Impact of Sound Shower Music Diffusion on Family Anxiety in Intensive Care Unit Waiting Room
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: Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room..
- Кому может быть актуально
- Состояния в реестре: Anxiety. 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Hospitalization in intensive care is a source of intense stress for both patients and their family. Post-intensive care syndrome (PICS) may affect both patients and their family. Outside the acute care in intensive care unit, non-drug therapies are gradually proving effective in reducing stress and pain. The investigators would like to know whether the beneficial effects of music therapy can be transferred to their intensive care patients. The aim of the project is to evaluate an innovative and personalized music diffusion system using a sound shower on the family anxiety in the intensive care waiting room. In this study, the investigators will compare the family anxiety in the intensive care waiting room, with or without music played through the sound shower.
Подробное описание
When a family member or a relative visits a patient in the intensive care unit for the first time, the investigators may ask to participate in the MUSICALITY research protocol. After randomization, relative will be included in either the control group or the music intervention group. Just before the intervention (music therapy or not), the investigators will ask them to complete the questionnaire State-Trait Anxiety Inventory-Y (STAI-Y, also called Spielberger questionnaire) and a numerical scale of experience. The relative will then wait in the waiting room with or without music during 20 to 30 minutes. At the end of the waiting period, the same questionnaire STAI-Y and the same numerical scale of experience will be completed again by the relative. For the music intervention group, the investigators will ask them also to complete a satisfaction questionnaire regarding their music listening experience. The relative will then be received by the medical and paramedical team in charge of the patient for health informations. A numerical scale of overall satisfaction will be completed by each group, at the end of the protocol intervention.
Вмешательства
- Устройство Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.
Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.
Первичные конечные точки
- Family/Relatives anxiety in the intensive care waiting room [Срок оценки: 20 to 30 minutes after randomization]
Вторичные конечные точки (10)
- Change in family/relatives anxiety (20-30 min of waiting vs pre-randomization) [Срок оценки: Before randomization and 20-30 minutes after randomization]
- Family/Relatives experience [Срок оценки: 20 to 30 minutes after randomization]
- Change in family/relatives experience (20-30 min of waiting vs pre-randomization) [Срок оценки: Before randomization and 20-30 minutes after randomization]
- Predefinded subgroups: Family relationship [Срок оценки: Before randomization]
- Predefinded subgroups: Age of relatives [Срок оценки: Before randomization]
- Predefinded subgroups: Gender of relatives [Срок оценки: Before randomization]
- Predefinded subgroups: Initial anxiety level of relatives [Срок оценки: Before randomization]
- Predefinded subgroups: Severity of hospitalized patients [Срок оценки: Before randomization]
- Family/Relatives satisfaction about musical intervention [Срок оценки: At the end of tntervention : 20 to 30 minutes after randomization]
- Overall satisfaction about the general welcome [Срок оценки: 4h after randomization (at the end of waiting and after the interview conducted by the medical and/or paramedical team in charge of the patient).]
Критерии участия
Критерии включения
- Relative aged ≥18 years
- First visit by a family member or a relative of a patient intubated and ventilated in intensive care unit
Критерии исключения
- Relative who does not speak French
- Relative who is deaf without hearing aids
- Relative refusing to participate in the study
- Relative under legal protection
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 · 3 центра
- Hospital centre — Le Mans
- University hospital — Orléans
- University hospital — Tours
Идентификаторы
NCT: NCT07506954 · DR230306 - MUSICALITY