清醒手部手术期间的音乐干预
清醒手部手术期间的音乐干预:一项随机对照试验
The purpose of this study is to examine if patients have a lower anxiety level during wide awake hand surgery while listening to their choice of music vs standardized relaxation music. Patients who are planning to undergo wide awake (local anesthetic only hand surgery) and agree to participate will be randomized to either a music intervention where they listen to their choice of music genre or standardized relaxation music during their time in the operating room. 170 participants will be enrolled and can expect to be on study for 2 weeks.
研究概览
详细说明
Music has been shown to decrease anxiety and pain during surgery. Wide awake local anesthesia no tourniquet (WALANT) surgery on the hand is gaining popularity due to efficiency, cost savings and patient safety.
Despite the popularity of WALANT, it still can be anxiety producing even for patients who choose to proceed with surgery without sedation. Music has been shown to decrease anxiety during surgery, but patients' music choices vary widely. The frequency (Hz) of the music intervention has been shown to impact pain reduction, and patient choice of music has been shown to increase sense of control which can decrease anxiety. No study has evaluated the intraoperative effect of patient choice of music vs standardized relaxation music on intraoperative anxiety.
The primary objective of this research is to compare the effect of patient music choice vs standardized relaxation music played during surgery on anxiety levels in patients undergoing WALANT hand surgery. The investigators hypothesize that standardized relaxation music will result in reduced anxiety compared to patient's choice of music.
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:Katie Schjei
- 电话号码:608-234-6719
- 邮箱:Schjei@ortho.wisc.edu
学习地点
-
-
Wisconsin
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Madison、Wisconsin、美国、53705
- 招聘中
- University of Wisconsin
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-
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:
- Adult (18 years of age or older) patients
- Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery
Exclusion Criteria:
- Patients under the age of 18
- Patients unable to consent for themselves
- Patients unwilling to consent
- Non-English speaking patients
- Patients with significant hearing impairment not able to be corrected with assistive devices
学习计划
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:标准化放松音乐
|
Participants listen to standardized relaxation music during surgery. |
|
有源比较器:个人音乐选择
|
Participants listen to their preferred music during surgery. |
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 Visual Analog Scale-Anxiety (VAS-A) Score
大体时间:day 0 post-operative, up to day 14
|
The VAS-A is scored from 0-10 where 0 is 'feeling calm' and 10 is 'extremely anxious'. |
day 0 post-operative, up to day 14
|
|
Change in State Trait Anxiety Inventory (STAI) Score
大体时间:day 0 post-operative, up to day 14
|
The STAI is a 20-item questionnaire (form Y-1) scored on a 4 point likert scale where 1 is 'not at all', 2 is 'somewhat', 3 is 'moderately so', and 4 is 'very much so' for a total possible range of scores from 20-80 where higher scores indicate increased anxiety. |
day 0 post-operative, up to day 14
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
参加者心率
大体时间:第 0 天,术前和术中
|
第 0 天,术前和术中
|
|
参与者收缩压
大体时间:第 0 天术前和术中
|
第 0 天术前和术中
|
|
参与者舒张压
大体时间:第 0 天术前和术中
|
第 0 天术前和术中
|
|
参与者呼吸频率
大体时间:第 0 天术前和术中
|
第 0 天术前和术中
|
合作者和调查者
调查人员
- 首席研究员:Lisa Kruse, MD、University of Wisconsin, Madison
出版物和有用的链接
一般刊物
- Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
- Palmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17.
- Feneberg AC, Kappert MB, Maidhof RM, Doering BK, Olbrich D, Nater UM. Efficacy, Treatment Characteristics, and Biopsychological Mechanisms of Music-Listening Interventions in Reducing Pain (MINTREP): Study Protocol of a Three-Armed Pilot Randomized Controlled Trial. Front Psychiatry. 2020 Nov 4;11:518316. doi: 10.3389/fpsyt.2020.518316. eCollection 2020.
- Mitchell LA, MacDonald RA. An experimental investigation of the effects of preferred and relaxing music listening on pain perception. J Music Ther. 2006 Winter;43(4):295-316. doi: 10.1093/jmt/43.4.295.
- Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
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
其他研究编号
- 2022-0674
- A536100 (其他标识符:UW Madison)
- Protocol Version 4/7/2023 (其他标识符:UW Madison)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Results will not be shared with patients or their primary care physicians. Study results will be shared via manuscript publication in a peer reviewed journal. Data will be pooled and deidentified. No individual results will be shared.
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