Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-02-26 @ 5:47 AM
Study NCT ID:
NCT03926403
Status:
UNKNOWN
Last Update Posted:
2023-03-22
First Post:
2019-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "variation in Spielberger's anxiety self-assessment questionnaire score between the patient's arrival in the operating room and his departure", 'timeFrame': 'on the day of surgery under local anaesthesia.', 'description': "The State-Trait Anxiety Inventory (STAI) (or Spielbergers's anxiety self-assessment questionnaire) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety."}], 'secondaryOutcomes': [{'measure': 'Value reported by the patient on the Visual Analogue Pain Scale after surgery', 'timeFrame': 'on the day of surgery under local anaesthesia.', 'description': 'The visual analogue scale (VAS) is commonly used as the outcome measure. It is usually presented as a 100-mm horizontal line on which the patient\'s pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."'}, {'measure': 'Variation of amount of local anaesthetic', 'timeFrame': 'on the day of surgery under local anaesthesia.', 'description': 'Amount of local anaesthetic consumed for a defined surgical procedure'}, {'measure': 'measure of operating time', 'timeFrame': 'on the day of surgery under local anaesthesia.', 'description': 'operating time for a defined surgical procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypnosis', 'local anaesthesia', 'outpatient surgery', 'face surgery'], 'conditions': ['Hypnosis', 'Local Anaesthesia', 'Outpatient Surgery', 'FACE']}, 'descriptionModule': {'briefSummary': "Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.\n\nThe purpose of this study is to evaluate the effectiveness of hypnosis support on the patient's state of anxiety before and after outpatient surgery under local anaesthesia in the Maxillofacial Surgery Department.", 'detailedDescription': 'Interventions performed under local anaesthesia may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines. Hypnosis in particular has long been used in the non-pharmacological management of pain and anxiety.\n\nMany clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.\n\nPatients requiring facial surgery under local anaesthesia in an ultra-short circuit will be informed of the study in consultation by the maxillofacial surgeon. If they give their informed consent, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") will be given to them and collected on the same day. Each patient\'s anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36). The latter will be randomized into 2 groups, one benefiting from experimental management based on hypnosis techniques and the other benefiting from conventional management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient treated under local anaesthesia in the Maxillo Facial Surgery department with ultra-short circuit\n* Patient undergoing face surgery\n* Patient who has received appropriate information and has provided informed consent\n* Adult patient ≥ 18 years old\n* Patient with a score of ≥ 36 on the initial anxiety self-assessment questionnaire\n\nExclusion Criteria:\n\n* Patient under general anaesthesia\n* Patients treated in conventional inpatient care or in the traditional ambulatory circuit\n* Patient under guardianship or trusteeship\n* Minor patient \\< 18 years of age\n* Patient who has not provided informed consent or who cannot submit to the study protocol\n* Patient suffering from cognitive disorders (ex: Alzheimer's disease)\n* Patients who are deaf or hearing-impaired"}, 'identificationModule': {'nctId': 'NCT03926403', 'acronym': 'HYPNOFACE', 'briefTitle': 'Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia in the Maxillo-Facial Surgery Department of the CHU Amiens-Picardie.', 'orgStudyIdInfo': {'id': 'PI2019_843_0007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnosis', 'description': 'Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.', 'interventionNames': ['Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire")', 'Procedure: hypnosis techniques']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional management', 'description': 'Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).', 'interventionNames': ['Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire")', 'Procedure: local anaesthesia']}], 'interventions': [{'name': 'State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire")', 'type': 'OTHER', 'description': 'Patients will be given, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") that will be collected on the same day. Each patient\'s initial anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36).', 'armGroupLabels': ['Hypnosis', 'conventional management']}, {'name': 'hypnosis techniques', 'type': 'PROCEDURE', 'description': 'Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.', 'armGroupLabels': ['Hypnosis']}, {'name': 'local anaesthesia', 'type': 'PROCEDURE', 'description': 'Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).', 'armGroupLabels': ['conventional management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie DAKPE, MD', 'role': 'CONTACT', 'email': 'dakpe.stéphanie@chu-amiens.fr'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Martine Gosset, ORN', 'role': 'CONTACT', 'email': 'gosset.martine@chu-amiens.fr', 'phone': '(33)322089050'}], 'overallOfficials': [{'name': 'Bernard Devauchelle, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Stéphanie Dakpe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Sylvie Testelin, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Jérémie Bettoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Stéphanie Mauquit, N', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}