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 Center132 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

132

Conditions

Stress Pain

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Stress and mood changes

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

Time frame: Through study cmpletion

Stress biomarkers

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

Time frame: Through study completion

Secondary Outcomes

BMEQ (Brief Music Experience Questionnaire)

Approximately 15 minutes to complete each time)