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)
NCT ID: NCT06536504
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
132 participants
INTERVENTIONAL
2024-12-19
2029-03-01
Brief Summary
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Detailed Description
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* To evaluate the effects of the two (live and recorded) prescribed preoperative containing CER on physiologic and perceived stress in patients undergoing Neurosurgery.
* To evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients.
Secondary Objectives:
• To measure correlative effects of demographic variables, prior musical training, experience, preference, and exposure to music.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Patients: Simulated Live Music
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Steinway Spirio M recording/player piano
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.
Patients: Recorded Music
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Steinway Spirio M recording/player piano
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.
Patients: Control: No Music
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Steinway Spirio M recording/player piano
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.
Interventions
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Steinway Spirio M recording/player piano
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
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Inclusion Criteria
Exclusion Criteria
2. Patient is deaf or hearing-disabled.
3. Patient is less than 18 years in age.
4. Patient was previously enrolled in the study.
5. Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.
6. Subjects on contact isolation precautions.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mei Rui, DMA
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Mei Rui, DMA
Role: primary
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2024-06549
Identifier Type: OTHER
Identifier Source: secondary_id
2024-0082
Identifier Type: -
Identifier Source: org_study_id