Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-03-05 @ 6:40 PM
Study NCT ID:
NCT03994159
Status:
UNKNOWN
Last Update Posted:
2022-04-01
First Post:
2019-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Quasi experimental before-after study, with a mixed qualitative and quantitative approach.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2019-06-06', 'studyFirstSubmitQcDate': '2019-06-20', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of the PARO robot on the quality of worklife among caregivers in a specialised unit dor dementia patients', 'timeFrame': '1 month', 'description': 'Semidirective interviews of the caregivers about their feelings at work, before the introduction of Paro and after 1 month of use. We will use textual analysis software to reveal speech classes to avoid analysis bias and interpretation.'}], 'secondaryOutcomes': [{'measure': 'Impact of PARO on the caregivers perception of their own health.', 'timeFrame': '1 month', 'description': 'Use of the Nottingham Health Profile (NHP). The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.'}, {'measure': 'Impact of PARO on the caregivers perception of their own stress at work.', 'timeFrame': '1 month', 'description': 'Measure of the level of stress using the Perceived Stress Scale: 10 item questionnaire, with responses ranging from 0 to 4 for each item, with a range from 0 to 40, 0 being no perceived stress ans 40 the maximum perceived stress.'}, {'measure': 'Impact of PARO on the caregivers perception of their own anxiety at work.', 'timeFrame': '1 month', 'description': 'Measure of the perceived anxiety through the Hospital Anxiety and Depression Scale (HADS, a 14 item questionnaire, each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression, 0 being no perceived anxiety and 21 the maximum perceived anxiety).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout, Professional', 'Stress', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Since February 2016, with the objective of improving the quality of life and the autonomy of residents, the Le Mans General Hospital uses an interactive "emotional" robot within its geriatric wards.\n\nThis emotional robot, Paro, is equipped with a dozen sensors, 3 microphones and interacts with its user: it reacts to touch, voice and heat making small sounds and moves its head, fins and tail. The algorithm that governs Paro\'s behavior allows him to offer a behavioral answer adapted to the user\'s stimuli. Thus, Paro is able to communicate beneficial emotions to patients.\n\nTo this day however there is no published study exploring the effect of such a robot on team dynamics among caregivers in hospital units.\n\nOur research aims at highlighting the benefits that a healthcare team perceives when working with this tool among patients suffering from dementia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non medical caregiver (nurse, nursing aid, orderly, psychological aid worker) working in one of the selected geriatric wards.\n\nExclusion Criteria:\n\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT03994159', 'acronym': 'PARO', 'briefTitle': 'Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit Specialized in Dementia', 'orgStudyIdInfo': {'id': 'CHM-2019/S18/06.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PARO emotional robot', 'description': 'Quasi-experimental before after study of the impact of the PARO robot on team dynamics among caregivers in geriatric wards caring for patients with dementia.\n\nPre intervention period: no PARO robot. Post-intervention period: with the PARO robot.', 'interventionNames': ['Device: Use of the "PARO" emotional robot']}], 'interventions': [{'name': 'Use of the "PARO" emotional robot', 'type': 'DEVICE', 'description': "PARO is an advanced interactive therapeutic robot designed to stimulate patients with Dementia, Alzheimer's, and other cognition disorders.", 'armGroupLabels': ['PARO emotional robot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72170', 'city': 'Beaumont-sur-Sarthe', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cathy LOIRAT', 'role': 'CONTACT', 'email': 'cloirat@ch-lemans.fr', 'phone': '0243434343'}], 'facility': 'Centre Hospitalier Local Beaumont sur Sarthe', 'geoPoint': {'lat': 48.22747, 'lon': 0.12923}}], 'centralContacts': [{'name': 'Christelle Jadeau, PD', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '0 (33) 2 43 43 43 43', 'phoneExt': '37 482'}], 'overallOfficials': [{'name': 'Cathy LOIRAT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier du Mans'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier de Chateau du Loir', 'class': 'UNKNOWN'}, {'name': 'Centre Hospitalier de Saint Calais', 'class': 'UNKNOWN'}, {'name': 'Centre Hospitalier Local de Beaumont sur Sarthe', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}