Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-04-16 @ 12:48 PM
Study NCT ID:
NCT02799459
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2016-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Medical and Economic Incidence of Hypnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D019092', 'term': 'Conization'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'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'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2016-06-03', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'economic benefit of Hypnosis in conization compare to GA', 'timeFrame': '1 month', 'description': 'The primary study endpoint will be the GA costs compare to Hypnosis in conization costs'}], 'secondaryOutcomes': [{'measure': 'time spent in the operating room', 'timeFrame': '1 day'}, {'measure': 'time spent in SSPI', 'timeFrame': '1 day'}, {'measure': 'time of participation in out-patient surgery department', 'timeFrame': '1 day'}, {'measure': 'hospital admission rates', 'timeFrame': '1 year'}, {'measure': 'postoperative pain using a visual analog scale', 'timeFrame': 'up to 1 month'}, {'measure': 'time to resumption of professional activity', 'timeFrame': '3 months'}, {'measure': 'patients satisfaction using a visual analog scale', 'timeFrame': 'up to 1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypnoanesthesia', 'Hypnosis', 'conization'], 'conditions': ['Surgery']}, 'referencesModule': {'references': [{'pmid': '9752483', 'type': 'BACKGROUND', 'citation': 'Defechereux T, Faymonville ME, Joris J, Hamoir E, Moscato A, Meurisse M. [Surgery under hypnosedation. A new therapeutic approach to hyperparathyroidism]. Ann Chir. 1998;52(5):439-43. French.'}, {'pmid': '15581727', 'type': 'BACKGROUND', 'citation': 'Sefiani T, Uscain M, Sany JL, Grousseau D, Marchand P, Villate D, Vincent JL. [Laparoscopy under local anaesthesia and hypnoanaesthesia about 35 cholecystectomies and 15 inguinal hernia repair]. Ann Fr Anesth Reanim. 2004 Nov;23(11):1093-101. doi: 10.1016/j.annfar.2004.08.014. French.'}, {'pmid': '10986765', 'type': 'BACKGROUND', 'citation': 'Defechereux T, Degauque C, Fumal I, Faymonville ME, Joris J, Hamoir E, Meurisse M. [[Hypnosedation, a new method of anesthesia for cervical endocrine surgery. Prospective randomized study]. Ann Chir. 2000 Jul;125(6):539-46. doi: 10.1016/s0003-3944(00)00238-8. French.'}, {'pmid': '9469526', 'type': 'BACKGROUND', 'citation': 'Faymonville EM, Mambourg HP, Joris J, Vrijens B, Fissette J, Albert A, Lamy M. Psychological approaches during conscious sedation. Hypnosis versus stress reducing strategies: a prospective randomized study. Pain. 1997 Dec;73(3):361-367. doi: 10.1016/S0304-3959(97)00122-X.'}]}, 'descriptionModule': {'briefSummary': "Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in Anesthesia's field.\n\nThis study wants to prove that the Hypnosis in conization are cheaper.", 'detailedDescription': 'Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in Anesthesia\'s field. There are few studies about this new anesthesia tool. The latter showed that it\'s possible to substitute GA by hypnosis. This tool could have many positive such as reduced pains, anxiety or post operative vomiting nausea (POVN). Hypnosis in conization also allows time reduction in post operative security monitoring room (SSPI), speedier hospital discharge and greater patient satisfaction. Most studies involves 1 or 2 practitioners and few patients. There is no reliable research which compare Hypnosis in conization costs and GA costs. Since 2010, anesthesia\'s team of Grenoble Mutualist Hospital group (GHM) realized many Hypnosis in conization surgical procedures. Half of the team had been trained to Hypnosis in conization and use it for several types of surgeries for a lot of surgeons. It\'s the case for conisations. Currently, the 7 gynaecologists surgeons of the team achieved between 150 and 200 per year , some of this used GA, others used Hypnosis in conization, and unusually they used " rachianesthesia ". Thus, it gives us the opportunity for studying Hypnosis in conization, without practitioner effect, for a relatively cohesive group of patients (vast majority of patients are between 30 and 50 years and they haven\'t any particular medical history).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all women whom need a conization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all women whom need a conization\n\nExclusion Criteria:\n\n* age\\<18 ans\n* guardianship\n* trusteeship\n* not affiliated to the social security'}, 'identificationModule': {'nctId': 'NCT02799459', 'acronym': 'HYPNONISAT°', 'briefTitle': 'Evaluation of Medical and Economic Incidence of Hypnosis', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Mutualiste de Grenoble'}, 'officialTitle': 'Evaluation of Medical and Economic Incidence of Hypnosis in Conization', 'orgStudyIdInfo': {'id': '15-MUTG-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General anaesthesia', 'description': 'this group will allow us to compare the results like it is the treatment used in current practice ie general anesthesia.', 'interventionNames': ['Procedure: General anaesthesia']}, {'label': 'Hypnosis in conization', 'description': 'This group is the treatment being tested , where hypnosis is used in the conization', 'interventionNames': ['Procedure: Hypnosis in conization']}], 'interventions': [{'name': 'General anaesthesia', 'type': 'PROCEDURE', 'description': 'the patient will receive a general anaesthesia do proceed at her conization', 'armGroupLabels': ['General anaesthesia']}, {'name': 'Hypnosis in conization', 'type': 'PROCEDURE', 'description': 'this is the experimental treatment which is allocated to the experimental group', 'armGroupLabels': ['Hypnosis in conization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38028', 'city': 'Grenoble', 'country': 'France', 'facility': 'Groupe Hospitalier Mutualiste de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jerome Schweitzer, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Hospitalier Mutualiste de Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Mutualiste de Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}