Effect of Using a Simulation Device for Ostomy Self-care Teaching in Iran: A Pilot, Randomized Clinical Trial

Abstract

The aim of this pilot study was to determine the effects of simulation in ostomy self-care training on self-efficacy and adjustment. A randomized clinical trial was conducted among patients at 2 public medical center surgical units in eastern Iran from April 2015 to December 2015 using consecutive sampling. Patients who spoke Persian, were 18 to 65 years of age, had a temporary or permanent intestinal stoma, and did not have comorbidities that might interfere with self-care teaching were invited to participate and randomly allocated to the simulation (SG) or the control group (CG). Both groups were provided 4 training sessions; the first and fourth session was the same for each group, but in sessions 2 and 3, the SG group used a wearable stoma simulator, whereas the CG group used the demonstration-return method. Demographic and stoma variables were collected, and the Stoma Self-Efficacy Scale (SSES) and Ostomy Adjustment Inventory-23 (OAI-23) were administered at baseline (following surgery), after 4 instructional sessions, and 45 days following the last education session. Descriptive statistics and chi-squared, Fisher's exact, Mann-Whitney U, repeated measure, and least significant difference tests were used to analyze the data. Of the 53 patients enrolled, 46 (23 in each group) completed the study. Mean age for SG and CG patients was 45.91 ± 10.40 and 53.78 ± 9.15, respectively (P = .009). The majority of patients were female (SG: 11 [47.8%]; CG: 14 [60.9%]), married (SG: 20 [87.0%]; CG: 19 [82.6%]), and had a diagnosis of cancer (SG: 20 [87.0%]; CG: 21 [91.3%]). The mean SSES score for stoma self-efficacy was 103.82 ± 15.81 in the SG and 89.91 ± 13.41 in the CG after the fourth session. Results indicated an improvement in self-efficacy in both groups from baseline to final follow-up visit (P <.0001). SSES in the SG was significantly different from baseline to final follow-up visit during the study (F = 3.183, P = .008). Mean OAI-23 scores were 51.04 ± 13.37 in the SG and 50.82 ± 13.84 in the CG at baseline and after the intervention (fourth session) were 60.56 ± 16.41 in the SG and 53.95 ± 13.22 in the CG group. The repeated measure test results indicated significant increases in adjustment scores from baseline to final follow-up visit in both groups (P = .000). The results of this pilot study suggest that using simulation to teach ostomy self-care improves self-efficacy after 3 and 9 weeks. Further randomized controlled trials that expand the sample size and demographic should be conducted.