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)

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Pain; Stress

Treatments: Other: Steinway Spirio M recording/player piano

Study type: Interventional

Funder types: Other

Identifiers

NCT06536504

NCI-2024-06549 (Other Identifier)

2024-0082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

Patients: Simulated Live Music

Experimental group

Description:

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

Treatment:

Other: Steinway Spirio M recording/player piano

Patients: Recorded Music

Experimental group

Description:

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

Treatment:

Other: Steinway Spirio M recording/player piano

Patients: Control: No Music

Experimental group

Description:

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

Treatment:

Other: Steinway Spirio M recording/player piano