NCT05002257已完成不适用
Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia
研究概览
简要总结
Our hypothesis is that listening to music has a beneficial effect on the French population receiving spinal anesthesia for a scheduled procedure. We think we can reduce anxiety when switching to SSPI, using creative music therapy software (Music Care) French validated by clinical research.
详细描述
We want to demonstrate that listening to music:
- decreases the anxiety of patients in PHC;
- improves their overall satisfaction unlike patients subjected to ambient noise from the SSPI. Demonstrate that there is a link between trait anxiety assessed preoperatively and state anxiety assessed immediate postoperative period to anticipate and improve patient care as soon as they arrive in SSPI. Extend music listening to all patients staying in a postoperative SSPI or for procedures performed in SSPI (bladder probing, central venous approach, post locoregional analgesia operative...) The Music Care software that we have chosen to use has been specifically developed to use the music as a therapeutic aid. Numerous abstracts and clinical studies have been published on the subject the use of this software in reducing anxiety, pain, behavioral and changes in hemodynamic parameters. It is based on the use of the so-called "U" method, which is a relaxation method based on hypno-analgesia, thus offering a complete relaxation session to patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •adult patients;
- •undergoing scheduled orthopedic surgery, under spinal anesthesia;
- •non-cancerous, functional;
- •in traditional or outpatient hospitalization;
- •requiring a passage in PACU;
- •agreeing to participate in the study (consent form).
排除标准
- •Children;
- •under tutorship or curatorship;
- •having known hearing problems (hearing loss or not, deafness) reported during the anesthesia consultation or detected during the collection of preoperative data; having cognitive disorders (dementia, disorientation) reported during the consultation of anesthesia, not allowing questions to be answered
- •Patients equipped with their personal music.
- •The following will be excluded when they arrive in SSPI:
- •Patients who received a benzodiazepine during the intraoperative period;
- •Patients whose spinal anesthesia has been converted to general anesthesia;
研究组 & 干预措施
Control arm
Active Comparator
干预措施: No music therapy (Other)
Experimental Arm
Experimental
干预措施: music therapy (Other)
结局指标
主要结局
anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia
时间窗: Day 0
Anxiety is assess by using Spielberg's STAI-Ya from 20 (no anxiety) to 80 (anxiety)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effect of Preoperative Music on AnxietyMusic on Postoperative AnxietyNCT03816501Ankara Diskapi Training and Research Hospital117
已完成
不适用
The Effects of Music on Perioperative Outcomes in Cataract SurgeryMusic Improving Outcomes in Cataract SurgeryStress LevelsCataract SurgeryNCT03873454National University Hospital, Singapore139
Unknown
不适用
Effects of Music on Post-operative Pain and AnxietyPostoperative PainClosed Fracture of Shaft of FemurPostoperative AnxietyNCT04175574Universiti Putra Malaysia108
已完成
不适用
Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive SurgeryPreoperative AnxietyNCT03651310Loyola University70
进行中（未招募）
不适用
Perioperative Music Listening on Anxiety, Analgesia Use and Patient SatisfactionMusicAnalgesiaAnxietyPatient SatisfactionPainNCT03226028KK Women's and Children's Hospital100