Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Change in total time of intubation
研究概览
简要总结
The purpose of this prospective pilot study is to determine if live music therapy reduces patients' perception of pain and anxiety, reduces benzodiazepine use and pain medication use, length of stay in the ICU, and length of stay in hospital, and improves sleep in post-lung transplant patients.
The purpose and objectives of the study are the following:
- To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived anxiety in post-lung transplant patients.
- To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived pain in post-lung transplant patients.
- To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's use of benzodiazepine medication for anxiety.
- To determine if music therapist delivered patient preferred live music and therapeutic intervention three times in post-lung transplant patients will reduce participant's use of pain medication.
- To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's total time of intubation, length of stay in ICU, and length of stay in the hospital.
- To determine if music therapist delivered patient preferred live music and therapeutic intervention will improve the quality and length of sleep in post-lung transplant patients.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All post-lung transplant patients at UTSW Clements University Hospital starting June 1, 2021
排除标准
- •Post-lung transplant patients with chests left open directly after OR (before being taken back to the OR and having their chests closed)
结局指标
主要结局
Change in total time of intubation
时间窗: Intubation prior to surgery until extubation (Post-surgery day 4)
Comparing duration of intubation between intervention group vs control group
Change in Anxiety levels
时间窗: Changes from baseline to post-surgery day 6
Comparing the scores from the Hamilton Anxiety Rating Scale (HAM-A) scale before and after music therapy. Scores range between 0-56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Change in Pain levels (CPOT)
时间窗: Changes from baseline to post-surgery day 6
Comparing the scores from the Critical Care Pain Observation Tool (CPOT) scale before and after music therapy. Scores ranges between 0 (no pain) to 8 (maximum pain).
Change in dosage of benzodiazepine medication
时间窗: Changes from baseline to post-surgery day 6
Comparing medication dosage between intervention group vs control group.
Change in dosage of pain medication
时间窗: Changes from baseline to post-surgery day 6
Comparing medication dosage between intervention group vs control group
Change in Pain levels (Pain number scale)
时间窗: Changes from baseline to post-surgery day 6
Comparing the scores from the Pain number scale before and after music therapy. Scores ranges between 0 (no pain) to 10 (maximum pain).
Change in length of sleep
时间窗: Changes from baseline to post-surgery day 6
Comparing Fitbit data on length of sleep between intervention group vs control group
Change in length of stay in ICU and in hospital
时间窗: Changes from baseline to post-surgery day 6
Comparing length of stay between intervention group vs control group
次要结局
未报告次要终点
研究者
Emily Pickett
Unit Based Educator for Clinical Care
University of Texas Southwestern Medical Center