BEnefit of HYpnosis on Pain During Stitches in Emergency Room
BE-HYPER
1 other identifier
interventional
180
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2028
April 30, 2026
April 1, 2026
3 years
May 29, 2024
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of hypnosis during stitches among emergency department patients
Impact of hypnosis will be evaluated by the heart rate variability measured by heart rate monitoring belt
Hour 0
Secondary Outcomes (12)
Impact of hypnosis on stress patients during stitches
Hour 0; Hour 0+30 minutes
Evaluation of stress biomarkers in blood samples
Hour 0; Hour 0+30 minutes
Evaluation of blood pressure
Hour 0; Hour 0+30 minutes
Evaluation of heart rate
Hour 0; Hour 0+30 minutes
Impact of sociodemographics parameters on pain and stress
Hour 0; Hour 0+30 minutes
- +7 more secondary outcomes
Study Arms (2)
Hypnosis
EXPERIMENTALPatients will be hypnotized by a trained person before suturing.
Standard of Care
NO INTERVENTIONStitches will be performed without hypnosis as usual
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patient over 18 years, admitted in Clermont-Ferrand University Hospital Emergency Department
- suturable wound
- patient's consent obtained
You may not qualify if:
- Pregnant or breast-feeding women
- Patient under guardianship, curators or safeguard of justice
- Person unable to give consent
- History of cardiac rhythm disorders (fibrillation, pacemaker)
- Psychiatric pathology
- Age \< 18 years
- Surgical wound
- Eyelid, nose, ear or mouth wounds
- Patients who do not speak French
- Hearing impairement
- Patients with no social security coverage
- Use of MEOPA
- Intake of toxic substances
- Head trauma with a Glasgow Score \< or = to 14
- Patient with endocrinal pathologies on cortisol axe
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Baptiste BOUILLON-MINOIS
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2024
First Posted
July 12, 2024
Study Start
May 15, 2025
Primary Completion (Estimated)
May 15, 2028
Study Completion (Estimated)
May 15, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04