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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Stress
• Pain

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-12-19
• Primary completion: 2027-03-01
• Completion: 2029-03-01
• First posted: 2024-08-05
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States