The Effect of Telephone Education and Counseling to Individuals With Stoma on Stoma Compliance and Complications: Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cukurova University
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- The effect of education and counseling given to individuals with stoma on complications.
Study Overview
Brief Summary
The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. The effect size calculated based on the preliminary data was 2.955, indicating a very large effect. Therefore, to obtain a more conservative sample size estimate, an effect size of 0.80 was used for the a priori power analysis, in accordance with Cohen's convention for a large effect size. The sample size was calculated using G*Power version 3.1.9.7, with a significance level of α = 0.05 and a statistical power (1 - β) of 0.85. Accordingly, the required sample size was determined as 30 participants per group. The Ostomy Adjustment Inventory and Pittman Ostomy Complication Severity Index will be completed. The scales will be collected for both groups on the first day, first month, and third month postoperatively. Patients were contacted five times postoperatively to provide education and counseling. SPSS will be used for data analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Having undergone stoma surgery in a university hospital,
- •No vision or hearing problems,
- •Verbal communication is possible,
- •Without diagnosed psychiatric problems.
Exclusion Criteria
- •Want to leave the research
Arms & Interventions
Telephone Education
Training and consultancy will be provided
Intervention: Education and counseling intervention (Other)
Control
Standard care will be given
Outcomes
Primary Outcomes
The effect of education and counseling given to individuals with stoma on complications.
Time Frame: 1 and 3 mounth
Pittman Ostomy Complication Severity Index will be used. This valid and reliable index was developed by Joyce Pittman in 2014 to evaluate the frequency and severity of complications developing in the early postoperative period during the follow-up period of individuals with a stoma. A higher total score indicates more serious ostomy complications. The lowest score that can be obtained from the scale is 0, while the highest score is 92.
The effect of education and counseling given to individuals with stoma on stoma compliance.
Time Frame: 1 and 3 mounth
Ostomy Adjustment Inventory will be used. The lowest score that can be obtained from the scale is 0, while the highest score is 92.This valid and reliable scale was developed to determine the adaptation levels of individuals with stoma. A high score from the scale means that compliance is high.
Secondary Outcomes
No secondary outcomes reported
Investigators
Seyma Yurtseven
Clinic Nurse
Cukurova University