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临床试验/NCT03091335
NCT03091335已完成不适用

The Effects of Music Listening on Intra-operative Anxiety in Patients Undergoing Awake Deep Brain Stimulation for Movement Disorders.

Darlene A. Lobel, MD2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Cortisol Response

研究概览

简要总结

This study aims to demonstrate that music listening in patients undergoing awake deep brain stimulation reduces subjective and objective measures of anxiety. Furthermore, the investigators aim to demonstrate that music may alter neuronal firing patterns based on the type of music played and the location in the brain.

详细描述

While conscious neurosurgical interventions are generally well-tolerated, they often cause some measure of pain and anxiety. Patients have been reported to suffer from recurring distressing recollections of, or dreams about, the surgery and other post-operative, Post-Traumatic Stress Disorder-like sequelae. High anxiety during surgery correlates with post-operative psychological disturbances. Notably, listening to music reduces anxiety in patients undergoing awake surgical procedures. Nonetheless, DBS is typically performed without music because ambient noise typically interferes with interpretation of neuronal recordings. Recording objective and subjective measures of stress during DBS provides a unique opportunity to determine the effect of music on intra-operative patient anxiety levels in patients listening to music compared to non-music listening control patients. The investigators hypothesize that playing music will improve intra-operative anxiety as measured by objective and subjective measures of stress, including blood pressure, heart rate, cortisol levels and anxiety questionnaires. Additionally, previous data in the investigator's lab has demonstrated that the subthalamic nucleus (STN) responds to melodic music by decreasing the average frequency of neuronal firing. The investigator's pilot study also suggests that STN and thalamic neurons respond differently to melodic music; the neurons in the STN increase synchrony of firing, while neurons in the thalamus decrease synchrony of firing over the course of the music clip. The investigators, therefore, aim to characterize the neuronal firing pattern changes in patients undergoing awake DBS procedures in greater detail, drawing from a larger sample size.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be unaware of their randomization group until all pre-operative measures have been acquired.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • STN or VIM targeted DBS surgery, awake DBS surgery

排除标准

  • No previous DBS surgeries, no history of deafness

研究组 & 干预措施

Music-listening group

Experimental

Patients in this group will listen to music of their choosing during the entirety of the awake portion of deep brain stimulation surgery

干预措施: Music-listening (Other)

Head-phone only group

No Intervention

Patients in this group will receive the same noise-canceling headphones as the patients in the music-listening group. However, they will remain without music per standard of care for awake deep brain stimulation procedures

结局指标

主要结局

Cortisol Response

时间窗: one year

Ratio of intra-operative salivary cortisol to pre-operative salivary cortisol in music-listening vs headphones only patients

次要结局

  • Medication Requirements(one year)
  • Blood Pressure(one year)
  • Post-operative Recall Questionnaire(one year)

研究者

发起方
Darlene A. Lobel, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Darlene A. Lobel, MD

Principal Investigator

The Cleveland Clinic

研究点 (2)

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