BEnefit of HYpnosis on Pain During Stitches in Emergency Room
- Conditions
- Wound of Skin
- Interventions
- Other: Hypnosis
- Registration Number
- NCT06497712
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- Patient over 18 years, admitted in Clermont-Ferrand University Hospital Emergency Department
- suturable wound
- patient's consent obtained
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypnosis Hypnosis Patients will be hypnotized by a trained person before suturing.
- Primary Outcome Measures
Name Time Method Impact of hypnosis during stitches among emergency department patients Hour 0 Impact of hypnosis will be evaluated by the variability of heart frequency measured by heart rate monitoring belt
- Secondary Outcome Measures
Name Time Method Impact of hypnosis on stress patients during stitches 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).Evaluation of blood pressure Hour 0; Hour 0+30 minutes Evaluation of hypnosis impact on systolic and diastolic blood pressure in millimeter of mercury (mmHg)
Impact of the depth of the wound on pain and stress 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)
Evaluation of stress biomarkers in blood samples Hour 0; Hour 0+30 minutes Evaluation of cortisol, DHEA, DHEA-s, ghrelin, leptin, IL-8, TNF-alpha, epinephrin, noradrenalin, dopamine
Evaluation of heart rate Hour 0; Hour 0+30 minutes Evaluation of hypnosis impact on physiological parameters heart rate in beats per minute (bpm)
Impact of sociodemographics parameters on pain and stress 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)
Impact of location of the wound on variability of heart frequency Hour 0; Hour 0+30 minutes Evaluation of the impact of location of the wound on the variability of heart frequency measured by heart rate monitoring belt (outcome n°1)
Impact of the length of the wound on pain and stress 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)
sinusal variability of cardiac frequency on healthcare professional during stitching Hour 0 and for 48 hours measurement of sinus variability of heart rate in healthcare professionals performing wound care by a heart rate transmitter holter positionned on the chest
Impact of location of the wound on pain and stress 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)
Impact of the length of the wound on variability of heart frequency 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)
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France