Comforting Conversation During Colonoscopy: A Randomised Controlled Trial on Patient Satisfaction
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Patient Satisfaction
研究概览
简要总结
Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management.
详细描述
Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management. A randomized controlled trial on comforting conversation or standard communication during colonoscopy. Using a mixed methods model, a qualitative study will be conducted to clarify what patients deem as important or effective conversation during colonoscopy. A randomized controlled trial will hereafter be conducted, where the results from the initial study will be utilized in the conversation during colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-85
- •Colonoscopy
- •Written informed content
排除标准
- •ASA Class 4 or higher
- •BMI 40 or higher
- •Analgesics taken prior to procedure
- •Pregnancy or breast feeding
- •Allergy to Fentanyl/Midazolam
- •Daily consumption of opioids
- •Unable to complete questionnaire
研究组 & 干预措施
Comforting Conversation
Conversation according to the initital qualitative study.
干预措施: Comforting Conversation (Behavioral)
Comforting Conversation
Conversation according to the initital qualitative study.
干预措施: Standard Communication (Behavioral)
Standard Communication
Standard information prior to and during endoscopy.
干预措施: Standard Communication (Behavioral)
结局指标
主要结局
Patient Satisfaction
时间窗: on average 20 minutes after completed colonoscopy.
Questionnaire with 5 point Likert like scale
次要结局
- Per-procedural Pain management(From inclusion to completed procedure. On average 45 minutes from first to last measurement.)
研究者
Jeppe Thue Jensen
MD
Copenhagen University Hospital at Herlev