跳至主要内容
临床试验/NCT01834027
NCT01834027已完成不适用

The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Change in Heart Rate From Baseline on Arrival in PACU

研究概览

简要总结

The purpose of this study is to investigate the effects of music on patients after surgery in the Post Anesthesia Care Unit (PACU). For many patients, surgery creates significant emotional stress and anxiety which can include discomfort or pain. Music therapy has proven to be a useful adjuvant in various inpatient and outpatient settings by providing a relaxing effect that decreases heart rate, blood pressure, and hormonal measures of stress. It has been shown that classical music can cause physiological and psychological differences in patient outcomes, but few studies have looked specifically at effects of jazz music. Some have argued that jazz may be too involved to provide the same relaxed state as classical music, but this may be due in part to the type of jazz played for the patient. It is our hypothesis that slow jazz music by artists including Miles Davis, Ella Fitzgerald, Diana Krall, Dave Brubeck, etc. will reduce measures of stress and anxiety in patients in the PACU following surgery for hysterectomy (laparoscopic or robotic) to a greater extent than the control group. Jazz music or "no music" will be played through headphones to participants in the study post-surgically while they are in the PACU and measures of stress, anxiety, and pain will be monitored.

详细描述

  • Patients will be identified the morning of surgery from the operating room schedule.
  • The patients will be randomized to two groups: jazz music or no music.
  • Head phones will be applied to all patients included in the study; in one group jazz music will be provided through the headphones. The second group no music will be played.
  • Blood pressure will be monitored by a non-invasive blood pressure cuff at 5 minute intervals throughout the patient's stay in the PACU.
  • Heart rate will be measured, using a pulse oximeter, at the same intervals as blood pressure.
  • Before the patient leaves the PACU, she will be asked to rate her perception of her levels of pain and anxiety on scales that use a numeric scale of 1-10. The primary variable outcomes are: heart rate and mean blood pressure. Secondary outcomes include: perceived pain, anxiety, and level of relaxation.
  • headphones will be used to deliver one of the following sounds to the patients: 1) jazz music (BPM<100) by artists including Miles Davis, Ella Fitzgerald, Diana Krall, Dave Brubeck, etc.; or 2) no music providing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergoing elective hysterectomy (laparoscopic or robotic)
  • ASA 1 or 2
  • Normotensive
  • Normal heart rate

排除标准

  • Patient does not wish to participate in the study
  • Deaf or hearing impaired patients
  • Ear deformities or abnormalities
  • Pre-existing diagnosis of anxiety disorder, depression, substance abuse, or any other psychiatric diagnoses

结局指标

主要结局

Change in Heart Rate From Baseline on Arrival in PACU

时间窗: 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU

Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry

次要结局

  • Mean Blood Pressure(60 minutes)
  • Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU(Once, at 30 minutes after the patient entered the PACU)
  • Mean Difference in Patient's Perception of Pain From Baseline(10, 20 , and 30 minutes after baseline measurement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sonia Vaida

Professor of Anesthesiology

Penn State University

研究点 (2)

Loading locations...

相似试验