Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06497712

BEnefit of HYpnosis on Pain During Stitches in Emergency Room

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Wound of Skin Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Heart rate variability

    Time frame: Hour 0

    The heart rate variability will be measured using Bittium Faros

Secondary outcomes

  1. Changes on visual analog scale of pain and stress

    Time frame: Hour 0; Hour 0+30 minutes

    Visual analog scale (VAS) of pain and stress will be performed at two different times by the patient.

    A VAS is a 100-mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling. Patients mark the point on the line that best corresponds to their pain and severity between 0 (no symptoms) to 100 (the worst pain and stress).

    Cut points on the pain VAS : no pain or low pain (0-29 mm), moderate pain (30-59 mm), and severe pain (>59 mm).

    Cut points on the stress VAS : no pain or low stress (0-19 mm), moderate stress (19-49 mm), severe stress (50-81 mm), and at-risk stress (>81 mm).

  2. Evaluation of stress biomarkers in blood samples

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of cortisol, DHEA, DHEA-s, ghrelin, leptin, TNF-alpha, epinephrin, norepinephrine, dopamine

  3. Evaluation of blood pressure

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of hypnosis impact on systolic and diastolic blood pressure in millimeter of mercury (mmHg)

  4. Evaluation of heart rate

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of hypnosis impact on physiological parameters heart rate in beats per minute (bpm)

  5. Impact of sociodemographics parameters on pain and stress

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of the impact of sociodemographics parameters on pain and stress evaluated by the visual analog scale (VAS) performed at two different times (outcome N°2)

  6. Impact of location of the wound on pain and stress

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of the impact of location of the wound on stress and pain evaluated by the visual analog scale (outcome n°2)

  7. Impact of location of the wound on variability of heart frequency

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of the impact of location of the wound on the variability of heart frequency measured by Bittium Faros (outcome n°1)

  8. Impact of the length of the wound on pain and stress

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of the impact of the length of the wound on stress and pain evaluated by the visual analog scale (outcome n°2)

  9. Impact of the length of the wound on variability of heart frequency

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of the impact of the length of the wound on the variability of heart frequency measured by heart rate monitoring belt (outcome n°1)

  10. Impact of the depth of the wound on pain and stress

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of the impact of the depth of the wound on stress and pain evaluated by the visual analog scale (outcome n°2)

  11. Impact of the depth of the wound on pain and stress

    Time frame: Hour 0; Hour 0+30 minutes

    Evaluation of the impact of the depth of the wound on the variability of heart frequency measured by heart rate monitoring belt (outcome n°1)

Study contacts

Contact information is provided by the study sponsor or research team.

LISE LACLAUTRE

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: BE-HYPER

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 12, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.