anxiety imaginable) will be compared between the two groups
Time Frame
between baseline and at the end of electro-neuro-myography exam

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Perrine Bocquillon, MD
Phone
0320445962
Ext
+33663616691
Email
perrine.bocquillon@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perrine Bocquillon, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Roger Salengro, CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962

12. IPD Sharing Statement

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

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