NCT05584423

Brief 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. 1.Receive routine colonoscopy
  2. 2.Fill out the GAD-7 and PHQ-9 scales
  3. 3.Fill out the Big Five Personality Questionnaire.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

November 4, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

October 7, 2022

Last Update Submit

October 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • insertion time

    Total time from the insertion of the colonoscope into the anus until the colonoscope reaches the cecum

    During colonoscopy procedure

Secondary Outcomes (2)

  • pain scores

    colonoscopy procedure

  • Willingness to undergo colonoscopy again questionnaire

    colonoscopy procedure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who meet the eligibility criteria and undergo colonoscopy at Peking Union Medical College Hospital.

You may qualify if:

  • Age 18-75 years old
  • Patients or family members were able to understand the study protocol and willing to participate in this study by signing informed consent.
  • Those who underwent colonoscopy at the Gastrointestinal Endoscopy Center of Peking Union Medical College Hospital.

You may not qualify if:

  • Patients who have taken colonoscopy before
  • Patients who are unable to read or write
  • Patients with severe mental disorders, organic brain mental disorders
  • those with poor bowel preparation (BBPS \< 6 )
  • patients with chronic constipation, history of intestinal diverticula
  • Patients who have undergone previous colorectal surgery
  • those with previous findings of severe colonic strictures or obstructive tumors
  • patients who are pregnant or breastfeeding
  • patients with severe infectious diseases.
  • Patients with inflammatory bowel disease, familial polyposis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 12094842BACKGROUND
  • 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.

    PMID: 24500977BACKGROUND
  • 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.

    PMID: 20533109BACKGROUND
  • Hull T, Church JM. Colonoscopy--how difficult, how painful? Surg Endosc. 1994 Jul;8(7):784-7. doi: 10.1007/BF00593441.

    PMID: 7974107BACKGROUND
  • 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.

    PMID: 17652041BACKGROUND
  • 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.

    PMID: 25886845BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • 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.

    PMID: 18708274BACKGROUND
  • Wang D, Zhang S, Jiang Y, Ren Y, Kuai D, Zhao R, Wu D. Correlation between colonoscopy difficulty and personality traits: study protocol for a prospective, observational, multicentre study. BMJ Open. 2024 Dec 2;14(12):e090606. doi: 10.1136/bmjopen-2024-090606.

Study Officials

  • DONG WU, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR
  • SHENGYU ZHANG

    Peking Union Medical College Hospital

    STUDY DIRECTOR
  • YINAN JIANG

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

SHENGYU ZHANG

CONTACT

DONG WU, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 18, 2022

Study Start

August 15, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

November 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations