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ColonoscopyNCT05584423

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

An observational study of Colonoscopy, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colonoscopy
How many people
322 participants
Where
1 siteChina
Study dates
15 Aug 2023to 1 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

SHENGYU ZHANG contact

18501155701

pumchzsy@126.com

DONG WU, M.D. contact

wudong@pumch.cn

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Dong Wu, M.D.

    Recruiting

Other trials in China

About this study

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.
Read the detailed 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.

Conditions
Colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. insertion time

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

    Measured: During colonoscopy procedure

Secondary outcomes (2)

  1. pain scores

    The degree of maximum abdominal pain

    Measured: colonoscopy procedure

  2. 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

    Measured: colonoscopy procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start15 Aug 2023
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion1 Nov 2024 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
322 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05584423
Sponsor's protocol ID
2022-DCPP
Status last verified
May 2024
First submitted
7 Oct 2022
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12094842

  • 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.

    PubMed 24500977

  • 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.

    PubMed 20533109

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

    PubMed 7974107

  • 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.

    PubMed 17652041

  • 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.

    PubMed 25886845

  • 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.

    PubMed 16717171

  • 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.

    PubMed 18708274

  • 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.

    PubMed 39622570

Questions about this trial

What is this clinical trial studying?

An observational study of Colonoscopy, run by Peking Union Medical College 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 4 Nov 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact SHENGYU ZHANG (18501155701, pumchzsy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

insertion time (time frame: During colonoscopy procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05584423, which also lists 9 linked publications.

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 4 Nov 2024.

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