Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT04671628
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2020-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D059265', 'term': 'Visceral Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gastrointestinal symptom severity', 'timeFrame': 'The intervention will last 2 weeks. Gastrointestinal symptoms will be collected for a 1-week period before the intervention and during the 2nd week of the intervention', 'description': 'The severity of several gastrointestinal symptoms will be assessed on a validated 0-10 scale.'}, {'measure': 'Change in anxiety levels', 'timeFrame': 'The intervention will last 2 weeks. The General Anxiety Disorder-7 will be assessed before the intervention begins and again after 2 weeks.', 'description': 'Levels of anxiety will be assessed with the General Anxiety Disorder-7 questionnaire. Scores on the General Anxiety Disorder-7 range from 0 to 21, with higher scores indicating higher levels of anxiety.'}], 'secondaryOutcomes': [{'measure': 'Change in visceral sensitivity', 'timeFrame': 'The intervention will last 2 weeks. The Visceral Sensitivity Index will be assessed before the intervention begins and again after 2 weeks.', 'description': 'Perceptions of visceral sensitivity will be assessed via the Visceral Sensitivity Index. Scores on the Visceral Sensitivity Index can range from 0 to 75, with higher scores indicating a higher level of visceral sensitivity.'}, {'measure': 'Change in perceived stress', 'timeFrame': 'The intervention will last 2 weeks. The Perceived Stress Scale 14 will be assessed before the intervention begins and again after 2 weeks.', 'description': 'Perceived life stress will be evaluated with the Perceived Stress Scale 14. Scores on this scale can range from 0 to 56, will higher scores indicating greater amounts of stress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal System--Abnormalities', 'Anxiety', 'Visceral Pain']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine the impacts of a 2-week relaxing music intervention on stress, anxiety, and gut symptoms in individuals who regularly perform structured aerobic exercise. Gut symptoms like bloating, reflux, cramping, nausea, etc. are relatively common during prolonged aerobic exercise. In addition, previous research has established that levels of anxiety and stress are associated with a higher occurrence of these gut symptoms. Relaxing music has reduced anxiety in certain populations, but currently, no studies are available on its effects on anxiety, stress, and gut symptoms in people who regularly do aerobic exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* be at least 18 years of age\n* do 120+ minutes per week of planned/structured aerobic exercise of at least moderate intensity\n* have had at least mild anxiety over the past 2 weeks (GAD-7 score of 5 or more)\n* not currently on a psychotropic medication, or if they are on one, they must have been on a stable dose for the past three months\n* not currently listening to music for relaxation purposes regularly (\\>60 minutes per week)\n* have at least sometimes experienced gut symptoms (nausea, gas, bloating, cramping, side stitching, urge to defecate, etc.) during aerobic exercise sessions over the last month\n* have access to the internet\n\nExclusion Criteria:\n\n* not at least 18 years of age\n* don't do 120+ minutes per week of planned/structured aerobic exercise of at least moderate intensity\n* haven't had at least mild anxiety over the past 2 weeks (GAD-7 score of 5 or more)\n* have recently started taking a psychotropic medication (within past 3 months)\n* currently listening to music for relaxation purposes regularly (\\>60 minutes per week)\n* have never or rarely experienced gut symptoms (nausea, gas, bloating, cramping, side stitching, urge to defecate, etc.) during aerobic exercise sessions over the last month\n* don't have internet access"}, 'identificationModule': {'nctId': 'NCT04671628', 'briefTitle': 'Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers', 'organization': {'class': 'OTHER', 'fullName': 'Old Dominion University'}, 'officialTitle': 'Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers', 'orgStudyIdInfo': {'id': '1690558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Relaxing music', 'interventionNames': ['Behavioral: Relaxing music']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Relaxing music', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to listen to relaxing music for 30 minutes each day. They will allowed to choose between several playlists based on their preference.', 'armGroupLabels': ['Relaxing music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23529', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Human Performance Laboratory', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Old Dominion University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Exercise Science', 'investigatorFullName': 'Patrick Wilson, PhD', 'investigatorAffiliation': 'Old Dominion University'}}}}