Clinical trial NCT06497712: BEnefit of HYpnosis on Pain During Stitches in Emergency Room
Official title: BEnefit of HYpnosis on Pain During Stitches in Emergency Room: the BE-HYPER Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound of Skin
Keywords: hypnosis
wound
stitches
pain
sinusal variability of cardiac frequency
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The aim of this randomized, controlled, single-center, prospective study is to evaluate the impact of hypnosis during suturing 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.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years, admitted in Clermont-Ferrand University Hospital Emergency Department
* suturable wound
* patient's consent obtained

Exclusion Criteria:

* 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
* Deaf patients
* 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
* Refusal to take part in the study

Primary outcomes:
measure: Impact of hypnosis during stitches among emergency department patients
timeFrame: Hour 0
Secondary outcomes:
measure: Impact of hypnosis on stress patients during stitches
timeFrame: Hour 0; Hour 0+30 minutes
measure: Evaluation of stress biomarkers in blood samples
timeFrame: Hour 0; Hour 0+30 minutes
measure: Evaluation of blood pressure
timeFrame: Hour 0; Hour 0+30 minutes
measure: Evaluation of heart rate
timeFrame: Hour 0; Hour 0+30 minutes
measure: Impact of sociodemographics parameters on pain and stress
timeFrame: Hour 0; Hour 0+30 minutes
measure: Impact of location of the wound on pain and stress
timeFrame: Hour 0; Hour 0+30 minutes
measure: Impact of location of the wound on variability of heart frequency
timeFrame: Hour 0; Hour 0+30 minutes
measure: Impact of the length of the wound on pain and stress
timeFrame: Hour 0; Hour 0+30 minutes
measure: Impact of the length of the wound on variability of heart frequency
timeFrame: Hour 0; Hour 0+30 minutes
measure: Impact of the depth of the wound on pain and stress
timeFrame: Hour 0; Hour 0+30 minutes
measure: Impact of the depth of the wound on pain and stress
timeFrame: Hour 0; Hour 0+30 minutes
measure: sinusal variability of cardiac frequency on healthcare professional during stitching
timeFrame: Hour 0 and for 48 hours
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Baptiste BOUILLON-MINOIS
role: PRINCIPAL_INVESTIGATOR
References: