Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 9:13 PM
Study NCT ID:
NCT04547595
Status:
RECRUITING
Last Update Posted:
2024-12-30
First Post:
2020-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypnosis Intervention for the Management of Pain Perception During Joint Lavage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2020-09-07', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessed by Visual Analog Scale', 'timeFrame': 'One Day, at end of lavage procedure', 'description': 'VAS range 0-10, 10 for most severe pain'}], 'secondaryOutcomes': [{'measure': 'Anxiety assessed by Visual Analog Scale', 'timeFrame': 'Day 1, before lavage procedure', 'description': 'VAS range 0-10, 10 for most severe anxiety'}, {'measure': 'Anxiety assessed by Visual Analog Scale', 'timeFrame': 'Day 1, at end of lavage procedure', 'description': 'VAS range 0-10, 10 for most severe anxiety'}, {'measure': 'Pain assessed by Visual Analog Scale', 'timeFrame': 'Day 1, before lavage procedure', 'description': 'VAS range 0-10, 10 for most severe pain'}, {'measure': 'Pain assessed by Visual Analog Scale', 'timeFrame': 'Day 7, after lavage procedure', 'description': 'VAS range 0-10, 10 for most severe pain -via phone call'}, {'measure': 'Gesture tolerability', 'timeFrame': 'Day 1, at end of lavage procedure', 'description': '4 points : Perfectly tolerable / tolerable / with difficulty / untolerable'}, {'measure': 'Analgesics consumption', 'timeFrame': 'Over 1 week after lavage procedure', 'description': 'Quantification'}, {'measure': 'Operator Impact', 'timeFrame': 'Over 1 week after lavage procedure', 'description': "pain VAS by linear regression, adjusted by the 'operator' variable"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypnosis intervention', 'analgesics', 'knee osteoarthritis', 'joint lavage'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether hypnosis intervention added to usual care is more effective than usual care alone to control pain during lavage procedure in patients with knee osteoarthrosis', 'detailedDescription': 'Joint lavage can be used in acute knee osteoarthritis, and can be repeated when it is effective. This procedure can generate pain and anxiety which are prevented by systematic prescription of analgesics and anxiolytics. To assess the benefit of hypnosis intervention, the investigators designed a monocentric prospective controlled randomised, single-blind study. Patients with acute and painful knee osteoarthritis, having an indication of lavage according to the rheumatologist, will be randomized to standard care, versus standard care and hypnosis. The hypothesis is that hypnosis intervention will decrease the level of pain during lavage, and the analgesics consumption during the week following the lavage. The sample size will be 100, 50 patients per group. Inclusion is scheduled for 18 months, and duration of the study will be 2 years. The main efficacy criterion is the pain score (assessed using VAS) difference between the 2groups; no interim analysis will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of knee osteoarthritis\n* indication for a lavage\n\nExclusion Criteria:\n\n* People who have had both knees washed on the same day.\n* People who have already received a joint lavage.\n* Patients with psychotic disorders.\n* Refusal to participate.\n* People who do not understand and/or speak French or who are deaf.'}, 'identificationModule': {'nctId': 'NCT04547595', 'acronym': 'HypnoArt', 'briefTitle': 'Hypnosis Intervention for the Management of Pain Perception During Joint Lavage', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis', 'orgStudyIdInfo': {'id': 'APHP200138'}, 'secondaryIdInfos': [{'id': '2020-A02333-36', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'CONTROL', 'description': 'Standard care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypnosis', 'description': 'Standard care + intervention', 'interventionNames': ['Other: Hypnosis']}], 'interventions': [{'name': 'Hypnosis', 'type': 'OTHER', 'otherNames': ['Ericksonienne Method'], 'description': 'given by Expert in this method', 'armGroupLabels': ['Hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Melissa CREHALET MONNIER, Nurse', 'role': 'CONTACT', 'email': 'melissa.crehalet-monnier@aphp.fr', 'phone': '+33 1 58 41 86 51'}], 'facility': 'Cochin Hospital - Rheumatology department', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Melissa CREHALET MONNIER, Nurse', 'role': 'CONTACT', 'email': 'melissa.crealet-monnier@aphp.fr', 'phone': '+ 33 1 58 41 86 51'}, {'name': 'Guillaume MASSON, MSc', 'role': 'CONTACT', 'email': 'guillaume.masson@aphp.fr', 'phone': '+33611208860'}], 'overallOfficials': [{'name': 'Anna MOLTO, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}