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Идёт набор NCT07365761

Emotional Assessment and Tiered Individualized Psychological Support of the Artificial Intelligence Robot

Без фазы С лечением Emotional Assessment Nursing Gynecological Cancers

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: E-MOTE group.
Кому может быть актуально
Состояния в реестре: Emotional Assessment, Nursing, Gynecological Cancers. 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
Тайвань
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

Emotional Assessment and Tiered Individualized Psychological Support for Newly Diagnosed Postoperative Gynecologic Patients: Development and Testing of the E-MOTE Artificial Intelligence Robot

Обзор

To develop the E-MOTE robot and evaluate its effectiveness in addressing psychological distress, physical symptom, stress index, and quality of life, as well as to explore its clinical applicability.

Подробное описание

This study is grounded in the Social Cognitive Theory of Self-Regulation as its theoretical framework and aims to develop a robot equipped with functions of Emotion, Monitor, Optimize, Tailor, and Engage (E-MOTE). The intervention is designed to support newly diagnosed gynecological cancer patients in more effectively managing their emotions throughout the surgical treatment process, with the goal of positively influencing symptom management and quality of life.At the same time, the investigators will conduct qualitative interviews with nursing staff to understand their perceptions and thoughts about the robot.

Вмешательства

  • Другое E-MOTE group
    Participants in the experimental group will receive the E-MOTE robot intervention on the first and second days after surgery. The intervention includes an emotional assessment, followed by appropriate dialogue modules tailored to the level of emotional distress. These are supplemented with emotion-generated empathetic conversations for deeper engagement, a session of self-affirmation relaxation training, and a subsequent Q\&A session.

Первичные конечные точки

  • Distress [Срок оценки: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.]
  • Depression [Срок оценки: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.]
Вторичные конечные точки (5)
  • Usability of the robot [Срок оценки: Measurements will be taken three days post-surgery.]
  • Quality of Life Measurement [Срок оценки: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.]
  • Loneliness [Срок оценки: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.]
  • Symptom Severity [Срок оценки: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.]
  • Physiological objective indicators [Срок оценки: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.]

Критерии участия

Stage 1 (For patients and nurse) \*\*\*Patients\*\*\*

Критерии включения

  • Aged 18 years or older.
  • Diagnosed with gynecologic cancer and undergoing surgery.
  • Willing to receive E-MOTE robot and wear a smart wearable device.
  • Willing to complete pre-test and post-test questionnaires.

Критерии исключения

  • Unable to communicate clearly.
  • Unwilling or unable to participate in the study in its entirety.

\*\*\*Nurse\*\*\*

Критерии включения

  • Aged 18 years or older.
  • As a clinical nurse and has cared for patients who received the E-MOTE robot

Критерии исключения

\- Unwilling to participate in the qualitative interview.

Stage 2 (only for patients) \*\*\*Intervention group\*\*\*

Критерии включения

  • Aged 18 years or older.
  • Diagnosed with gynecologic cancer and scheduled to undergo surgery.
  • Willing to receiveE-MOTE robot and to wear a smart wearable device.
  • Willing to complete pre-test and post-test questionnaires.

Критерии исключения

  • Unable to communicate clearly.
  • Unwilling or unable to participate in the study in its entirety.

\*\*\*Control group\*\*\*

Критерии включения

  • Aged 18 years or older.
  • Diagnosed with gynecologic cancer and scheduled to undergo surgery.
  • Willing to complete pre-test and post-test questionnaires.

Критерии исключения

  • Unable to communicate clearly.
  • Unwilling or unable to participate in the study in its entirety.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Тайвань · 1 центр
  • National Taiwan University — Taipei

Идентификаторы

NCT: NCT07365761 · 202504008RINC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗