The Correlation Between the Difficulty of Colonoscopy and the Patient's Personality

Colonoscopy Clinical Trial

Official title:

The Correlation Between the Difficulty of Colonoscopy and the Patient's Personality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584423
• Other study ID #: 2022-DCPP
• Status: Recruiting
• Start date: August 15, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Peking Union Medical College Hospital
• Contact: SHENGYU ZHANG
• Phone: 18501155701
• Email: pumchzsy[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to explore the correlation between the difficulty of colonoscopy and the patients' personality in the population receiving initial colonoscopy in Peking Union Medical College Hospital. The main question it aims to answer is: Whether the difficulty of colonoscopy is related to any personality score of big five personality dimensions Participants will: 1. Receive routine colonoscopy 2. Fill out the GAD-7 and PHQ-9 scales 3. Fill out the Big Five Personality Questionnaire.

Description:

Colonoscopy as an invasive test may cause pain, discomfort and anxiety to the patient . Insertion time and patient pain scores are indicators of the degree of colonoscopy difficulty, with the incidence of difficult colonoscopy being approximately 25% . It is usually defined as a difficult colonoscopy when the insertion time is more than 10 minutes. Several studies have shown that certain risk factors can help us predict the occurrence of difficult colonoscopy, such as gender, age, BMI, bowel preparation, and history of abdominal or pelvic surgery . In addition to the objective factors mentioned above, the patient's personality, mood and psychological state may also have an impact on the difficulty of colonoscopy. In clinical practice, endoscopists have observed that patients with anxiety-prone or obsessive personalities tend to have a higher incidence of difficult colonoscopies, but few studies have explored the predictive role of patient personality on the degree of difficulty in colonoscopy. In addition, because personality stability may be influenced by anxiety and depression levels as well as specific strong situations, the patient's recent anxiety and depression levels should also be taken into account. We therefore used the Generalized Anxiety Scale (GAD-7) and the 9-item Patient Health Questionnaire Depression Scale (PHQ-9) to assess patients' recent levels of anxiety and depression, respectively. The Big Five is currently recognized as the most comprehensive model of personality analysis and has been widely used in clinical and scientific research. The Big Five includes extraversion、extraversion、conscientiousness、neuroticism、openness. This study intends to use the Chinese version of the Big Five Personality Questionnaire to test the scores of patients in the five personality dimensions, in order to observe whether the difficulty of colonoscopy is related to the scores of any personality dimension.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years old

2. Patients or family members were able to understand the study protocol and willing to participate in this study by signing informed consent.

3. Those who underwent colonoscopy at the Gastrointestinal Endoscopy Center of Peking Union Medical College Hospital.

Exclusion Criteria:

1. Patients who have taken colonoscopy before

2. Patients who are unable to read or write

3. Patients with severe mental disorders, organic brain mental disorders

4. those with poor bowel preparation (BBPS < 6 )

5. patients with chronic constipation, history of intestinal diverticula

6. Patients who have undergone previous colorectal surgery

7. those with previous findings of severe colonic strictures or obstructive tumors

8. patients who are pregnant or breastfeeding

9. patients with severe infectious diseases.

10. Patients with inflammatory bowel disease, familial polyposis.

Related Conditions & MeSH terms

• Colonoscopy

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Chung YW, Han DS, Yoo KS, Park CK. Patient factors predictive of pain and difficulty during sedation-free colonoscopy: a prospective study in Korea. Dig Liver Dis. 2007 Sep;39(9):872-6. doi: 10.1016/j.dld.2007.04.019. Epub 2007 Jul 24. — View Citation

Ersoz F, Toros AB, Aydogan G, Bektas H, Ozcan O, Arikan S. Assessment of anxiety levels in patients during elective upper gastrointestinal endoscopy and colonoscopy. Turk J Gastroenterol. 2010 Mar;21(1):29-33. doi: 10.4318/tjg.2010.0044. — View Citation

Hull T, Church JM. Colonoscopy--how difficult, how painful? Surg Endosc. 1994 Jul;8(7):784-7. doi: 10.1007/BF00593441. — View Citation

Jia H, Wang L, Luo H, Yao S, Wang X, Zhang L, Huang R, Liu Z, Kang X, Pan Y, Guo X. Difficult colonoscopy score identifies the difficult patients undergoing unsedated colonoscopy. BMC Gastroenterol. 2015 Apr 9;15:46. doi: 10.1186/s12876-015-0273-7. — View Citation

Rex DK, Bond JH, Winawer S, Levin TR, Burt RW, Johnson DA, Kirk LM, Litlin S, Lieberman DA, Waye JD, Church J, Marshall JB, Riddell RH; U.S. Multi-Society Task Force on Colorectal Cancer. Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2002 Jun;97(6):1296-308. doi: 10.1111/j.1572-0241.2002.05812.x. No abstract available. — View Citation

Samuel DB, Widiger TA. A meta-analytic review of the relationships between the five-factor model and DSM-IV-TR personality disorders: a facet level analysis. Clin Psychol Rev. 2008 Dec;28(8):1326-42. doi: 10.1016/j.cpr.2008.07.002. Epub 2008 Jul 4. — View Citation

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation

van Doorn SC, van Vliet J, Fockens P, Dekker E. A novel colonoscopy reporting system enabling quality assurance. Endoscopy. 2014 Mar;46(3):181-7. doi: 10.1055/s-0034-1364877. Epub 2014 Feb 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insertion time	Total time from the insertion of the colonoscope into the anus until the colonoscope reaches the cecum	During colonoscopy procedure
Secondary	pain scores	The degree of maximum abdominal pain	colonoscopy procedure
Secondary	Willingness to undergo colonoscopy again questionnaire	After colonoscopy, ask the patient if they are willing to accept colonoscopy again if they have the same chief complaint	colonoscopy procedure