Effects of Biofeedback-based Music Program Using a Smart Device Application on Perioperative Sleep Quality in Patients Undergoing Breast Cancer Surgery: an Open-labeled Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- The Richards-Campbell Sleep Questionnaire on the day of the surgery
研究概览
简要总结
The purpose of this study is to investigate whether the effects of biofeedback-based music programs using a smart device application can improve perioperative sleep quality in patients undergoing breast cancer surgery.
详细描述
In a biofeedback-based music group, the patient performs an active respiratory intervention session, which induces a slow breathing pattern. If breathing has been slow enough, the automatic mode is activated to provide music based on the patient's own breathing pattern. The investigators will provide biofeedback-based music, which incorporates the patient's respiratory information, while no intervention will be performed in the control group.
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
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective breast cancer surgery
排除标准
- •Patients' refusal
- •Day surgery or urgent surgery
- •Neurocognitive impairment, hearing disorder (ex : (dementia, impaired cognitive dysfunction, cerebral infarction, transient cerebral ischemic attack))
- •Patients with psychiatric diseases, psychological drug intake
- •Pre-existing conditions associated with sleep disorders or drug intake related to sleep
结局指标
主要结局
The Richards-Campbell Sleep Questionnaire on the day of the surgery
时间窗: The daytime after the surgery (POD1)
sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome
次要结局
- Quality of recovery score 15 (QoR 15)(after the surgery (POD1; Postoperative 24 hours))
- Pittsburgh Sleep Quality Index(on the day before the surgery)
- Hospital Anxiety and Depression scale(on the day before the surgery)
- Postoperative Pain(after the surgery (POD1; Postoperative 24 hours))
- Time to fall asleep (minutes)(The daytime after the surgery (POD1))
- Sleep disturbance(The daytime after the surgery (POD1))
- The Richards-Campbell Sleep Questionnaire on the day before the surgery(on the day of the surgery before surgery)
- The incidence of postoperative nausea and vomiting(after the surgery (POD1; Postoperative 24 hours))
- Total sleep time (hours)(The daytime after the surgery (POD1))
- The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern)(on the day before the surgery)
- Analgesics requirement(after the surgery (POD1; Postoperative 24 hours))
- Sleep quality (0-100)(The daytime after the surgery (POD1))
- The reasons of sleep disturbance(The daytime after the surgery (POD1))
- Postoperative opioid consumption(after the surgery (POD1; Postoperative 24 hours))
研究者
Hojin Lee, MD
Professor
Seoul National University Hospital