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临床试验/NCT03667911
NCT03667911Unknown不适用

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

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2018年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
322
试验地点
1
主要终点
Boston bowel preparation score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: virtual reality videos (Other)

结局指标

主要结局

Boston bowel preparation score

时间窗: 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.

次要结局

  • cecal intubation rate(During colonoscopy)
  • adenoma detection rate (ADR)(During colonoscopy)
  • polyp detection rate (PDR)(During colonoscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DONG WU

Associate Professor of Gastroenterology

Peking Union Medical College Hospital

研究点 (1)

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