Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pre-procedure State-Trait Anxiety Inventory (STAI) Score
研究概览
简要总结
The purpose of this study is to evaluate, subjectively and objectively, whether playing music during procedures for treatment of chronic lower back pain has an effect on patients' anxiety and pain. The investigators hypothesize that playing music will result in reduced patient reported anxiety and pain scores and less variation from baseline of vital signs versus patients in the control group without music therapy. This is a pilot study.
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
- None
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
- •Age greater than or equal to 18
- •Female or male
- •Patients undergoing standard of care lumbar spinal interventional procedures including: epidural steroid injections, facet injections, medial branch blocks
排除标准
- •Patients who cannot consent for themselves, including cognitively impaired patients.
- •Non-English speaking patients
- •Patients taking beta blocker medication
- •Patients that have a pacer and have a set rate
- •Patients with self-reported hearing problems or with hearing aids
研究组 & 干预措施
Music Therapy
Music of the subject's preferred genre will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks).
干预措施: Music Therapy (Other)
No Music
No music will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks).
干预措施: No Music (Other)
结局指标
主要结局
Pre-procedure State-Trait Anxiety Inventory (STAI) Score
时间窗: Within 30 minutes prior to the subject's interventional procedure
A measure of anxiety in a person. Higher score correlates increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160.
Post-procedure State-Trait Anxiety Inventory (STAI) Score
时间窗: Within 30 minutes following to the subject's interventional procedure
A measure of anxiety in a person. Higher score correlates with increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160.
次要结局
- Pre-procedural Visual Analog Score (VAS) for pain(Within 30 minutes prior to the subject's interventional procedure)
- Post procedural Visual Analog Score (VAS)(Within 30 minutes following the subject's interventional procedure)
研究者
Bunty Shah
Assistant Professor of Anesthesiology & Perioperative Medicine
Milton S. Hershey Medical Center