跳至主要内容
临床试验/NCT06904443
NCT06904443尚未招募不适用

Effectiveness of a Temporal and Sound Space in the Paramedical Management of "Crisis" States of Patients Hospitalized in Psychiatry: Quasi-experimental Study With a Single Arm

Centre Hospitalier St Anne0 个研究点目标入组 172 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
172
主要终点
administrations of conditional or emergency prescription medications for crisis conditions (states of stress, agitation, anxiety, etc.), during the first month of hospitalization for patients benefiting from the PSYSON system

研究概览

简要总结

This project could potentially lead to better crisis management in psychiatry, using music as a mediator. The integration of a well-designed sound device could help caregivers build trust with patients, alleviate anxiety, and foster an environment conducive to healing. In addition, it would offer a less invasive and more patient-centered alternative, creating an atmosphere that facilitates communication and calming.

详细描述

The patient will receive specific, individualized paramedical monitoring. The PSYSON device will be presented to the patient during a paramedical interview within 3 days of the inclusion visit, by a pair of investigators composed of a nurse and a paramedic (occupational therapist or psychomotor therapist) or a psychologist.

This interview will help define the patient's personalized sound environment, adapted to moments of anxiety. The pair of investigators plays a key role in creating the playlist, which will constitute the patient's specific sound environment.

The first caregiver investigator will act as a close observer, observing the patient's reactions and psycho-corporal state, which could indicate psychomotor relaxation. The second caregiver investigator will use a tablet or computer provided by the department to enter the patient's choices into the application.

During this interview, the investigator will focus on the patient's emotions and sensory perception. It will begin with the patient's musical request, and to help the patient express his preferences, the investigator can rely on photo language, using "musical atmosphere" cards created for this purpose. These cards highlight a central musical theme, likely to arouse the patient's attention, emotion and certain ideas. Musical instruments can also be made available to observe the patient's musical and rhythmic desires and preferences.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Be between 18 and 65 years old.
  • •Diagnosis of bipolar disorder or schizophrenia DSM
  • •Be hospitalized full-time in an acute psychiatric ward with or without compulsory care (SPL, SPDT, SPDTU, SPPI, SPDRE).
  • •Prior written informed consent of the patient or his legal representative.
  • •Benefit from a social protection scheme.

排除标准

  • •Have a severe cognitive disorder assessed during the clinical interview, making it impossible to focus one's attention.
  • •Hearing-impaired subjects who do not wear hearing aids.

研究组 & 干预措施

a historic control

No Intervention

a historical cohort constructed from the GHU Health Data Warehouse (EDS), including all patients meeting the inclusion/exclusion criteria, relating to the years 2022 and 2023, in the same departments participating in the study.

psyson device

Experimental

during his hospitalization, the patient can benefit from listening sessions thanks to an original and innovative device, a sort of listening chair equipped with high-quality speakers, thus offering an immersive and enveloping experience (see photo). These sessions aim to anticipate or manage a moment of crisis, of "less well", which patients often face in institutions.

干预措施: PsySon is an innovative device that uses music in crisis management in hospitals (Other)

结局指标

主要结局

administrations of conditional or emergency prescription medications for crisis conditions (states of stress, agitation, anxiety, etc.), during the first month of hospitalization for patients benefiting from the PSYSON system

时间窗: 1 month

change in the number of administrations of conditional or emergency prescription

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier St Anne
申办方类型
Other
责任方
Sponsor

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