This study was a single-blind, RCT based on 2010 consort guidelines.37 Data were collected between April 2015 and December 2015. The trial was conducted in the surgical units of 2 public hospitals in Iran (ie, Omid and Emam Reza Hospitals, Mashhad, Iran). As noted previously, ostomies were created by laparotomy. Patients in these hospitals generally have the same socioeconomic background, and patient education policies were similar in these institutions.38,39 The education of ostomy patients before surgery was not a routine procedure; a nurse did not site the stoma before surgery, and a surgeon explained the surgery. Patient training was performed using the demonstration-return-demonstration method after surgery.
Participation criteria. Inclusion criteria for the participants stipulated patients had to have a temporary or permanent intestinal stoma, be Muslim and between 18 and 65 years old, speak Persian, have no vision or hearing impairments, have no disability affecting movement and balance, and have had no previous ostomy care experience or education. Patients who were unwilling to participate in the study, who had comorbidities that might interfere with the intervention/training (eg, clinical depression), or complications such as necrosis, prolapse, and bleeding were excluded.
All consecutively admitted patients were screened for study participation. Patients were asked to provide written informed consent and complete the study questionnaires. If a patient was illiterate, the researcher, who was blinded as to the patient’s group, wrote down the answers. Patients were randomly assigned to the simulation group (SG) or the control group (CG) by lottery. Privacy and anonymity were safeguarded by assigning identiﬁcation numbers.
The sample size was estimated to be 23 for each group using the mean attribute estimate formula α = 0.05 and β = 0.2. Allowing for a 20% loss, this number was decided to be 28 in each group. The power of this study was estimated based on the primary outcome measure, the psychosocial adjustment score, with a moderate effect size of 0.42.
Procedure. All interventions were provided after surgery and included 3 training sessions during the hospital stay and a fourth session after the patient’s discharge when he/she returned to the hospital clinic for follow-up. Patients were typically in the hospital for ~3 weeks.
Physical simulator. The physical simulator developed for this study was installed on the abdomen. The simulation device was tested on 3 patients with positive results before the current study with the approval of the ethics committee.
SG. Patients in this group received 4 sessions of ostomy care teaching, 2 of which used simulation. In the first session (3 days after surgery, 30 to 45 minutes in duration), an enterostomal therapy (ET) nurse taught patients about their stoma type, diet, bathing, what activities are permitted, warning signs of ostomy complication (eg, not passing many or passing watery stools, bloating, cramps, stoma swelling, nausea, and vomiting), gas and odor control in colostomy, signs and symptoms of dehydration, and the importance of leakage prevention with an ileostomy. The enterostomal therapy (ET) nurse then presented a 6-minute multimedia instructional session regarding changing the ostomy appliance that showed an ET nurse changing an ostomy appliance on the simulator. Patients also had the opportunity to practice preparing (cutting) the appliance for application. At the end of the session, patients received 3 pamphlets on ostomy care and changing appliances.
In the second session (held 1 to 3 days after the first session), an ET nurse taught patients how to change the ostomy appliance and how to care for the skin around the ostomy. The patients participated in skin care using the physical simulators and were provided time for questions during the 30- to 45-minute session.
In the third session (held 1 week after the second session), patients wore the simulator and practiced changing the ostomy appliance independently. After identifying any problems they encountered, they practiced care on the actual stoma.
The 45-minute fourth session was a group session. In this session (held 1 week after session 3), patients were taught using PowerPoint slides about common ostomy complications and prevention strategies, including skin complications, flatus, ostomy retraction, parastomal hernia, obstruction, prolapse, ostomy necrosis, and stenosis. Patients were divided into groups of 5 to 7 and discussed and responded to each other’s questions for 15 minutes (see Table 1).
CG. The CG received routine ostomy care in the hospital (demonstration method) during 4 sessions of training. The first session was similar to the first session of SG, sometimes without multimedia. General information on stoma care was as similar as possible between the 2 groups to reduce the effect of different content rather than different delivery.
In the second session, the ET nurse taught patients how to change their ostomy appliance and care for the skin around their ostomy via the demonstration method. Patients also had the opportunity to practice cutting the appliance. This session was held 1 to 3 days after the first.
In the third session, held 1 week after the second, patients changed their ostomy appliance and practiced skin care around the ostomy without a nurse’s help.
The fourth session of the CG was similar to the fourth session of the SG (see Table 1).
Demographic information. At their initial visit, patients completed a paper-and-pencil demographic information form designed for this study. The demographic information collected in this study included age, gender, marital status, level of education, diagnosis, ostomy type, residence, and insurance status.
Self-efficacy. Bekkers et al40 developed the Stoma Self-Efficacy Scale (SSES) in 1996 and tested it by factor analysis among 59 patients (26 cancer patients and 33 patients with benign diseases) who had undergone intestinal stoma surgery in the Netherlands. The scale was translated into Persian using forward- backward translations41 and then validated by 10 expert faculty members. Reliability of the instrument was obtained using Cronbach’s α (α = 0.88). The Persian translation of the SSES was used in this study.
The 29-question instrument comprises 2 components: 1) Stoma Care Self-Efficacy (α = 0.94), which assesses expected self-efficacy regarding the capability to care for one’s stoma; and 2) Social Self-Efficacy (α = 0.95), which evaluates self-efficacy regarding social functioning with the stoma. Respondents choose from among 5 responses ranging from “not at all confident” to “extremely confident.” The SSES score ranges from 28 to 140, with higher scores corresponding to higher levels of confidence. The form was completed independently by study participants or with the help of a research assistant if a participant was illiterate.
Adjustment to stoma. Simmons et al42 developed the Ostomy Adjustment Inventory-23 (OAI-23) in 2009 in the United Kingdom as a self-report multidimensional scale designed to measure psychosocial adjustment in patients with an ostomy and tested it among 570 persons with a colostomy, ileostomy, or urostomy. The OAI-23 (α = 0.93) consists of 23 items, each measured on a 5-point Likert-type scale (0–4), with higher scores indicating better adjustment. Twelve (12) items (2, 5, 7, 8, 10-13, 16, 17, 18, and 21) are negatively phrased/reverse scored. The scale was translated into Persian using forward-backward translations33 and then validated by 10 faculty members of Mashhad University of Medical Sciences (α = 0.86). The Persian OAI-23 was used in this study.
Data collection and statistical analysis. For both groups, the 2 assessment instruments were completed at 3 timepoints: 1) before the intervention, 2) after 4 instructional sessions, and 3) 45 days after the fourth session. Figure 2 illustrates the ﬂow of participants through the research. All data were collected to pencil/paper tools, coded for anonymity, and entered into SPSS software, version 11.5 (SPSS Inc, Chicago, IL) by a research assistant who was blinded to the study. Data were double-entered to ensure accuracy and analyzed using descriptive statistics. Chi-squared test, Fisher’s exact test, and the Mann-Whitney U test were used to assess differences between groups for demographic data. Changes in self-efficacy and adjustment during the study (from baseline to follow-up) were analyzed using the repeated measure tests, and the least significant difference (LSD) test was used for pairwise comparison. All values were reported as mean ± SD, with P <.05 considered statistically signiﬁcant.
Ethical consideration. The project was approved by the Ethics Committee of Mashhad University of Medical Sciences (No.IR.MUMS.REC.1393.953). Written informed consent was obtained from all participants before the study. Participants could leave the study at any time. All identifiable data were kept confidential.