The Effect of Sleep Quality Before Breast Surgery on Postoperative Pain

NCT07892924 | Completed

• 1 other identifier: E-48670771-514.99-279156331
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the relationship between preoperative sleep quality and postoperative pain in patients undergoing mastectomy or breast-conserving surgery under general anesthesia. This prospective observational study included 146 patients aged 18-70 years with American Society of Anesthesiologists (ASA) physical status I-II. Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Postoperative pain was evaluated using the Numeric Rating Scale (NRS), including assessments during the early postoperative period and at the three-month follow-up. The study aimed to determine whether poor sleep quality before surgery was associated with greater postoperative pain. No additional medical interventions were performed as part of the research, and all patients received routine clinical care.

Conditions

Postoperative Pain; Preoperative Sleep Quality

Keywords

Pittsburgh Sleep Quality Index; Breast Surgery; Mastectomy; Breast-Conserving Surgery; Numeric Rating Scale; Postoperative Pain; Sleep Quality; Chronic Postsurgical Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS)

  Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores were recorded at 1, 6, 12, and 24 hours, as well as 3 weeks and 3 months after surgery. NRS scores were compared between patients with good and poor preoperative sleep quality, classified according to the Pittsburgh Sleep Quality Index (PSQI).

  1, 6, 12, and 24 hours; 3 weeks; and 3 months postoperatively

Secondary Outcomes (4)

• Pain Catastrophizing Assessed by the Pain Catastrophizing Scale (PCS)

  Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery

• Anxiety Assessed by the Hospital Anxiety and Depression Scale (HADS-A)

  Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery

• Depression Assessed by the Hospital Anxiety and Depression Scale (HADS-D)

  Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery

• Mental Health-Related Quality of Life Assessed by SF-12 Mental Component Summary (MCS)

  Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery

Study Arms (1)

Breast Surgery Patients

This cohort included 146 patients aged 18-70 years with ASA physical status I-II who underwent mastectomy or breast-conserving surgery under general anesthesia. Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Patients were subsequently classified into good sleep quality (PSQI ≤ 5) and poor sleep quality (PSQI \> 5) groups for comparative analysis of postoperative pain outcomes. No study-specific therapeutic intervention was administered.

Other: Sleep Quality and Postoperative Pain Assessment

Interventions

Sleep Quality and Postoperative Pain Assessment OTHER

Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Patients were classified as having good sleep quality (PSQI ≤ 5) or poor sleep quality (PSQI \> 5). Postoperative pain intensity was evaluated using the Numeric Rating Scale (NRS) at predefined postoperative time points, including a three-month follow-up. No experimental therapeutic intervention was administered, and all perioperative care followed routine clinical practice.

Breast Surgery Patients

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 consisted of female patients aged 18-70 years with ASA physical status I-II who underwent mastectomy or breast-conserving surgery under general anesthesia at Prof. Dr. Cemil Taşcıoğlu City Hospital in Istanbul, Türkiye. Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Patients were subsequently classified into good and poor sleep quality groups based on their PSQI scores. Postoperative pain intensity, anxiety, depression, pain catastrophizing, and mental health-related quality of life were evaluated at predefined postoperative time points.

You may qualify if:

• Female patients aged 18-70 years
• American Society of Anesthesiologists (ASA) physical status I-II
• Patients scheduled to undergo mastectomy or breast-conserving surgery under general anesthesia.
• Modified Aldrete score greater than 8 in the postoperative recovery period.

You may not qualify if:

• History of alcohol and/or substance abuse.
• Diagnosis of obstructive sleep apnea.
• History of pre-existing sleep disorders or use of additional sleep medications.
• Dementia or mild cognitive impairment.
• History of drug abuse, hepat renal dysfunction, psychosis, or neuropathy.
• Severe hearing impairment or inability to understand or complete the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
• Communication barriers preventing adequate interaction with the anesthesiologist

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr Cemil Tascıoglu City Hospital

Istanbul, Istanbul, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ayşegül Bilen, MD

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: June 23, 2025
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)