CClinicalTrials.gg
RecruitingNCT06536504Updated Jun 12, 2026

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)

An interventional study of Steinway Spirio M recording/player piano in Stress and Pain, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Primary Objectives:

  • 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.
02

Conditions studied

  • Stress
  • Pain

Browse trials for

03

In context

Pain

2,219 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's planned enrollment of 132 is above the median of 70 across 1,904 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

1) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.

Exclusion criteria

Exclusion Criteria

  1. Patient is unable or unwilling to provide informed consent.
  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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    Patients: Simulated Live Music

    Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

    Other: Steinway Spirio M recording/player piano

  • Experimental
    Patients: Recorded Music

    Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

    Other: Steinway Spirio M recording/player piano

  • Experimental
    Patients: Control: No Music

    Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

    Other: Steinway Spirio M recording/player piano

Interventions

  • OtherSteinway 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.

06

What researchers measure

Primary outcomes

  1. Stress and mood changes

    Pre-post intervention changes in physiologic and perceived stress and mood changes by BP, STAI-S, VASP and POM-S.

    Time frame: Through study cmpletion

  2. Stress biomarkers

    Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine.

    Time frame: Through study completion

Secondary outcomes

  1. BMEQ (Brief Music Experience Questionnaire)

    Approximately 15 minutes to complete each time)

    Time frame: Through study completion

07

Study locations

1 of 1 sites recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06536504
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Aug 5, 2024
Start date
Dec 19, 2024
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2029 (estimated)
Last update
Jun 12, 2026

Study contacts

Mei Rui, DMA
Contact
mrui@mdanderson.org
7137454243
Mei Rui, DMA
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion