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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RECRUITING
356 participants
OBSERVATIONAL
2025-03-10
2026-12-31
Brief Summary
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The study will answer these questions:
* Does the Chinese COMPAT-SF work well to measure pain in people with chronic pancreatitis?
* Is the Chinese COMPAT-SF accurate and reliable over time?
Participants will:
* Complete the Chinese COMPAT-SF questionnaire two times, with a 2-week gap.
* Answer additional pain-related questions using the Brief Pain Inventory (BPI) and the Izbicki Pain Score.
* Participate in a follow-up to check if the questionnaire gives consistent results over time.
This study will help make sure that doctors in China have a useful and reliable tool to measure pain in people with chronic pancreatitis.
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Detailed Description
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A total of 356 participants diagnosed with CP will be recruited from Changhai Hospital (Naval Medical University) and Peking Union Medical College Hospital. The study will follow a structured translation process, including forward translation, back translation, expert panel review, and cognitive debriefing to ensure cultural and linguistic appropriateness. Participants will complete the Chinese COMPAT-SF at baseline and again after two weeks to assess test-retest reliability, alongside additional pain assessments using the Brief Pain Inventory (BPI) and Izbicki Pain Score.
Psychometric analysis will evaluate internal consistency (Cronbach's α), test-retest reliability (intraclass correlation coefficient, ICC), construct validity (confirmatory factor analysis, CFA), and criterion validity (correlation with BPI and Izbicki Pain Score). Data will be securely recorded in an electronic database with quality control measures, including predefined range checks, consistency verification, and source data validation against medical records. Standard Operating Procedures (SOPs) will guide participant recruitment, data collection, and statistical analysis, with missing data handled using multiple imputation techniques.
Statistical analyses will include descriptive statistics, Cronbach's α for internal consistency, ICC for reliability, CFA for construct validity, and Pearson correlation to assess criterion validity. This study is expected to provide a scientifically validated, culturally adapted pain assessment tool for chronic pancreatitis, improving clinical evaluation and patient care.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 2\. Experience of pancreatic pain in the past 12 months
Exclusion Criteria
* No pancreatic-related pain.
* Diagnosed with pancreatic cancer or other tumors.
* Presence of communication or reading impairments.
* Refusal to participate in the study.
18 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Locations
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Changhai Hospital
Shanghai, Shanghai 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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CHEC2025-050
Identifier Type: -
Identifier Source: org_study_id
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