BEnefit of HYpnosis on Pain During Stitches in Emergency Room

NCT ID: NCT06497712

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-07-15

Brief Summary

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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

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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.

Conditions

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Wound of Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hypnosis

Patients will be hypnotized by a trained person before suturing.

Group Type EXPERIMENTAL

Hypnosis

Intervention Type OTHER

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.

Standard of Care

Stitches will be performed without hypnosis as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Baptiste BOUILLON-MINOIS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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LISE LACLAUTRE

Role: CONTACT

+33473754963

Facility Contacts

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Jean Baptiste Bouillon, MD, PhD

Role: primary

+33473751999

Léa Pérard

Role: backup

Other Identifiers

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RBHP 2023 BOUILLON-MINOIS

Identifier Type: -

Identifier Source: org_study_id

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