An observational study in Breast Cancer, Postoperative Pain and Inflammation, sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 150 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
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The study population will include female patients aged 18-70 years undergoing elective breast cancer surgery at a tertiary oncology center. Eligible procedures include breast-conserving surgery, lumpectomy, and mastectomy with or without axillary dissection. Preoperative sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). All patients will receive standard perioperative care without any intervention. This observational cohort represents real-world clinical practice and allows evaluation of the association between preoperative sleep quality and postoperative outcomes.
Exclusion Criteria:
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.
Other: Preoperative Sleep Quality Assessment (PSQI)
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.
Other: Preoperative Sleep Quality Assessment (PSQI)
Preoperative sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-reported questionnaire evaluating sleep quality over the previous month. Based on PSQI scores, patients will be categorized into two cohorts: good sleep quality (PSQI ≤ 5) and poor sleep quality (PSQI \> 5). No intervention or modification to standard clinical care will be applied. All perioperative management will be conducted according to routine institutional protocols. This study is purely observational, and the PSQI assessment is used solely for grouping and analytical purposes.
Also known as: Pittsburgh Sleep Quality Index (PSQI)
Postoperative Systemic Inflammatory Response (SII)
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.
Time frame: At 24 hours postoperatively (± 6 hours)
Postoperative Pain Intensity (Visual Analog Scale, VAS)
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS; 0-10 cm), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be compared between patients with good and poor preoperative sleep quality.
Time frame: At 2, 6, 12, and 24 hours postoperatively.
Total Postoperative Analgesic Consumption
Total analgesic consumption, including opioid and non-opioid medications, will be recorded and compared between groups.
Time frame: Cumulative dose within the first 24 hours postoperatively
Change in Systemic Immune-Inflammation Index (ΔSII)
The change in SII will be calculated as the difference between preoperative and postoperative values and compared between groups.
Time frame: From preoperative baseline to 24 hours postoperatively
Plan to share: No — Individual participant data (IPD) will not be shared. The study involves sensitive clinical data collected from patients in a single-center setting, and data sharing is restricted in order to protect patient confidentiality and comply with institutional and ethical regulations. De-identified and aggregated data may be available from the corresponding author upon reasonable request, subject to approval by the institutional ethics committee.
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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital