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Набор по приглашению NCT05772468

Virtual Pain Care Trial

Без фазы С лечением Wound Wound and Injuries Pain

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: Virtual Reality ('VRelax' VR system).
Кому может быть актуально
Состояния в реестре: Wound, Wound and Injuries, Pain. 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
Нидерланды
Следующий шаг
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Официальное название

Virtual Pain Care; the Effectiveness of Virtual Reality Therapy on Reducing Pain, and Anxiety During Complex Wound Care Procedures in Adults

Обзор

The main objective of this study is to evaluate the effect on pain of Virtual Reality Therapy as add-on therapy during wound care procedures in adults.

Подробное описание

After inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1 ratio. Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system during wound care or not wearing the VR system.

Patients are randomly assigned to one of two groups:

Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Control group, care as usual

Вмешательства

  • Устройство Virtual Reality ('VRelax' VR system)
    The intervention group 1 will be wearing the 'VRelax' Virtual Reality system during the wound care moment in addition to the standard procedure. The VR system consists of Virtual Reality glasses, and a headphone. The VRelax Application will be used.

Первичные конечные точки

  • The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS). [Срок оценки: Baseline, during the procedure, immediately after procedur]
Вторичные конечные точки (12)
  • Mean VAS change of all wound care procedures included in the study [Срок оценки: Baseline, during the procedure, immediately after procedure]
  • Change from baseline in level of anxiety at 10 minutes after procedure [Срок оценки: Baseline, 10 minutes after procedure]
  • Patient satisfaction [Срок оценки: Through study completion, an average of 1 week]
  • Provider satisfaction [Срок оценки: Through study completion, an average of 1 year]
  • Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure [Срок оценки: Baseline, 5 minutes after procedure]
  • Change of systolic blood pressure and diastolic blood pressure during procedure [Срок оценки: During procedure]
  • Change from baseline blood oxygen level at 5 minutes after procedure [Срок оценки: Baseline, 5 minutes after procedure]
  • Change of blood oxygen level during procedure [Срок оценки: During procedure]
  • Change from baseline pulse rate at 5 minutes after procedure [Срок оценки: Baseline, 5 minutes after procedure]
  • Change of pulse rate during procedure [Срок оценки: During procedure]
  • Change from baseline respiratory rate at 5 minutes after procedure [Срок оценки: Baseline, 5 minutes after procedure]
  • Change of respiratory rate during procedure [Срок оценки: During procedure]

Критерии участия

Критерии включения

  • Individuals aged 18 or older with wounds receiving wound care
  • Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures
  • At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure.

Критерии исключения

  • Individuals not being able to understand Dutch language at primary school level
  • Individuals not being able to read or write Dutch
  • Individuals diagnosed with dementia and/or cognitive impairment
  • Individuals diagnosed with epilepsy
  • Individuals diagnosed with migraine
  • Individuals with severe dizziness and/or nausea
  • Individuals with a known history of claustrophobia
  • Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide
  • Individuals who have no feeling in the wound care area
  • Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Нидерланды · 1 центр
  • Amsterdam University Medical Center — Amsterdam

Идентификаторы

NCT: NCT05772468 · NL82360.029.22

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗