Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT03253159
Status:
COMPLETED
Last Update Posted:
2020-08-10
First Post:
2016-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2017-08-16', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of pain scale', 'timeFrame': 'through study completion, an average of 5 year', 'description': 'Pain intensity assessment'}], 'secondaryOutcomes': [{'measure': 'Reduction of the pain using Visual Analogic Scale', 'timeFrame': 'through study completion, an average of 5 year', 'description': 'Reduction of the pain adverse postoperative outcome:\n\nUsing Visual Analogic Scale (VAS \\> 3/10)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30646110', 'type': 'DERIVED', 'citation': 'Amraoui J, Pouliquen C, Fraisse J, Dubourdieu J, Rey Dit Guzer S, Leclerc G, de Forges H, Jarlier M, Gutowski M, Bleuse JP, Janiszewski C, Diaz J, Cuvillon P. Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181164. doi: 10.1001/jamanetworkopen.2018.1164.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.', 'detailedDescription': 'Drug premedication with anxiolytics (benzodiazepine or equivalent) are usually prescribed to alleviate patient anxiety. However, alternative techniques, additional non-pharmacological, have proven effective in alleviating pain and anxiety perioperative. These techniques are retained relaxation therapy, reinsurance, breathing techniques and medical hypnosis as a technique of choice. Regarding medical hypnosis techniques, many studies have shown that performing a hypnotic technique performed perioperative could reduce the doses of anesthetics, postoperative pain, length of stay in the post room Interventional (SSPI) and a number of postoperative adverse effects.\n\nAmong the various techniques of hypnosis that can be offered to patients in the perioperative, conversational hypnosis is to accompany the patient on admission to the block to realization of general anesthesia. This technique aims to suggest a pleasant environment and not anxiety.\n\nThis study evaluate the impact of this support in reducing postoperative major adverse effects in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female \\> 18 years\n* Patient with ASA\\* score 1, 2, 3\n* Minor Unilateral breast surgery indication (tumorectomy, lumpectomy, limited axillary node dissection, minor breast reconstruction…)\n* Day case surgery (ambulatory surgery - living Day0-Day1)\n* General anesthesia required\n* Written informed consent\n* French medical benefit\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Patient with ASA score \\> 4;\n* Body mass index \\< 15 or 45kg/T;\n* Major Surgery indication : mastectomy, bilateral surgery, full axillary dissection, major breast reconstruction\n* Patient refusing hypnosis\n* Psychic or mental Disorders\n* Chronic pain\n* Opiate therapeutic \\> 3 months\n* Not ability to speak and read French language\n* Deaf and dumb patient\n* Under guardianship patient or guardianship'}, 'identificationModule': {'nctId': 'NCT03253159', 'acronym': 'HYPNOSEIN', 'briefTitle': 'Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)', 'orgStudyIdInfo': {'id': 'ICM-URC-2014/30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnosis group', 'description': 'The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room', 'interventionNames': ['Behavioral: Hypnosis']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No special preparation before intravenous general anesthesia induction in the operative room'}], 'interventions': [{'name': 'Hypnosis', 'type': 'BEHAVIORAL', 'description': 'The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room.', 'armGroupLabels': ['Hypnosis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut réginal du Cancer de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'jibba AMRAOUI', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut régional du Cancer de Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}