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临床试验/NCT07036549
NCT07036549已完成不适用

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

Izmir City Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Postoperative Pain Score (Numeric Rating Scale)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Postoperative Pain Score (Numeric Rating Scale)

时间窗: Postoperative Day 1 (within 24 hours after surgery)

Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 0, 4, 8, 12, and 24 hours after surgery. Higher scores indicate greater pain intensity.

次要结局

  • Postoperative Complication Rate(Up to 30 days after surgery)
  • Additional Analgesic Requirement(Postoperative Day 1 (within 24 hours after surgery))
  • Length of Hospital Stay(From day of surgery until discharge (mean: 4.2 days))

研究者

发起方
Izmir City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Celal Akdemir

MD

Izmir City Hospital

研究点 (1)

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