Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2025-12-30
132
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of live and recorded music-based interventions on patients undergoing neurosurgical procedures. The study aims to measure changes in vital signs, stress biomarkers, and self-reported pain, anxiety, and mood before and after the music sessions. It also explores how prior musical experience and preferences might influence responses to music in reducing stress and anxiety. Participants will be randomly assigned to one of three groups: simulated live music, recorded music using a Steinway Spirio M player piano, or no music as a control. The study uses a randomized controlled design to compare these interventions. Each participant will receive their assigned music intervention before surgery, and the study will monitor physiological and psychological responses. During the study, participants will provide demographic information and complete questionnaires, including the Brief Musical Experience Questionnaire (BMEQ), to assess their musical background. Researchers will monitor stress and mood changes as primary outcomes throughout the study, along with serum and plasma stress biomarkers. The study will continue assessing these outcomes through completion, with a focus on understanding the effects of music on preoperative stress and pain.
CONDITIONS
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing neurosurgical procedures are eligible to enroll
- Participants must be 18 years of age or older
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Deaf or hearing-disabled
- Under 18 years of age
- Previously enrolled in the study
- Non-English-speaking or requiring translation services
- On contact isolation precautions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Pre-operative period as defined by the surgical schedule
Participants receive one of three music-based interventions (simulated live music, recorded music, or no music) before neurosurgical procedures to assess effects on pre-operative stress, mood, pain, and biomarkers.
1 visit (in-person) before surgery
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Mei Rui, DMA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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