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Preoperative Sleep Quality and Postoperative Outcomes in Breast Surgery

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Summary

A prospective observational study (NCT07547774) registered on ClinicalTrials.gov is investigating whether preoperative sleep quality predicts postoperative inflammation, pain severity, and analgesic consumption in patients undergoing elective breast cancer surgery. The study will assess sleep quality using the Pittsburgh Sleep Quality Index (PSQI), inflammatory response via the Systemic Immune-Inflammation Index (SII), pain using the Visual Analog Scale (VAS), and analgesic consumption within the first 24 hours post-surgery. The study aims to determine whether poor sleep quality is associated with increased inflammatory response, higher pain scores, and greater analgesic requirement.

“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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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This ClinicalTrials.gov registration describes a prospective observational study (NCT07547774) evaluating whether preoperative sleep quality predicts postoperative outcomes in patients undergoing elective breast cancer surgery. The study will use the Pittsburgh Sleep Quality Index (PSQI) to assess baseline sleep quality, the Systemic Immune-Inflammation Index (SII) to measure inflammatory response, the Visual Analog Scale (VAS) for pain assessment, and will record analgesic consumption within 24 hours post-surgery. The study's stated aim is to determine whether poor sleep quality is associated with increased inflammatory response, higher pain scores, and greater analgesic requirement.

Healthcare providers and clinical investigators conducting perioperative research should note this study as a data point on the relationship between sleep quality and surgical outcomes. Patients undergoing elective breast cancer surgery may benefit from sleep quality screening as part of preoperative assessment protocols, though this study's findings remain pending publication and do not yet constitute clinical guidance.

Archived snapshot

Apr 23, 2026

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← ClinicalTrials.gov Studies

Preoperative Sleep Quality and Postoperative Outcomes in Breast Surgery

Observational NCT07547774 Kind: OBSERVATIONAL Apr 23, 2026

Abstract

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

Interventions: Preoperative Sleep Quality Assessment (PSQI)

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Last updated

Classification

Agency
NIH
Published
April 23rd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07547774

Who this affects

Applies to
Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical research Observational study
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Pharmaceuticals

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