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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Stress and mood changes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Patients undergoing neurosurgical procedures will be eligible to enroll in this study.
排除标准
- •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.
研究组 & 干预措施
Patients: Simulated Live Music
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
干预措施: Steinway Spirio M recording/player piano (Other)
Patients: Recorded Music
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
干预措施: Steinway Spirio M recording/player piano (Other)
Patients: Control: No Music
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
干预措施: Steinway Spirio M recording/player piano (Other)
结局指标
主要结局
Stress and mood changes
时间窗: 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
时间窗: Through study completion
Proteomic and metabolomic analyses, in stress biomarkers and cytokines including IL-6, cortisol and epinephrine.
次要结局
- BMEQ (Brief Music Experience Questionnaire)(Through study completion)