An observational study in Postoperative Pain and Preoperative Sleep Quality, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Observational
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.
This prospective observational study was conducted at the University of Health Sciences, Prof. Dr. Cemil Tascioglu City Hospital, Department of Anesthesiology and Reanimation, following approval by the Clinical Research Ethics Committee on June 17, 2025.
The study included 146 patients aged 18-70 years, classified as ASA physical status I-II, who underwent mastectomy or breast-conserving surgery under general anesthesia.
Eligible patients were informed about the study during the preoperative period, and written informed consent was obtained before participation.
Preoperative sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS), with measurements during the early postoperative period and follow-up assessments extending to three months after surgery.
The primary objective was to investigate the association between preoperative sleep quality and postoperative pain intensity. The study also aimed to evaluate the potential clinical importance of identifying patients with poor preoperative sleep quality.
No study-specific therapeutic interventions were administered. All anesthetic, surgical, and postoperative management procedures were performed according to routine clinical practice
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 146 is above the median of 100 across 622 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 86 studies on the registry; 17 are open to participants now.
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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.
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Exclusion Criteria:
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
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.
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).
Time frame: 1, 6, 12, and 24 hours; 3 weeks; and 3 months postoperatively
Pain Catastrophizing Assessed by the Pain Catastrophizing Scale (PCS)
Pain catastrophizing was assessed using the Pain Catastrophizing Scale (PCS), a 13-item questionnaire with a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing. Assessments were performed within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery. PCS scores were compared between patients with good and poor preoperative sleep quality.
Time frame: 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)
Anxiety symptoms were assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale consists of 7 items, with scores ranging from 0 to 21. Higher scores indicate greater anxiety symptoms. Assessments were performed within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery. Scores were compared between patients with good and poor preoperative sleep quality.
Time frame: 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)
Depressive symptoms were assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale consists of 7 items, with total scores ranging from 0 to 21. Higher scores indicate greater depressive symptoms. Assessments were performed within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery. HADS-D scores were compared between patients with good and poor preoperative sleep quality, classified according to the Pittsburgh Sleep Quality Index (PSQI).
Time frame: 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)
Mental health-related quality of life was assessed using the Mental Component Summary (MCS) score of the 12-item Short Form Health Survey (SF-12). Higher MCS scores indicate better mental health-related quality of life. Assessments were performed within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery. SF-12 MCS scores were compared between patients with good and poor preoperative sleep quality, classified according to the Pittsburgh Sleep Quality Index (PSQI).
Time frame: Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery
Plan to share: No — Individual participant data will not be publicly shared due to patient confidentiality and data privacy considerations. Study findings will be reported in an aggregated and anonymized format.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization