Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT05818969
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2023-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Perioperative Anxiety - Amsterdam Preoperative Anxiety and Information Scale (APAIS)', 'timeFrame': '7 days prior to surgery, 10 days postoperative day, 49 days postoperative day', 'description': 'Patient-reported anxiety in the perioperative period'}], 'secondaryOutcomes': [{'measure': 'Change in Perioperative Pain - Knee Society Score/ Knee Injury and Osteoarthritis Scores', 'timeFrame': '7 days prior to surgery, 10 days postoperative day, 49 days postoperative day', 'description': 'Patient-reported pain in the perioperative period'}, {'measure': 'Change in Opioid Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client', 'timeFrame': '7 days prior to surgery, 10 days postoperative day, 49 days postoperative day', 'description': 'Change in Anxiolytic Consumption'}, {'measure': 'Change in Anxiolytic Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client', 'timeFrame': '7 days prior to surgery, 10 days postoperative day, 49 days postoperative day', 'description': 'Change in Anxiolytic Consumption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypnosis', 'Total Knee Arthroplasty', 'Total Knee'], 'conditions': ['Anxiety', 'Opioid Use']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. Patients are randomly assigned to one of two treatment groups: (I) usual care, or; (II) hypnotherapy treatment. Patients have an equal chance of being assigned to one of the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary knee arthritis, in need of a total knee arthroplasty.\n* The ability to read, speak, and understand English\n* The ability and willingness to use a web-based application (OBERD) on a smartphone, pad/tablet, or computer\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Revision total knee arthroplasty\n* Any knee procedure except a primary knee arthroplasty, since these procedures have shown to result on increased postoperative pain compared to primary surgery\n* Patients with active cancer or receiving palliative care'}, 'identificationModule': {'nctId': 'NCT05818969', 'briefTitle': 'Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Orthopaedic Research and Education'}, 'officialTitle': 'Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement', 'orgStudyIdInfo': {'id': '2.0 - 20203698'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnosis Therapy Group', 'description': 'Experimental: Hypnosis Therapy Group\n\nPatients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, \\& knee function. 7 days prior to surgery, they will receive a pre-recorded video (-19 min) of guided hypnosis to be watched at least 1x/day, until surgery. Postoperative course will be otherwise completely standard of care, including a clinic visit at 10 days after surgery, where they will be given these same questionnaires. Patients will answer them again on postoperative day 49, constituting a study endpoint. Access to pain medication \\& study doctor will be the same as any total knee arthroplasty regardless of study participation.', 'interventionNames': ['Behavioral: Hypnosis Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Care Group', 'description': 'No Intervention: Control Care Group\n\nPatients will receive questionnaires to establish their attitudes/beliefs toward hypnosis, baseline pain, anxiety, \\& knee function. 7 days prior to surgery, they will receive a pre-recorded video (-19 min) of guided information to be watched at least 1x/day, until surgery. Postoperative course will be otherwise completely standard of care, including a clinic visit at 10 days after surgery, where they will be given these same questionnaires. Patients will answer them again on postoperative day 49, constituting a study endpoint. Access to pain medication \\& study doctor will be the same as any total knee arthroplasty regardless of study participation.'}], 'interventions': [{'name': 'Hypnosis Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Hypnotherapy'], 'description': 'Pre-recorded hypnosis therapy audio recording with accompanying visual of a calming ocean scene to be played at least once daily for 7 days preoperatively.', 'armGroupLabels': ['Hypnosis Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33637', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Orthopaedic Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Brian T Palumbo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Orthopaedic Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Orthopaedic Research and Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}