Virtual Reality Videos in Improving Bowel Preparation Quality of Colonoscopy

NCT ID: NCT03667911

Last Updated: 2019-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Patient Compliance Colo-rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control Group

Only routine patient education on bowel preparation of colonoscopy. Give oral instructions on bowel preparation(including definition, significance, correct steps as well as dietary limitations) by a well-trained nurses or doctors. Written instructions are offered, which have the some contents.

Group Type NO_INTERVENTION

No interventions assigned to this group

Virtual-reality Group

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.

Group Type EXPERIMENTAL

virtual reality videos

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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DONG WU

Associate Professor of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Wu, M.D.

Role: CONTACT

8618612671010

Facility Contacts

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Dong Wu, M.D.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34807255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31434774 (View on PubMed)

Other Identifiers

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ZS-1647

Identifier Type: -

Identifier Source: org_study_id

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