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BEnefit of HYpnosis on Pain During Stitches in Emergency Room (BE-HYPER)

U

University Hospital, Clermont-Ferrand

Status

Enrolling

Conditions

Wound of Skin

Treatments

Other: Hypnosis

Study type

Interventional

Funder types

Other

Identifiers

NCT06497712
RBHP 2023 BOUILLON-MINOIS

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

180 participants in 2 patient groups

Hypnosis
Experimental group
Description:
Patients will be hypnotized by a trained person before suturing.
Treatment:
Other: Hypnosis
Standard of Care
No Intervention group
Description:
Stitches will be performed without hypnosis as usual

Trial contacts and locations

1

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Central trial contact

LISE LACLAUTRE

Data sourced from clinicaltrials.gov

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