BEnefit of HYpnosis on Pain During Stitches in Emergency Room
NCT Number: NCT06497712
Acronym: BE-HYPER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wound of Skin
Interventions: OTHER: Hypnosis
Sponsor: University Hospital, Clermont-Ferrand
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-15
Completion Date: 2025-07-15
Locations: CHU de Clermont-Ferrand, Clermont-Ferrand, 63000, France

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.

Primary Outcome Measures: Impact of hypnosis during stitches among emergency department patients, Impact of hypnosis will be evaluated by the variability of heart frequency measured by heart rate monitoring belt, Hour 0
Secondary Outcome Measures: Impact of hypnosis on stress patients during stitches, 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)., Hour 0; Hour 0+30 minutes|Evaluation of stress biomarkers in blood samples, Evaluation of cortisol, DHEA, DHEA-s, ghrelin, leptin, IL-8, TNF-alpha, epinephrin, noradrenalin, dopamine, Hour 0; Hour 0+30 minutes|Evaluation of blood pressure, Evaluation of hypnosis impact on systolic and diastolic blood pressure in millimeter of mercury (mmHg), Hour 0; Hour 0+30 minutes|Evaluation of heart rate, Evaluation of hypnosis impact on physiological parameters heart rate in beats per minute (bpm), Hour 0; Hour 0+30 minutes|Impact of sociodemographics parameters on pain and stress, 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), Hour 0; Hour 0+30 minutes|Impact of location of the wound on pain and stress, Evaluation of the impact of location of the wound on stress and pain evaluated by the visual analog scale (outcome n°2), Hour 0; Hour 0+30 minutes|Impact of location of the wound on variability of heart frequency, Evaluation of the impact of location of the wound on the variability of heart frequency measured by heart rate monitoring belt (outcome n°1), Hour 0; Hour 0+30 minutes|Impact of the length of the wound on pain and stress, Evaluation of the impact of the length of the wound on stress and pain evaluated by the visual analog scale (outcome n°2), Hour 0; Hour 0+30 minutes|Impact of the length of the wound on variability of heart frequency, 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), Hour 0; Hour 0+30 minutes|Impact of the depth of the wound on pain and stress, Evaluation of the impact of the depth of the wound on stress and pain evaluated by the visual analog scale (outcome n°2), Hour 0; Hour 0+30 minutes|Impact of the depth of the wound on pain and stress, 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), Hour 0; Hour 0+30 minutes