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)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06536504
Status
Recruiting
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Conditions

  • Pain
  • Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Steinway Spirio M recording/player piano — OTHER
    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.

Study Details

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.

Key Dates

Start date
Dec 19, 2024
Status verified
Dec 2025
Primary completion
Mar 1, 2027
Completion
Mar 1, 2029

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Patients: Simulated Live Music
    Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
  • Experimental: Patients: Recorded Music
    Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
  • Experimental: Patients: Control: No Music
    Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

Primary Outcome Measure

Stress and mood changes [ Time Frame: Through study cmpletion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Mei Rui, DMA
[email protected]
713-745-4243

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By research site
MD Anderson Cancer Center· Houston, TX

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