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The Effects of Perioperative Music Therapy on Women Undergoing Breast Biopsy Surgery

2015年8月21日 更新者:Case Comprehensive Cancer Center

The purpose of this research is to study the effect music has on women undergoing surgical breast biopsy. Through the facilitation of live and/or recorded music listening, we will examine the perception of patient anxiety, the total amount of propofol required to obtain a BIS reading of 70, and recovery time in the PACU. We will also collect data and evaluate the effect of live and/or recorded music on patient satisfaction. It is hypothesized that:

  1. Patients in the live and recorded music groups will experience less anxiety than the non-music (standard care) group.
  2. Patients in the live and recorded music groups will experience a reduction in the amount of anesthesia needed to reach a state of moderate sedation compared to the non-music (standard care) group.

研究概览

详细说明

Music therapy's effect on anxiety in Preoperative.(live vs. recorded):

If the patient is randomly selected to the live music group, the music therapist will prepare a preferred song to be performed live in the preoperative room. If the patient is randomly selected for the recorded music group, she will be given an iPod and headphones and will listen to a recorded version of her preferred song. If the patient is randomly selected for the control group, she will receive standard care and no music. Pre/posttests will be given using a Global Anxiety Visual Analog Scale (GA-VAS).

Music therapy's effect on propofol requirements intraoperatively:

Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively. All subjects will receive equal amounts of fentanyl and versed. Subjects will receive fentanyl in the amount of 1 microgram per kilogram and versed (midazolam) in the amount of 0.02 milligrams per kilogram from the nurse anesthetist. An ipod with headphones will be given to the subject when she is being prepared to move to the operating room. The board certified music therapist will initiate recorded music (harp selections). Recorded music will be relaxing harp selections. The board certified music therapist will accompany the subject to the operating room and assure volume levels and electronic equipment function properly.

Anesthesia personnel will apply BIS monitor before propofol administration. Anesthesia personnel will titrate propofol to obtain BIS reading of 70 or lower and record the propofol in micrograms per kilogram per minute, infusing at that point. Signal Quality Index (SQI) will be recorded when the BIS reaches 70 to give credibility to the BIS monitor. SQI is a measure of the signal quality for the EEG channel source and is calculated based on impedance data, artifact, and other variables. The total amount of propofol for the case will be recorded as total milligrams received. Anesthesia personnel will record Observer's Assessment of the Alertness/Sedation (OAA/S) when BIS monitor reaches 70 or below as incidental data point. A score of 3 on OAA/S indicates that the patient responds only after mild prodding and shaking. OAA/S will be compared to BIS reading.

Time in PACU and Patient Satisfaction:

Recorded music will continue playing until the subject has met discharge criteria according to University Hospital's policy and procedure. The amount of time between when the patient leaves the operating room and meets discharge criteria (determined by nurse) will be recorded. Patient satisfaction will be recorded using a Likert scale: 7= highly satisfied; 1=not at all satisfied after the subject has met her discharge criteria.

Controls: The control group subjects will receive standard anesthesia, nursing and surgical care. All rating procedures will be the same. Controls will wear noise reducing headphones. The music therapist will not accompany control patients following surgery. When the trial is complete, the music therapist will offer the control subject a CD of the recorded music once she has met discharge criteria and all data is recorded. This will occur for the sake of ethics.

研究类型

介入性

注册 (实际的)

201

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。

学习地点

    • Ohio
      • Cleveland、Ohio、美国、44118
        • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

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

19年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Subjects who will undergo surgical breast biopsy under monitored anesthesia care
  • English speaking women
  • >18 years
  • ASA classification of I (no systematic disease) or II (mild to moderate disease who are medically stable) or III (severe systematic disease, not incapacitating)

Exclusion Criteria:

  • Patients with profound mental illness
  • with developmental disability
  • with significant hearing loss where music would not be heard from headphones
  • currently taking narcotics

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:随机化
  • 介入模型:并行分配
  • 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:Live/Recorded Music Group
The music therapist will prepare a preferred song to be performed live in the preoperative room. Subjects in the live music group will listen to recorded music intraoperatively.
Recorded or live music will be played prior to surgery in the preoperative room. Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively. An ipod with headphones will be given to the subject when she is being prepared to move to the operating room. The board certified music therapist will initiate recorded music (harp selections). Recorded music will be relaxing harp selections. The board certified music therapist will accompany the subject to the operating room and assure volume levels and electronic equipment function properly.
其他名称:
  • Recorded Music
  • Live Music
实验性的:Recorded Music Group
Recorded music group will be given an iPod and headphones and will listen to a recorded version of a preferred song.
Recorded or live music will be played prior to surgery in the preoperative room. Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively. An ipod with headphones will be given to the subject when she is being prepared to move to the operating room. The board certified music therapist will initiate recorded music (harp selections). Recorded music will be relaxing harp selections. The board certified music therapist will accompany the subject to the operating room and assure volume levels and electronic equipment function properly.
其他名称:
  • Recorded Music
  • Live Music
有源比较器:No Music (Standard of care)
The control group will receive standard of care and no music.
The control group subjects will receive standard anesthesia, nursing and surgical care.

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
The cumulative intra-operative dose of propofol(mg) given to each patient
大体时间:at the time of surgery
The primary outcome for this study will be the amount of propofol administered intra-operatively. Each of the groups receiving music pre-operatively and/or peri-operatively will be compared to the control (no music) group. Anesthesia personnel will apply BIS (Bispectral Index Monitor) monitor before propofol administration. Anesthesia personnel will titrate propofol to obtain BIS reading of 70 or lower and record the propofol in micrograms per kilogram per minute, infusing at that point. The total amount of propofol for the case will be recorded as total milligrams received.
at the time of surgery
Change in anxiety levels
大体时间:Pr- and post- music therapy prior to surgery
Pre/posttests will be given using a Global Anxiety Visual Analog Scale (GA-VAS). A pretest will be given in the preoperative area before intervention and a posttest will be given after the live song, the recorded song, or five minutes of standard care has occurred. The investigators will measure the subject's marking (vertical line) on the GA-VAS from the left side of the GA-VAS to the subject's line using millimeters on a ruler.
Pr- and post- music therapy prior to surgery

次要结果测量

结果测量
措施说明
大体时间
Amount of time in the PACU (post-anesthesia care unit)
大体时间:at time of discharge from PACU
Amount of time between when the patient leaves the operating room and meets discharge criteria (determined by nurse) using a clock.
at time of discharge from PACU
Patient satisfaction to music therapy
大体时间:at the time of PACU discharge
Qualitative data will be taken on the subject's subjective comments regarding their thoughts about their surgical experience using a 1-10 Likert Scale.
at the time of PACU discharge

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:Deforia Lane, PhD、Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

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

2012年8月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2012年8月16日

首先提交符合 QC 标准的

2012年8月17日

首次发布 (估计)

2012年8月21日

研究记录更新

最后更新发布 (估计)

2015年8月24日

上次提交的符合 QC 标准的更新

2015年8月21日

最后验证

2015年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • CASE5112

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