Clinical trial NCT06904443: Effectiveness of a Temporal and Sound Space in the Paramedical Management of "Crisis"
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychiatric Hospitalization
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental efficacy study, using a historical control arm. The evaluation of the efficacy of the intervention will be carried out by comparing the results of the patients benefiting from the PSYSON device integrated into the nursing and paramedical monitoring with those of a historical cohort built from the GHU Health Data Warehouse (EDS) for the years 2022 and 2023, in the same departments participating in the study.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Be between 18 and 65 years old.
* Diagnosis of bipolar disorder or schizophrenia DSM5.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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