Translation and Validation of Chinese COMPAT-SF

NCT06917716 | Recruiting

• 1 other identifier: CHEC2025-050
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Keywords

Chronic Pancreatitis; Pain Assessment; Cross-Cultural Adaptation; Comprehensive Pain Assessment Tool Short Form

Outcome Measures

Primary Outcomes (4)

• Internal Consistency of COMPAT-SF-CV

  Internal consistency will be evaluated using Cronbach's alpha for each domain and the total score of the Chinese version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF-CV).

  Baseline

• Test-Retest Reliability of COMPAT-SF-CV

  Test-retest reliability will be assessed using intraclass correlation coefficient (ICC) between baseline and 2-week follow-up responses on COMPAT-SF-CV.

  Baseline and 2-week follow-up

• Construct Validity of COMPAT-SF-CV

  Construct validity will be examined through confirmatory factor analysis (CFA) to assess the underlying factor structure of COMPAT-SF-CV.

  Baseline

• Criterion Validity of COMPAT-SF-CV

  Criterion validity will be assessed by calculating correlations between COMPAT-SF-CV scores and established measures of pain severity, including the Brief Pain Inventory (BPI) and Izbicki pain score.

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.
• \. Experience of pancreatic pain in the past 12 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jia-Yun Chen, Master's

CONTACT

+86-18221058071; 18221058071@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 8, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)