BEnefit of HYpnosis on Pain During Stitches in Emergency Room
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Hypnosis.
- Кому может быть актуально
- Состояния в реестре: Wound of Skin. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
BEnefit of HYpnosis on Pain During Stitches in Emergency Room: The BE-HYPER Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Hypnosis
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.
Первичные конечные точки
- Heart rate variability [Срок оценки: Hour 0]
Вторичные конечные точки (11)
- Changes on visual analog scale of pain and stress [Срок оценки: Hour 0; Hour 0+30 minutes]
- Evaluation of stress biomarkers in blood samples [Срок оценки: Hour 0; Hour 0+30 minutes]
- Evaluation of blood pressure [Срок оценки: Hour 0; Hour 0+30 minutes]
- Evaluation of heart rate [Срок оценки: Hour 0; Hour 0+30 minutes]
- Impact of sociodemographics parameters on pain and stress [Срок оценки: Hour 0; Hour 0+30 minutes]
- Impact of location of the wound on pain and stress [Срок оценки: Hour 0; Hour 0+30 minutes]
- Impact of location of the wound on variability of heart frequency [Срок оценки: Hour 0; Hour 0+30 minutes]
- Impact of the length of the wound on pain and stress [Срок оценки: Hour 0; Hour 0+30 minutes]
- Impact of the length of the wound on variability of heart frequency [Срок оценки: Hour 0; Hour 0+30 minutes]
- Impact of the depth of the wound on pain and stress [Срок оценки: Hour 0; Hour 0+30 minutes]
- Impact of the depth of the wound on pain and stress [Срок оценки: Hour 0; Hour 0+30 minutes]
Критерии участия
Критерии включения
- Age > 18 years old
- Admitted in the emergency department of Clermont-Ferrand University Hospital
- Stitchable wound
- Patient's agreement
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Франция · 1 центр
- CHU de Clermont-Ferrand — Clermont-Ferrand
Публикации
- Perard L, Clinchamps M, Dutheil F, De Saint-Vincent S, Lucchini-Roche C, Schmidt J, Moustafa F, Baker JS, Pereira B, Bouillon-Minois JB. BEnefit of HYpnosis on Pain during stitches in an Emergency Room: a study protocol using a randomised controlled trial - the BE-HYPER protocol. BMJ Open. 2026 Jul 9;16(7):e108925. doi: 10.1136/bmjopen-2025-108925. PMID 42425558
Идентификаторы
NCT: NCT06497712 · RBHP 2023 BOUILLON-MINOIS