A Prospective, Single-Center Study to Assess the Impact of Pre- and Post-Surgical Ostomy Care Education on Patient Outcomes and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Stoma Quality of Life Scale (SQOLS)
研究概览
简要总结
This is a randomized study of standard versus extra ostomy education.
详细描述
The purpose of this study is to evaluate the effectiveness of pre-operative and post-operative ostomy education compared to standard of care ostomy education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or greater than 18 years of age at the time of consent.
- •Scheduled to undergo surgery at IU Health North Hospital that will results in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process.
- •Are willing and able to provide written informed consent for participation in the study and authorization for release of health information.
- •Are willing and able to attend up to two additional clinic visits at IU Health North Hospital for the purpose of ostomy teaching and care.
- •Subjects who currently do NOT have a urostomy or any other type of urinary diversion and/or are NOT planning to have a urostomy or any other type of urinary diversion as part of the surgery procedures at the time of their surgery for placement of colostomy or ileostomy.
- •Subjects who do NOT have any history of prior colostomy or ileostomy.
排除标准
- •Subjects not meeting any of the above eligibility criteria.
研究组 & 干预措施
Standard
Subjects will receive standard ostomy education.
干预措施: Standard (Behavioral)
Pre-Operative Education
In addition to standard ostomy education, subjects will receive additional education pre-operatively.
干预措施: Standard (Behavioral)
Pre-Operative Education
In addition to standard ostomy education, subjects will receive additional education pre-operatively.
干预措施: Pre-operative Education (Behavioral)
Two-week Post Operative Education
In addition to standard ostomy education, subjects will receive additional education two weeks following surgery.
干预措施: Standard (Behavioral)
Two-week Post Operative Education
In addition to standard ostomy education, subjects will receive additional education two weeks following surgery.
干预措施: Pre-operative Education (Behavioral)
Two-week Post Operative Education
In addition to standard ostomy education, subjects will receive additional education two weeks following surgery.
干预措施: Two-week Post Operative Education (Behavioral)
结局指标
主要结局
Stoma Quality of Life Scale (SQOLS)
时间窗: Six weeks
The SQOLS assesses patient quality of life on a 5-point Likert type scale, where 1 = Never and 5 = Always. Higher scores indicate a greater self-reported quality of life.
次要结局
- Skin integrity at the ostomy site by location(Six weeks)
- Stoma Care Self-Efficacy Scale (SCSES)(Six weeks)
- Skin integrity at the ostomy site by lesion type(Six weeks)
- Number of appliance changes(Six weeks)
研究者
Bruce W. Robb
Clinical Associate Professor of Surgery
Indiana University