Preoperative Sleep Quality and Postoperative Outcomes in Breast Surgery

NCT07547774 | Recruiting

• 1 other identifier: 2026-04/76
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Postoperative Pain; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative Pain Intensity (Visual Analog Scale, 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

Study Arms (2)

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)

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)

Interventions

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.

Also known as: Pittsburgh Sleep Quality Index (PSQI)

Good Sleep Quality (PSQI ≤ 5); Poor Sleep Quality (PSQI > 5)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 25061767 BACKGROUND

• 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.

  PMID: 31207606 BACKGROUND

• 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.

  PMID: 24290442 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Inflammation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mustafa Kemal Şahin

CONTACT

+905075800976; mksahin@msn.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)