NCT06917716 Translation and Validation of Chinese COMPAT-SF
| NCT ID | NCT06917716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changhai Hospital |
| Condition | Chronic Pancreatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 356 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 356 participants in total. It began in 2025-03-10 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06917716 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06917716 currently recruiting?
Yes, NCT06917716 is actively recruiting participants. Contact the research team at 18221058071@163.com for enrollment information.
Where is the NCT06917716 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06917716 clinical trial?
NCT06917716 is sponsored by Changhai Hospital. The trial plans to enroll 356 participants.