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)

Not Applicable

Recruiting

• Conditions: Pain; Stress
• Interventions: Other: Steinway Spirio M recording/player piano

• Registration Number: NCT06536504
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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.

Study Timeline

• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Study Start: 2025-01-31
• Primary Completion: 2027-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients: Recorded Music	Steinway Spirio M recording/player piano	Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Patients: Control: No Music	Steinway Spirio M recording/player piano	Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Patients: Simulated Live Music	Steinway Spirio M recording/player piano	Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

Primary Outcome Measures

Name	Time	Method
Stress and mood changes	Through study cmpletion	Pre-post intervention changes in physiologic and perceived stress and mood changes by BP, STAI-S, VASP and POM-S.
Stress biomarkers	Through study completion	Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine.

Secondary Outcome Measures

Name	Time	Method
BMEQ (Brief Music Experience Questionnaire)	Through study completion	Approximately 15 minutes to complete each time)

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States