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)
2 other identifiers
interventional
132
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2024
CompletedFirst Posted
Study publicly available on registry
August 5, 2024
CompletedStudy Start
First participant enrolled
December 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
June 12, 2026
June 1, 2026
2.2 years
July 31, 2024
June 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Stress and mood changes
Pre-post intervention changes in physiologic and perceived stress and mood changes by BP, STAI-S, VASP and POM-S.
Through study cmpletion
Stress biomarkers
Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine.
Through study completion
Secondary Outcomes (1)
BMEQ (Brief Music Experience Questionnaire)
Through study completion
Study Arms (3)
Patients: Simulated Live Music
EXPERIMENTALPatients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Patients: Recorded Music
EXPERIMENTALPatients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Patients: Control: No Music
EXPERIMENTALPatients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.
You may not qualify if:
- Patient is unable or unwilling to provide informed consent.
- Patient is deaf or hearing-disabled.
- Patient is less than 18 years in age.
- Patient was previously enrolled in the study.
- Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.
- Subjects on contact isolation precautions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mei Rui, DMA
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2024
First Posted
August 5, 2024
Study Start
December 19, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2029
Last Updated
June 12, 2026
Record last verified: 2026-06