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Recruiting NCT06497712

BEnefit of HYpnosis on Pain During Stitches in Emergency Room

No phase Interventional Wound of Skin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypnosis.
Who it may be relevant to
Registry conditions: Wound of Skin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

BEnefit of HYpnosis on Pain During Stitches in Emergency Room: The BE-HYPER Study

Overview

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.

Interventions

  • Other Hypnosis
    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.

Primary outcome measures

  • Heart rate variability [Time frame: Hour 0]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

Inclusion criteria

  • Age > 18 years old
  • Admitted in the emergency department of Clermont-Ferrand University Hospital
  • Stitchable wound
  • Patient's agreement

Exclusion criteria

  • 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)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

France · 1 center
  • CHU de Clermont-Ferrand — Clermont-Ferrand

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. PMID 42425558

Identifiers

NCT: NCT06497712 · RBHP 2023 BOUILLON-MINOIS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗