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Status unknownNCT03667911Updated Jul 2, 2019

Virtual Reality Videos in Improving Bowel Preparation Quality of Colonoscopy

An interventional study of virtual reality videos in Patient Compliance and Colo-rectal Cancer, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-02.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
322
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Patient Compliance
  • Colo-rectal Cancer

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Keywords

  • bowel preparation
  • colonoscopy
  • virtual reality
  • patient education
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In context

Rectal Neoplasms

1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 322 is above the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
322 participants (estimated)

Study arms

  • No intervention
    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.

  • Experimental
    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.

    Other: virtual reality videos

Interventions

  • Othervirtual 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.

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What researchers measure

Primary outcomes

  1. 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. 1. = 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. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3. = 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.

    Time frame: During colonoscopy

Secondary outcomes

  1. polyp detection rate (PDR)

    Proportion of patients found to have polyp, may be a quality indictor of colonoscopy

    Time frame: During colonoscopy

  2. adenoma detection rate (ADR)

    Proportion of patients found to have adenoma, may be a quality indictor of colonoscopy

    Time frame: During colonoscopy

  3. 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

    Time frame: During colonoscopy

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Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    • Dong Wu, M.D. · Contact
    Recruiting
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References and documents

Publications

  • 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. PubMed 34807255 ↗
  • 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. PubMed 31434774 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03667911
Lead sponsor
Peking Union Medical College Hospital
Responsible party
DONG WU (Associate Professor of Gastroenterology, Peking Union Medical College Hospital) — Principal investigator
First posted
Sep 12, 2018
Start date
Sep 15, 2018
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Jul 2, 2019

Study contacts

Dong Wu, M.D.
Contact
dongwu@pumc.edu.cn
8618612671010
Dong Wu, M.D.
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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