3D Ostomy Simulation for Patient Education
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Develop 3D printed model for urologic bowel diversion
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for urologic bowel diversion patient education. Using a randomized two group design, we aim to determine whether the use of this model enhances patient knowledge, self-care skills, and confidence in ostomy care. We will also evaluate changes in quality of life (QOL) and patient satisfaction comparing patients exposed to the 3D model to those receiving standard of care.
The secondary aim of the study is to examine the differences between groups on patient outcomes including hospital duration, mortality, emergency/urgent health care visits, readmissions, and infections.
Participants will be educated using 3D model simulation as part of their preoperative education (experimental group) or have standard education without using the simulation model (comparator group). Both groups will complete quality of life (QOL), ostomy adjustment, and satisfaction with education surveys during their preoperative education visit and again during their routine follow-up visits (a) within 3 weeks after surgery, (b) between 5- 8 weeks after surgery, and (c) at approximately 3 months after surgery.
详细描述
Inclusion Criteria:
Age>18 and planning to undergo bowel diversion urologic surgery.
Exclusion Criteria: Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.
Radom allocation and concealment: During a regularly schedule preoperative clinic visit participants that consent to the study will be asked to complete a short 36 item quality-of-life questionnaire (SF-36). The participant then be placed in either the experimental or comparator group using a random method similar to flipping a coin. Random allocation sequencing will be predetermined by a database specialist, who has no other role in the study. Therefore, all study staff, clinic staff and investigators will be blinded to the allocation sequencing, and will not be able to influence the group participants are assigned to.
Preoperative education: The clinic staff will provide participants with preoperative education according to their group assignment. Participants in the experimental group, will receive standard ostomy education supplemented by use of the simulation model. Those allocated to the comparator group will receive standard preoperative education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The post-operative soma care nurses and statistician will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18, undergoing bowel diversion urologic surgery.
排除标准
- •Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.
研究组 & 干预措施
3D model simulator preoperative education
Participants will receive standard preoperative education regarding ostomy care enhanced by the hands on use of a the ostomy simulator.
干预措施: 3D Ostomy simulator (Device)
Standard preoperative education
Participants will receive standard preoperative education.
结局指标
主要结局
Develop 3D printed model for urologic bowel diversion
时间窗: Models were created and approved prior to start of the project
3D printed model for urinary bowel diversion education
Quality of life using SF-36 scale
时间窗: Preoperatively before education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
Determine differences between groups in QOL using the (36-Item Short Form Health Survey)SF-36 Scale.
Adjustment of Ostomy
时间窗: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
Determine differences between groups in adjustment to ostomy using the ostomy adjustment scale (OAS) Scale.
Satisfaction with ostomy education
时间窗: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
Determine differences between groups in adjustment to ostomy using the Visual Analog Scale VAS Scale.
次要结局
- Post operative hospital duration(Day the patient is deemed ready for hospital discharge, up to 52 weeks)
- In-hospital mortality(Up to 12 weeks)
- Unplanned visit to urgent healthcare after discharge from the hospital(Measured at 3 weeks and 3 months)
- Hospital readmission after discharge from the hospital.(Measured at 3 weeks and 3 months)
- Surgical site infection(Measured at 3 weeks and 3 months)