Pain ManagementHYPNAUSNCT07872891
Hypnosis Antalgia Emergency Stitching
A study testing hypnotic guidance in people with Pain Management, run by University Hospital, Angers.
Trial summary
Pain is one of the most common reasons patients seek care in emergency departments. Managing pain effectively is an important part of emergency care because it can improve patients' comfort and overall experience. Wounds that require stitches are also a common reason for visiting the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- hypnotic guidance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 aged over 18
- Presenting to the emergency department with a wound requiring a single suture
- Admitted to a participating emergency department
- Affiliated with a social security scheme
- Having provided verbal informed consent to participate in the study
Who cannot join
- Patient with a prior negative experience with hypnosis
- Patients who have received MEOPA or Penthrox
- Patient with a contraindication to lidocaine (notably an allergy)
- Patient with hearing impairment
- Patient unable to rate their pain using the numerical scale
- Wound requiring stapling
Show all 12Show fewer
- Scalp or ENT wound preventing the use of headphones
- Patient with poor understanding of the French language
- Pregnant woman, woman in labor, or breastfeeding mother
- Person deprived of liberty by judicial or administrative decision, or subject to a legal protection measure
- Person subject to involuntary psychiatric care or suffering from an unstable psychiatric condition
- Person unable to provide free and informed consent (cognitive impairment, intoxication, etc.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Hypnotic Guidance Via Audio Headset for Pain Management During Stitching of Wound in the Emergency Department: A Randomized, Multicenter Study.
Pain is one of the most common reasons patients seek care in emergency departments. Managing pain effectively is an important part of emergency care because it can improve patients' comfort and overall experience. Wounds that require stitches are also a common reason for visiting the emergency department. Stitching a wound can be painful, both because of the original injury and because of the procedure itself, even when local anesthetic is used. Hypnosis is a state of focused attention in which people may become more responsive to suggestions. It is increasingly used as a non-drug approach to managing pain and anxiety, including during medical and surgical procedures. However, hypnosis is still not widely used in emergency departments, mainly because it usually requires trained staff and additional time. One possible solution is to use a pre-recorded hypnosis audio. Instead of a healthcare professional performing hypnosis directly, the patient could listen to a guided recording during the procedure. Previous research suggests that this approach may provide pain relief similar to that achieved with live hypnosis. HYPNAUS is a study comparing the use of local anesthesia via subcutaneous lidocaine injection with hypnotic guidance via headphones combined with local anesthesia via subcutaneous lidocaine injection alone. We hypothesize that patients receiving hypnotic guidance combined with local anesthesia via subcutaneous lidocaine injection will experience less pain during the stitching procedure.
- Conditions
- Pain Management
- Being tested
- hypnotic guidance
- Keywords
- Hypnosis, stitching, emergency, pain
- Medical subject headings
- Agnosia, Emergencies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnotic guidanceCombination product
In the experimental group, patients will listen to a pre-recorded hypnotic guidance session selected from three options. Headphones for the session will be fitted approximately five minutes before the procedure begins.
These audio recordings consist of three distinct phases: induction, trance, and termination. Each recording lasts 15 minutes. However, if the procedure takes longer, the post-hypnotic suggestions included in the recording can extend the trance for as long as necessary.
The remainder of the patient's care is identical to that of the control group and involves local anesthesia via subcutaneous lidocaine prior to stitching.
Patients assigned to the hypnotic guidance arm who do not listen to the entire audio recording will still be analyzed as part of that arm. However, if stitching is finished before the recording ends, it is recommended that you allow it to finish so as not to interfere with the patient's trance termination.
| Study group | Role | What they receive |
|---|---|---|
| hypnotic guidance | Experimental | In the experimental arm, the patient will listen to a pre-recorded hypnotic guidance session selected from three options. Receives: Combination Product: hypnotic guidance |
| local anesthesia via subcutaneous lidocaine injection | No intervention | The control arm will receive standard care for suturable wounds, including local anesthesia with subcutaneous lidocaine prior to stitching. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in pain level between pain assessed before the stitching procedure and the maximum pain experienced during the procedure.
The primary outcome measure is the change in pain intensity-assessed using a 0-10 numerical rating scale (NRS)-from baseline (pain experienced prior to the stitching procedure) to the maximum pain experienced during the procedure. A greater reduction in pain intensity is expected in the hypnotic guidance arm compared with the control arm.
Measured: Peri-procedural: pain experienced before the suturing procedure is assessed immediately before the procedure, and pain experienced during the suturing procedure is assessed immediately after completion of the procedure
Secondary outcomes (3)
The evolution of the patient's comfort level before and during the stitching procedure
The change in the patient's comfort level before and during stitching, assessed using a numerical scale from 0 to 10,
Measured: Peri-procedural: before and during the suturing procedure.
The evolution of the anxiety level before and after stitching
Changes in anxiety levels will also be assessed using the State-Trait Anxiety Inventory questionnaire before and after stitching. The minimum values is 20 and maximum values is 80. A higher scores mean worse outcome
Measured: Peri-procedural: before and during the suturing procedure.
The subjective experience of the healthcare professional performing the procedure
The healthcare provider's experience is assessed using a specific questionnaire, which is administered after the stitching procedure to best evaluate both their perception of the conditions under which the stitching was performed and their assessment of the patient's comfort. This questionnaire was developed specifically for this study because, to our knowledge, no such questionnaire is available in the literature. It includes data collection items and three questions assessing subjective response levels based on a 4-point Likert scale.
Measured: Peri-procedural: before and during the suturing procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aurélie FIENI, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872891
- Sponsor's protocol ID
- 49RC25_0290
- Other IDs
- 2026-A01716-45
- Acronym
- HYPNAUS
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hypnotic Guidance Via Audio Headset for Pain Management During Stitching of Wound in the Emergency Department: A Randomized, Multicenter Study.
- ClinicalTrials.gov ID
- NCT07872891
- Acronym / sponsor ID
- HYPNAUS / 49RC25_0290
- Conditions
- Pain Management
- Keywords
- Hypnosis, stitching, emergency, pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 14 Oct 2026 (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.
Pain is one of the most common reasons patients seek care in emergency departments. Managing pain effectively is an important part of emergency care because it can improve patients' comfort and overall experience. Wounds that require stitches are also a common reason for visiting the emergency department. Stitching a wound can be painful, both because of the original injury and because of the procedure itself, even when local anesthetic is used. Hypnosis is a state of focused attention in which people may become more responsive to suggestions. It is increasingly used as a non-drug approach to managing pain and anxiety, including during medical and surgical procedures. However, hypnosis is still not widely used in emergency departments, mainly because it usually requires trained staff and additional time. One possible solution is to use a pre-recorded hypnosis audio. Instead of a healthcare professional performing hypnosis directly, the patient could listen to a guided recording during the procedure. Previous research suggests that this approach may provide pain relief similar to that achieved with live hypnosis. HYPNAUS is a study comparing the use of local anesthesia via subcutaneous lidocaine injection with hypnotic guidance via headphones combined with local anesthesia via subcutaneous lidocaine injection alone. We hypothesize that patients receiving hypnotic guidance combined with local anesthesia via subcutaneous lidocaine injection will experience less pain during the stitching procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypnotic guidance | Experimental | Combination Product: hypnotic guidanceIn the experimental arm, the patient will listen to a pre-recorded hypnotic guidance session selected from three options. |
| local anesthesia via subcutaneous lidocaine injection | No intervention | –The control arm will receive standard care for suturable wounds, including local anesthesia with subcutaneous lidocaine prior to stitching. |
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 aged over 18
- Presenting to the emergency department with a wound requiring a single suture
- Admitted to a participating emergency department
- Affiliated with a social security scheme
- Having provided verbal informed consent to participate in the study
Key exclusion criteria (12 listed)
- Patient with a prior negative experience with hypnosis
- Patients who have received MEOPA or Penthrox
- Patient with a contraindication to lidocaine (notably an allergy)
- Patient with hearing impairment
- Patient unable to rate their pain using the numerical scale
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 |
|---|---|---|
| hypnotic guidanceIn the experimental group, patients will listen to a pre-recorded hypnotic guidance session selected from three options. Headphones for the session will be fitted approximately five minutes before the procedure begins. These audio recordings consist of three distinct phases: induction, trance, and termination. Each recording lasts 15 minutes. However, if the procedure takes longer, the post-hypnotic suggestions included in the recording can extend the trance for as long as necessary. The remainder of the patient's care is identical to that of the control group and involves local anesthesia via subcutaneous lidocaine prior to stitching. Patients assigned to the hypnotic guidance arm who do not listen to the entire audio recording will still be analyzed as part of that arm. However, if stitching is finished before the recording ends, it is recommended that you allow it to finish so as not to interfere with the patient's trance termination. | Combination product | hypnotic guidance |
Primary outcome
The change in pain level between pain assessed before the stitching procedure and the maximum pain experienced during the procedure.
Time frame: Peri-procedural: pain experienced before the suturing procedure is assessed immediately before the procedure, and pain experienced during the suturing procedure is assessed immediately after completion of the procedure
The primary outcome measure is the change in pain intensity-assessed using a 0-10 numerical rating scale (NRS)-from baseline (pain experienced prior to the stitching procedure) to the maximum pain experienced during the procedure. A greater reduction in pain intensity is expected in the hypnotic guidance arm compared with the control arm.
3 secondary outcomes
The evolution of the patient's comfort level before and during the stitching procedure
Time frame: Peri-procedural: before and during the suturing procedure.
The evolution of the anxiety level before and after stitching
Time frame: Peri-procedural: before and during the suturing procedure.
The subjective experience of the healthcare professional performing the procedure
Time frame: Peri-procedural: before and during the suturing procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Related trials for Pain Management
Not yet recruiting
Intravenous Lidocaine Versus Erector Spinae Plane Block After Lumbar Arthrodesis (LIBERA)
Single-level Lumbar Arthrodesis
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
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.
Aurélie FIENI, MD principal investigator
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
A study testing hypnotic guidance in people with Pain Management, run by University Hospital, Angers.
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 12 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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurelie FIENI, MD (02 41 35 36 37 ext. +33, Aurelie.Fieni@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in pain level between pain assessed before the stitching procedure and the maximum pain experienced during the procedure. (time frame: Peri-procedural: pain experienced before the suturing procedure is assessed immediately before the procedure, and pain experienced during the suturing procedure is assessed immediately after completion of the procedure). 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 14 Oct 2026.