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Идёт набор NCT06839950

Sensory Profile and Early Clinical Signs of Calm Room Users

— Наблюдательное Psychotic Disorders Personality Disorders Mood Disorders

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: Calm room.
Кому может быть актуально
Состояния в реестре: Psychotic Disorders, Personality Disorders, Mood Disorders. Базовые параметры: 18 лет — 65 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

This descriptive study aims primarily to characterize the sensory profile of patients in a closed psychiatric hospital unit who use a calming room. The main questions it aims to answer are : * Could sensory information processing disorders be the cause of distress and tension in these patients? * Could users of the calming room present extreme sensory processing profiles, characterized by either hypersensitivity or hyposensitivity ? Participants will answer a survey to determine their the sensory profile. Participants can already use the calming room as part of their regular medical care and they will answer surveys before and after each use.

Вмешательства

  • Другое Calm room
    The calm room combines the effects of music, light, and videos designed with natural atmospheres. Four themes are offered in the calm room: Comfort, Optimism, Freshness, and Lullaby. These themes feature nature videos, combining relaxing images with calm musical ambiance. The lighting can be adjusted by the user, who can choose from a varied color palette. The available lights have a low glare level, and the light intensity can also be adjusted by the user. They can be used by patients any time

Первичные конечные точки

  • Scores of Sensory Sensitivity from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room [Срок оценки: At enrollment]
Вторичные конечные точки (12)
  • Scores of the Low Registration from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room [Срок оценки: At enrollment]
  • Scores of the Sensation Seeking from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room [Срок оценки: At enrollment]
  • Scores of the Sensation Avoiding from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room [Срок оценки: At enrollment]
  • Comparison of Adolescent/Adult Sensory Profile score between the user and non-user of the calming room [Срок оценки: From enrollment to the end of observation at 2 weeks]
  • Anxiety for users or non-user of the calming room [Срок оценки: From enrollment to the end of observation at 2 weeks]
  • Frequency of use of the calming room [Срок оценки: From enrollment to the end of observation at 2 weeks]
  • Initiative for the use of the calming room [Срок оценки: From enrollment to the end of observation at 2 weeks]
  • Reason for resquesting of the calming room [Срок оценки: From enrollment to the end of observation at 2 weeks]
  • Autonomy for the use of the calming room [Срок оценки: From enrollment to the end of observation at 2 weeks]
  • User frenquecy of the calming room [Срок оценки: From enrollment to the end of observation at 2 weeks]
  • Description of anxiety leading to the use of the calming room among patients who use this room. [Срок оценки: From enrollment to the the end of observation at 2 weeks]
  • Description of well-being leading to the use of the calming room among patients who use this room. [Срок оценки: From enrollment to the the end of observation at 2 weeks]

Критерии участия

Критерии включения

  • Gender and Age: Male or female, aged 18 to 65
  • Hospitalization: Admitted to the closed hospitalization unit for less than 10 days
  • Social security: Affiliated or beneficiary of a social security system
  • Consent: Free, informed, and written consent, signed by the participant and/or their legal representative (for participants under protection measures) and the investigator (at the latest on the day of inclusion and before any research-related examination).

Критерии исключения

  • Inability to understand information related to the study
  • Proven sensory disability
  • Dementia
  • Pregnancy
  • Lack of social protection
  • Previous Participation in this research protocol (in the case of a new hospitalization)
  • Expression abilities incompatible with completing the AASP Scale (e.g., french language comprehension issues, mute individuals, patients in restraint and/or therapeutic isolation)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 1 центр
  • Esquirol Hsopital Center — Limoges

Идентификаторы

NCT: NCT06839950 · EVAL-APAISE · 2023-A00580-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗