Clinical trial NCT03667911: Virtual Reality Videos in Improving Bowel Preparation Quality of Colonoscopy
Official title: Educational Virtual Reality Videos in Improving Bowel Preparation Quality and Satisfaction of Outpatients Intended for Colonoscopy: a Prospective Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Compliance
Colo-rectal Cancer
Keywords: bowel preparation
colonoscopy
virtual reality
patient education
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Colonoscopy is the most important method to screen for colorectal cancer and precancerous lesions, whose efficacy is closely related with the quality of bowel preparation, requiring consuming purgatives and restricting the diet. Compliance to bowel preparation is highly dependent on patient education. In most cases, such education is offered only once at the time of colonoscopy scheduling by either oral or written instructions. However, about one in fourth patients still cannot achieve satisfactory bowel preparation quality. Various methods, including booklet, telephone or message reminders, smartphone applications, social media, online videos, have been used to aid patient education and prove effective. These methods can increase patient activation, which is an independent factor related to bowel preparation quality. Virtual reality(VR) videos are used in this study, giving patients direct impressions of colonoscopy. This study aims to explore whether VR videos can increase patient adherence and experience, as well as improve bowel preparation quality, compared with conventional patient education methods.


Eligibility criteria: Inclusion Criteria:

* Outpatients indicated for elective colonoscopy: 1) For screening purposes: asymptomatic patients with average or high risk for colorectal cancer\[1\]; 2) For diagnostic purposes: patients presented with abnormal imaging or lower gastrointestinal symptoms including bloody stool, chronic diarrhea and abdominal pain\[2\].
* Never undergo colonoscopy before.
* Age 18-75 years.
* Written informed consent.

Exclusion Criteria:

* History of bowel surgery
* Comorbidity disorder (ascites, congestive heart failure, chronic renal failure, coronary vessel disease within the last 6 months)
* Drug use (eg, constipation drugs, laxatives, or anti-diarrheal agents)
* Pregnancy
* Severe constipation (\<3 bowel movement/week)
* Inflammatory bowel disease
* Unable to watch VR videos (eg, blindness)

Primary outcomes:
measure: Boston bowel preparation score
timeFrame: During colonoscopy
Secondary outcomes:
measure: polyp detection rate (PDR)
timeFrame: During colonoscopy
measure: adenoma detection rate (ADR)
timeFrame: During colonoscopy
measure: cecal intubation rate
timeFrame: During colonoscopy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Dong Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen G, Zhao Y, Xie F, Shi W, Yang Y, Yang A, Wu D. Educating Outpatients for Bowel Preparation Before Colonoscopy Using Conventional Methods vs Virtual Reality Videos Plus Conventional Methods: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2135576. doi: 10.1001/jamanetworkopen.2021.35576.
citation: Zhao Y, Xie F, Bai X, Yang A, Wu D. Educational virtual reality videos in improving bowel preparation quality and satisfaction of outpatients undergoing colonoscopy: protocol of a randomised controlled trial. BMJ Open. 2019 Aug 20;9(8):e029483. doi: 10.1136/bmjopen-2019-029483.