Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 3:43 PM
Study NCT ID:
NCT05054595
Status:
WITHDRAWN
Last Update Posted:
2023-03-31
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of provider bandwidth', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-09-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-22', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0', 'timeFrame': 'During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment', 'description': 'The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale.\n\nT-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score indicates better physical functioning.'}], 'primaryOutcomes': [{'measure': 'Change in Pain Intensity Numeric Rating Scale', 'timeFrame': 'Baseline and after the 10 minute preoperative nurse visit', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Unpleasantness Numeric Rating Scale', 'timeFrame': 'Baseline and after the 10 minute preoperative nurse visit', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.'}, {'measure': 'Change in Pain Medication Desire Numeric Rating Scale', 'timeFrame': 'Baseline and after the 10 minute preoperative nurse visit', 'description': 'Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Osteoarthritis, Knee', 'Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': 'This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a nurse-led, very brief, preoperative mindfulness-based intervention for hip and knee replacement patients will be investigated relative to an audio-recorded very brief, preoperative mindfulness-based intervention delivered during the standard nurse consult and a nurse-led preoperative pain psychoeducation intervention during the standard nurse consult.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Age ≥18,\n* 2\\) Scheduled to undergo unilateral total knee or hip arthroplasty\n\nExclusion Criteria:\n\n* 1\\) Cognitive impairment preventing completion of study procedures.\n* 2\\) Current cancer diagnosis,\n* 3\\) Contralateral knee or hip replaced in the previous 3 months,\n* 4\\) Intent to have contralateral knee or hip replaced or other, additional surgical procedure during the study period,\n* 5\\) Intent to add new pain treatments during the study period (except for what is part of the study),\n* 6\\) Other unstable illness judged by medical staff to interfere with study treatment.'}, 'identificationModule': {'nctId': 'NCT05054595', 'briefTitle': 'Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Comparing the Effects of an Audio-Recorded Brief Mindfulness-Based Intervention With a Nurse-Led Brief Mindfulness-Based Intervention for Preoperative Knee and Hip Replacement Patients', 'orgStudyIdInfo': {'id': 'IRB_00085446: AM_00040605 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Pain Psychoeducation', 'interventionNames': ['Behavioral: Standard Pain Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Audio-Recorded Mindfulness-Based Intervention', 'interventionNames': ['Behavioral: Audio-Recorded Mindfulness-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Nurse-Led Mindfulness-Based Intervention', 'interventionNames': ['Behavioral: Nurse-Led Mindfulness-Based Intervention']}], 'interventions': [{'name': 'Standard Pain Management', 'type': 'BEHAVIORAL', 'description': 'Nurses will provide psychoeducation about pain along with common pain coping strategies, such as rest, ice, and elevation, for use any time they experience intense pain or take pain medication before and after surgery.', 'armGroupLabels': ['Standard Pain Psychoeducation']}, {'name': 'Audio-Recorded Mindfulness-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then have them listen to a very brief (1 minute 30 second) guided mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time.', 'armGroupLabels': ['Audio-Recorded Mindfulness-Based Intervention']}, {'name': 'Nurse-Led Mindfulness-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then guide them through a very brief (1 minute 30 second) mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time.', 'armGroupLabels': ['Nurse-Led Mindfulness-Based Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Adam Hanley', 'investigatorAffiliation': 'University of Utah'}}}}