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Behavioural Intervention

Patients: Control: No Music for Pain

N/A
Waitlist Available
Led By Mei Rui, DMA
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing awake craniotomy for resection of presumed or confirmed brain tumor(s) will be eligible to enroll in this study.
All neurosurgical attendings, residents, fellows, OR, staff, anesthesiologists, speech pathologists and neuropsychologists will be eligible to enroll. Providers will only be included and paired with patients who have consented.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

Summary

The study plans to enroll a total of 132 patients and 30 distinct providers. The goal of this study is to measure pre-, intra- and post-intervention changes in patients' vital signs (BP, HR, HRV, MAP), serum- and plasma-level biomarkers by proteomics analysis (including but not limited to interleukin-6, cortisol, ACTH, oxytocin, dopamine, epinephrine, norepinephrine, B-endorphin, growth hormone, and IgA.), total amount of pain meds and sedatives, and validated measures or surveys.

Who is the study for?
This trial is for neurosurgical patients who are experiencing stress and pain before surgery. It aims to include a diverse group of 132 patients and 30 providers. Participants must meet certain health criteria, but specific inclusion and exclusion details aren't provided.
What is being tested?
The Music-STAR Trial is testing the effects of live and recorded music from a Steinway Spirio M piano on pre-operative stress, mood, pain levels, vital signs, and various biomarkers in blood samples like hormones and immune indicators.
What are the potential side effects?
Since this trial involves music-based interventions rather than medications or invasive procedures, side effects are expected to be minimal if any. However, individual reactions to music therapy can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BMEQ (Brief Music Experience Questionnaire)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Patients: Simulated Live MusicExperimental Treatment1 Intervention
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Group II: Patients: Recorded MusicExperimental Treatment1 Intervention
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Group III: Patients: Control: No MusicExperimental Treatment1 Intervention
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

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Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,115 Total Patients Enrolled
16 Trials studying Pain
1,368 Patients Enrolled for Pain
Mei Rui, DMAPrincipal InvestigatorM.D. Anderson Cancer Center
~88 spots leftby Mar 2027
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