Patients Requiring ElectromyogramHYPNOKNCT06193785
Evaluation of Hypnosis Practice During a Semi-invasive and Painful Medical Examination in Neurology: the Electromyogram
A study testing Hypnosis in people with Patients Requiring Electromyogram, run by Centre Hospitalier de PAU at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Requiring Electromyogram
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Mar 2024to 10 Mar 2025
- 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
- adult patient
- patient who must perform an electromyogram
- patient who have given their free and informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
Read the 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.
- Conditions
- Patients Requiring Electromyogram
- Being tested
- Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
hypnosis realised by expert practitioner, before and during the electromyogram procedure
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | hypnosis realised by expert practitioner during electromyogram realisation Receives: Other: Hypnosis |
| control | No intervention | standard electromyogram realisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative pain
Evaluation of Pain reduction during the electromyogram following the concomitant practice of hypnosis, assessed quantitatively using the Visual Analog Scale
Measured: 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
Evaluation of Pain reduction during the electromyogram following the concomitant practice of hypnosis, assessed qualitatively assessment, using the Saint-Antoine Pain Questionary
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start25 Mar 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Requiring ElectromyogramStudies of the same condition, open and under way.
- 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
- Model description
- Prospective therapeutic study comparing two groups, open, quasi-randomised, single-centre
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de PAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193785
- Sponsor's protocol ID
- CHPAU2023/02
- Acronym
- HYPNOK
- Status last verified
- Apr 2025
- First submitted
- 11 Dec 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hypnosis Practice During a Semi-invasive and Painful Medical Examination in Neurology: the Electromyogram
- ClinicalTrials.gov ID
- NCT06193785
- Acronym / sponsor ID
- HYPNOK / CHPAU2023/02
- Conditions
- Patients Requiring Electromyogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier de PAUUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 5 Jan 2024 (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.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective therapeutic study comparing two groups, open, quasi-randomised, single-centre
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Other: Hypnosishypnosis realised by expert practitioner during electromyogram realisation |
| control | No intervention | –standard electromyogram realisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patient
- patient who must perform an electromyogram
- patient who have given their free and informed consent
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Hypnosishypnosis realised by expert practitioner, before and during the electromyogram procedure | Other | Hypnosis |
Primary outcome
Quantitative pain
Time frame: 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
Evaluation of Pain reduction during the electromyogram following the concomitant practice of hypnosis, assessed quantitatively using the Visual Analog Scale
2 secondary outcomes
Qualitative pain
Time frame: Saint-Antoine Pain Questionary will be completed by the patient 5 minutes before and 5 minutes after the end of the electromyogram
Anxiety
Time frame: 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
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 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Patients Requiring Electromyogram, run by Centre Hospitalier de PAU at 2 sites 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 3 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quantitative pain (time frame: 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). 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 8 Apr 2025.