Clinical trial NCT06917716: Translation and Validation of Chinese COMPAT-SF
Official title: Translation and Validation of a Chinese Version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) in Patients With Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pancreatitis
Keywords: Chronic Pancreatitis
Pain Assessment
Cross-Cultural Adaptation
Comprehensive Pain Assessment Tool Short Form
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit individuals diagnosed with chronic pancreatitis (CP) experiencing pancreatic pain from Changhai Hospital and Peking Union Medical College Hospital. Eligible participants are those who meet the diagnostic criteria outlined in the Guidelines for the Diagnosis and Treatment of Chronic Pancreatitis in China (2018 edition) and have experienced pancreatic pain in the past 12 months. The study will be conducted between March 2025 and June 2026, enrolling participants during their hospital visits.

Brief summary: The goal of this observational study is to translate, adapt, and test the reliability of a Chinese version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) for people with chronic pancreatitis.

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.

Detailed description: This multicenter observational study aims to translate, culturally adapt, and validate the Chinese version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) for individuals with chronic pancreatitis (CP), ensuring it is a reliable and valid pain assessment tool in China.

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.

Eligibility criteria: Inclusion Criteria:

* 1. Diagnosed with chronic pancreatitis (CP) according to the Guidelines for the Diagnosis and Treatment of Chronic Pancreatitis in China (2018 edition). Diagnosis can be confirmed by: •Primary diagnostic criteria: (i) Definitive imaging findings, and (ii) Histopathological confirmation. •Secondary diagnostic criteria: (i) Recurrent upper abdominal pain, (ii) Abnormal serum amylase levels, (iii) Pancreatic exocrine insufficiency, (iv) Pancreatic endocrine insufficiency, (v) Pathogenic gene mutations, and (vi) History of heavy alcohol consumption. •Diagnosis is confirmed if at least one primary criterion or two secondary criteria are met.
* 2. Experience of pancreatic pain in the past 12 months

Exclusion Criteria:

* Under 18 years of age.
* No pancreatic-related pain.
* Diagnosed with pancreatic cancer or other tumors.
* Presence of communication or reading impairments.
* Refusal to participate in the study.

Primary outcomes:
measure: Internal Consistency of COMPAT-SF-CV
timeFrame: Baseline
measure: Test-Retest Reliability of COMPAT-SF-CV
timeFrame: Baseline and 2-week follow-up
measure: Construct Validity of COMPAT-SF-CV
timeFrame: Baseline
measure: Criterion Validity of COMPAT-SF-CV
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References: