Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT05098561
Status:
UNKNOWN
Last Update Posted:
2022-12-23
First Post:
2021-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Therapy for Post-cardiac Surgery Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Randomize patients into music treatment group and non-music treatment control group. 30 patients per group. Patients will be enrolled into each group on an alternate bases.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-09-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2021-09-18', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of Opioid type pain medication used', 'timeFrame': 'In the immediate post operative period, while patient still in the ICU', 'description': 'To assess whether the use of music therapy can decrease the amount of opioid type pain medications used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use']}, 'descriptionModule': {'briefSummary': 'Music therapy as a supplement to post surgery pain management in cardiac surgery patients following median sternotomy.', 'detailedDescription': '2\\. Specific Aims:\n\n1. Primary Aim: To assess whether music therapy can decrease the amount of opioid type pain medications used.\n\n Hypothesis: Music therapy reduces the amount of opioid type pain medication used in management of post-operative pain and discomfort.\n2. Secondary Aims:\n\ni. To identify the gender and age groups of patients who can benefit from music therapy as a supplement to post-operative pain management.\n\nHypothesis: Majority of the population of patient benefits from music therapy as a supplement to postoperative pain management.\n\nii. To assess whether music therapy can increase patient satisfaction.\n\nHypothesis: Music therapy increases patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cardiac surgery via median sternotomy\n\nExclusion Criteria:\n\n* Emergency cases.\n* Patients with hearing impairment.\n* Patients with dementia or other mental status changes.\n* Patients who are clinically unstable postoperatively.\n* Patients who develop postoperative complications.\n* Patients who are non-English speaking.'}, 'identificationModule': {'nctId': 'NCT05098561', 'briefTitle': 'Music Therapy for Post-cardiac Surgery Pain Management', 'organization': {'class': 'OTHER', 'fullName': "Steward St. Elizabeth's Medical Center of Boston, Inc."}, 'officialTitle': 'Music Therapy as a Supplement to Post Surgery Pain Management in Cardiac Surgery Patient Following Median Sternotomy', 'orgStudyIdInfo': {'id': '00770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music treatment group', 'description': "The nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service.", 'interventionNames': ['Other: Music Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No music treatment will be used. Standard pain and comfort measure only.'}], 'interventions': [{'name': 'Music Treatment', 'type': 'OTHER', 'description': "The nurse will set up the appropriate music genre for the each music treatment patient, based on patient's preference obtained from the pre-operative questionnaire, by using the bedside computer and using Pandora, the internet music streaming service.", 'armGroupLabels': ['Music treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02135', 'city': 'Brighton', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stanley Tam', 'role': 'CONTACT', 'email': 'stanley.tam@steward.org', 'phone': '617-789-2045'}], 'facility': 'Steward St. Elizabeth medical Center', 'geoPoint': {'lat': 42.3501, 'lon': -71.15644}}], 'centralContacts': [{'name': 'Stanley Tam, MD', 'role': 'CONTACT', 'email': 'stanley.tam@steward.org', 'phone': '617-789-2045'}], 'overallOfficials': [{'name': 'Stanley Tam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steward St Elizabeth Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Steward St. Elizabeth's Medical Center of Boston, Inc.", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Surgeon', 'investigatorFullName': 'Stanley Tam', 'investigatorAffiliation': "Steward St. Elizabeth's Medical Center of Boston, Inc."}}}}