A randomized control trial to assess the effectiveness of a brief educational intervention on colonoscopy preparation and experience in patients with inflammatory bowel disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Adequate bowel preparation as defined using Boston bowel preparation score of 6 or more
研究概览
简要总结
Inthis randomised trial, patients with inflammatory bowel disease who are plannedfor a colonoscopy for established indication will be randomized to eitherreceive or not receive a brief video-based education intervention. All patientswill receive a written document in the language of their choice to explain thecolonoscopy and its need and preparation. However, half of the patients willrandomly receive a video in English / Hindi/ Punjabi which provides explanationof the colonoscopy and need for adequate preparation. We will assess if thosewho receive an educational video intervention have a better colonoscopypreparation, and if their experience of the procedure is better than those whodo not receive the educational intervention. The trial will not entail anyadditional costs, procedures, visits than are clinically indicated
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with inflammatory bowel disease undergoing colonoscopy for mapping of disease extent or dysplasia screening.
排除标准
- •Contraindications for colonoscopy eg active disease precluding colonoscopy, acute obstruction Suspected stricturing disease on previous imaging or clinical symptoms Severe systemic illness- symptomatic heart failure, CTP -C cirrhosis, chronic kidney disease with GFR < 30 Unwilling to participate Pregnant and breastfeeding females Psychiatric co morbidities (clinical depression, bipolar disorder or schizophrenia) Re procedure for a patient already randomized or already included in a trial Patients undergone an abdominal surgery in the past related to bowel disease.
结局指标
主要结局
Adequate bowel preparation as defined using Boston bowel preparation score of 6 or more
时间窗: baseline on day of colonoscopy
次要结局
- Perfect bowel preparation as defined using Boston bowel preparation score of 9(Day Zero)
- Tolerance of bowel preparation(Day zero)
- Time to cecal intubation
- Willingness to undergo colonoscopy again if needed(14 days)
- Anxiety as assessed by GAD-7 score(14 days)
- Worsening of disease activity as per increase in SCCAI or HBI score(14 days)
- Satisfaction with bowel preparation(Day zero)
- Tolerance of procedure(14 days)