Psychotic DisordersEVAL-APAISENCT06839950
Sensory Profile and Early Clinical Signs of Calm Room Users
An observational study of Psychotic Disorders and Personality Disorders, run by Centre Hospitalier Esquirol at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders, Personality Disorders, Mood Disorders
- What is being tested?
- Calm room
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2023to 19 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Esquirol Hsopital Center
Limoges, New Aquitaine, 87025
Théodore Vinais, Master degree, +33 + 5-87-50-91-29, theodore.vinais@ch-esquirol-limoges.fr
Aude Paquet, PhD in Psychology
About this study
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
- Being tested
- Calm room
- Keywords
- Calm room, Psychotic Disorders, Sensory Profile, Mood Disorders, Personality Disorders
- Medical subject headings
- Psychotic Disorders, Personality Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm roomOther
Also called Sensory room, Comfort room
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At enrollment
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
Measured: From enrollment to the end of observation at 2 weeks
Anxiety for users or non-user of the calming room
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.
Measured: From enrollment to the end of observation at 2 weeks
Frequency of use of the calming room
- Frequency of Calming Room Use during the 14-Day Participation Period: Total number of uses of the room / time (hours)
Measured: From enrollment to the end of observation at 2 weeks
Initiative for the use of the calming room
Modes of use of the calming room among patients who use this room.
Qualitative measure is used for initiative :
Patient initiative or team initiative
Measured: From enrollment to the end of observation at 2 weeks
Reason for resquesting of the calming room
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
Measured: From enrollment to the end of observation at 2 weeks
Autonomy for the use of the calming room
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)
Measured: From enrollment to the end of observation at 2 weeks
User frenquecy of the calming room
Number of uses of the calming room during the hospitalization
Measured: 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.
Description of early clinical signs leading to the use of the calming room among patients who use this room.
Visual Analog Score for anxiety
Measured: 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.
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
Measured: 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.
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
Measured: From enrollment to the the end of observation at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start19 Dec 2023
- Primary completion19 Dec 2027 (estimated)
- Study completion19 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aude Paquet, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839950
- Sponsor's protocol ID
- EVAL-APAISE
- Other IDs
- 2023-A00580-45
- Acronym
- EVAL-APAISE
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Profile and Early Clinical Signs of Calm Room Users
- ClinicalTrials.gov ID
- NCT06839950
- Acronym / sponsor ID
- EVAL-APAISE / EVAL-APAISE
- Conditions
- Psychotic Disorders, Personality Disorders, Mood Disorders
- Keywords
- Calm room, Psychotic Disorders, Sensory Profile, Mood Disorders, Personality Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 19 Dec 2027 (estimated)
- Study completion
- 19 May 2028 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- Inability to understand information related to the study
- Proven sensory disability
- Dementia
- Pregnancy
- Lack of social protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm roomAlso: Sensory room, Comfort roomThe 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 | – |
Primary outcome
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.
13 secondary outcomes
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
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
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
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
Anxiety for users or non-user of the calming room
Time frame: 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
Initiative for the use of the calming room
Time frame: 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
Autonomy for the use of the calming room
Time frame: 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
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 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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders and Personality Disorders, run by Centre Hospitalier Esquirol at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aude Paquet, PhD in Psychology (+33 5-55-43-11-27, aude.paquet@ch-esquirol-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.