NCT06497712

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
May 2025May 2028

First Submitted

Initial submission to the registry

May 29, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

May 29, 2024

Last Update Submit

April 27, 2026

Conditions

Keywords

hypnosiswoundstitchespainsinusal variability of cardiac frequency

Outcome Measures

Primary Outcomes (1)

  • Impact of hypnosis during stitches among emergency department patients

    Impact of hypnosis will be evaluated by the heart rate variability measured by heart rate monitoring belt

    Hour 0

Secondary Outcomes (12)

  • Impact of hypnosis on stress patients during stitches

    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

  • +7 more secondary outcomes

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

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • Hearing impairement
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Wounds and InjuriesPain

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jean-Baptiste BOUILLON-MINOIS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

April 30, 2026

Record last verified: 2026-04

Locations