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Идёт набор NCT05779852

Pain Management of Amputation Wounds With AutoHypnosis

Без фазы С лечением Vascular Surgical Procedures

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: self-hypnosis and dressing, dressing.
Кому может быть актуально
Состояния в реестре: Vascular Surgical Procedures. 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
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Обзор

Amputation in vascular surgery mainly concerns the lower limb and is often linked to Obliterative Arterial Disease of the Lower Limbs. It indicates the impossibility or failure of revascularisation after an exhaustive assessment aimed at saving the limb. It is also performed to limit the spread of gangrene, an affection of the limb that can evolve into septicaemia. The principle is to amputate in a healthy and vascularised area to allow good healing of the amputation stump. Amputations of one, several or all toes, called complete transmetatarsal amputations, may take several months to heal. Amputations require directed healing and, above all, monitoring of the underlying tissues of the amputated area by daily detersions and wiping performed by a nurse at home. The mechanical detersion of the wound necessary for the healing process and cell migration, as well as optimal deep meshing, facilitate the evolution of the healing process. These treatments often cause pain, despite oral analgesics and local anaesthetics prior to the treatment. For several years, studies have shown the benefits of hypnosis in modifying the perception of pain, particularly during treatment. Studies have also shown that self-hypnosis allows a reduction in the intensity of pain. The clinical experience of the vascular surgery department of the University Hospital of Rennes suggests that patients who use self-hypnosis during the daily dressing of their amputation experience the moment more serenely, increasing their comfort and decreasing their pain and anxiety.

Вмешательства

  • Другое self-hypnosis and dressing
    self-hypnosis during dressing
  • Другое dressing
    dressing without self-hypnosis

Первичные конечные точки

  • Level of pain [Срок оценки: Day 2 (during the 3rd post-operative amputation bandage)]

Критерии участия

Критерии включения

  • Age ≥ 18 years;
  • Naïve to amputation procedures;
  • Amputated, within 24 hours prior to inclusion, one, more or all toes
  • Pain level on the Numerical Scale ≥ 3 during the first dressing;
  • Affiliated to a social security scheme;
  • Having signed a free, informed and written consent.

Критерии исключения

  • Cognitive impairments that limit understanding of instructions;
  • Cultural limitations reducing abstraction skills;
  • Previous practice of hypnosis;
  • Contraindications to hypnosis: Bipolar disorder or decompensated schizophrenia;
  • Chronic non-vascular pain;
  • Already in care for painful chronic wounds (ulcer wounds, bedsores...)
  • On morphine before surgery;
  • Analgesia by perineural catheter;
  • Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declarative), nursing woman and minor).

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
Другое

Центры проведения

Франция · 1 центр
  • CHU Rennes — Rennes

Идентификаторы

NCT: NCT05779852 · 35RC20_8896_MODOUPAAH · 2022-A00638-35

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗