Music Interventions During Wide-Awake Hand Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change in State Trait Anxiety Inventory (STAI) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 支持治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Adult (18 years of age or older) patients
- Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery
排除标准
- 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
研究组 & 干预措施
Standardized Relaxation Music
干预措施: Standardized Relaxation Music (Other)
Personal Choice of Music
干预措施: Personal Choice of Music (Other)
结局指标
主要结局
Change in State Trait Anxiety Inventory (STAI) Score
时间窗: 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.
Change in Visual Analog Scale-Anxiety (VAS-A) Score
时间窗: 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'.
次要结局
- Participant Heart Rate(day 0, pre- and intraoperative)
- Participant Respiratory Rate(pre- and intraoperative on day 0)
- Participant Systolic Blood Pressure(pre- and intraoperative on day 0)
- Participant Diastolic Blood Pressure(pre- and intraoperative on day 0)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05472909
- 其他研究编号
- 2022-0674, Protocol Version 4/7/2023, A536100
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (9个月后)
- 研究完成日期
- (9个月后)
- 最近核实
- (12个月前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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.