Sensory Profile and Early Clinical Signs of Calm Room Users
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCentre Hospitalier Esquirol
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Inability to understand information related to the study
Proven sensory disability
Dementia
Pregnancy
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Calm room
Other interventionThe calm room combines the effects of music, light, and videos designed with natural atmospheres. Four themes are offered in the calm room: Comfort, Optimism, Freshness, and Lullaby. These themes feature nature videos, combining relaxing images with calm musical ambiance. The lighting can be adjusted by the user, who can choose from a varied color palette. The available lights have a low glare level, and the light intensity can also be adjusted by the user. They can be used by patients any time they want and for as long as they want.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
The sensory profile scores will be obtained through the Adolescent/Adult Sensory Profile (AASP) scale during an individual interview following the participant inclusion. The following Sensory Sensitivity sub-score will be collected. The minimum and maximum values are from 15 to 75. A high score indicate a high sensory sensitivity.
Time frame
At enrollmentSecondary outcomes
1
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
The sensory profile scores will be obtained through the Adolescent/Adult Sensory Profile (AASP) scale during an individual interview following the participant inclusion. The following Low Registration sub-score will be collected. The minimum and maximum values are from 15 to 75. A high score indicate a high Low Registration.
Time frame
At enrollment2
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
The sensory profile scores will be obtained through the Adolescent/Adult Sensory Profile (AASP) scale during an individual interview following the participant inclusion. The following Sensation Seeking sub-score will be collected. The minimum and maximum values are from 15 to 75. A high score indicate a high Sensation Seeking.
Time frame
At enrollment3
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
The sensory profile scores will be obtained through the Adolescent/Adult Sensory Profile (AASP) scale during an individual interview following the participant inclusion. The following Sensation Avoiding sub-score will be collected. The minimum and maximum values are from 15 to 75. A high score indicate a high Sensation Avoiding.
Time frame
At enrollment4
Comparison of Adolescent/Adult Sensory Profile score between the user and non-user of the calming room
* Adolescent/Adult Sensory Profile scores (Sensory Sensitivity / Low Registration / Sensation Seeking / Sensory Avoidance) among calming room user * Adolescent/Adult Sensory Profile scores (Sensory Sensitivity / Low Registration / Sensation Seeking / Sensory Avoidance) among calming room non-user
Time frame
From enrollment to the end of observation at 2 weeksSponsors and contacts
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Source ClinicalTrials.gov