Clinical Trials Directory

Trials / Completed

CompletedNCT07036549

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

Impact of Preoperative Sleep Quality and Anxiety on Postoperative Outcomes in Abdominal Gynecologic Cancer Surgery: A Prospective Observational Study

Status
Completed
Phase
Study type
Observational
Enrollment
72 (actual)
Sponsor
Izmir City Hospital · Other Government
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2025-02-15
Primary completion
2025-03-20
Completion
2025-05-15
First posted
2025-06-25
Last updated
2025-06-25

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07036549. Inclusion in this directory is not an endorsement.