Evaluation of Music Therapy for Pre-op/Intra-op During Hernia Surgery to Decrease the Need for Narcotics
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Total narcotic administered
研究概览
简要总结
The purpose of this study is to investigate if audible distraction, in the form of music, before and/or during hernia repair surgery will decrease pain post-operatively.
详细描述
After performing a thorough review of the literature, no studies were found that examined whether having a patient listen to a genre of music of their choosing before or during surgery impacts their postoperative pain. Music is a way to relax patients and could potentially decrease pain, which is a goal of perioperative services. The current study seeks to fill the gap and examine the impact of music on pain for surgical patients undergoing a hernia repair.
This study will use a randomized, double-blinded, controlled design with four arms:
- Arm 1: Patient will listen to music before their surgery in pre-operative area only
- Arm 2: Patient will listen to music before and during their surgery
- Arm 3: Patient will listen to music during their surgery only
- Arm 4: Patient will not listen to music during their visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Preoperative music will be unmasked. Intraoperative music will be masked - Only research nurse will know if music was turned on or off intraoperatively.
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
- •Aged 18 years or older
- •Receiving surgery at Bethesda Surgery Center
排除标准
- •Does not speak English
- •Unable to consent to involvement in the research study
- •Having more than 1 hernia repair performed
- •Wears hearing aids
- •Currently on medication-assisted treatment for substance use disorder (ex: suboxone or methadone)
研究组 & 干预措施
PreOp Only
Patient will listen to music before their surgery in pre-operative area only
干预措施: Music (Other)
PreOp and IntraOp
Patient will listen to music before and during their surgery
干预措施: Music (Other)
IntraOp Only
Patient will listen to music during their surgery only
干预措施: Music (Other)
No Music
Patient will not listen to music during their visit
结局指标
主要结局
Total narcotic administered
时间窗: from admission to discharge from PACU, up to 8 hours
Total morphine milligram equivalent (MME) of narcotics administered while in PACU
Highest pain score reported
时间窗: from admission to discharge from PACU, up to 8 hours
Highest pain score reported in the Post Anesthesia Care Unit (PACU); Pain is measured on a 0-10 scale where a higher number corresponds with more pain
次要结局
未报告次要终点