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

The appearance of a stoma and the potential for contact with stool may negatively affect postoperative teaching effectiveness, especially for patients with cultural and religious backgrounds that consider stool untouchable. Instruction that involves the use of a physical stoma simulator for practice may help address this problem. PURPOSE: The aim of this pilot study was to determine the effects of simulation in ostomy self-care training on self-efficacy and adjustment. METHOD: 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. RESULTS: 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). CONCLUSION: 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. 

According to quantitative study,¹ patients with an ostomy may experience various physical, social, and emotional issues such as lack of bowel control, body deformation, lack of required self-confidence to participate in society, occupational and family problems, acceptance of the ostomy,² feeling stigmatized, and the anxiety of ostomy revelation.^3,4 These issues may severely affect the patient’s adjustment^4,5 to this new situation. In this regard, Muslim patients, perhaps more than other religions, also encounter problems in participating in religious practices. Prayer, fasting, giving alms and Sadaqah, and going on pilgrimage to Mecca require cleanliness to a degree not achievable with an ostomy under Muslim doctrine, as shown in cross-sectional study.^6,7 Passage of flatus and excretions from the ostomy pouch (common when praying in the knee-elbow position) are among the common reasons Muslims avoid attending Friday prayer, an issue that effects acceptance and adjustment to having an ostomy.⁷

A phenomenological study⁸ showed patients find it difficult to look at or touch their ostomy for the first time. In a phenomenological study in Iran,⁹ patients often mentioned they needed to call a family member or close friend to help them care for their ostomy. This undesired necessity affects their feelings of self-efficacy. According to research by Cavdar,^7,10 patients with an abdominal ostomy may think their prayer is not religiously acceptable due to uncontrolled evacuation. In a cross-sectional study by Su et al,¹¹ persons with temporary ostomies reported low or moderate levels of self-efficacy. 

A sociopsychological concept derived from the social learning theory developed by Albert Bandura,¹²self-efficacy is defined as one’s belief in his/her ability to successfully accomplish necessary behaviors in order to obtain favorable outcomes,¹³ Results of a study presented in a doctoral thesis¹⁴ showed that in patients with an intestinal stoma, higher postoperative self-efficacy predicted fewer emotional disorders in the early postoperative years. According to correlational studies,^9,14-17 a direct relationship exists between ostomy self-care and adjustment to the ostomy. Moreover, a correlational study¹⁸ showed that self-efficacy with stomas is a major predictor in promoting psychological adjustment in colostomy patients. 

Based on Bandura’s theory, training methods should engage learners in participating in their own learning activities while creating successful or vicarious experiences.¹² A precourse-postcourse, single-group comparison design study⁹ and a cross-sectional study¹⁹ conducted in Iran showed that psychological disorders are rarely encountered in patients who can take care of themselves — that is, most patients who are capable of handling their own ostomy show higher levels of postoperative adjustment,¹⁶ making it critical to implement training methods that engage patients in their own care.

Several experimental studies have investigated the effects of different ostomy care training methods, including a quantitative study¹ regarding planned group interactions in Turkey, a randomized controlled trial²⁰ (RCT) on preoperative intensive community-based training in the United Kingdom, a RCT²¹ on traditional nurse instruction versus 2-session nurse instruction that included a multimedia presentation in the midwestern United States, an evaluation of multimedia education programs,²² expert patient programs,¹⁹ a RCT²³ on nurse telephone follow-up in China, and a RCT²⁴ on ostomy management reinforcement education in Korea on desired therapy outcomes in patients with ostomy. However, these studies did not clarify which training method had been used to teach how to change an ostomy appliance.

According to an ostomy guideline,²⁵ most protocols recommend the demonstration-return-demonstration method as the most appropriate for ostomy training. This method is commonly used for ostomy training in Iran. Despite the advantages of the demonstration method in creating direct experiences, patients still have feelings of disgust toward their ostomy when changing their ostomy appliance and have difficulty facing the physical appearance of the ostomy, especially in the presence of their caregivers.⁸ 

Bandura instructs that acquiring self-efficacy includes enactive attainment (ie, past experiences, success, and failure), vicarious experiences, and visualizing other similar people performing a certain behavior, concepts that have been utilized in the research.^26-29 On the other hand, the current authors believe a training method that could make patients’ first encounter with their ostomy and their first experience handling their own ostomy more pleasant has a good chance of improving self-efficacy among these patients.

The simulation method provides the opportunity for patients to practice and gain confidence.³⁰ Using this method, patients are provided the opportunity to gradually improve their ostomy care ability through practice. Recent developments in the form of visual tangible instruments and models help patients directly encounter nearly real-life experience. One such model is the anatomic apron, an educational tool that helps demonstrate both the physical and physiological revisions that result from ostomy creation. This tool is mostly used to teach patients about ostomy surgery, particularly in the preoperative stage, as noted in its United States patent information (PCT/US2005/036653).³¹ Other simulators, such as those in clinical skills centers, also can be used to train patients, as noted in a review article.³² An experimental study showed these simulators help patients (as well as health care providers) practice ostomy appliance care on a mannequin.³³ Existing simulators such as mannequins³⁴ cannot create a pseudo-real life experience that allows patients to apply what they have learned to their own bodies (ie, a mannequin cannot be worn by the patient), so the authors developed a physical simulator in the form of a truss on which the stoma bag can be installed (see Figure 1). This simulator was constructed using plastic materials with the intent for the patient to wear the truss over the actual ostomy to learn how best to manage the ostomy device without worrying about stool passage or other similar problems. 

The context of Iran. In Iran, ostomies are formed using laparotomy; laparoscopic ostomy formation is rare.³⁵ Routine education is provided in the hospital after surgery using the demonstration-return-demonstration method by a nonspecialist nurse. Patients do not receive systematic stoma care education before surgery, do not meet an ostomy care nurse, and are not provided information regarding whether theirs is a temporary or permanent ostomy. Moreover, the patients’ families do not allow the health care team to inform patients of the facts regarding the inability to perform religious practices and potential postsurgical problems; instead, the authors use a “breaking bad news protocol.”³⁶ Most of the authors’ patients are Muslims who believe that urine and stool are untouchable. They eat with the right hand and clean stool with the left hand. Exiting of stool from the abdomen causes Muslim patients to feel unclean, especially in the presence of others.

In the authors’ opinions, choosing the appropriate training method can be highly effective in promoting self-efficacy and adjustment of ostomy patients. Thus, the aim of this pilot study was to determine the effects of simulation in ostomy care training on self-efficacy and adjustment of patients with an intestinal stoma in Iran. 

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). 

Instruments.

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. 

Over a 9-month period, 56 patients were screened for eligibility and 3 were excluded for not meeting the inclusion criteria. The remaining 53 patients who agreed to participate were randomly allocated to the 2 groups. Seven (7) patients (3 from the SG and 4 from the CG) were excluded from the analyses (see Figure 1), leaving 23 in each group who completed the study.

The mean age in SG and CG was 45.91 ± 10.40 and 53.78 ± 9.15 years, respectively. 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%]). Most of the study participants had a temporary ostomy (SG: 17 [73.9%]; CG: 12 [52.2%]). No statistically significant difference was found between the 2 groups in terms of demographic variables (P >.05), except for age (P = .009) (see Table 2). 

Self-efficacy scores for each of the 2 groups were normally distributed at all studied times. Mean self-efficacy scores in the SG at baseline, after fourth session, and at follow-up (45 days after the fourth session) were 69.30 ± 12.07, 103.82 ± 15.81, and 111.43 ± 15.79, respectively. Mean self-efficacy scores in the CG before and after intervention and follow-up were 71.00 ± 12.76, 89.91 ± 13.41, and 95.60 ± 12.95, respectively. 

Self-efficacy improved from baseline to follow-up in both groups (P <.0001). A repeated measures test was conducted to analyze the changes of self-efficacy score during intervention with age as a covariate (F = 0.012; P = .954). Excluding age, the SSES showed a significant difference in the SG from baseline (69.30 ± 12.07), fourth session (103.82 ± 15.81), to follow-up (111.43 ± 15.79) (F = 3.183; P = .008). 

Distribution of stoma care self-efficacy scores was normal in both groups at all times. Based on repeated measures test results, the SG and CG showed significant differences in scores on the stoma care self-efficacy component during the intervention (see Table 3). In addition, the SSES was significantly different in the SG (F = 13.56; P = .001). The LSD test showed a significant difference between groups in terms of the self-efficacy score fourth session (P = .004) and follow-up (P <.0001). 

Social self-efficacy scores were normally distributed. According to a repeated measure test, no significant difference was noted between the 2 groups in terms of the mean score of social self-efficacy during intervention in the SG (baseline [35.34 ± 10.64], fourth session [47.82 ± 9.72],  and follow up [49.39 ± 11.26]) and in the CG (baseline [34.47 ± 10.41], fourth session [40.91 ± 9.29], and follow up [44.17 ± 8.43] (P = .069). According to the LSD test, SSES improved significantly in the SG from baseline to the fourth session (P = .018). 

Adjustment scores for both groups were normally distributed at all times. Mean adjustment scores in the SG at baseline, after the fourth session, and follow-up were 51.04 ± 13.37, 60.56 ± 16.41, and 64.60 ± 16.74, respectively. Mean adjustment scores in the CG at baseline, after the fourth session, and follow-up were 50.82 ± 13.84, 53.95 ± 13.22, and 58.17 ± 13.07, respectively. Based on repeated measures test results, both groups showed significant differences in adjustment during the intervention from base line to follow-up (P = .000). According to repeated measure testing, no significant difference was found between the 2 groups in terms of mean adjustment scores during the intervention from base line to follow-up (P = .517) (see Table 4). The LSD test showed no significant difference between groups in terms of adjustment score after the fourth session and follow-up.

This pilot study was conducted to determine the effects of simulation in ostomy care training on self-efficacy and adjustment of patients with an intestinal stoma. Self-efficacy scores increased significantly from baseline to follow-up during the study, but mean self-efficacy scores in the SG were significantly higher compared with the CG after the fourth session and at follow-up. Mean adjustment scores significantly improved in both groups, but between-group differences were not significantly different. 

No comparative study related to simulation was found in the literature. Two (2) studies evaluated the effects of other training methods on patients’ self-efficacy. The single-group, quantiative comparison study by Cheng et al¹⁹ in which 11 experts educated patients with a permanent colostomy reported results similar to those of the present study; patient self-efficacy improved significantly (P = .001). This study was similar to the current study in terms of intervention duration and number of training hours, session content, and instruments used to measure adjustment and self-efficacy.

Zhang et al²³ conducted a study among 119 patients with a permanent colostomy and found follow-up telephone calls can enhance patients’ adjustment and self-efficacy in the third month after surgery. The results of that study did not show significant differences in mean self-efficacy scores between intervention and control groups 1 month after surgery.²³ In the current study, self-efficacy improvement occurred in the first month after the intervention in both groups, which could be related to the content of the educational intervention that included teaching about different ostomy types, diet, personal hygiene, permitted/not permitted activities, emptying ostomy appliance, changing the ostomy appliance, common complications, prevention strategies, and warning signs of ostomy complication.

Although social self-efficacy was improved in both groups from baseline to follow-up, the only significant between-group difference was found after the fourth session. Likewise, differences in mean adjustment scores between the 2 groups were not significant; adjustment level increased in both groups during the intervention. Contrary to the current results, adjustment was significantly improved in the Cheng et al¹⁹ study. Zhang et al²³ showed that follow-up telephone calls could enhance patients’ adjustment levels in month 3 after the surgery; however, in the present study, a significant improvement was noted in the adjustment scores in both groups from baseline to the fourth session (during week 9), and between-group differences in adjustment were nonsignificant. When interpreting this finding, it must be considered that the content of the education was the same for both groups and that most of the study participants had a temporary ostomy. In this regard, a descriptive study by Pieper et al⁴³ showed that patients with permanent ostomies created as a result of disease, temporary ostomies as a result of disease, or temporary ostomies as a result of trauma did not differ significantly with respect to their scores on the Psychosocial Adjustment to Illness Scale.⁴³ The theory of the researchers was that simulation of ostomy care training would affect self-efficacy and adjustment. Simulation avoids the potentially unfavorable conditions of completing training with a functioning ostomy and patients can learn to successfully and effectively change their ostomy appliance without feeling worried about discharging stool and staining the bed and their surroundings. Based on Bandura’s self-efficacy theory,²⁶ when a certain behavior is learned, its regulation depends on successful experiences that could improve self-confidence and self-efficacy, while failure to accomplish responsibilities may reduce self-efficacy. In the simulation method, patients do not worry about the involuntary discharge of stool and they also can compare the simulation with real-life conditions in the actual ostomy location.

Sampling a larger number of cancer treatment centers could have enhanced the findings. Nonequivalence of the 2 groups in terms of age was another limitation of this study. However, the effect of age on self-efficacy and adjustment scores was not statistically significant. Another limitation of the study is the uncontrollable nature of mental, physical, and personal differences between participants. Most patients were female; extrapolating these results to men must be done with caution. 

This study can be generalized to patients who have recently had a permanent or temporary colostomy created and to geographical areas where no systematic ostomy care is provided. Simulation also can be used to teach stoma care before surgery. However, the religious and cultural differences among Muslims can present a challenge in the application of current study results in countries with different religions and cultures.

The aim of this randomized, controlled pilot study was to determine the effects of simulation in ostomy care training on self-efficacy and adjustment of patients with an intestinal stoma in Iran. 

Self-efficacy scores increased significantly from baseline to follow-up during the study, and mean self-efficacy scores in the SG were significantly higher compared with the CG in fourth session and follow-up. Mean adjustment scores significantly improved in both groups, but between-group differences were not significantly different. This study also highlights the need for more research on the role of using a physical simulator on reducing the unpleasant feeling of the first encounter with an ostomy. Further research should be conducted to confirm the results of this pilot study, evaluate patient satisfaction with simulation interventions, and investigate which patients benefit most from such intervention. 

The authors are grateful to the patient participants, the authorities of Mashhad Medical Science University for sponsoring the study, and the authorities of the Faculty of Nursing and Midwifery and participants for their valuable support. 

Please address correspondence to: Fatemeh Heshmati Nabavi, Associate Professor, Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Dr. Abdollahi is an Associate Professor, Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; email: heshmati.nabavi@gmail.com.

This project was supported by funding from Mashhad University of Medical Sciences (Grant No. 930866).