Translation and validation of a pain assessment tool for chronic pancreatitis in Chinese patients
Official title: Translation and Validation of a Chinese Version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) in Patients With Chronic Pancreatitis
Run by Changhai Hospital · NCT06917716 · Data updated 2026-11-12
This study is testing a new Chinese pain assessment tool for people with chronic pancreatitis to see if it accurately measures their pain.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 356 (estimated) |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | March 10, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 8, 2025 |
| Trial ID | NCT06917716 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults diagnosed with chronic pancreatitis who have experienced pancreatic pain in the past 12 months.
✕Probably not a fit
Patients under 18 years of age or those without pancreatic-related pain will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This 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. A total of 356 participants diagnosed with chronic pancreatitis will be recruited from Changhai Hospital and Peking Union Medical College Hospital. Participants will complete the Chinese COMPAT-SF questionnaire twice, with a two-week gap, alongside additional pain assessments to evaluate the tool's reliability and validity. The study will employ rigorous psychometric analysis to ensure the tool is effective for measuring pain in this population.
Why it matters
Potential benefit: If successful, this study could provide a reliable pain assessment tool for doctors in China to better evaluate and manage pain in patients with chronic pancreatitis.
How similar studies have gone: Other studies have successfully validated similar pain assessment tools in different cultural contexts, suggesting a positive outlook for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Changhai Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Jia-Yun Chen, Master's
- Email: 18221058071@163.com
- Phone: +86-18221058071
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.