Clinical trial NCT06839950: Sensory Profile and Early Clinical Signs of Calm Room Users
Official title: Sensory Profile and Early Clinical Signs of Calm Room Users
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psychotic Disorders
Personality Disorders
Mood Disorders
Keywords: Calm room
Psychotic Disorders
Sensory Profile
Mood Disorders
Personality Disorders
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled from the Deniker unit in the Esquirol Hospital Center of Limoges, France.

This study may involve a vulnerable population. In psychiatric settings, calming rooms are typically installed in closed units that admit crisis patients. These individuals may be hospitalized involuntarily or be under protective measures. Since the study focuses on individuals who are able to use such devices within the participating unit, they can be considered vulnerable.

Brief summary: This descriptive study aims primarily to characterize the sensory profile of patients in a closed psychiatric hospital unit who use a calming room.

The main questions it aims to answer are :

* Could sensory information processing disorders be the cause of distress and tension in these patients?
* Could users of the calming room present extreme sensory processing profiles, characterized by either hypersensitivity or hyposensitivity ?

Participants will answer a survey to determine their the sensory profile. Participants can already use the calming room as part of their regular medical care and they will answer surveys before and after each use.


Eligibility criteria: Inclusion Criteria:

* Gender and Age: Male or female, aged 18 to 65
* Hospitalization: Admitted to the closed hospitalization unit for less than 10 days
* Social security: Affiliated or beneficiary of a social security system
* Consent: Free, informed, and written consent, signed by the participant and/or their legal representative (for participants under protection measures) and the investigator (at the latest on the day of inclusion and before any research-related examination).

Exclusion Criteria:

* Inability to understand information related to the study
* Proven sensory disability
* Dementia
* Pregnancy
* Lack of social protection
* Previous Participation in this research protocol (in the case of a new hospitalization)
* Expression abilities incompatible with completing the AASP Scale (e.g., french language comprehension issues, mute individuals, patients in restraint and/or therapeutic isolation)

Primary outcomes:
measure: Scores of Sensory Sensitivity from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room
timeFrame: At enrollment
Secondary outcomes:
measure: Scores of the Low Registration from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room
timeFrame: At enrollment
measure: Scores of the Sensation Seeking from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room
timeFrame: At enrollment
measure: Scores of the Sensation Avoiding from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room
timeFrame: At enrollment
measure: Comparison of Adolescent/Adult Sensory Profile score between the user and non-user of the calming room
timeFrame: From enrollment to the end of observation at 2 weeks
measure: Anxiety for users or non-user of the calming room
timeFrame: From enrollment to the end of observation at 2 weeks
measure: Frequency of use of the calming room
timeFrame: From enrollment to the end of observation at 2 weeks
measure: Initiative for the use of the calming room
timeFrame: From enrollment to the end of observation at 2 weeks
measure: Reason for resquesting of the calming room
timeFrame: From enrollment to the end of observation at 2 weeks
measure: Autonomy for the use of the calming room
timeFrame: From enrollment to the end of observation at 2 weeks
measure: User frenquecy of the calming room
timeFrame: From enrollment to the end of observation at 2 weeks
measure: Description of anxiety leading to the use of the calming room among patients who use this room.
timeFrame: From enrollment to the the end of observation at 2 weeks
measure: Description of well-being leading to the use of the calming room among patients who use this room.
timeFrame: From enrollment to the the end of observation at 2 weeks
measure: Description of physical tension leading to the use of the calming room among patients who use this room.
timeFrame: From enrollment to the the end of observation at 2 weeks
Other outcomes:
Locations:
city: Limoges
country: France
facility: Esquirol Hsopital Center
state: Nouvelle-Aquitaine
Study officials:
References: