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Набор скоро начнётся NCT07395323

Impact of Relaxation Sessions Using a Virtual Reality Application on the Sleep Quality of Caregivers Working Night Shifts

Без фазы С лечением Sleep Disorder

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: Arm 1: Experimental (VR) Intervention: Virtual reality sessions, Arm 2: Control (No VR / Standard Care).
Кому может быть актуально
Состояния в реестре: Sleep Disorder. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

Impact of Using a Virtual Reality Application on the Sleep Quality of Caregivers Working Night Shifts

Обзор

This project aims to evaluate the impact of relaxation sessions conducted using a virtual reality device on the sleep quality of night-shift healthcare workers. The intervention specifically targets the immediate post-night-shift period, a critical time for recovery, by offering immersive guided relaxation experiences designed to reduce anxiety and promote both mental and physiological relaxation.

Подробное описание

Paramedical staff working night shifts are particularly exposed to sleep disorders and psychological difficulties due to the length and organization of their working hours. The ANSES report highlights the central role of anxiety, both as a consequence of night work and as a factor that worsens sleep disturbances.

In response to this situation, the GHU Directorate of Nursing, in collaboration with Occupational Health, the CHRONOS team, and the pain specialist physician, has initiated a reflection on preventive actions aimed at better addressing the vulnerability of healthcare professionals. The objective is to provide concrete responses to psychological distress and the high levels of stress experienced by healthcare workers, which have been further intensified by the health crisis.

Within this framework, it is proposed to specifically address immediate post-night-shift sleep disturbances by implementing a relaxation program using a virtual reality application. This non-pharmacological approach aims to reduce anxiety and improve recovery among paramedical professionals working night shifts.

Вмешательства

  • Устройство Arm 1: Experimental (VR) Intervention: Virtual reality sessions
    During the virtual reality period (1 month), the participant receives a VR headset and an actigrapher, provided by a Registered Nurse Practitioner (RNP). A training session is organized and scheduled following enrollment. The participant will keep the VR headset and actigrapher at home for one month. The devices will be collected by the night shift supervisor at the end of the usage period. A paper sleep diary will be provided to assess sleep quality.
  • Устройство Arm 2: Control (No VR / Standard Care)
    Intervention: No virtual reality or standard care Description: Participants do not undergo virtual reality sessions during this period. The sleep-wake rhythm will be analyzed using an actimeter.

Первичные конечные точки

  • Compare the evolution of sleep quality of paramedical professionals assessed by the PSQI scale, with or without intervention, (cross-over design). [Срок оценки: 15 months]
Вторичные конечные точки (3)
  • Severity of sleep disorders: ISI, [Срок оценки: 15 months]
  • Level of Anxiety: GAD-7 [Срок оценки: 15 months]
  • Level of anxiety and depression: QIDS [Срок оценки: 15 months]

Критерии участия

Критерии включения

  • State-certified nurse or nursing assistant (GHU, GHPG staff)
  • Regularly working night shifts and on duty in the units
  • Age 18 years and over
  • Informed individuals who have signed written consent
  • Individuals affiliated with a social security scheme and must be able to understand and read French.

Критерии исключения

  • No possibility of follow-up (subjects on fixed-term contracts, ongoing transfers, student reinforcements, etc.)
  • Subjects with insufficient command of the French language, preventing them from taking the tests
  • Pregnant or breastfeeding women (disruption of the sleep cycle), or women with young children.
  • Individuals with a pacemaker or any other implanted medical device, unless medically advised otherwise (due to the radio-magnetic waves emitted by the virtual reality headset)
  • Individuals with epilepsy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07395323 · D24-P018

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗