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NCT Number: NCT06839950

Sensory Profile and Early Clinical Signs of Calm Room Users

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.

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Key information

Conditions

Psychotic Disorders Mental Disorders Mood Disorders Personality Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Esquirol Hsopital Center

Limoges, New Aquitaine, 87025, France

Location status: Recruiting

Location contact

Aude Paquet, PhD in Psychology

CONTACT

Théodore Vinais, Master degree

CONTACT

[email protected]

+33 + 5-87-50-91-29

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Sensory room, Comfort room

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

    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.

Secondary 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

    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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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)

  7. 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

  8. 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

  9. 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)

  10. 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

  11. 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

  12. 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

  13. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Aude Paquet, PhD in Psychology

CONTACT

[email protected]

+33 5-55-43-11-27

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Esquirol

Other

Registry information

Acronym: EVAL-APAISE

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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