Ostomy
Conditions
Keywords
Ostomy education, Education, care of ostomy site
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.
Interventions
BEHAVIORALStandard
Standard ostomy education
BEHAVIORALPre-operative Education
In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.
BEHAVIORALTwo-week Post Operative Education
In addition to standard ostomy education and an additional pre-operative ostomy education session, another ostomy education session will be conducted with the subject two weeks post-op.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Subjects not meeting any of the above eligibility criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed