Role of Preoperative Sleep Quality in Predicting Postoperative Inflammation, Pain Severity, and Analgesic Requirement After Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Postoperative Systemic Inflammatory Response (SII)
研究概览
简要总结
Sleep quality is a key physiological factor influencing immune function, inflammatory response, and pain perception. This prospective observational study aims to evaluate whether preoperative sleep quality predicts postoperative inflammation, pain severity, and analgesic consumption in patients undergoing elective breast cancer surgery.
Preoperative sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Systemic inflammatory response will be evaluated using the Systemic Immune-Inflammation Index (SII), calculated from routine hematological parameters. Postoperative pain will be assessed using the Visual Analog Scale (VAS), and analgesic consumption will be recorded within the first 24 hours.
The study aims to determine whether poor sleep quality is associated with increased inflammatory response, higher pain scores, and greater analgesic requirement.
详细描述
Sleep plays a crucial role in regulating immune responses, inflammatory pathways, and pain modulation. Sleep disturbances have been associated with increased pro-inflammatory cytokine activity and altered pain perception.
Surgical procedures represent a significant physiological stressor that triggers inflammatory responses and postoperative pain. Identifying modifiable preoperative factors that influence these outcomes is of clinical importance.
This prospective observational study will be conducted in patients undergoing elective breast cancer surgery. Preoperative sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Inflammatory response will be evaluated using the Systemic Immune-Inflammation Index (SII), calculated from neutrophil, lymphocyte, and platelet counts.
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), and total analgesic consumption within the first 24 hours will be recorded.
The study aims to determine whether preoperative sleep quality is an independent predictor of postoperative inflammatory response, pain severity, and analgesic requirement.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 70 years
- •Scheduled for elective breast cancer surgery
- •American Society of Anesthesiologists (ASA) physical status I to III
- •Able to understand and complete the Pittsburgh Sleep Quality Index (PSQI)
- •Willing to participate in the study
- •Provided written informed consent
排除标准
- •Active infection
- •History of chronic inflammatory disease or autoimmune disease
- •Use of steroids or immunosuppressive drugs within the past 6 months
- •Known diagnosis of obstructive sleep apnea syndrome
- •Severe cognitive impairment preventing completion of the questionnaire
- •Planned emergency surgery
- •Refusal to participate or failure to provide informed consent
研究组 & 干预措施
Good Sleep Quality (PSQI ≤ 5)
Patients with good preoperative sleep quality, defined as a Pittsburgh Sleep Quality Index (PSQI) score of 5 or less, will be included in this cohort. Sleep quality will be assessed during the preoperative period using the validated PSQI questionnaire. No intervention will be applied, and patients will receive standard perioperative care. Postoperative inflammatory response (SII), pain severity (VAS), and analgesic consumption will be recorded and compared with the poor sleep quality group.
干预措施: Preoperative Sleep Quality Assessment (PSQI) (Other)
Poor Sleep Quality (PSQI > 5)
Patients with poor preoperative sleep quality, defined as a Pittsburgh Sleep Quality Index (PSQI) score greater than 5, will be included in this cohort. Sleep quality will be assessed during the preoperative period using the validated PSQI questionnaire. No intervention will be applied, and patients will receive standard perioperative care. Postoperative inflammatory response (SII), pain severity (VAS), and analgesic consumption will be recorded and compared with the good sleep quality group.
干预措施: Preoperative Sleep Quality Assessment (PSQI) (Other)
结局指标
主要结局
Postoperative Systemic Inflammatory Response (SII)
时间窗: At 24 hours postoperatively (± 6 hours)
The primary outcome is the postoperative systemic inflammatory response, assessed using the Systemic Immune-Inflammation Index (SII). SII will be calculated using the formula: platelet count × (neutrophil count / lymphocyte count), derived from routine hematological parameters. Postoperative SII values will be compared between patients with good and poor preoperative sleep quality, as defined by the Pittsburgh Sleep Quality Index (PSQI). The analysis will evaluate whether preoperative sleep quality is associated with differences in postoperative inflammatory response.
次要结局
- Postoperative Pain Intensity (VAS)(At 2, 6, 12, and 24 hours postoperatively)
- Total Postoperative Analgesic Consumption(Cumulative dose within the first 24 hours postoperatively)
- Change in Systemic Immune-Inflammation Index (ΔSII)(From preoperative baseline to 24 hours postoperatively)
- Postoperative Pain Intensity (Visual Analog Scale, VAS)(At 2, 6, 12, and 24 hours postoperatively.)
研究者
Mustafa Kemal ŞAHİN
M.D
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital