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TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE)

2026年8月3日 更新者:Case Comprehensive Cancer Center

TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE): A Single Arm Pilot Study

Participants may take part in this study if they are scheduled to undergo a surgery that meets the following: (1) traditional open surgery via laparotomy, (2) length of surgery >3 hours, and (3) curative-intent surgical resection of a cancer in the stomach, pancreas, bile ducts, liver, or peritoneal surfaces. The purpose of this study is (1) to evaluate the feasibility of collecting blood samples prior to surgery, post-surgery and pre- music-assisted relaxation and imagery (MARI) intervention, and immediately post-MARI intervention and (2) to identify gene expression changes associated with MARI and explore their relationship with immediate changes in pain intensity. Participants will be in this study for the duration of their hospital admission for surgery.

研究概览

详细说明

People undergoing surgery for abdominal cancer often experience high levels of pain, stress, and anxiety. Managing these symptoms after surgery is difficult. People often require strong medications for pain relief and may have other comorbidities and anxiety that accompany surgery. Non-pharmacologic approaches, like music therapy (MT) are needed.

Music-assisted relaxation and imagery (MARI) combines live music with guided relaxation, breathing, and imagery. MARI can be personalized to people's preferences. MARI can also be recorded live so that a recording can be given to the participant to use afterward. In a prior study conducted by researchers, people who receiving palliative care reported a decrease in pain after experiencing MARI. In an additional study, MARI was found to more likely result in bigger decreases in pain when compared to traditional MT alone.

Even though there are several studies that support the efficacy of music interventions, like MARI and MT, for addressing pain after surgery, the biological mechanisms are not well understood. Recent advances in functional genomic science provide an opportunity to understand transcriptomic mechanisms. These approaches have been applied to mind-body therapies, recreational music making (RMM), and music listening. However, they have not yet been applied to MT.

A previous study showed that RMM led to a decrease in stress-induced immune response-related genetic markers in a group of healthy volunteers when compared to a control group. In a similar study, adults with cardiovascular disease also showed changes in their genetic markers when exposed to RMM.

However, to date no research has investigated the relationship between gene expression and pain in a medical population experiencing acute post-surgical pain. Given that people undergoing abdominal cancer surgery often experience severe pain, this population is well-suited for investigating the mechanisms by which MT influences acute pain.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Ohio
      • Cleveland、Ohio、美国、44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
        • 接触:
        • 首席研究员:
          • Samuel N Rodgers-Melnick, PhD, MPH

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 50 to 80
  • Able to speak and understand English
  • Scheduled to undergo a surgery meeting the following criteria: (1) traditional open surgery (not laparoscopic or robotic) via laparotomy (midline or subcostal incisions), (2) length of surgery >3 hours, and (3) curative-intent surgical resection of a cancer in the stomach, pancreas, bile ducts, liver, or peritoneal surfaces
  • Participant reports pain intensity of 4/10 or above to study staff on day 1 post-surgery or any other day post-surgery through discharge

Exclusion Criteria:

  • Significant visual impairment that has not been corrected
  • Significant hearing impairment that has not been corrected
  • Significant cognitive impairment that would prevent participant from participating in the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 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-assisted relaxation and imagery (MARI)
Participants will complete questionnaires to assess pain scores, participate in the MARI intervention, and undergo phlebotomy. Phlebotomy will occur prior to surgery (Day 0) as part of routine labs, post-surgery and pre- and post-MARI intervention (Day 1), and pre- and post-MARI intervention at a second timepoint determined by participant preference (up to Day 30).
Participants will provide their music and imagery preferences, which will be incorporated into the intervention. The intervention will consist of live guitar accompaniment personalized to participants' music preferences and a standardized script directing participants to release tension, take deep breaths, and explore a relaxing place. The MARI intervention will last about 30 minutes. The MARI intervention will be conducted on Day 1 (post-surgery) and a second timepoint determined by participant preference before the participant's hospital discharge (up to Day 30).
其他名称:
  • MARI

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
Proportion of participants whose phlebotomy was collected prior to surgery
大体时间:Within 2 weeks prior to surgery
The feasibility of collecting blood samples prior to surgery is measured by the proportion of participants whose phlebotomy was successfully collected.
Within 2 weeks prior to surgery
Proportion of participants whose phlebotomy was collected post-surgery (pre-MARI)
大体时间:Post-surgery and prior to MARI intervention (up to 30 days)
The feasibility of collecting blood samples post-surgery (and pre-MARI intervention) is measured by the proportion of participants whose phlebotomy was successfully collected.
Post-surgery and prior to MARI intervention (up to 30 days)
Proportion of participants whose phlebotomy was collected post-MARI
大体时间:Post-MARI intervention (up to 30 days)
The feasibility of collecting blood samples post-MARI is measured by the proportion of participants whose phlebotomy was successfully collected.
Post-MARI intervention (up to 30 days)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Samuel N Rodgers-Melnick, PhD, MPH、Case Comprehensive Cancer Center, University Hospitals

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年6月11日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年8月5日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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