Preoperative Sleep Quality and Postoperative Outcomes in Breast Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorDr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Preoperative Sleep Quality Assessment (PSQI)
Other interventionPreoperative 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Good Sleep Quality (PSQI ≤ 5)1 intervention
Group B: Poor Sleep Quality (PSQI > 5)1 intervention
Trial outcomes
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.
Time frame
At 24 hours postoperatively (± 6 hours)Secondary outcomes
1
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.
Time frame
At 2, 6, 12, and 24 hours postoperatively.2
Total Postoperative Analgesic Consumption
Total analgesic consumption, including opioid and non-opioid medications, will be recorded and compared between groups.
Time frame
Cumulative dose within the first 24 hours postoperatively3
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.
Time frame
From preoperative baseline to 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov