The Use of Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction in Patients Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Change in Pain score
研究概览
简要总结
The use of music to relieve pain has been studied in many forms of medicines and has been proven to reduce anxiety, pain and analgesic use in the perioperative setting. However, music listening as an inexpensive and duplicable method has not been investigated and implemented in the local context. The investigators hereby propose a prospective study to recruit patients undergoing surgery to evaluate the effectiveness of music in pain relief and post-operative recovery; as well as the implementation and operational readiness of music listening.
详细描述
Some tissue injury is often unavoidable during surgery, which leads to unavoidable pain and anxiety during the perioperative and post-operative period. Acute post-operative pain and anxiety have been managed via pharmacological interventions. However, non-pharmacological interventions have also been shown to be safe and cost-effective, improve the overall patient experience, and improve outcomes across a variety of surgical settings.
Music has been shown to decrease perioperative pain and modulate the inflammatory response. Additionally, anxiety scores and pain scores have shown statistically significant reductions in the perioperative period, when music therapy was available. Currently only few studies investigate its effects during perioperative period especially in local setting. Thus, the investigators will investigate the feasibility and practicability of deploying music listening in KKH pain management and further determine the nature of the music (duration, genre) by fitting the local context in order to improve the patient outcome in perioperative settings.
Phase 1: A total of 300 patients will be offered to select from pre-determined lists of music of different genres or patient choice, before and after surgery. Hospital Anxiety and Depression Scale (HADS) score, pain scores, analgesia usage, patient satisfaction, and quality of life measurement will be collected. Analysis of the type of music, duration of music listening, and the genre chosen will be analysed.
Phase 2: A hundred and ten women undergoing Caesarean delivery at KK Women's and Children's Hospital (KKH) in 1:1 allocation ratio of experimental (music listening) and control (no music listening) groups. Pain and psychological assessments and demographic data collection will be conducted before surgery, and those allocated to experimental group will be asked to use music listening before, during and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy participants who are American Society of Anesthesiologists (ASA) 1 and 2 (with well-controlled medical problems);
- •Undergo day surgery, same-day-admission gynecologic surgery or cesarean section;
- •No hearing impairment.
排除标准
- •Patients with significant respiratory disease and obstructive sleep apnea;
- •Patients who are unable to read and understand the hospital anxiety questionnaire.
研究组 & 干预措施
Music listening
Phase 1: Before and after surgery, 300 patients will be offered an ipod with earphone, in which the ipod is equipped with saved playlist of different music genres to select from pre-determined lists of music of different genres or patient choice. Patient will choose the desired playlist and listen to the music for about 30 minutes. Hospital Anxiety and Depression Scale (HADS) score, pain scores, analgesia usage, patient satisfaction, and quality of life measurement will be collected. Analysis of the type of music, duration of music listening, and the genre chosen will be analysed.
Phase 2: One hundred and ten women undergoing Caesarean delivery assigned to experimental (music listening) group will listen to the music before, during and after surgery. Pain and psychological assessments and demographic data collection will be conducted before and after surgery.
干预措施: Music listening (Procedure)
No Music Listening
Phase 2: Patients assigned to this group (n=55) will only have pain, psychological assessments and demographic data collection conducted before and after surgery.
结局指标
主要结局
Change in Pain score
时间窗: Baseline and 1 day
Difference of Pain score before and after surgery. Pain scores (Numeric Rating Scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.
次要结局
- Change in Analgesia usage(Baseline and 1 day)
- Change in Patient's satisfaction with the use of music listening (only music listening group)(Baseline and 1 day)
- Change in Hospital Anxiety and Depression Scale (HADS) score (Phase 1 only)(Baseline and 1 day)
- Change in EQ-5D-3L score(Baseline and 1 day)
- Change in Visual analog scale - anxiety (VAS-A) score(Baseline and 1 day)
研究者
Sng Ban Leong
Principal Investigator
KK Women's and Children's Hospital