Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-03-08 @ 3:30 AM
Study NCT ID:
NCT06718218
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Combination Mindfulness and Music Intervention for Acute Pain
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Unpleasantness Numeric Rating Scale', 'timeFrame': 'Immediately before and after 5-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 and after 5-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 and after 5-minute audio recording', 'description': 'Change in anxiety from baseline will be assessed with an item adapted from the Generalized Anxiety Disorder 2-item. Scores range from 0 to 10, 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 evaluating a combination mindfulness + music intervention on acute pain among patients in an orthopedic clinic waiting room. Participants will be randomized to one of four conditions: 1) a 5-minute mindfulness recording, 2) a 5-minute mindfulness recording with an accompanying sustained tone at 65.41 Hertz, 3) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear, or 4) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear as well as instrumental, theta wave music.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years of age or older\n* Receiving pain treatment at Tallahassee Orthopedic Center\n* Understanding English instructions fluently\n\nExclusion Criteria:\n\n* Unable to consent because of physical or mental incapacity.'}, 'identificationModule': {'nctId': 'NCT06718218', 'briefTitle': 'A Combination Mindfulness and Music Intervention for Acute Pain', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'A Combination Mindfulness and Music Intervention for Acute Pain', 'orgStudyIdInfo': {'id': 'STUDY00004916_BB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness Pain Management', 'interventionNames': ['Behavioral: Mindfulness Pain Management']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness Recording With Sustained Tone', 'interventionNames': ['Behavioral: Mindfulness Recording With Sustained Tone']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness Recording with Binaural Beats', 'interventionNames': ['Behavioral: Mindfulness Recording with Binaural Beats']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness Recording with Binaural Beats and Theta Music', 'interventionNames': ['Behavioral: Mindfulness Recording with Binaural Beats and Theta Music']}], 'interventions': [{'name': 'Mindfulness Pain Management', 'type': 'BEHAVIORAL', 'description': 'Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice.', 'armGroupLabels': ['Mindfulness Pain Management']}, {'name': 'Mindfulness Recording With Sustained Tone', 'type': 'BEHAVIORAL', 'description': 'Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice, that is accompanied by a sustained low C tone at 65.41 Hertz.', 'armGroupLabels': ['Mindfulness Recording With Sustained Tone']}, {'name': 'Mindfulness Recording with Binaural Beats', 'type': 'BEHAVIORAL', 'description': 'Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice that is accompanied by binaural beats resulting from the delivery of a sustained 65.41 Hertz tone in the left ear and a sustained 69.41 Hertz tone in the right ear.', 'armGroupLabels': ['Mindfulness Recording with Binaural Beats']}, {'name': 'Mindfulness Recording with Binaural Beats and Theta Music', 'type': 'BEHAVIORAL', 'description': 'Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice that is accompanied by binaural beats resulting from the delivery of a sustained 65.41 Hertz tone in the left ear and a sustained 69.41 Hertz tone in the right ear as well as instrumental theta wave music.', 'armGroupLabels': ['Mindfulness Recording with Binaural Beats and Theta Music']}]}, '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'}}}}