Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Inflammation | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative Sleep Quality Assessment (PSQI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Good Sleep Quality (PSQI ≤ 5)
- description
- 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.
- interventionNames
- Other: Preoperative Sleep Quality Assessment (PSQI)
- label
- Poor Sleep Quality (PSQI > 5)
- description
- 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.
- interventionNames
- Other: Preoperative Sleep Quality Assessment (PSQI)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDIrwin 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
- BACKGROUNDHaack 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
- BACKGROUNDFinan 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