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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-06549 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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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:
Secondary Objectives:
• To measure correlative effects of demographic variables, prior musical training, experience, preference, and exposure to music.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients: Simulated Live Music | Experimental | Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1. |
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| Patients: Recorded Music | Experimental | Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1. |
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| Patients: Control: No Music | Experimental | Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steinway Spirio M recording/player piano | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stress and mood changes | Pre-post intervention changes in physiologic and perceived stress and mood changes by BP, STAI-S, VASP and POM-S. | Through study cmpletion |
| Stress biomarkers | Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine. | Through study completion |
| Measure | Description | Time Frame |
|---|---|---|
| BMEQ (Brief Music Experience Questionnaire) | Approximately 15 minutes to complete each time) | Through study completion |
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Inclusion Criteria
1) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Rui, DMA | Contact | 7137454243 | mrui@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Mei Rui, DMA | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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