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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Steinway Spirio M recording/player piano.
- Who it may be relevant to
- Registry conditions: Stress, Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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
- Other Steinway 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.
Primary outcome measures
- Stress and mood changes [Time frame: Through study cmpletion]
- Stress biomarkers [Time frame: Through study completion]
Secondary outcome measures (1)
- BMEQ (Brief Music Experience Questionnaire) [Time frame: Through study completion]
Eligibility criteria
Inclusion criteria
1\) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.
Exclusion criteria
- Patient is unable or unwilling to provide informed consent.
- Patient is deaf or hearing-disabled.
- Patient is less than 18 years in age.
- Patient was previously enrolled in the study.
- Non-English-speaking patients (patient must be fluent in English and not require translation services per MDACC institutional policy.
- Subjects on contact isolation precautions.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06536504 · 2024-0082 · NCI-2024-06549