Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT01095705
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2010-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypnosis for Transesophageal Echocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2010-03-29', 'studyFirstSubmitQcDate': '2010-03-29', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of patient comfort', 'timeFrame': 'at Day 0', 'description': 'Visual Analogic Scale'}], 'secondaryOutcomes': [{'measure': 'Rate of procedure failure or non-diagnostic study', 'timeFrame': 'at Day 0'}, {'measure': 'Duration of the procedure', 'timeFrame': 'at Day 0'}, {'measure': 'Quality of the procedure as assessed by the operator', 'timeFrame': 'at Day 0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypnosis', 'Transesophageal Echocardiography', 'Efficiency of Hypnosis'], 'conditions': ['Discomfort']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE).', 'detailedDescription': 'TEE is a widely used diagnostic test in cardiovascular medicine. However, the test may be a source of discomfort to the patient. Patient intolerance of the echocardiography probe limits the duration of the procedure and therefore its diagnostic success. Current strategies to reduce patient discomfort involve global anesthesia, which carries its own side effects and risks of adverse events. Hypnosis may reduce patient discomfort without impairing alertness. The main goal of this study is to determine the additive value of hypnosis to improve patient comfort during TEE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient with indication for a Transesophageal Echo (TEE)\n* Patient competent to provide written informed consent\n\nExclusion criteria:\n\n* Patient not subscribed to French Social Security System\n* Patient non-French speaking\n* Age \\< 18 years\n* Follow-up not possible\n* patient declared non competent to give informed consent for the study\n* History of severe personality disorder\n* Patient with a psychiatric treatment started 30 days before the exam\n* Patient pregnant or breast-feeding\n* Emergency TEE\n* Other indication for general anesthesia'}, 'identificationModule': {'nctId': 'NCT01095705', 'acronym': 'I-SLEPT', 'briefTitle': 'Hypnosis for Transesophageal Echocardiography', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Utility of Hypnosis for Transesophageal Echocardiography', 'orgStudyIdInfo': {'id': 'P090802'}, 'secondaryIdInfos': [{'id': '2009-A01156-51', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional procedure', 'description': 'Local anaesthesia (Lidocaïne)', 'interventionNames': ['Procedure: Conventional procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional procedure + Hypnosis', 'description': 'Local anaesthesia (Lidocaïne) and Hypnosis', 'interventionNames': ['Procedure: Conventional procedure + Hypnosis']}], 'interventions': [{'name': 'Conventional procedure', 'type': 'PROCEDURE', 'description': 'Local anaesthesia (Lidocaïne)', 'armGroupLabels': ['Conventional procedure']}, {'name': 'Conventional procedure + Hypnosis', 'type': 'PROCEDURE', 'description': 'Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)', 'armGroupLabels': ['Conventional procedure + Hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': "Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'François TOURNOUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}