Mechanisms Within the Autonomic Nervous SysTEm undeRlying MusIc Therapy's aNalgesic Effects in Sickle Cell Disease (MASTERMIND)
Sickle cell disease causes very painful episodes that can happen without warning. Pain is one of the biggest problems for people with SCD. Medicines like opioids can help, but they have serious side effects. Doctors are looking for other ways to treat pain.
Investigators have already found that music therapy - breathing exercises guided by a trained music therapist - can lower pain in adults with SCD. But investigators don't know exactly how it works yet inside the body.
This study will look at two possible reasons why music therapy helps:
- It may calm the body's "fight-or-flight" (sympathetic) nervous system, which can make pain worse when it is too active.
- It may boost the "calming" (parasympathetic) nervous system, which may ease pain and reduce inflammation.
- It may lower swelling and inflammation in the body, which also drives pain.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Kaitlyn Super
- 电话号码：216-844-1800
- 邮箱：kaitlyn.super@uhhospitals.org
学习地点
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-
Ohio
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Cleveland、Ohio、美国、44106
- University Hospitals
-
接触：
- Kaitlyn Super
- 电话号码：216-844-1800
- 邮箱：kaitlyn.super@uhhospitals.org
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- (1) are age ≥18 years
- (2) have a diagnosis of SCD documented in the electronic health record (EHR)--- (3) meet Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy (AAPT) criteria for chronic SCD pain
- (4) are able to speak and understand English
- (5) have an email address and access to a mobile device with a functioning data plan (to get pain diaries)
- (6) report that pain interfered with daily activities at least 1-2 days in past week will be eligible for the study. -
Exclusion Criteria:
- (1) have < 3 vaso-occlusive crises (VOCs) per year and no VOCs in the past 3 months
- (2) have significant visual, hearing, psychiatric or cognitive impairment
- (3) are currently engaged in mind-body therapies under the supervision of a healthcare professional specifically for pain management
- (4) have a planned major medical event in next 8 weeks (e.g., childbirth, orthopedic surgery, gene therapy, stem cell transplant) that does not include routine disease modifying therapies (e.g., blood transfusions)
- (5) are unable or unwilling to refrain from stopping all medications that interfere with the autonomic nervous system for 5 half-lives prior to autonomic testing and from changing their medication regimen during the 2 weeks that separate autonomic testings and blood draws
- (6) develop active VOC requiring hospitalization at enrollment
- (7) have conditions that would significantly affect autonomic testing interpretation, such as severe arrhythmias or pregnancy, will be excluded from the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Music Therapy
The MT-BC will engage the participant in a 20-minute deep breathing exercise with live music beating at a defined tempo. Participants will repeat this session on their own. |
Participants will undergo a 20-minute music therapy session with a board certified music therapist, then will repeat this on their own once daily for 2 weeks. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in electrodermal activity (EDA) as measured by change in electrical potential at the surface of the skin
大体时间：Baseline and after 2 weeks
|
Lower EDA reflects less sympathetic tone |
Baseline and after 2 weeks
|
|
Change in Quantitative Sudomotor Axon Reflex Test (QSART) as measured by sweat output values
大体时间：Baseline and after 2 weeks
|
Lower QSART values reflect less sympathetic activity |
Baseline and after 2 weeks
|
|
Changes in Pupillometry parameters as measured by constriction velocity
大体时间：Baseline and after 2 weeks
|
Faster constriction velocity indicates a higher pupillary vagal tone. |
Baseline and after 2 weeks
|
|
Changes in Pupillometry parameters as measured by percent reflex amplitude
大体时间：Baseline and after 2 weeks
|
Larger percentage of reflex amplitude indicates higher pupillary vagal tone. |
Baseline and after 2 weeks
|
|
Changes in Pupillometry parameters as measured by dilation velocity.
大体时间：Baseline and after 2 weeks.
|
Slower dilation velocity indicates lower pupillary sympathetic tone. |
Baseline and after 2 weeks.
|
|
Change in Heart Rate Response to deep breathing
大体时间：Baseline and after 2 weeks
|
Increased heart rate response to deep breathing denotes increased cardiovagal tone. |
Baseline and after 2 weeks
|
|
Measurement of average supine resting Blood Pressure (BP)
大体时间：Baseline and after 2 weeks
|
Lower average resting BP denote lower cardiac sympathetic tone |
Baseline and after 2 weeks
|
|
Measurement of average supine resting Heart Rate (HR)
大体时间：Baseline and after 2 weeks
|
Lower average resting HR denote lower cardiac sympathetic tone |
Baseline and after 2 weeks
|
|
Change in supine resting respiratory rate
大体时间：Baseline and after 2 weeks
|
A lower resting respiratory rate reflects a shift of autonomic balance toward parasympathetic (vagal) dominance with reduced central sympathetic outflow. |
Baseline and after 2 weeks
|
|
Change in the maximum heart rate during the Valsalva maneuver
大体时间：Baseline and after 2 weeks
|
An increased Valsalva Ratio (maximum heart rate to the minimum heart rate) reflects an increase in cardiac parasympathetic tone. |
Baseline and after 2 weeks
|
|
Change in the minimum heart rate shortly after the Valsalva maneuver
大体时间：Baseline and after 2 weeks
|
An increased Valsalva Ratio (maximum heart rate to the minimum heart rate) reflects an increase in cardiac parasympathetic tone. |
Baseline and after 2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in C Reactive Protein as measured by bloodwork
大体时间：Baseline and after 2 weeks
|
Lower levels of CRP indicate lower levels of inflammation |
Baseline and after 2 weeks
|
|
Change in Cytokine levels as measured by bloodwork
大体时间：Baseline and after 2 weeks
|
Lower levels of cytokines indicate lower levels of inflammation |
Baseline and after 2 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain intensity changes as measured by the Visual Analog Scale (VAS)
大体时间：Baseline and after 2 weeks of daily music therapy
|
The VAS is a straight 100 mm line-usually horizontal-with descriptive word anchors at each end representing opposite extremes of a subjective experience, such as 0 being "no pain" and 10 being "worst possible pain". |
Baseline and after 2 weeks of daily music therapy
|
|
Pain intensity changes as measured by the Brief Pain Inventory (BPI)
大体时间：Baseline and after 2 weeks of daily music therapy
|
Brief Pain Inventory (BPI) is a self-administered questionnaire used to evaluate pain severity and how pain interferes with daily life on scales from 0 to 10, with 0 being no pain, and 10 being severe pain. |
Baseline and after 2 weeks of daily music therapy
|
|
Pain diaries
大体时间：Daily for 2 weeks
|
Daily pain intensity and analgesic use |
Daily for 2 weeks
|
|
Music therapy adherence
大体时间：Daily for 2 weeks
|
Daily log of adherence to the home-based music therapy protocol |
Daily for 2 weeks
|
合作者和调查者
调查人员
- 首席研究员：Kamal R Chémali, MD、University Hospitals
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY20260271
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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