BEnefit of HYpnosis on Pain During Stitches in Emergency Room

NCT06497712 | Recruiting

• 1 other identifier: RBHP 2023 BOUILLON-MINOIS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 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.

Conditions

Wound of Skin

Keywords

hypnosis; wound; stitches; pain; sinusal variability of cardiac frequency

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  The heart rate variability will be measured using Bittium Faros

  Hour 0

Secondary Outcomes (11)

• Changes on visual analog scale of pain and stress

  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

Study Arms (2)

Hypnosis

EXPERIMENTAL

Patients will be hypnotized by a trained person before suturing.

Other: Hypnosis

Standard of Care

NO INTERVENTION

Stitches will be performed without hypnosis as usual

Interventions

Hypnosis 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.

Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Pain

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jean-Baptiste BOUILLON-MINOIS

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LISE LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

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: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

FR (1)