Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT02629302
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2015-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056447', 'term': 'Animal Assisted Therapy'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of consciousness', 'timeFrame': '4 weeks', 'description': 'assessed via behavioral coding in Noldus Observer'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '4 weeks', 'description': 'assessed via non-invasive HR monitoring belts (Polar® RS800CX, Polar® Electro Oy)'}, {'measure': 'Behavioral reaction', 'timeFrame': '4 weeks', 'description': "measured via therapist's ratings on the BAVESTA scale (Basler Assessment Vegetative State)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Disorder of Consciousness']}, 'referencesModule': {'references': [{'pmid': '31574106', 'type': 'DERIVED', 'citation': 'Hediger K, Petignat M, Marti R, Hund-Georgiadis M. Animal-assisted therapy for patients in a minimally conscious state: A randomized two treatment multi-period crossover trial. PLoS One. 2019 Oct 1;14(10):e0222846. doi: 10.1371/journal.pone.0222846. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The study investigates the effects of animal-assisted therapy on patients with severe disorders of consciousness. The focus lies on the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 10 patients during 16 therapy sessions.\n\nWhile half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. In this study, patients in a minimal conscious state are recruited.', 'detailedDescription': 'This pilot study is designed as a controlled cross-over, within-subject trial with repeated measurement. The experimental condition is the standardised therapy session using therapy animals (AAT), while the control condition is the comparable "standard" therapy session without the presence of an animal.\n\nOver a period of four weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 16 therapy sessions (8 experimental, 8 control) for each patient.\n\nEach therapy session lasts about 20 minutes.\n\nThe study takes place at REHAB Basel. Animal-assisted therapies are held in a special room at REHAB Basel in the presence of one or more small animals that will be selected by the therapist.\n\nPatients are allocated randomly to start with either the experimental or the control condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inpatients of REHAB Basel\n* Disorder of consciousness: minimal conscious state defined via:\n* CRS Score (Coma Remission Scale) of auditory 3-4 or visual 2-5 or motor 3-5 or oromotor/verbal = 3 or communication = 1\n* BAVESTA Score of 2.8\n\nExclusion Criteria:\n\n* Enrolment of the investigator, his/her family members, employees and other dependent persons\n* medical contraindications for contact with animals as allergy, phobia etc.\n* If the patient's medication changes radically during the time of data collection"}, 'identificationModule': {'nctId': 'NCT02629302', 'briefTitle': 'Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Tropical & Public Health Institute'}, 'officialTitle': 'Effects of Animal-assisted Therapy in Patients With Severe Disorders of Consciousness at REHAB Basel: a Randomised-controlled Trial', 'orgStudyIdInfo': {'id': 'EKNZ 2015-153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'animal assisted therapy', 'description': '"Standard" therapy (speech therapy, occupational therapy and physiotherapy) that is done in the presence and with Integration of an animal.', 'interventionNames': ['Other: animal assisted therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard therapy', 'description': 'standard physiotherapy, standard speech therapy and standard occupational therapy', 'interventionNames': ['Other: standard therapy']}], 'interventions': [{'name': 'animal assisted therapy', 'type': 'OTHER', 'description': 'physiotherapy, speech therapy and occupational therapy in the presence of an animal', 'armGroupLabels': ['animal assisted therapy']}, {'name': 'standard therapy', 'type': 'OTHER', 'description': 'standard physiotherapy, speech therapy and occupational therapy', 'armGroupLabels': ['standard therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4012', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'REHAB Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Karin Hediger', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehab Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Tropical & Public Health Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute for Interdisciplinary Research on the Human-Pet Relationship', 'class': 'OTHER'}, {'name': 'Rehab Basel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}