NCT01409044终止3 期
The Effect of Music Listening on the Amount of Opioids Used in Surgical Intensive Care Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Opiate use
研究概览
简要总结
Background:
- Studies have shown that listening to music can decrease pain and anxiety. Following surgery, patients in intensive care units (ICUs) often need drugs to treat their pain and anxiety. But these drugs can cause side effects such as low blood pressure and confusion. If listening to music can help lower pain and anxiety levels, less medication might be needed and these side effects could be avoided.
Objectives:
- To determine the effects of music on patient pain and anxiety in the first few days after surgery.
Eligibility:
- Individuals at least 18 years of age who are scheduled to have surgery that requires a 24-48-hour stay in intensive care afterward.
Design:
- All participants will be screened with a medical history before having surgery.
- Participants will be divided into two groups: one group will listen to music after surgery, and the other will not.
- Before surgery, participants will answer questions about their pain and anxiety levels. They will also be shown how to control the device that lets them administer their own pain medication after surgery.
- Following surgery, all participants will be transferred to the ICU and will answer the same questions about pain and anxiety levels.
- The music group will listen to a specially created CD of instrumental music for about 50 minutes, four times a day. The standard group will not listen to this music. All other treatments will be the same in both groups. Both groups will continue to answer the same questions about pain and anxiety levels.
- Participants will have a final 15- to 20-minute interview after leaving the ICU. They will answer questions about the ICU stay and (for those in the music listening group) the music.
详细描述
Background:
- Listening to music is a common human activity. Music listening has been associated with decreased pain scores, increase in attentiveness and decrease in anxiety scores. Recently, with interest in holistic and complementary and alternative therapies, there has been increased awareness of the potential positive health effects of music listening.
- Inadequate pain management remains common especially in postoperative patients. Acute perioperative pain affects over 46 million Americans every year.
- As music is processed by the limbic system, enkephalins and endorphins are released. These substances are natural occurring opioids, suggesting music may decrease patient s requirements for opioids.
Primary Objective:
To determine the effects of music listening on the amount of opioids delivered postoperatively to adult ICU patients via patient-controlled analgesia (PCA) during the first 48 hours.
Secondary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Music
Experimental
Research participant listened to music
干预措施: Music (Other)
结局指标
主要结局
Opiate use
时间窗: 48 hours in the ICU
次要结局
- Pain, anxiety and distress outcome measures(48 hours in the ICU)
研究者
研究点 (2)
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