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NCT Number: NCT06536504

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)

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.

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Key information

Conditions

Stress Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Mei Rui, DMA

CONTACT

[email protected]

713-745-4243

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient is unable or unwilling to provide informed consent.
  • Patient is deaf or hearing-disabled.
  • Patient is less than 18 years in age.
  • Patient was previously enrolled in the study.
  • Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.
  • Subjects on contact isolation precautions.

Treatment and study plan

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.

Primary outcomes

  1. Stress and mood changes

    Time frame: Through study cmpletion

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

  2. Stress biomarkers

    Time frame: Through study completion

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

Secondary outcomes

  1. BMEQ (Brief Music Experience Questionnaire)

    Time frame: Through study completion

    Approximately 15 minutes to complete each time)

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Rui, DMA

CONTACT

[email protected]

7137454243

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Aug 5, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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