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NCT Number: NCT07547774

Preoperative Sleep Quality and Postoperative Outcomes in Breast Surgery

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Inflammation Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mustafa Kemal SAHIN, Dr

CONTACT

[email protected]

+905075800976

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Preoperative Sleep Quality Assessment (PSQI)

Other

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.

Other names: Pittsburgh Sleep Quality Index (PSQI)

Primary outcomes

  1. Postoperative Systemic Inflammatory Response (SII)

    Time frame: 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.

Secondary outcomes

  1. Postoperative Pain Intensity (Visual Analog Scale, VAS)

    Time frame: At 2, 6, 12, and 24 hours postoperatively.

    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.

  2. Total Postoperative Analgesic Consumption

    Time frame: Cumulative dose within the first 24 hours postoperatively

    Total analgesic consumption, including opioid and non-opioid medications, will be recorded and compared between groups.

  3. Change in Systemic Immune-Inflammation Index (ΔSII)

    Time frame: From preoperative baseline to 24 hours postoperatively

    The change in SII will be calculated as the difference between preoperative and postoperative values and compared between groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Mustafa Kemal Şahin

CONTACT

[email protected]

+905075800976

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

Role of Preoperative Sleep Quality in Predicting Postoperative Inflammation, Pain Severity, and Analgesic Requirement After Breast Cancer Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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