Chronic PancreatitisCOMPAT-SF-CVNCT06917716
Translation and Validation of Chinese COMPAT-SF
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 31 Dec 2026
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Guo-Xiu Ma, 86-18018598652, maguoxiu@126.com
About this study
Official title: Translation and Validation of a Chinese Version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) in Patients With Chronic Pancreatitis
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:
Read more
- 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.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Keywords
- Chronic Pancreatitis, Pain Assessment, Cross-Cultural Adaptation, Comprehensive Pain Assessment Tool Short Form
- Medical subject headings
- Pancreatitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start10 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 356 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917716
- Sponsor's protocol ID
- CHEC2025-050
- Acronym
- COMPAT-SF-CV
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of a Chinese Version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) in Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT06917716
- Acronym / sponsor ID
- COMPAT-SF-CV / CHEC2025-050
- Conditions
- Chronic Pancreatitis
- Keywords
- Chronic Pancreatitis, Pain Assessment, Cross-Cultural Adaptation, Comprehensive Pain Assessment Tool Short Form
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internal Consistency of COMPAT-SF-CV
Time frame: Baseline
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).
Test-Retest Reliability of COMPAT-SF-CV
Time frame: Baseline and 2-week follow-up
Test-retest reliability will be assessed using intraclass correlation coefficient (ICC) between baseline and 2-week follow-up responses on COMPAT-SF-CV.
Construct Validity of COMPAT-SF-CV
Time frame: Baseline
Construct validity will be examined through confirmatory factor analysis (CFA) to assess the underlying factor structure of COMPAT-SF-CV.
Criterion Validity of COMPAT-SF-CV
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia-Yun Chen, Master's (+86-18221058071, 18221058071@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency of COMPAT-SF-CV (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.