Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 11:50 PM
Study NCT ID:
NCT06582758
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2024-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Choice Improve the Pain Relief Derived From a Brief Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Unpleasantness Numeric Rating Scale', 'timeFrame': 'Immediately before to after 7 to 10-minute audio recording', 'description': 'Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Intensity Numeric Rating Scale', 'timeFrame': 'Immediately before to after 7 to 10-minute audio recording', 'description': 'Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.'}, {'measure': 'Change in Anxiety Numeric Rating Scale', 'timeFrame': 'Immediately before to after 7 to 10-minute audio recording', 'description': 'Change in anxiety from baseline will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness'], 'conditions': ['Pain', 'Acute Pain']}, 'descriptionModule': {'briefSummary': 'This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience.', 'detailedDescription': 'This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Participants will be randomized to one of three conditions: 1) a 4-minute pain psychoeducation recording, 2) a 4-minute mindfulness recording, or 3) choice. In the choice condition, participants will be able to choose which recoding (i.e., pain psychoeducation or mindfulness) they would like to listen to.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving pain treatment at Tallahassee Orthopedic Center\n* Understanding English instructions fluently\n* Being 18 years of age or older\n\nExclusion Criteria:\n\n* Unable to consent because of physical or mental incapacity.'}, 'identificationModule': {'nctId': 'NCT06582758', 'briefTitle': 'Does Choice Improve the Pain Relief Derived From a Brief Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Brief (<10 Minute) Behavioral Interventions for Pain', 'orgStudyIdInfo': {'id': 'STUDY00004916_MOD5065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindful Pain Management (randomized)', 'description': 'In the control mindful pain management intervention, participants will be randomized to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.', 'interventionNames': ['Behavioral: Mindful Pain Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Psychoeducation (randomized)', 'description': 'In the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.', 'interventionNames': ['Behavioral: Pain Psychoeducation']}, {'type': 'EXPERIMENTAL', 'label': 'Choice: Mindful Pain Management', 'description': 'In the choice mindful pain management intervention, participants will choose to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.', 'interventionNames': ['Behavioral: Mindful Pain Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Choice: Pain Psychoeducation', 'description': 'In the choice pain psychoeducation intervention, participants will choose to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.', 'interventionNames': ['Behavioral: Pain Psychoeducation']}], 'interventions': [{'name': 'Pain Psychoeducation', 'type': 'BEHAVIORAL', 'description': 'In the pain psychoeducation intervention, participants will be provided a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.', 'armGroupLabels': ['Choice: Pain Psychoeducation', 'Pain Psychoeducation (randomized)']}, {'name': 'Mindful Pain Management', 'type': 'BEHAVIORAL', 'description': 'In the mindful pain management intervention, participants will listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.', 'armGroupLabels': ['Choice: Mindful Pain Management', 'Mindful Pain Management (randomized)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Orthopedic Clinic (TOC)', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adam Hanley', 'investigatorAffiliation': 'Florida State University'}}}}