AnxietyHYPNOMADENCT04372537
Medical Hypnosis Against Anxiety and Pain in Electro-neuro-myography
A study testing hypnosis in people with Anxiety, run by University Hospital, Lille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2021to 29 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- hypnosis, standard care
- Keywords
- hypnosis, electro-neuro-myography, anxiety, pain, analgesia
- Medical subject headings
- Anxiety Disorders, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisBehavioural
use of hypnosis.
standard careBehavioural
standard clinical procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at the end of electro-neuro-myography exam
Secondary outcomes (2)
Anxiety score evaluated by analogue visual scale
EVA measures the intensity of anxiety on a scale of 0 (calm) to 10 (maximum anxiety)
Measured: at the end of electro-neuro-myography exam
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
Measured: between baseline and at the end of electro-neuro-myography exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start22 Mar 2021
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perrine Bocquillon, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372537
- Sponsor's protocol ID
- 2019_42
- Other IDs
- 2020-A00092-37
- Acronym
- HYPNOMADE
- Status last verified
- Dec 2025
- First submitted
- 29 Apr 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Hypnosis Against Anxiety and Pain in Electro-neuro-myography
- ClinicalTrials.gov ID
- NCT04372537
- Acronym / sponsor ID
- HYPNOMADE / 2019_42
- Conditions
- Anxiety
- Keywords
- hypnosis, electro-neuro-myography, anxiety, pain, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Behavioral: hypnosisPatients 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. |
| Standard procedure group. | Active comparator | Behavioral: standard carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypnosisuse of hypnosis. | Behavioural | Hypnosis |
| standard carestandard clinical procedure | Behavioural | Standard procedure group. |
Primary outcome
Pain score evaluated by analogue visual scale
Time frame: at the end of electro-neuro-myography exam
EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable)
2 secondary outcomes
Anxiety score evaluated by analogue visual scale
Time frame: at the end of electro-neuro-myography exam
anxiety score evolution evaluated by analogue visual scale
Time frame: between baseline and at the end of electro-neuro-myography exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perrine Bocquillon, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnosis in people with Anxiety, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score evaluated by analogue visual scale (time frame: at the end of electro-neuro-myography exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.