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临床试验/NCT07051434
NCT07051434尚未招募不适用

Sleep During Recovery: Does Preoperative Regional Block Affect Postoperative Sleep Quality in Mastectomy Patients? A Prospective Evaluation Using Two Validated Sleep Quality Scales

Istinye University0 个研究点目标入组 66 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
主要终点
Postoperative Sleep Quality Measured by RCSQ

研究概览

简要总结

This prospective observational study investigates the impact of preoperative regional anesthesia on postoperative sleep quality in patients undergoing mastectomy. Sleep quality will be assessed using two validated tools: the Richards-Campbell Sleep Questionnaire (RCSQ) for all participants, and the Pittsburgh Sleep Quality Index (PSQI) in a subgroup. The study also examines the relationship between sleep quality and postoperative pain, patient satisfaction, and psychological status measured by the Hospital Anxiety and Depression Scale (HADS). Patients will be grouped based on anesthesia technique-general anesthesia alone or general anesthesia combined with regional block-and sleep outcomes will be compared. The study aims to provide evidence on how anesthetic technique and psychological factors affect recovery and sleep quality after breast cancer surgery.

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

入选标准

  • Female patients aged 18 years or older
  • Undergoing elective mastectomy surgery
  • ASA physical status I to III
  • Willing and able to provide written informed consent
  • Expected to remain hospitalized for at least 24 hours postoperatively

排除标准

  • History of major psychiatric or neurological disorders
  • Regular use of antidepressants, anxiolytics, or hypnotics
  • Difficult airway management during anesthesia (e.g., intubation or ventilation complications)
  • Reoperation within the first 24 hours after surgery
  • Inability to complete questionnaires due to deep sedation or visual/auditory impairment

结局指标

主要结局

Postoperative Sleep Quality Measured by RCSQ

时间窗: Postoperative Day 1 (the morning after surgery)

Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) on the first morning after surgery. The total score ranges from 0 (poor sleep) to 100 (excellent sleep). Comparison will be made between patients receiving general anesthesia alone and those receiving general anesthesia combined with regional block.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İlke Dolgun

Assoc. prof

Haseki Training and Research Hospital

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