ClinicalTrials.gg
Not yet recruitingNCT06904443PsySonUpdated Apr 1, 2025

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

An interventional study of PsySon is an innovative device that uses music in crisis management in hospitals in Psychiatric Hospitalization, sponsored by Centre Hospitalier St Anne. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Other

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Phase
Not applicable
Study type
Interventional
Enrollment
172
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psychiatric Hospitalization
03

In context

Lead sponsor

Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 of the patient or his legal representative.
  • Benefit from a social protection scheme.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
172 participants (estimated)

Study arms

  • No intervention
    a historic control

    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.

  • Experimental
    psyson device

    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

  • OtherPsySon is an innovative device that uses music in crisis management in hospitals

    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.

06

What researchers measure

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

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2025; primary completion for Jul 2027, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2025
First posted
Apr 1, 2025
StartEst.
Jul 1, 2025
Primary completionEst.
Jul 1, 2027
CompletionEst.
Sep 1, 2027
Last update
Apr 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06904443
Responsible party
Sponsor
First posted
Apr 1, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Apr 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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