Translation and validation of a pain assessment tool for chronic pancreatitis in Chinese patients
Translation and Validation of a Chinese Version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) in Patients With Chronic Pancreatitis
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 |
|---|---|
| Enrollment | 356 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06917716 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with chronic pancreatitis who have experienced pancreatic pain in the past 12 months.
Not a fit: Patients under 18 years of age or those without pancreatic-related pain will not benefit from this study.
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 performed: Other studies have successfully validated similar pain assessment tools in different cultural contexts, suggesting a positive outlook for this approach.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jia-Yun Chen, Master's
- Email: 18221058071@163.com
- Phone: +86-18221058071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.