Pain, Stress
Conditions
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.
Interventions
OTHERSteinway 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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| BMEQ (Brief Music Experience Questionnaire) | Through study completion | Approximately 15 minutes to complete each time) |
Countries
United States
Contacts
CONTACTMei Rui, DMA
PRINCIPAL_INVESTIGATORMei Rui, DMA
M.D. Anderson Cancer Center
Outcome results
None listed