Wound of SkinBE-HYPERNCT06497712
BEnefit of HYpnosis on Pain During Stitches in Emergency Room
A study testing Hypnosis in people with Wound of Skin, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Suturing is a daily practice in the emergency department, but it can be painful and stressful for patients. Hypnosis is increasingly used as a complement to the usual painkillers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound of Skin
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2025to 15 May 2028
- 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
- Age > 18 years old
- Admitted in the emergency department of Clermont-Ferrand University Hospital
- Stitchable wound
- Patient's agreement
Who cannot join
- Pregnancy
- Breast feeding
- Refusal to participate
- Patient not able to participate
- Patients under guardianship, curatorship, deprived of liberty or safeguard of justice.
- History of cardiac rhythm disorders (atrial fibrillation, pacemaker)
Show all 17Show fewer
- Psychotic disorder
- Age < 18 years old
- Surgery needed
- Patients who don't speak French
- Wound of the eyelids, nose, ears or mouth
- Deaf patients
- Patients without a social security coverage
- Nitrous oxyde use
- Substance abuse
- Head trauma with GSC ≤ 14
- Patient with endocrine diseases on the cortisol axis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Jean Baptiste Bouillon, MD, PhD, +33473751999, jbbouillon-minois@chu-clermontferrand.fr
Léa Pérard, lperard@chu-clermontferrand.fr
About this study
Official title: BEnefit of HYpnosis on Pain During Stitches in Emergency Room: The BE-HYPER Study
Suturing is a daily practice in the emergency department, but it can be painful and stressful for patients. Hypnosis is increasingly used as a complement to the usual painkillers. The aim of our study was to investigate the impact of hypnosis on stitch placement in emergency department patients presenting with lacerations assessed by heart rate variability.
Read the detailed description
The aim of this randomized, controlled, single-center, prospective study is to evaluate the impact of hypnosis during stitching in emergency department patients presenting with a laceration assessed by heart rate variability.
All patients with eligibility criteria will be included if the patient gave his written consent.
Patients will be randomized to one of two arms: (1) Hypnosis or (2) Standard Of Care (SOC) A heart rate monitoring belt will be fitted to the patient for both groups. The patient will be asked to complete a self-assessment questionnaire on pain and stress, as well as socio-demographic parameters.
A blood sample will be collected and the heart rate and blood pressure will be measured.
Stitches will be taken with or without hypnosis, and after 30 minutes, the pain and stress self-assessment questionnaire will again be completed by the patient, and a new blood test will be taken.
the heart rate monitoring belt will be removed, and the study will be completed for the patient.
- Conditions
- Wound of Skin
- Being tested
- Hypnosis
- Keywords
- hypnosis, wound, stitches, pain, sinusal variability of cardiac frequency
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
Before the beginning of stitches, the patient will be offered a hypnotic induction. The hypnotic induction is the initial phase of the hypnosis process. Its goal is to bring the patient to a state of dissociation: the hypnotic trance. Induction is usually achieved through progressive relaxation, sensory focusing, and a process of confusion.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | Patients will be hypnotized by a trained person before suturing. Receives: Other: Hypnosis |
| Standard of Care | No intervention | Stitches will be performed without hypnosis as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
The heart rate variability will be measured using Bittium Faros
Measured: Hour 0
Secondary outcomes (11)
Changes on visual analog scale of pain and stress
Visual analog scale (VAS) of pain and stress will be performed at two different times by the patient.
A VAS is a 100-mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their pain and severity between 0 (no symptoms) to 100 (the worst pain and stress).
Cut points on the pain VAS : no pain or low pain (0-29 mm), moderate pain (30-59 mm), and severe pain (>59 mm).
Cut points on the stress VAS : no pain or low stress (0-19 mm), moderate stress (19-49 mm), severe stress (50-81 mm), and at-risk stress (>81 mm).
Measured: Hour 0; Hour 0+30 minutes
Evaluation of stress biomarkers in blood samples
Evaluation of cortisol, DHEA, DHEA-s, ghrelin, leptin, TNF-alpha, epinephrin, norepinephrine, dopamine
Measured: Hour 0; Hour 0+30 minutes
Evaluation of blood pressure
Evaluation of hypnosis impact on systolic and diastolic blood pressure in millimeter of mercury (mmHg)
Measured: Hour 0; Hour 0+30 minutes
Evaluation of heart rate
Evaluation of hypnosis impact on physiological parameters heart rate in beats per minute (bpm)
Measured: Hour 0; Hour 0+30 minutes
Impact of sociodemographics parameters on pain and stress
Evaluation of the impact of sociodemographics parameters on pain and stress evaluated by the visual analog scale (VAS) performed at two different times (outcome N°2)
Measured: Hour 0; Hour 0+30 minutes
Impact of location of the wound on pain and stress
Evaluation of the impact of location of the wound on stress and pain evaluated by the visual analog scale (outcome n°2)
Measured: Hour 0; Hour 0+30 minutes
Impact of location of the wound on variability of heart frequency
Evaluation of the impact of location of the wound on the variability of heart frequency measured by Bittium Faros (outcome n°1)
Measured: Hour 0; Hour 0+30 minutes
Impact of the length of the wound on pain and stress
Evaluation of the impact of the length of the wound on stress and pain evaluated by the visual analog scale (outcome n°2)
Measured: Hour 0; Hour 0+30 minutes
Impact of the length of the wound on variability of heart frequency
Evaluation of the impact of the length of the wound on the variability of heart frequency measured by heart rate monitoring belt (outcome n°1)
Measured: Hour 0; Hour 0+30 minutes
Impact of the depth of the wound on pain and stress
Evaluation of the impact of the depth of the wound on stress and pain evaluated by the visual analog scale (outcome n°2)
Measured: Hour 0; Hour 0+30 minutes
Impact of the depth of the wound on pain and stress
Evaluation of the impact of the depth of the wound on the variability of heart frequency measured by heart rate monitoring belt (outcome n°1)
Measured: Hour 0; Hour 0+30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 May 2025
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste BOUILLON-MINOIS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497712
- Sponsor's protocol ID
- RBHP 2023 BOUILLON-MINOIS
- Acronym
- BE-HYPER
- Status last verified
- May 2026
- First submitted
- 29 May 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that underlie the results reported in this protocol, will be made available upon reasonable request to the corresponding author. Data will be shared with researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be directed to LP. To gain access, data requestors will need to sign a data access agreement.
Publications
Perard L, Clinchamps M, Dutheil F, De Saint-Vincent S, Lucchini-Roche C, Schmidt J, Moustafa F, Baker JS, Pereira B, Bouillon-Minois JB. BEnefit of HYpnosis on Pain during stitches in an Emergency Room: a study protocol using a randomised controlled trial - the BE-HYPER protocol. BMJ Open. 2026 Jul 9;16(7):e108925. doi: 10.1136/bmjopen-2025-108925.
PubMed 42425558
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEnefit of HYpnosis on Pain During Stitches in Emergency Room: The BE-HYPER Study
- ClinicalTrials.gov ID
- NCT06497712
- Acronym / sponsor ID
- BE-HYPER / RBHP 2023 BOUILLON-MINOIS
- Conditions
- Wound of Skin
- Keywords
- hypnosis, wound, stitches, pain, sinusal variability of cardiac frequency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 12 Jul 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.
Suturing is a daily practice in the emergency department, but it can be painful and stressful for patients. Hypnosis is increasingly used as a complement to the usual painkillers. The aim of our study was to investigate the impact of hypnosis on stitch placement in emergency department patients presenting with lacerations assessed by heart rate variability.
Detailed description
The aim of this randomized, controlled, single-center, prospective study is to evaluate the impact of hypnosis during stitching in emergency department patients presenting with a laceration assessed by heart rate variability.
All patients with eligibility criteria will be included if the patient gave his written consent.
Patients will be randomized to one of two arms: (1) Hypnosis or (2) Standard Of Care (SOC) A heart rate monitoring belt will be fitted to the patient for both groups. The patient will be asked to complete a self-assessment questionnaire on pain and stress, as well as socio-demographic parameters.
A blood sample will be collected and the heart rate and blood pressure will be measured.
Stitches will be taken with or without hypnosis, and after 30 minutes, the pain and stress self-assessment questionnaire will again be completed by the patient, and a new blood test will be taken.
the heart rate monitoring belt will be removed, and the study will be completed for the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Other: HypnosisPatients will be hypnotized by a trained person before suturing. |
| Standard of Care | No intervention | –Stitches will be performed without hypnosis as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Admitted in the emergency department of Clermont-Ferrand University Hospital
- Stitchable wound
- Patient's agreement
Key exclusion criteria (17 listed)
- Pregnancy
- Breast feeding
- Refusal to participate
- Patient not able to participate
- Patients under guardianship, curatorship, deprived of liberty or safeguard of justice.
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 |
|---|---|---|
| HypnosisBefore the beginning of stitches, the patient will be offered a hypnotic induction. The hypnotic induction is the initial phase of the hypnosis process. Its goal is to bring the patient to a state of dissociation: the hypnotic trance. Induction is usually achieved through progressive relaxation, sensory focusing, and a process of confusion. | Other | Hypnosis |
Primary outcome
Heart rate variability
Time frame: Hour 0
The heart rate variability will be measured using Bittium Faros
11 secondary outcomes
Changes on visual analog scale of pain and stress
Time frame: Hour 0; Hour 0+30 minutes
Evaluation of stress biomarkers in blood samples
Time frame: Hour 0; Hour 0+30 minutes
Evaluation of blood pressure
Time frame: Hour 0; Hour 0+30 minutes
Evaluation of heart rate
Time frame: Hour 0; Hour 0+30 minutes
Impact of sociodemographics parameters on pain and stress
Time frame: Hour 0; Hour 0+30 minutes
Impact of location of the wound on pain and stress
Time frame: Hour 0; Hour 0+30 minutes
Impact of location of the wound on variability of heart frequency
Time frame: Hour 0; Hour 0+30 minutes
Impact of the length of the wound on pain and stress
Time frame: Hour 0; Hour 0+30 minutes
Impact of the length of the wound on variability of heart frequency
Time frame: Hour 0; Hour 0+30 minutes
Impact of the depth of the wound on pain and stress
Time frame: Hour 0; Hour 0+30 minutes
Impact of the depth of the wound on pain and stress
Time frame: Hour 0; Hour 0+30 minutes
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 2 Jun 2026.
- Derived from this study: PubMed 42425558Perard L, Clinchamps M, Dutheil F, De Saint-Vincent S, Lucchini-Roche C, Schmidt J, Moustafa F, Baker JS, Pereira B, Bouillon-Minois JB. BEnefit of HYpnosis on Pain during stitches in an Emergency Room: a study protocol using a randomised controlled trial - the BE-HYPER protocol. BMJ Open. 2026 Jul 9;16(7):e108925. doi: 10.1136/bmjopen-2025-108925.
- Individual participant dataSharing planned: Yes. Data that underlie the results reported in this protocol, will be made available upon reasonable request to the corresponding author. Data will be shared with researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be directed to LP. To gain access, data requestors will need to sign a data access agreement.
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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.
Jean-Baptiste BOUILLON-MINOIS principal investigator
University Hospital, Clermont-Ferrand
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 Wound of Skin, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. 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?
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 LISE LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: Hour 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06497712, which also lists 1 linked publication.
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 2 Jun 2026.