Clinical trial NCT06871891: Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain
Official title: Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Post-Surgical Pain
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
First posted: 2025-03-12
Enrollment: 1138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from Peking Union Medical College Hospital, Fuwai Hospital, and Cancer Hospital to reflect diverse clinical practices.

Brief 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).


Eligibility criteria: Inclusion Criteria:

1. Aged 18-80 years.
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:

1. History of surgery within the past 3 months.
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).

Primary outcomes:
measure: chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI)
timeFrame: at 3 months after surgery
measure: Subjective sleep assessment: Richards - Campbell Sleep Questionnaire (RCSQ)
timeFrame: 1 day before surgery and 1st, 2nd, and 3rd days after surgery.
Secondary outcomes:
measure: Pain assessment: Numerical rating scale (NRS)
timeFrame: 1st, 2nd, 3rd days after surgery and at 1 months after surgery
measure: chronic post-surgical pain (CPSP) : Brief Pain Inventory (BPI)
timeFrame: at 6 months after surgery
measure: Quality of life assessment: Short Form-36 Health Survey Questionnaire (SF-36)
timeFrame: 1, 3, 6 months after surgery
measure: Quality of recovery assessment: Quality of Recovery-15 (QoR-15) assessment scale
timeFrame: 1st and 3rd days after surgery
measure: Subjective sleep assessment: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1, 3, and 6 months after surgery.
Other outcomes:
measure: Objective sleep assessment: Total sleep duration, wake - up time during sleep, and deep sleep time.
timeFrame: Preoperative day 1 (the night before surgery), the night of surgery (postoperative day 0), and postoperative days 1, 2, and 3
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology, Peking Union Medical College Hospital
state: Beijing
Study officials:
References: