Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 10:21 PM
Study NCT ID:
NCT04855968
Status:
TERMINATED
Last Update Posted:
2024-02-08
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'whyStopped': 'Poor patient compliance', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scale', 'timeFrame': '2 weeks post-op', 'description': 'single-item measure of pain and consists of a 100 millimeter (mm) horizontal line with the labels "No Pain" at the leftmost portion and "Worst Pain" at the rightmost portion of the line'}, {'measure': 'visual analog scale', 'timeFrame': '6 weeks post-op, 3months post-op and 6 months post-op', 'description': 'single-item measure of pain and consists of a 100 millimeter (mm) horizontal line with the labels "No Pain" at the leftmost portion and "Worst Pain" at the rightmost portion of the line'}, {'measure': 'visual analog scale', 'timeFrame': '3months post-op', 'description': 'single-item measure of pain and consists of a 100 millimeter (mm) horizontal line with the labels "No Pain" at the leftmost portion and "Worst Pain" at the rightmost portion of the line'}, {'measure': 'visual analog scale', 'timeFrame': '6 months post-op', 'description': 'single-item measure of pain and consists of a 100 millimeter (mm) horizontal line with the labels "No Pain" at the leftmost portion and "Worst Pain" at the rightmost portion of the line'}, {'measure': 'number of opioid pills', 'timeFrame': '2 weeks post-op', 'description': 'number of pills taken at each time point'}, {'measure': 'number of opioid pills', 'timeFrame': '6 weeks post-op', 'description': 'number of pills taken at each time point'}, {'measure': 'number of opioid pills', 'timeFrame': '3 months post-op', 'description': 'number of pills taken at each time point'}, {'measure': 'number of opioid pills', 'timeFrame': '6months post-op', 'description': 'number of pills taken at each time point'}], 'secondaryOutcomes': [{'measure': 'compliance of the intervention in the MM groups which will be tracked via the Headspace application.', 'timeFrame': '2 weeks post-op', 'description': 'used to detect the association between using the Headspace application and the amount of post-operative pain'}, {'measure': 'compliance of the intervention in the MM groups which will be tracked via the Headspace application.', 'timeFrame': '6 weeks post-op', 'description': 'used to detect the association between using the Headspace application and the amount of post-operative pain'}, {'measure': 'compliance of the intervention in the MM groups which will be tracked via the Headspace application.', 'timeFrame': '3 months post-op', 'description': 'used to detect the association between using the Headspace application and the amount of post-operative pain'}, {'measure': 'compliance of the intervention in the MM groups which will be tracked via the Headspace application.', 'timeFrame': '6 months post-op', 'description': 'used to detect the association between using the Headspace application and the amount of post-operative pain'}, {'measure': 'Patient reported out comes :Single Assessment Numeric Evaluation (SANE)', 'timeFrame': '2 weeks post-op', 'description': 'composed of a single question, would be a valid and responsive instrument to provide a global assessment of patients shoulder function on a scale of 1-100'}, {'measure': 'Patient reported out comes :Single Assessment Numeric Evaluation (SANE)', 'timeFrame': '6 weeks post-op', 'description': 'composed of a single question, would be a valid and responsive instrument to provide a global assessment of patients shoulder function on a scale of 1-100'}, {'measure': 'Patient reported out comes :Single Assessment Numeric Evaluation (SANE)', 'timeFrame': '3 months post-op', 'description': 'composed of a single question, would be a valid and responsive instrument to provide a global assessment of patients shoulder function on a scale of 1-100'}, {'measure': 'Patient reported out comes :Single Assessment Numeric Evaluation (SANE)', 'timeFrame': '6 moths post-op.', 'description': 'composed of a single question, would be a valid and responsive instrument to provide a global assessment of patients shoulder function on a scale of 1-100'}, {'measure': 'Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)', 'timeFrame': '2 weeks post-op.', 'description': "12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health."}, {'measure': 'Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)', 'timeFrame': '6 weeks post-op.', 'description': "12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health."}, {'measure': 'Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)', 'timeFrame': '3 months post-op.', 'description': "12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health."}, {'measure': 'Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)', 'timeFrame': '6 months post-op.', 'description': "12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shoulder Arthroscopy', 'head space', 'mindfulness', 'Subacromial bursitis', 'biceps tenodesis'], 'conditions': ['Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to examine the effectiveness of mindfulness/meditation using the Headspace App on post-operative pain and opioid consumption in patients after arthroscopic rotator cuff repairs, biceps tenodesis, and Mumford procedures.', 'detailedDescription': 'The purpose of this study is to examine the effectiveness of mindfulness/meditation on post-operative pain and opioid consumption. Patients will be randomized into one of two standardized groups after shoulder arthroscopy: Control group (CON) and mindfulness/meditation group (MM). All participants will be consented and enrolled into the study before surgery. Both groups will receive the same standardized method of post-operative pain medication for post-operative pain relief. Participants in the MM group will utilize a Headspace application on their smart phone meditate twice a day while the control group will not perform any meditation or mindfulness. Patient reported outcomes will be collected at regular intervals. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis and/or Mumford procedure. The study includes 3 visits which are standard of care pre-operative and post-operative visits. The duration of the study will be 6 months which will include 3 standard of care post-operative visits and electronic surveys to track patient reported outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Status post shoulder arthroscopy for rotator cuff repair, biceps tendinopathy, and/or Mumford Procedure\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Patients undergoing a simultaneous arthroscopic procedure that is not in the inclusion criteria.\n* History of shoulder osteoarthritis'}, 'identificationModule': {'nctId': 'NCT04855968', 'briefTitle': 'The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption', 'orgStudyIdInfo': {'id': 'STUDY00000950'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control (CON)', 'description': 'will receive the usual standard of care post-operative pain pills for the involved shoulder (Control Group)', 'interventionNames': ['Other: Patients will take standard post-op pain medication']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness/Meditation (MM)', 'description': 'will receive the usual standard of care post-operative pain pills for the involved shoulder with the addition of access to the Headspace application for mindfulness/meditation (Mindfulness/Meditation Group)', 'interventionNames': ['Other: In addition to standard post-op medication patient will have access to the head space meditation application.']}], 'interventions': [{'name': 'In addition to standard post-op medication patient will have access to the head space meditation application.', 'type': 'OTHER', 'description': 'Patients will receive access to head space meditation application in addition to standard pain medication post surgery.', 'armGroupLabels': ['Mindfulness/Meditation (MM)']}, {'name': 'Patients will take standard post-op pain medication', 'type': 'OTHER', 'description': 'Standard post-op pain medication', 'armGroupLabels': ['control (CON)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kerlan Jobe', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Michael Banffy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedar Sinai -Kerlan Jobe'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Michael Banffy, MD', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}