Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention After Laparoscopic Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Change in anxiety as assessed by Spielberg STAI Questionnaire
研究概览
简要总结
A randomized comparison clinical trial will be conducted in laparoscopic radical prostatectomy patients in the Weinberg PACU at the Johns Hopkins Hospital. 50 patients will be recruited and randomly assigned by a table of random numbers to either the music listening group (n=35) or the relaxation breathing group (n=35).
详细描述
Hypothesis:
Laparoscopic radical prostatectomy patients who experience music listening will report decreased anxiety scores and improved pain control scores compared with patients listening to relaxation and breathing.
Null Hypothesis:
There will be no difference in reported anxiety scores and pain control scores between laparoscopic radical prostatectomy patients listening to music versus listening to relaxation and breathing instructions.
Music listening participants who meet inclusion criteria will be consented in the PreOp Unit and asked to complete the Spielberg State Trait Anxiety Inventory (STAI) questionnaire. Patient vital signs will be taken and patient will be invited to listen to music study iPod for 15 minutes prior to changing into a hospital gown.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
PI will be working collaboratively with primary nurse. Both PI and primary nurse will maintain nursing personal protective equipment (PPE) standard of care required for the PreOp and PACU units. Prep and PACU nurses will be blinded to type of intervention
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All adult male patients schedule to have a laparoscopic radical prostatectomy surgery who are ages 45 to 80 years of age
- •All ethnic backgrounds
- •All religions
排除标准
- •All patients who do not speak or understand the English language to the extent that it precludes their ability to provide informed consent for the study
研究组 & 干预措施
Preferred music listening
Patients will be randomized to listen to music with iPod that has preferred music selections that patients can choose.
干预措施: Preferred music listening (Behavioral)
Hypnotic music with relaxation breathing
Patients will be randomized to listen to hypnotic music with relaxation breathing narrative.
干预措施: Relaxation breathing narrative over hypnotic music listening (Behavioral)
结局指标
主要结局
Change in anxiety as assessed by Spielberg STAI Questionnaire
时间窗: Baseline and at recovery from PACU, up to 120 minutes
The Spielberg STAI Questionnaire has a score range of 20-80, with higher scores indicating greater anxiety.
Change in pain score
时间窗: Baseline and at recovery from PACU, up to 120 minutes
Pain will be assessed on a 0-10 scale with higher scores signifying more pain.
次要结局
未报告次要终点