Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain
NCT ID: NCT06871891
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1138 participants
OBSERVATIONAL
2025-03-30
2025-06-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SLEEP-CPSP Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Scheduled for elective video-assisted thoracic surgery (VATS).
3. Scheduled for elective modified radical mastectomy (MRM).
4. Scheduled for elective coronary artery bypass grafting (CABG).
5. American Society of Anesthesiologists (ASA) physical status classification I-III.
6. Willing to sign the informed consent form, participate in the study, and complete all follow-up assessments.
Exclusion Criteria
2. Chronic use of opioids or sedatives (defined as use for 3 months or longer).
3. Expected completion time of surgery after 16:00 on the day of operation.
4. Planned transfer to the intensive care unit (ICU) postoperatively.
5. Anticipated hospital stay \<24 hours.
6. Contraindications to wearable device use (e.g., infection at the wrist site, allergy to the wristband material).
18 Years
80 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
UNKNOWN
Peking Union Medical College Hospital
OTHER
Responsible Party
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Lu Che
Attending Anesthesiologist
Locations
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Department of Anesthesiology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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K7648
Identifier Type: -
Identifier Source: org_study_id
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