A Combination Mindfulness and Music Intervention for Acute Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Change in Pain Unpleasantness Numeric Rating Scale
研究概览
简要总结
This project is a single-site, four-arm, randomized controlled trial evaluating a combination mindfulness + music intervention on acute pain among patients in an orthopedic clinic waiting room. Participants will be randomized to one of four conditions: 1) a 5-minute mindfulness recording, 2) a 5-minute mindfulness recording with an accompanying sustained tone at 65.41 Hertz, 3) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear, or 4) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear as well as instrumental, theta wave music.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Being 18 years of age or older
- •Receiving pain treatment at Tallahassee Orthopedic Center
- •Understanding English instructions fluently
排除标准
- •Unable to consent because of physical or mental incapacity.
研究组 & 干预措施
Mindfulness Recording with Binaural Beats and Theta Music
干预措施: Mindfulness Recording with Binaural Beats and Theta Music (Behavioral)
Mindfulness Pain Management
干预措施: Mindfulness Pain Management (Behavioral)
Mindfulness Recording With Sustained Tone
干预措施: Mindfulness Recording With Sustained Tone (Behavioral)
Mindfulness Recording with Binaural Beats
干预措施: Mindfulness Recording with Binaural Beats (Behavioral)
结局指标
主要结局
Change in Pain Unpleasantness Numeric Rating Scale
时间窗: Immediately before and after 5-minute audio recording
Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.
次要结局
- Change in Pain Intensity Numeric Rating Scale(Immediately before and after 5-minute audio recording)
- Change in Anxiety Numeric Rating Scale(Immediately before and after 5-minute audio recording)
研究者
Adam Hanley
Principal Investigator
Florida State University