Impact of Preoperative Sleep Quality and Anxiety on Postoperative Outcomes in Abdominal Gynecologic Cancer Surgery

NCT ID: NCT07036549

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2025-05-15

Brief Summary

This prospective observational study aims to evaluate the effects of preoperative sleep quality and anxiety levels on postoperative outcomes in patients undergoing abdominal gynecologic cancer surgery. A total of 72 patients were included and assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Beck Anxiety Inventory (BAI) prior to surgery. Postoperative outcomes including pain scores (measured by the Numeric Rating Scale), complication rates, additional analgesic use, and length of hospital stay were recorded. The findings suggest that poor sleep quality and high anxiety levels prior to surgery are significantly associated with higher postoperative pain, increased complication rates, and prolonged hospital stay. These results emphasize the importance of preoperative psychological evaluation and supportive interventions to improve perioperative care in gynecologic oncology.

Detailed Description

This prospective observational study was conducted between February and May 2025 at a tertiary gynecologic oncology center. The aim was to evaluate the association between preoperative sleep quality and anxiety levels with postoperative outcomes in patients undergoing open abdominal surgery for gynecologic cancer.

Eligible participants were women aged 18 years or older who were scheduled for elective laparotomy with general anesthesia. Patients with psychiatric disorders, major neurological conditions, or incomplete postoperative data were excluded.

Sleep quality was assessed preoperatively using the Pittsburgh Sleep Quality Index (PSQI), and anxiety was measured using the Beck Anxiety Inventory (BAI). Patients with a PSQI score ≥5 were classified as having poor sleep quality, and those with BAI scores ≥16 were classified as having high anxiety.

Postoperative pain was evaluated using the Numeric Rating Scale (NRS) at 0, 4, 8, 12, and 24 hours after surgery. Additional analgesic requirements, early postoperative complications (e.g., surgical site infection, ileus, nausea-vomiting, atelectasis), and length of hospital stay were recorded.

The study also examined potential psychosocial contributors such as mobile phone use during sleep, internet-based health information seeking, and patients' satisfaction with preoperative counseling using a structured Likert scale.

All data were collected via face-to-face interviews and hospital records. Statistical analyses included Mann-Whitney U test, chi-square test, and Spearman correlation coefficients. The study was approved by the Institutional Ethics Committee (Approval No: 2025/38), and all participants provided written informed consent.

Conditions

Gynecologic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgical Cohort

Patients undergoing abdominal gynecologic cancer surgery were prospectively observed for postoperative outcomes including pain, complications, analgesic requirement, and hospital stay. Preoperative sleep quality and anxiety levels were measured and analyzed in relation to clinical outcomes.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Female patients aged ≥18 years
• Diagnosed with gynecologic malignancy
• Scheduled for elective abdominal surgery (laparotomy)
• Able to provide informed consent
• Completed preoperative sleep and anxiety assessments

Exclusion Criteria

• History of psychiatric or cognitive disorders interfering with questionnaire participation
• Emergency surgical procedures
• Incomplete follow-up data within 30 days postoperatively
• Patients admitted for inpatient observation prior to surgery
• Major previous pelvic surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Izmir City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Celal Akdemir

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Celal Akdemir, md

Role: PRINCIPAL_INVESTIGATOR

Izmir City Hospital

Locations

İzmir City Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ISHSLANXPAIN

Identifier Type: -

Identifier Source: org_study_id