Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-31 @ 8:02 AM
Study NCT ID:
NCT05979103
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generalized Anxiety Disorder (GAD-7) Score', 'timeFrame': '4 weeks', 'description': 'Anxiety levels will be evaluated using the General Anxiety Disorder (GAD-7) questionnaire. Range 0-21, where higher score is greater anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': "Social psychological research has demonstrated that internalized stereotypes affect people's attitudes and behaviors. Music-based interventions that rely on stereotypes might have promise for keeping participants engaged in health interventions, reducing stress, and improving wellbeing.", 'detailedDescription': 'Group Assignments\n\nParticipants will be randomized into one of four groups.\n\n1. Group 1 (Reggae): Participants in this group will receive the stereotype and listen to the music over the 4 weeks.\n2. Group 2 (Preferred): Participants in this group will listen to preferred music over the 4 weeks.\n3. Control Group: Participants in this group will serve as a control and will not receive any intervention until the study is completed. They will complete a baseline survey and a follow-up survey at four weeks, as well as similar daily surveys. Some recordings will be sent to this group after the study is completed, without tracking their usage.\n\nIntervention\n\nAll groups will complete a baseline and 4-week follow-up survey.\n\nParticipants in Group 1 and Group 2 will engage in daily listening 4-week intervention.They will have access to electronic audio recordings, with the order of listening labeled for each day. It is up to them if they want to listen to the daily recordings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are 18+\n2. Live in the US\n3. Are an English-proficient adult with a chronic pain diagnosis (no restrictions placed on type)\n4. Have a pain rating of four or greater in average pain on a 0-10 numeric rating scale in the preceding week\n5. Have had pain for at least 3 months and for at least 15 days in the preceding 30 days\n6. Have moderate to severe anxiety based on GAD-7\n\nExclusion Criteria:\n\n1. Are currently using or have used prescription opioids in the past 3 months to minimize a known treatment confound and increase sample homogeneity\n2. Have a current cancer diagnosis'}, 'identificationModule': {'nctId': 'NCT05979103', 'briefTitle': 'Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients', 'orgStudyIdInfo': {'id': '3585'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reggae Music', 'description': 'Group 1 (Reggae): Participants in this group will be told about he stereotype of reggae in making people more calm. They will listen to reggae music over the 4 weeks.', 'interventionNames': ['Behavioral: Listening to Reggae Music and told the stereotype']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preferred Music', 'description': 'Group 2 (Preferred): Participants in this group will listen to preferred music over the 4 weeks and will not be told any stereotypes.', 'interventionNames': ['Behavioral: Listening to Preferred Music']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Group 3 (Waitlist- Control): Participants are not providing with any intervention. They only complete surveys.'}], 'interventions': [{'name': 'Listening to Reggae Music and told the stereotype', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will be told about he stereotype of reggae in making people more calm. They will listen to reggae music over the 4 weeks. Each day, we will send them a playlist to listen to.', 'armGroupLabels': ['Reggae Music']}, {'name': 'Listening to Preferred Music', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will NOT be told the stereotype for the audio they are listening to. They will listen to preferred music over the 4 weeks. Each day, we will remind them to listen to preferred music.', 'armGroupLabels': ['Preferred Music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sean D Young', 'investigatorAffiliation': 'University of California, Irvine'}}}}