Clinical Trial

Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain

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Record status
This record was last updated March 12, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this prospective observational cohort study is to assess the impact of perioperative sleep quality on the development of chronic post-surgical pain (CPSP) in adult patients (aged 18-80 years, ASA I-III) undergoing elective video-assisted thoracic surgery (VATS), modified radical mastectomy (MRM), or coronary artery bypass grafting (CABG). The main questions it aims to answer are: Does poor perioperative sleep quality increase the risk of CPSP at 3 months post-surgery? How do subjective and objective sleep parameters (e.g., total sleep duration, deep sleep time) correlate with CPSP and recovery outcomes? Researchers will compare patients with varying perioperative sleep quality levels (assessed via the Richards-Campbell Sleep Questionnaire \[RCSQ\] and wearable device data) to evaluate differences in CPSP incidence, pain and quality of life. Participants will: Wear a Huawei wearable device to collect objective sleep data (e.g., sleep duration, deep sleep time) during hospitalization. Complete questionnaires preoperatively and postoperatively, including RCSQ, Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Brief Pain Inventory (BPI). Undergo follow-up assessments at 1, 3, and 6 months post-surgery to evaluate pain scores , CPSP status, and quality of life (SF-36).
Trial Details
NCT Number NCT06871891
Lead Sponsor Peking Union Medical College Hospital
Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital, National Cancer Center, China
Conditions Chronic Post-Surgical Pain
Enrollment 1,138 participants
Start Date 2025-03-30
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-12