Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 1:26 PM
Study NCT ID:
NCT06536504
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2024-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': '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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress and mood changes', 'timeFrame': 'Through study cmpletion', 'description': 'Pre-post intervention changes in physiologic and perceived stress and mood changes by BP, STAI-S, VASP and POM-S.'}, {'measure': 'Stress biomarkers', 'timeFrame': 'Through study completion', 'description': 'Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine.'}], 'secondaryOutcomes': [{'measure': 'BMEQ (Brief Music Experience Questionnaire)', 'timeFrame': 'Through study completion', 'description': 'Approximately 15 minutes to complete each time)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress', 'Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.", 'detailedDescription': 'Primary Objectives:\n\n* To evaluate the effects of the two (live and recorded) prescribed preoperative containing CER on physiologic and perceived stress in patients undergoing Neurosurgery.\n* To evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients.\n\nSecondary Objectives:\n\n• To measure correlative effects of demographic variables, prior musical training, experience, preference, and exposure to music.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1\\) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.\n\nExclusion Criteria\n\n1. Patient is unable or unwilling to provide informed consent.\n2. Patient is deaf or hearing-disabled.\n3. Patient is less than 18 years in age.\n4. Patient was previously enrolled in the study.\n5. Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.\n6. Subjects on contact isolation precautions.'}, 'identificationModule': {'nctId': 'NCT06536504', 'briefTitle': 'A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Randomized Controlled Trial to Assess the Impact of Live and Recorded Music-Based Interventions on Pre-operative Stress, Mood, Pain and Biomarkers, in Neurosurgical Patients (Music-STAR Trial)', 'orgStudyIdInfo': {'id': '2024-0082'}, 'secondaryIdInfos': [{'id': 'NCI-2024-06549', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients: Simulated Live Music', 'description': 'Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.', 'interventionNames': ['Other: Steinway Spirio M recording/player piano']}, {'type': 'EXPERIMENTAL', 'label': 'Patients: Recorded Music', 'description': 'Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.', 'interventionNames': ['Other: Steinway Spirio M recording/player piano']}, {'type': 'EXPERIMENTAL', 'label': 'Patients: Control: No Music', 'description': 'Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.', 'interventionNames': ['Other: Steinway Spirio M recording/player piano']}], 'interventions': [{'name': 'Steinway Spirio M recording/player piano', 'type': 'OTHER', 'description': 'Patients will be equally randomized into one of the three arms (simulated live music, recorded music, or no music) applying the random permutated block. Randomization will be conducted via an approved institutional database with the randomization list generated by the study statistician.', 'armGroupLabels': ['Patients: Control: No Music', 'Patients: Recorded Music', 'Patients: Simulated Live Music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mei Rui, DMA', 'role': 'CONTACT', 'email': 'mrui@mdanderson.org', 'phone': '713-745-4243'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Mei Rui, DMA', 'role': 'CONTACT', 'email': 'mrui@mdanderson.org', 'phone': '7137454243'}], 'overallOfficials': [{'name': 'Mei Rui, DMA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}