Preoperative Sleep Quality and Postoperative Outcomes in Breast Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 i

Первичные конечные точки

• Postoperative Systemic Inflammatory Response (SII) [Срок оценки: At 24 hours postoperatively (± 6 hours)]

Вторичные конечные точки (3)

• Postoperative Pain Intensity (Visual Analog Scale, VAS) [Срок оценки: At 2, 6, 12, and 24 hours postoperatively.]
• Total Postoperative Analgesic Consumption [Срок оценки: Cumulative dose within the first 24 hours postoperatively]
• Change in Systemic Immune-Inflammation Index (ΔSII) [Срок оценки: From preoperative baseline to 24 hours postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesth — Ankara

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07547774 · 2026-04/76

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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