Recruiting

Music-Based Interventions

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06536504

Conditions

Stress

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Steinway Spirio M recording/player piano

Study Details

Brief 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.

Conditions

Stress

Pain

Study ID

NCT06536504

Start date

Dec 19, 2024

Status verified date

Jun, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

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

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.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Steinway 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mei Rui, DMA

7137454243mrui@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Mei Rui, DMA

713-745-4243mrui@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-12.