Sensory Profile and Early Clinical Signs of Calm Room Users (EVAL-APAISE)

February 17, 2025 updated by: Aude Paquet, Centre Hospitalier Esquirol

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Other: Calm room

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Aude Paquet, PhD in Psychology
Phone Number: +33 5-55-43-11-27
Email: aude.paquet@ch-esquirol-limoges.fr

Study Locations

France
- Nouvelle-Aquitaine
  - Limoges, Nouvelle-Aquitaine, France, 87025
    - Recruiting
    - Esquirol Hsopital Center
    - Contact:
      
      Théodore Vinais, Master degree
      
      Phone Number: +33 + 5-87-50-91-29
      
      Email: theodore.vinais@ch-esquirol-limoges.fr
    - Contact:
      
      Aude Paquet, PhD in Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: At enrollment	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.	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: At enrollment	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.	At enrollment
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 Time Frame: At enrollment	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.	At enrollment
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 Time Frame: At enrollment	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.	At enrollment
Comparison of Adolescent/Adult Sensory Profile score between the user and non-user of the calming room Time Frame: From enrollment to the end of observation at 2 weeks	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	From enrollment to the end of observation at 2 weeks
Anxiety for users or non-user of the calming room Time Frame: From enrollment to the end of observation at 2 weeks	Anxiety is assessed from the Hamilton Anxiety Rating Scale for users and non-users of the calming room. The overall score ranges from 0 to 60. The generally accepted threshold for significant anxiety is 20.	From enrollment to the end of observation at 2 weeks
Frequency of use of the calming room Time Frame: From enrollment to the end of observation at 2 weeks	- Frequency of Calming Room Use during the 14-Day Participation Period: Total number of uses of the room / time (hours)	From enrollment to the end of observation at 2 weeks
Initiative for the use of the calming room Time Frame: From enrollment to the end of observation at 2 weeks	Modes of use of the calming room among patients who use this room. Qualitative measure is used for initiative : Patient initiative or team initiative	From enrollment to the end of observation at 2 weeks
Reason for resquesting of the calming room Time Frame: From enrollment to the end of observation at 2 weeks	Modes of use of the calming room among patients who use this room. Qualitative measure is used for reason for resquesting use of the calming room : Anxiety / Sadness / Fatigue / Physical Tension / Seeking Well-being	From enrollment to the end of observation at 2 weeks
Autonomy for the use of the calming room Time Frame: From enrollment to the end of observation at 2 weeks	Modes of use of the calming room among patients who use this room. Qualitative measure is used for autonomy for the use of the calming room : Presence of caregiver / Partial autonomy (one-off intervention by a caregiver) / Total autonomy (nocaregiver intervention during the use)	From enrollment to the end of observation at 2 weeks
User frenquecy of the calming room Time Frame: From enrollment to the end of observation at 2 weeks	Number of uses of the calming room during the hospitalization	From enrollment to the end of observation at 2 weeks
Description of anxiety leading to the use of the calming room among patients who use this room. Time Frame: From enrollment to the the end of observation at 2 weeks	Description of early clinical signs leading to the use of the calming room among patients who use this room. Visual Analog Score for anxiety	From enrollment to the the end of observation at 2 weeks
Description of well-being leading to the use of the calming room among patients who use this room. Time Frame: From enrollment to the the end of observation at 2 weeks	Description of early clinical signs leading to the use of the calming room among patients who use this room. - Visual Analog Score for well-being	From enrollment to the the end of observation at 2 weeks
Description of physical tension leading to the use of the calming room among patients who use this room. Time Frame: From enrollment to the the end of observation at 2 weeks	Description of early clinical signs leading to the use of the calming room among patients who use this room. - Visual Analog Score for physical tension	From enrollment to the the end of observation at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Esquirol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

December 19, 2027

Study Completion (Estimated)

May 19, 2028

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)