Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-28 @ 8:47 AM
Study NCT ID:
NCT06839950
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2025-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensory Profile and Early Clinical Signs of Calm Room Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-05-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'At enrollment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'At enrollment', 'description': '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.'}, {'measure': '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', 'timeFrame': 'At enrollment', 'description': '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.'}, {'measure': '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', 'timeFrame': 'At enrollment', 'description': '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.'}, {'measure': 'Comparison of Adolescent/Adult Sensory Profile score between the user and non-user of the calming room', 'timeFrame': 'From enrollment to the end of observation at 2 weeks', 'description': '* Adolescent/Adult Sensory Profile scores (Sensory Sensitivity / Low Registration / Sensation Seeking / Sensory Avoidance) among calming room user\n* Adolescent/Adult Sensory Profile scores (Sensory Sensitivity / Low Registration / Sensation Seeking / Sensory Avoidance) among calming room non-user'}, {'measure': 'Anxiety for users or non-user of the calming room', 'timeFrame': 'From enrollment to the end of observation at 2 weeks', 'description': 'Anxiety is assessed from the Hamilton Anxiety Rating Scale for users and non-users of the calming room.\n\nThe overall score ranges from 0 to 60. The generally accepted threshold for significant anxiety is 20.'}, {'measure': 'Frequency of use of the calming room', 'timeFrame': 'From enrollment to the end of observation at 2 weeks', 'description': '\\- Frequency of Calming Room Use during the 14-Day Participation Period: Total number of uses of the room / time (hours)'}, {'measure': 'Initiative for the use of the calming room', 'timeFrame': 'From enrollment to the end of observation at 2 weeks', 'description': 'Modes of use of the calming room among patients who use this room.\n\nQualitative measure is used for initiative :\n\nPatient initiative or team initiative'}, {'measure': 'Reason for resquesting of the calming room', 'timeFrame': 'From enrollment to the end of observation at 2 weeks', 'description': 'Modes of use of the calming room among patients who use this room.\n\nQualitative measure is used for reason for resquesting use of the calming room :\n\nAnxiety / Sadness / Fatigue / Physical Tension / Seeking Well-being'}, {'measure': 'Autonomy for the use of the calming room', 'timeFrame': 'From enrollment to the end of observation at 2 weeks', 'description': 'Modes of use of the calming room among patients who use this room.\n\nQualitative measure is used for autonomy for the use of the calming room :\n\nPresence of caregiver / Partial autonomy (one-off intervention by a caregiver) / Total autonomy (nocaregiver intervention during the use)'}, {'measure': 'User frenquecy of the calming room', 'timeFrame': 'From enrollment to the end of observation at 2 weeks', 'description': 'Number of uses of the calming room during the hospitalization'}, {'measure': 'Description of anxiety leading to the use of the calming room among patients who use this room.', 'timeFrame': 'From enrollment to the the end of observation at 2 weeks', 'description': 'Description of early clinical signs leading to the use of the calming room among patients who use this room.\n\nVisual Analog Score for anxiety'}, {'measure': 'Description of well-being leading to the use of the calming room among patients who use this room.', 'timeFrame': 'From enrollment to the the end of observation at 2 weeks', 'description': 'Description of early clinical signs leading to the use of the calming room among patients who use this room.\n\n\\- Visual Analog Score for well-being'}, {'measure': 'Description of physical tension leading to the use of the calming room among patients who use this room.', 'timeFrame': 'From enrollment to the the end of observation at 2 weeks', 'description': 'Description of early clinical signs leading to the use of the calming room among patients who use this room.\n\n\\- Visual Analog Score for physical tension'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Calm room', 'Psychotic Disorders', 'Sensory Profile', 'Mood Disorders', 'Personality Disorders'], 'conditions': ['Psychotic Disorders', 'Personality Disorders', 'Mood Disorders']}, 'descriptionModule': {'briefSummary': 'This descriptive study aims primarily to characterize the sensory profile of patients in a closed psychiatric hospital unit who use a calming room.\n\nThe main questions it aims to answer are :\n\n* Could sensory information processing disorders be the cause of distress and tension in these patients?\n* Could users of the calming room present extreme sensory processing profiles, characterized by either hypersensitivity or hyposensitivity ?\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be enrolled from the Deniker unit in the Esquirol Hospital Center of Limoges, France.\n\nThis 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gender and Age: Male or female, aged 18 to 65\n* Hospitalization: Admitted to the closed hospitalization unit for less than 10 days\n* Social security: Affiliated or beneficiary of a social security system\n* 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).\n\nExclusion Criteria:\n\n* Inability to understand information related to the study\n* Proven sensory disability\n* Dementia\n* Pregnancy\n* Lack of social protection\n* Previous Participation in this research protocol (in the case of a new hospitalization)\n* Expression abilities incompatible with completing the AASP Scale (e.g., french language comprehension issues, mute individuals, patients in restraint and/or therapeutic isolation)'}, 'identificationModule': {'nctId': 'NCT06839950', 'acronym': 'EVAL-APAISE', 'briefTitle': 'Sensory Profile and Early Clinical Signs of Calm Room Users', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Esquirol'}, 'officialTitle': 'Sensory Profile and Early Clinical Signs of Calm Room Users', 'orgStudyIdInfo': {'id': 'EVAL-APAISE'}, 'secondaryIdInfos': [{'id': '2023-A00580-45', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Calm room', 'type': 'OTHER', 'otherNames': ['Sensory room', 'Comfort room'], 'description': '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.\n\nThey can be used by patients any time they want and for as long as they want.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87025', 'city': 'Limoges', 'state': 'Nouvelle-Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Théodore Vinais, Master degree', 'role': 'CONTACT', 'email': 'theodore.vinais@ch-esquirol-limoges.fr', 'phone': '+33 + 5-87-50-91-29'}, {'name': 'Aude Paquet, PhD in Psychology', 'role': 'CONTACT'}], 'facility': 'Esquirol Hsopital Center', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'centralContacts': [{'name': 'Aude Paquet, PhD in Psychology', 'role': 'CONTACT', 'email': 'aude.paquet@ch-esquirol-limoges.fr', 'phone': '+33 5-55-43-11-27'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Esquirol', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Psychomotor Therapist, Doctor in Psychology', 'investigatorFullName': 'Aude Paquet', 'investigatorAffiliation': 'Centre Hospitalier Esquirol'}}}}