Chronic Post-Surgical PainNCT06871891
Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain
An observational study of Chronic Post-Surgical Pain, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Post-Surgical Pain
- How many people
- 1,138 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2025to 30 Jun 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from Peking Union Medical College Hospital, Fuwai Hospital, and Cancer Hospital to reflect diverse clinical practices.
Who may be able to join
- Aged 18-80 years.
- Scheduled for elective video-assisted thoracic surgery (VATS).
- Scheduled for elective modified radical mastectomy (MRM).
- Scheduled for elective coronary artery bypass grafting (CABG).
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Willing to sign the informed consent form, participate in the study, and complete all follow-up assessments.
Who cannot join
- History of surgery within the past 3 months.
- Chronic use of opioids or sedatives (defined as use for 3 months or longer).
- Expected completion time of surgery after 16:00 on the day of operation.
- Planned transfer to the intensive care unit (ICU) postoperatively.
- Anticipated hospital stay <24 hours.
- Contraindications to wearable device use (e.g., infection at the wrist site, allergy to the wristband material).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Anesthesiology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Lu Che, 15901045120, tracymaobao@126.com
About this study
Official title: Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain: a Prospective Cohort Study
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.
Read more
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).
- Conditions
- Chronic Post-Surgical Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLEEP-CPSP Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) is a widely used pain assessment tool for evaluating pain intensity and impact, suitable for chronic pain patients. It measures current, least, worst and average pain in the past 24 hours on a 0 - 10 scale (0=no pain, 10=extreme pain), and assesses pain's effect on 7 daily life aspects, scored 0 - 10 (0=no interference, 10=total interference). If a participant's BPI evaluation shows a pain condition and also meets these five criteria: (1) Pain arises or intensifies following surgery; (2) Pain persists for at least three months and impacts quality of life; (3)Pain occurs after a pain-free interval or evolves from ongoing acute postoperative pain; (4) Pain is localized to the surgical site or radiates to areas corresponding to the relevant nerve distribution; and (5) Other potential causes of pain are excluded.
Measured: at 3 months after surgery
Subjective sleep assessment: Richards - Campbell Sleep Questionnaire (RCSQ)
The Richards-Campbell Sleep Questionnaire (RCSQ) is a prominent tool in sleep research and clinical practice for gauging sleep quality. It comprehensively evaluates sleep aspects from respondents' subjective views. Comprising multiple items, it covers sleep onset latency (time to fall asleep), sleep depth, sleep duration, and wake-up frequency at night. It may also involve related factors like sleep environment quality and sleep's impact on daily life. With specific questions and response options, individuals rate sleep experiences numerically or descriptively. Data from the RCSQ aids in diagnosing sleep disorders, evaluating treatment efficacy, and conducting sleep-related epidemiological studies. It is mainly intended for the assessment of short-term sleep conditions during hospitalization.
Measured: 1 day before surgery and 1st, 2nd, and 3rd days after surgery.
Secondary outcomes (5)
Pain assessment: Numerical rating scale (NRS)
The Numerical Rating Scale (NRS) for pain is a commonly used tool in healthcare to gauge patients' pain intensity. It's a subjective measure where patients rate pain on a 0 - 10 scale. 0 means no pain; 10 is the worst imaginable pain. Scores 3 and below suggest mild pain with little impact, 4 - 6 moderate pain affecting daily life somewhat, and 7 and above severe pain needing prompt attention. It's practical for its simplicity. Medical staff can administer it quickly during consultations. Patients can easily understand and use it to convey pain feelings. This helps professionals evaluate pain severity, plan treatments, and monitor pain relief. Overall, the NRS is vital in pain assessment and management, enhancing medical care quality and patient comfort.
Measured: 1st, 2nd, 3rd days after surgery and at 1 months after surgery
chronic post-surgical pain (CPSP) : Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) is a widely used pain assessment tool for evaluating pain intensity and impact, suitable for chronic pain patients. It measures current, least, worst and average pain in the past 24 hours on a 0 - 10 scale (0=no pain, 10=extreme pain), and assesses pain's effect on 7 daily life aspects, scored 0 - 10 (0=no interference, 10=total interference). If a participant's BPI evaluation shows a pain condition and also meets these five criteria: (1) Pain arises or intensifies following surgery; (2) Pain persists for at least three months and impacts quality of life; (3)Pain occurs after a pain-free interval or evolves from ongoing acute postoperative pain; (4) Pain is localized to the surgical site or radiates to areas corresponding to the relevant nerve distribution; and (5) Other potential causes of pain are excluded.
Measured: at 6 months after surgery
Quality of life assessment: Short Form-36 Health Survey Questionnaire (SF-36)
Short Form-36 Health Survey Questionnaire (SF-36) The SF-36 is a widely recognized and commonly used instrument for assessing quality of life. It consists of 36 questions covering eight domains, such as physical functioning, role limitations due to physical problems, social functioning, and mental health.The scale provides a comprehensive view of an individual's quality of life, generating scores that help healthcare providers understand patients' well-being and make more informed decisions in diagnosis, treatment, and care, with good reliability and validity demonstrated in various studies.
Measured: 1, 3, 6 months after surgery
Quality of recovery assessment: Quality of Recovery-15 (QoR-15) assessment scale
The Quality of Recovery-15 (QoR-15) assessment scale is a professional tool for evaluating the recovery quality of patients post-surgery or after certain medical interventions. It is composed of 15 items, with each item scored from 0 to 10 points, and the total score ranges from 0 to 150 points. The higher the score, the better the quality of recovery. These 15 items cover five dimensions: physical comfort, emotional state, physical independence, psychological support, and pain. The QoR-15 scale is recognized for its high reliability and validity. It is easy to administer and score, which is of great significance in assessing patients' recovery status and guiding medical staff to formulate appropriate treatment and care plans.
Measured: 1st and 3rd days after surgery
Subjective sleep assessment: Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI), developed by Dr. Daniel J. Buysse and his colleagues at the University of Pittsburgh in 1989, contains 19 self-rated and 5 observer-rated questions grouped into 7 components including subjective sleep quality and sleep latency etc., with each component scored 0 - 3 and total score 0 - 21, where 5 or less means good sleep quality and 5 or more indicates poor sleep quality, and it's widely used in sleep medicine, psychology and clinical research to evaluate sleep problems, monitor treatment effects and conduct epidemiological investigations, being a reliable and valid tool for assessing sleep quality and crucial for understanding and managing sleep-related issues.
Measured: 1, 3, and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start30 Mar 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post-Surgical PainStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,138 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, National Cancer Center, China
- Responsible party
- Principal investigator, Lu Che, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871891
- Sponsor's protocol ID
- K7648
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ndividual participant data (including demographic, clinical, and sleep monitoring data) will not be made publicly available to protect participant privacy and comply with ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06871891
- Acronym / sponsor ID
- K7648
- Conditions
- Chronic Post-Surgical Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,138 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, National Cancer Center, China
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLEEP-CPSP Cohort | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from Peking Union Medical College Hospital, Fuwai Hospital, and Cancer Hospital to reflect diverse clinical practices.
Key inclusion criteria (6 listed)
- Aged 18-80 years.
- Scheduled for elective video-assisted thoracic surgery (VATS).
- Scheduled for elective modified radical mastectomy (MRM).
- Scheduled for elective coronary artery bypass grafting (CABG).
- American Society of Anesthesiologists (ASA) physical status classification I-III.
Key exclusion criteria (6 listed)
- History of surgery within the past 3 months.
- Chronic use of opioids or sedatives (defined as use for 3 months or longer).
- Expected completion time of surgery after 16:00 on the day of operation.
- Planned transfer to the intensive care unit (ICU) postoperatively.
- Anticipated hospital stay <24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI)
Time frame: at 3 months after surgery
The Brief Pain Inventory (BPI) is a widely used pain assessment tool for evaluating pain intensity and impact, suitable for chronic pain patients. It measures current, least, worst and average pain in the past 24 hours on a 0 - 10 scale (0=no pain, 10=extreme pain), and assesses pain's effect on 7 daily life aspects, scored 0 - 10 (0=no interference, 10=total interference). If a participant's BPI evaluation shows a pain condition and also meets these five criteria: (1) Pain arises or intensifies following surgery; (2) Pain persists for at least three months and impacts quality of life; (3)Pain occurs after a pain-free interval or evolves from ongoing acute postoperative pain; (4) Pain is localized to the surgical site or radiates to areas corresponding to the relevant nerve distribution; and (5) Other potential causes of pain are excluded.
Subjective sleep assessment: Richards - Campbell Sleep Questionnaire (RCSQ)
Time frame: 1 day before surgery and 1st, 2nd, and 3rd days after surgery.
The Richards-Campbell Sleep Questionnaire (RCSQ) is a prominent tool in sleep research and clinical practice for gauging sleep quality. It comprehensively evaluates sleep aspects from respondents' subjective views. Comprising multiple items, it covers sleep onset latency (time to fall asleep), sleep depth, sleep duration, and wake-up frequency at night. It may also involve related factors like sleep environment quality and sleep's impact on daily life. With specific questions and response options, individuals rate sleep experiences numerically or descriptively. Data from the RCSQ aids in diagnosing sleep disorders, evaluating treatment efficacy, and conducting sleep-related epidemiological studies. It is mainly intended for the assessment of short-term sleep conditions during hospitalization.
5 secondary outcomes
Pain assessment: Numerical rating scale (NRS)
Time frame: 1st, 2nd, 3rd days after surgery and at 1 months after surgery
chronic post-surgical pain (CPSP) : Brief Pain Inventory (BPI)
Time frame: at 6 months after surgery
Quality of life assessment: Short Form-36 Health Survey Questionnaire (SF-36)
Time frame: 1, 3, 6 months after surgery
Quality of recovery assessment: Quality of Recovery-15 (QoR-15) assessment scale
Time frame: 1st and 3rd days after surgery
Subjective sleep assessment: Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1, 3, and 6 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No. ndividual participant data (including demographic, clinical, and sleep monitoring data) will not be made publicly available to protect participant privacy and comply with ethical regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Post-Surgical Pain, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Che (+8615901045120, tracymaobao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic post-surgical pain (CPSP): Brief Pain Inventory (BPI) (time frame: at 3 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.