Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,138
- 试验地点
- 1
- 主要终点
- chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI)
研究概览
简要总结
The goal of this prospective observational cohort study is to assess the impact of perioperative sleep quality on the development of chronic post-surgical pain (CPSP) in adult patients (aged 18-80 years, ASA I-III) undergoing elective video-assisted thoracic surgery (VATS), modified radical mastectomy (MRM), or coronary artery bypass grafting (CABG). The main questions it aims to answer are:
Does poor perioperative sleep quality increase the risk of CPSP at 3 months post-surgery? How do subjective and objective sleep parameters (e.g., total sleep duration, deep sleep time) correlate with CPSP and recovery outcomes? Researchers will compare patients with varying perioperative sleep quality levels (assessed via the Richards-Campbell Sleep Questionnaire [RCSQ] and wearable device data) to evaluate differences in CPSP incidence, pain and quality of life.
Participants will:
Wear a Huawei wearable device to collect objective sleep data (e.g., sleep duration, deep sleep time) during hospitalization.
Complete questionnaires preoperatively and postoperatively, including RCSQ, Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Brief Pain Inventory (BPI).
Undergo follow-up assessments at 1, 3, and 6 months post-surgery to evaluate pain scores , CPSP status, and quality of life (SF-36).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years.
- •Scheduled for elective video-assisted thoracic surgery (VATS).
- •Scheduled for elective modified radical mastectomy (MRM).
- •Scheduled for elective coronary artery bypass grafting (CABG).
- •American Society of Anesthesiologists (ASA) physical status classification I-III.
- •Willing to sign the informed consent form, participate in the study, and complete all follow-up assessments.
排除标准
- •History of surgery within the past 3 months.
- •Chronic use of opioids or sedatives (defined as use for 3 months or longer).
- •Expected completion time of surgery after 16:00 on the day of operation.
- •Planned transfer to the intensive care unit (ICU) postoperatively.
- •Anticipated hospital stay <24 hours.
- •Contraindications to wearable device use (e.g., infection at the wrist site, allergy to the wristband material).
结局指标
主要结局
chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI)
时间窗: at 3 months after surgery
The Brief Pain Inventory (BPI) is a widely used pain assessment tool for evaluating pain intensity and impact, suitable for chronic pain patients. It measures current, least, worst and average pain in the past 24 hours on a 0 - 10 scale (0=no pain, 10=extreme pain), and assesses pain's effect on 7 daily life aspects, scored 0 - 10 (0=no interference, 10=total interference). If a participant's BPI evaluation shows a pain condition and also meets these five criteria: (1) Pain arises or intensifies following surgery; (2) Pain persists for at least three months and impacts quality of life; (3)Pain occurs after a pain-free interval or evolves from ongoing acute postoperative pain; (4) Pain is localized to the surgical site or radiates to areas corresponding to the relevant nerve distribution; and (5) Other potential causes of pain are excluded.
Subjective sleep assessment: Richards - Campbell Sleep Questionnaire (RCSQ)
时间窗: 1 day before surgery and 1st, 2nd, and 3rd days after surgery.
The Richards-Campbell Sleep Questionnaire (RCSQ) is a prominent tool in sleep research and clinical practice for gauging sleep quality. It comprehensively evaluates sleep aspects from respondents' subjective views. Comprising multiple items, it covers sleep onset latency (time to fall asleep), sleep depth, sleep duration, and wake-up frequency at night. It may also involve related factors like sleep environment quality and sleep's impact on daily life. With specific questions and response options, individuals rate sleep experiences numerically or descriptively. Data from the RCSQ aids in diagnosing sleep disorders, evaluating treatment efficacy, and conducting sleep-related epidemiological studies. It is mainly intended for the assessment of short-term sleep conditions during hospitalization.
次要结局
- Pain assessment: Numerical rating scale (NRS)(1st, 2nd, 3rd days after surgery and at 1 months after surgery)
- chronic post-surgical pain (CPSP) : Brief Pain Inventory (BPI)(at 6 months after surgery)
- Quality of life assessment: Short Form-36 Health Survey Questionnaire (SF-36)(1, 3, 6 months after surgery)
- Quality of recovery assessment: Quality of Recovery-15 (QoR-15) assessment scale(1st and 3rd days after surgery)
- Subjective sleep assessment: Pittsburgh Sleep Quality Index (PSQI)(1, 3, and 6 months after surgery.)
研究者
Lu Che
Attending Anesthesiologist
Peking Union Medical College Hospital