Different Levels of Patient Education for Care of Ostomy Site
- Conditions
- Ostomy
- Interventions
- Behavioral: StandardBehavioral: Pre-operative EducationBehavioral: Two-week Post Operative Education
- Registration Number
- NCT02036268
- Lead Sponsor
- Indiana University
- Brief Summary
This is a randomized study of standard versus extra ostomy education.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 53
- 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.
- Subjects not meeting any of the above eligibility criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Standard Standard Subjects will receive standard ostomy education. Pre-Operative Education Standard In addition to standard ostomy education, subjects will receive additional education pre-operatively. Two-week Post Operative Education Standard In addition to standard ostomy education, subjects will receive additional education two weeks following surgery. Two-week Post Operative Education Two-week Post Operative Education In addition to standard ostomy education, subjects will receive additional education two weeks following surgery. Two-week Post Operative Education Pre-operative Education In addition to standard ostomy education, subjects will receive additional education two weeks following surgery. Pre-Operative Education Pre-operative Education In addition to standard ostomy education, subjects will receive additional education pre-operatively.
- Primary Outcome Measures
Name Time Method Stoma Quality of Life Scale (SQOLS) 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.
- Secondary Outcome Measures
Name Time Method Skin integrity at the ostomy site by location Six weeks Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion location.
Stoma Care Self-Efficacy Scale (SCSES) Six weeks The SCSES assesses patient quality of life on a 4-point Likert type scale, where 1 = Not At All and 5 = Almost Always. Higher scores indicate a greater self-reported quality of life related to self-confidence in stoma care.
Skin integrity at the ostomy site by lesion type Six weeks Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion type.
Number of appliance changes Six weeks Subjects will be asked to record the number of wafer and/or bag changes completed during study participation in a patient diary.
Trial Locations
- Locations (1)
Indiana University Health North Hospital
🇺🇸Carmel, Indiana, United States