Patient ComplianceNCT03667911
Virtual Reality Videos in Improving Bowel Preparation Quality of Colonoscopy
A study testing virtual reality videos in people with Patient Compliance and Colo-rectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patient Compliance, Colo-rectal Cancer
- What is being tested?
- virtual reality videos
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Dong Wu, M.D.
About this study
Official title: Educational Virtual Reality Videos in Improving Bowel Preparation Quality and Satisfaction of Outpatients Intended for Colonoscopy: a Prospective Randomised Controlled Study
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.
- Conditions
- Patient Compliance, Colo-rectal Cancer
- Being tested
- virtual reality videos
- Keywords
- bowel preparation, colonoscopy, virtual reality, patient education
- Medical subject headings
- Patient Compliance, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality videosOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| Virtual-reality Group | Experimental | 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. Receives: Other: virtual reality videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During colonoscopy
Secondary outcomes (3)
polyp detection rate (PDR)
Proportion of patients found to have polyp, may be a quality indictor of colonoscopy
Measured: During colonoscopy
adenoma detection rate (ADR)
Proportion of patients found to have adenoma, may be a quality indictor of colonoscopy
Measured: During 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
Measured: During colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start15 Sep 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DONG WU, Peking Union Medical College Hospital
- Investigators
- Dong Wu, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667911
- Sponsor's protocol ID
- ZS-1647
- Status last verified
- Jul 2019
- First submitted
- 4 Sep 2018
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34807255Zhao 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Virtual Reality Videos in Improving Bowel Preparation Quality and Satisfaction of Outpatients Intended for Colonoscopy: a Prospective Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03667911
- Acronym / sponsor ID
- ZS-1647
- Conditions
- Patient Compliance, Colo-rectal Cancer
- Keywords
- bowel preparation, colonoscopy, virtual reality, patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| Virtual-reality Group | Experimental | Other: virtual reality videosWatch 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality videosWatch 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 Group |
Primary outcome
Boston bowel preparation score
Time frame: During colonoscopy
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.
3 secondary outcomes
polyp detection rate (PDR)
Time frame: During colonoscopy
adenoma detection rate (ADR)
Time frame: During colonoscopy
cecal intubation rate
Time frame: During colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Derived from this study: PubMed 34807255Chen 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.
- Derived from this study: PubMed 31434774Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Wu, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality videos in people with Patient Compliance and Colo-rectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Wu, M.D. (8618612671010, dongwu@pumc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston bowel preparation score (time frame: During colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03667911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.