Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain

NCT ID: NCT06871891

Last Updated: 2025-03-12

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-30

Study Completion Date

2025-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Post-Surgical Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SLEEP-CPSP Cohort

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

UNKNOWN

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lu Che

Attending Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Lu Che

Role: CONTACT

+8615901045120

Facility Contacts

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Lu Che

Role: primary

15901045120

Other Identifiers

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K7648

Identifier Type: -

Identifier Source: org_study_id

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