Preoperative Sleep Quality and Postoperative Outcomes in Breast Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Breast Cancer; Postoperative Pain
• Intervention / Treatment: Other: Preoperative Sleep Quality Assessment (PSQI)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Mustafa Kemal Şahin; Phone Number: +905075800976; Email: mksahin@msn.com

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06200
      • Recruiting
      • Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
      • Contact: Mustafa Kemal SAHIN, Dr; Phone Number: +905075800976; Email: mksahin@msn.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: Pittsburgh Sleep Quality Index (PSQI)
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.	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.; Other Names: Pittsburgh Sleep Quality Index (PSQI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 24 hours postoperatively (± 6 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Postoperative Analgesic Consumption	Total analgesic consumption, including opioid and non-opioid medications, will be recorded and compared between groups.	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.	From preoperative baseline to 24 hours postoperatively
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.	At 2, 6, 12, and 24 hours postoperatively.

Collaborators and Investigators

• Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Publications and helpful links

General Publications

• Finan PH, Goodin BR, Smith MT. The association of sleep and pain: an update and a path forward. J Pain. 2013 Dec;14(12):1539-52. doi: 10.1016/j.jpain.2013.08.007.
• Irwin MR. Why sleep is important for health: a psychoneuroimmunology perspective. Annu Rev Psychol. 2015 Jan 3;66:143-72. doi: 10.1146/annurev-psych-010213-115205. Epub 2014 Jul 21.
• Haack M, Simpson N, Sethna N, Kaur S, Mullington J. Sleep deficiency and chronic pain: potential underlying mechanisms and clinical implications. Neuropsychopharmacology. 2020 Jan;45(1):205-216. doi: 10.1038/s41386-019-0439-z. Epub 2019 Jun 17.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pain, Postoperative; Breast Neoplasms; Inflammation
• Other Study ID Numbers: 2026-04/76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No