Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
450 participants
OBSERVATIONAL
2024-07-30
2025-05-01
Brief Summary
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Detailed Description
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Research has identified factors that influence CIT, including age, gender, body mass index (BMI), waist circumference, bowel preparation, and prior abdominal surgery history.
Personality traits have been found to be associated with the onset of many diseases, such as hypertension and A-type personality, depression, and neurotic personality. According to the Big Five personality theory, personality can be decomposed into five dimensions: openness (O), conscientiousness (C), extraversion (E), agreeableness (A), and neuroticism (N). The Big Five personality theory is a commonly used personality typology in scientific research and has been confirmed in numerous studies. The Big Five Personality Inventory (BFI) is a tool for detecting the classification of the Big Five personality traits. The Chinese version of the Big Five Personality Inventory and norms were jointly revised by Professor Li Jian from the Department of Psychology, Beijing Normal University, and the scale norms were constructed to include people of different age groups. The scale has shown excellent reliability and validity.
The discovery of the brain-gut axis suggests that neural activity can affect the intestinal activity in various ways directly or indirectly, thereby affecting the difficulty of colonoscopy, but there is still a lack of research on the relationship between personality types and difficult colonoscopy, and the specific correlation has not been clarified. What's more important is that previous studies often used ordinary least squares regression (OLS regression) or logistic regression The purpose of this study is to investigate whether personality, BMI, age, gender, anxiety and depression index, metabolic diseases, and history of abdominal and pelvic surgery are associated with prolonged colonoscopy insertion time and difficult colonoscopy, and to construct a clinical diagnostic model by using machine learning methods to predict colonoscopy insertion time and identify difficult colonoscopy patients based on significant variables.
The basic research framework is designed as follows:
Invite patients scheduled for colonoscopy to fill out the "Personality Tendency and Colonoscopy Survey Questionnaire" before colonoscopy.
Record the completion of colonoscopy and CIT for patients during colonoscopy and record the preparation of the colon and the presence of serious organic diseases.
Collect other patient information, including age, gender, and history of major diseases.
All patients included in the study should meet the inclusion criteria and not meet the exclusion criteria.
Organize the data and divide the patients into two groups based on whether their CIT time is greater than 10 minutes.
Use t-tests and chi-square analysis to determine whether each factor is related to difficult colonoscopy, with a significance threshold of P\<0.05.
Include significant variables in logistic regression for initial analysis and calculate OR.
Use LASSO regression for sparse selection and include non-zero features in the machine learning model construction.
Divide the data into training set and test set and construct random forest models, artificial neural network models, and support vector machine models, etc. Through receiver operating curve (ROC), precision, accuracy, recall rates, etc., the model's error can be evaluated, and the model's generalization ability can be compared.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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High neuroticism score group
The neuroticism score was higher than the average score identified by the norm
Fill in personality questionnaires
For patients who need to undergo colonoscopy, we invite them to fill out a personality survey questionnaire after obtaining their informed consent. The questionnaire contains 60 survey questions, which cover the five dimensions of the Big Five personality traits. Each question has five options, corresponding to the five states of very disagree to very agree. The questionnaire was developed based on the Chinese population and has four norms applicable to different age groups to ensure the reliability of the questionnaire.
Low neuroticism score group
The neuroticism score was lower than the average score identified by the norm
Fill in personality questionnaires
For patients who need to undergo colonoscopy, we invite them to fill out a personality survey questionnaire after obtaining their informed consent. The questionnaire contains 60 survey questions, which cover the five dimensions of the Big Five personality traits. Each question has five options, corresponding to the five states of very disagree to very agree. The questionnaire was developed based on the Chinese population and has four norms applicable to different age groups to ensure the reliability of the questionnaire.
Interventions
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Fill in personality questionnaires
For patients who need to undergo colonoscopy, we invite them to fill out a personality survey questionnaire after obtaining their informed consent. The questionnaire contains 60 survey questions, which cover the five dimensions of the Big Five personality traits. Each question has five options, corresponding to the five states of very disagree to very agree. The questionnaire was developed based on the Chinese population and has four norms applicable to different age groups to ensure the reliability of the questionnaire.
Eligibility Criteria
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Inclusion Criteria
* Insert the cecum complete colonoscopy examination (successfully)
* Agree and complete personality questionnaire and anxiety depression
Exclusion Criteria
* Has a history of colorectal resection of colorectal surgery
* Have organic diseases such as severe ulcerative colitis or intestinal tumors
* Inadequate bowel preparation (bowel with feces and less than 90% visible area of mucosa)
* Confirmed with the immune system (SLE), nervous system (Alzheimer's disease), mental system (such as schizophrenia, depression), urinary system disease (CKD), and other digestive system disease
* Unable or unwilling to sign informed consent
18 Years
60 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Feixue Chen
Role: primary
References
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Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
Center MM, Jemal A, Smith RA, Ward E. Worldwide variations in colorectal cancer. CA Cancer J Clin. 2009 Nov-Dec;59(6):366-78. doi: 10.3322/caac.20038.
Brenner H, Chang-Claude J, Rickert A, Seiler CM, Hoffmeister M. Risk of colorectal cancer after detection and removal of adenomas at colonoscopy: population-based case-control study. J Clin Oncol. 2012 Aug 20;30(24):2969-76. doi: 10.1200/JCO.2011.41.3377. Epub 2012 Jul 23.
Jaruvongvanich V, Sempokuya T, Laoveeravat P, Ungprasert P. Risk factors associated with longer cecal intubation time: a systematic review and meta-analysis. Int J Colorectal Dis. 2018 Apr;33(4):359-365. doi: 10.1007/s00384-018-3014-x. Epub 2018 Mar 9.
Terracciano A. The Italian version of the NEO PI-R: Conceptual and empirical support for the use of targeted rotation. Pers Individ Dif. 2003;35(8):1859-1872. doi: 10.1016/S0191-8869(03)00035-7.
Zhang B, Li YM, Li J, Luo J, Ye Y, Yin L, Chen Z, Soto CJ, John OP. The Big Five Inventory-2 in China: A Comprehensive Psychometric Evaluation in Four Diverse Samples. Assessment. 2022 Sep;29(6):1262-1284. doi: 10.1177/10731911211008245. Epub 2021 Apr 22.
Other Identifiers
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KYLL-202406-030
Identifier Type: -
Identifier Source: org_study_id