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Behavioural Intervention
Music Therapy for Pre-operative Stress and 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
Be older than 18 years old
Must not have
Patient is less than 18 years in age
Patient is deaf or hearing-disabled
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study cmpletion
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to enroll 132 patients and 30 providers to study changes in patients' vital signs, biomarkers, pain medication usage, and validated surveys before, during, and after an intervention.
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 belowSelect...
I am having an awake craniotomy to remove a brain tumor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
I am deaf or have a hearing disability.
Select...
I cannot or do not want to give permission for treatment.
Select...
I have had brain surgery before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stress and mood changes
Stress biomarkers
Secondary study objectives
BMEQ (Brief Music Experience Questionnaire)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,413 Total Patients Enrolled
17 Trials studying Pain
1,384 Patients Enrolled for Pain
Mei Rui, DMAPrincipal InvestigatorM.D. Anderson Cancer Center