Sensory Profile and Early Clinical Signs of Calm Room Users

NCT06839950 | Recruiting

• 2 other identifiers: EVAL-APAISE2023-A00580-45
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders; Personality Disorders; Mood Disorders

Keywords

Calm room; Psychotic Disorders; Sensory Profile; Mood Disorders; Personality Disorders

Outcome Measures

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.

  At enrollment

Secondary Outcomes (13)

• 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

  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

  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

  At enrollment

• Comparison of Adolescent/Adult Sensory Profile score between the user and non-user of the calming room

  From enrollment to the end of observation at 2 weeks

• Anxiety for users or non-user of the calming room

  From enrollment to the end of observation at 2 weeks

Interventions

Calm room OTHER

The 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.

Also known as: Sensory room, Comfort room

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Esquirol: lead

Study Sites (1)

Esquirol Hsopital Center

Limoges, Nouvelle-Aquitaine, 87025, France

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Personality Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Aude Paquet, PhD in Psychology

CONTACT

+33 5-55-43-11-27; aude.paquet@ch-esquirol-limoges.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychomotor Therapist, Doctor in Psychology

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 21, 2025
• Study Start: December 19, 2023
• Primary Completion (Estimated): December 19, 2027
• Study Completion (Estimated): May 19, 2028
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)