Virtual Reality Videos in Improving Bowel Preparation Quality of Colonoscopy

Colo-rectal Cancer Clinical Trial

Official title:

Educational Virtual Reality Videos in Improving Bowel Preparation Quality and Satisfaction of Outpatients Intended for Colonoscopy: a Prospective Randomised Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03667911
• Other study ID #: ZS-1647
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Peking Union Medical College Hospital
• Contact: Dong Wu, M.D.
• Phone: 8618612671010
• Email: dongwu[@]pumc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colorectal Neoplasms
• Patient Compliance

Intervention

Other:
• virtual reality videos
Watch virtual reality videos after routine patient education(both oral and written instructions). Videos give instructions on correct steps of bowel preparation, points for attention, as well as actual images of bowel during colonoscopy in the case of both excellent and unsatisfactory bowel preparation.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston bowel preparation score	A 10-point scale assessing bowel preparation. A four-point scoring system applied to each of the three broad regions of the colon: the right colon (including the cecum and ascending colon), the transverse colon (including the hepatic and splenic flexures), and the left colon (including the descending colon, sigmoid colon, and rectum).; 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.; = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.; = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.; = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.	During colonoscopy
Secondary	polyp detection rate (PDR)	Proportion of patients found to have polyp, may be a quality indictor of colonoscopy	During colonoscopy
Secondary	adenoma detection rate (ADR)	Proportion of patients found to have adenoma, may be a quality indictor of colonoscopy	During colonoscopy
Secondary	cecal intubation rate	Proportion of passage of the colonoscope tip to a point proximal to the ileocecal valve, may be a quality indictor of colonoscopy	During colonoscopy