Effectiveness of a Temporal and Sound Space in the Paramedical Management of "Crisis"

NCT06904443 | Not Yet Recruiting DMC

• 1 other identifier: D23 P005
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychiatric Hospitalization

Outcome Measures

Primary Outcomes (1)

• 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

  change in the number of administrations of conditional or emergency prescription

  1 month

Study Arms (2)

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.

Other: PsySon is an innovative device that uses music in crisis management in hospitals

Interventions

PsySon is an innovative device that uses music in crisis management in hospitals OTHER

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.

psyson device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

MeSH Terms

Interventions

Hospitals

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 1, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-01