Pediatric Cardiac Surgery Pre-operative Counselling Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Family satisfaction and stress score
研究概览
简要总结
We have developed a pre-operative educational / counselling booklet with the focus on informing parents / patients about the different stages before, during, and after cardiac surgery that they will encounter; both chronologically and emotionally. With this approach and study our objectives are:
- To provide anticipatory guidance for parents to decrease parental stress and improve parental experience and preparedness, thus involving the parent as a partner in caring for their child.
We hypothesize that this additional tool will improve parental satisfaction in regards to being prepared for their child's heart surgery.
详细描述
Our study objectives are to provide anticipatory guidance for parents to decrease parental stress and improve parental experience and preparedness, thus involving the parent as a partner in caring for their child.
A Case-control trial comparing family satisfaction between families that did and did not receive the STAGES-booklet.
Primary endpoints are Family satisfaction score and Family stress score. Secondary endpoints are Percentage of families that would recommend the STAGES-booklet as routine pre-operative educational tool, as well as Family Stress score during each stage as outlined in the STAGES-booklet
The Study period either 1 year or once 100 participants enrolled have completed their post-operative survey
Methods Group allocation: The first 50 families will be assigned to the STAGES-post group, and the last 50 to the STAGES-pre group. In both groups participants will be blinded to their timing of exposure to the intervention. This randomization in an attempt to minimize educator bias of possibly giving the STAGES-post group information pertaining to the intervention proposed.
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
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consented families of children <18 years that will be sent out of province for cardiac surgery from the Variety Children's Heart Centre
排除标准
- •Families that can't read or write english
结局指标
主要结局
Family satisfaction and stress score
时间窗: up to 6 weeks post-operatively
At post-operative visit families will complete a study questionnaire evaluating their satisfaction of pre-operative preparation and their stress levels during the surgical period
次要结局
- Percentage of families that would recommend the STAGES-booklet as routine pre-operative educational tool.(1 day (At post-operative visit))
- Family Stress score during each stage as outlined in the STAGES-booklet(1 day (At post-operative visit))
研究者
Dr. David Horne
Doctor
University of Manitoba