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Идёт набор NCT04571736

Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform

Без фазы С лечением Thyroid

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: access to the internet information platform.
Кому может быть актуально
Состояния в реестре: Thyroid. Базовые параметры: 18 лет — 75 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

Interest of Improving Preoperative Medical Information by Video Support and Personalized and Secure Web Platform: Pilot Study in Thyroid Surgery (AMEDOP)

Обзор

The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient. There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time. The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.

Подробное описание

The objective is to assess the impact of additional, personalized and accessible preoperative medical information via a secure internet platform on the anxiety level of patients before their surgery. For this, patients agreeing to participate in the study will be randomized (drawn at random) during the inclusion visit and divided into one of the following two groups:

* The control group: patients included in this group will receive the usual medical information as part of the surgery performed; * The experimental group: the patients included in this group will have, in addition to the usual medical information, personalized and secure access to a platform so that they can have additional information on the surgery performed.

Вмешательства

  • Другое access to the internet information platform
    This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time.

Первичные конечные точки

  • Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE [Срок оценки: Baseline Day [-90 / -7] and Surgery Day [-1 / 0]]
Вторичные конечные точки (7)
  • State-Trait Anxiety Inventory (STAI-ETAT) SCORE [Срок оценки: Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30]]
  • Internet use self-questionnaire [Срок оценки: Baseline Day [-90 / -7]]
  • Internet use self-questionnaire [Срок оценки: Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30]]
  • specific questionnaire EDOP [Срок оценки: post-operative visit Day [5-30] after viewing the screening video]
  • satisfaction assessment questionnaire and understanding of the preoperative medical information for control group [Срок оценки: Baseline Day [-90 / -7], Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]]
  • satisfaction assessment questionnaire and understanding of the preoperative medical information for experimental groupe [Срок оценки: 2 times at Baseline Day [-90 / -7] before and after the presentation of EDOP platform, Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]]
  • State-Trait Anxiety Inventory (STAI-TRAIT) SCORE [Срок оценки: Baseline Day[ -90 / -7]]

Критерии участия

Критерии включения

  • Age between 18 and 75,
  • Indication of lobo-isthmectomy or total thyroidectomy
  • Compliance for the completion of self-questionnaires
  • Person affiliated or beneficiary of a social security scheme.
  • Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Критерии исключения

  • Difficulty understanding the French language
  • Lack of internet access
  • Persons placed under the protection of justice,
  • Person under guardianship or curatorship
  • Person participating in another research including an exclusion period still in progress,
  • Subject with severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant
  • Pregnant / lactating woman

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 1 центр
  • CHU Gui de Chauliac — Montpellier

Идентификаторы

NCT: NCT04571736 · RECHMPL19_0085 (7782) · 2019-A02241-56

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗