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Virtual Reality Videos in Improving Bowel Preparation Quality of Colonoscopy

Primary Purpose

Patient Compliance, Colo-rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
virtual reality videos
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Patient Compliance focused on measuring bowel preparation, colonoscopy, virtual reality, patient education

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Virtual-reality Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

polyp detection rate (PDR)
Proportion of patients found to have polyp, may be a quality indictor of colonoscopy
adenoma detection rate (ADR)
Proportion of patients found to have adenoma, may be a quality indictor of colonoscopy
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

Full Information

First Posted
September 4, 2018
Last Updated
July 1, 2019
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03667911
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Compliance, Colo-rectal Cancer
Keywords
bowel preparation, colonoscopy, virtual reality, patient education

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
322 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Virtual-reality Group
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
virtual reality videos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Boston bowel preparation score
Description
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.
Time Frame
During colonoscopy
Secondary Outcome Measure Information:
Title
polyp detection rate (PDR)
Description
Proportion of patients found to have polyp, may be a quality indictor of colonoscopy
Time Frame
During colonoscopy
Title
adenoma detection rate (ADR)
Description
Proportion of patients found to have adenoma, may be a quality indictor of colonoscopy
Time Frame
During colonoscopy
Title
cecal intubation rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Wu, M.D.
Phone
8618612671010
Email
dongwu@pumc.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Wu, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Wu, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34807255
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.
Results Reference
derived
PubMed Identifier
31434774
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.
Results Reference
derived

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Virtual Reality Videos in Improving Bowel Preparation Quality of Colonoscopy

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