Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-30 @ 2:44 AM
Study NCT ID:
NCT01320956
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2011-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000844', 'term': 'Ankylosis'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal 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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of anxiety at day 1 (24 hours after surgery)', 'timeFrame': '24 hours', 'description': 'Level anxiety will be measured 24 hours after exit of operating room, using A-VAS (Anxiety visual analog scale) by a single blind assessor.'}], 'secondaryOutcomes': [{'measure': 'Anxiety level', 'timeFrame': '24 hours', 'description': 'difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)'}, {'measure': 'Pain after surgery', 'timeFrame': '24 hours', 'description': 'need for analgesics (morphine)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypnosis', 'HYPNOANALGESIA', 'surgery', 'children', 'anxiety', 'morphine', 'pain', 'A-VAS', 'orthopaedics', 'osteotomy', 'tenotomy', 'arthrodesis', 'spinal column surgery'], 'conditions': ['Osteotomy and Spinal Column Surgery']}, 'referencesModule': {'references': [{'pmid': '28403569', 'type': 'RESULT', 'citation': 'Duparc-Alegria N, Tiberghien K, Abdoul H, Dahmani S, Alberti C, Thiollier AF. Assessment of a short hypnosis in a paediatric operating room in reducing postoperative pain and anxiety: A randomised study. J Clin Nurs. 2018 Jan;27(1-2):86-91. doi: 10.1111/jocn.13848. Epub 2017 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.', 'detailedDescription': 'Undergoing surgery can cause anxiety among children. Thus, peri operative anxiety can increase levels of pain, need for painkillers, and even length of stay in hospital.\n\nCaring for children must take in account their anxiety. This anxiety can be treated through drugs or others means such as hypnosis. Thus, the use hypnosis in surgery has been very poorly assessed.\n\nParents will be given a consent form as well as an information note. This study aims to compare the level of post operative anxiety (D1)of children having hypnosis before receiving anaesthetics to the level of anxiety of children getting the usual care.\n\nAll the children included in this study will have a pre operative consultation with the Pain Management Nurse.\n\nThe study applies to inpatients, aged 10 to 18 years, who must go through orthopaedics surgery such as osteotomy (bone section) and spinal column surgery. 120 patients will be included in this study (60 in each arm) The primary outcome measure is the level of anxiety at day 1 (24 hours after surgery) Other outcome measure are\n\n* the difference in anxiety level between D-1 (the day before surgery) and D1 (24 hours after surgery)\n* the use of morphine during the first 24 hours This study is a prospective randomized trial, comparing a usual analgesics procedure to an experimental analgesics procedure including hypnosis before anaesthesia.\n\nExpected impact of this study :change in procedures, decrease of anxiety levels in patients by the use of hypnosis before anaesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '215 Months', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 10-18 years\n* Orthopaedics surgery (spinal column, osteotomy)\n* ASA 1 \\& 2\n\nExclusion Criteria:\n\n* casualty surgery\n* patient or family unable to understand the study (language, disability ...)\n* patient or family refusing the study'}, 'identificationModule': {'nctId': 'NCT01320956', 'acronym': 'HYPOPANX', 'briefTitle': 'Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of Pre Operative Hypnosis on Anxiety in Children Aged 10 to 18 Years', 'orgStudyIdInfo': {'id': 'P100112'}, 'secondaryIdInfos': [{'id': '2010-A01165-34', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnosis', 'description': 'Pre operative nurse consultation and Hypnosis:\n\nwill have hypnosis', 'interventionNames': ['Behavioral: Pre operative nurse consultation and Hypnosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Pre operative nurse consultation:\n\nusual nurse consultation without hypnosis', 'interventionNames': ['Other: Pre operative nurse consultation']}], 'interventions': [{'name': 'Pre operative nurse consultation and Hypnosis', 'type': 'BEHAVIORAL', 'otherNames': ['Hypnosis, HYPNOANALGESIA'], 'description': 'Pre operative nurse consultation with pain management nurse, the day before surgery and 5 to 10 minutes of hypnosis, just before anesthesia, with trained nurse.', 'armGroupLabels': ['Hypnosis']}, {'name': 'Pre operative nurse consultation', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'Pre operative nurse consultation with pain management nurse. Usual care and anesthesia', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Chantal WOOD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}