ABSTRACT
Aim
The aim of this study is to develop a novel Stoma Care Training Belt for patients undergoing intestinal stoma surgery and to evaluate the effects of preoperative training with the belt on stoma care skills, stoma adjustment, anxiety, and satisfaction with education.
Design
A randomized controlled trial.
Methods
This study was conducted between May 2024 and April 2025 in the general surgery departments of two university hospitals. A total of 170 patients scheduled to undergo intestinal stoma surgery were randomly assigned to either the intervention group, which received preoperative training using the Stoma Care Training Belt in addition to standard clinical care, or the control group, which received standard clinical care alone. Outcome measures were assessed on the day before surgery, the day of discharge, and at 5, 15, and 30 days after discharge.
Results
Compared with the control group, patients in the intervention group had significantly higher stoma care skill and stoma adjustment scores at all postoperative follow‐ups, significantly lower anxiety scores from discharge through postdischarge day 30, and significantly higher satisfaction with education at the preoperative and discharge assessments.
Conclusions
The Stoma Care Training Belt is a novel, ergonomic, wearable educational device that allows patients to practice stoma care safely during the preoperative period and to keep the belt on during daily activities, thereby promoting familiarity with stoma management and supporting skill acquisition without direct adhesive exposure. Preoperative education with a new Stoma Care Training Belt may increase patients' stoma care skills, stoma adjustment and satisfaction, and decrease anxiety levels.
Implications for the Profession and Patient Care
Incorporating the Stoma Care Training Belt into routine preoperative nursing education may provide a practical, evidence‐based approach to improving patients’ stoma care skills, reducing anxiety, and supporting earlier adaptation and more independent self‐care after surgery.
Impact
What Problem Did the Study Address?
This study addressed the limited availability of structured and evidence‐based preoperative stoma care education interventions designed to improve patients’ self‐care skills, adjustment, and outcomes, including anxiety and satisfaction.
What Were the Main Findings?
Preoperative education using the Stoma Care Training Belt was associated with better stoma care skills, better stoma adjustment, lower anxiety, and higher satisfaction with education compared with standard care alone.
Where and on Whom Will the Research Have an Impact ?
The findings are relevant to nurses providing perioperative stoma education and to patients undergoing intestinal stoma surgery, with potential to improve patient preparation, self‐care competence, and adaptation after discharge.
Reporting Method
Consolidated Standards of Reporting Trials (CONSORT) 2025.
Patient or Public Contribution
Patients participating in the pilot study were invited to provide feedback on the comfort, functionality, and usability of the Stoma Care Training Belt.
Trial Registration
ClinicalTrials.gov (Identifier: NCT06391398; Date: April 29, 2024)
Keywords: anxiety, education of patients, ostomy, patient satisfaction
1. Introduction
An intestinal stoma is a surgically created opening on the abdomen to divert bowel contents. It is commonly formed, either temporarily or permanently, due to diseases such as cancer, bowel obstruction, or inflammatory bowel disease (Abdelmohsen 2020; Basim and Argun 2021). Although stoma surgery is essential and life‐saving, it leads to significant changes in patients' daily lives. Many patients face physical discomfort, psychological stress, and social difficulties, which can adversely affect their quality of life (Ayaz‐Alkaya 2019). Common challenges include anxiety, depression, reduced self‐esteem, and altered body image, often leading to social withdrawal and isolation (Ayaz‐Alkaya 2019). Proper stoma care education helps patients manage these challenges effectively. Studies have shown that structured education provided both before and after surgery significantly improves patients' self‐care skills, reduces complications, and enhances overall quality of life (Abdelmohsen 2020; Koc et al. 2023). However, many patients receive insufficient education, leaving them unprepared to manage their stoma independently (Basim and Argun 2021). Nurses play a central role in supporting adjustment to a stoma and developing patients' stoma care skills through education, counselling, and ongoing follow‐up (Rolls et al. 2023). Educational tools and tailored materials can facilitate learning and support adjustment to life with a stoma (Dalmolin et al. 2017).
2. Background
To prevent complications and hospital readmissions related to stoma care, the literature emphasizes the importance of structured pre‐discharge education. Various strategies have been used to deliver this education, including audiovisual materials (Basim and Argun 2021; Dalmolin et al. 2017), nurse‐led counselling, home visits, and practical guidelines on correct and incorrect care techniques (Rojanasarot 2018; Bulkley et al. 2018; Wasserman and McGee 2017), role‐playing (Berti‐Hearn and Elliott 2019), and introducing patients to stoma equipment before surgery to familiarize patients with self‐care routines (Koc et al. 2023). Most educational interventions are implemented during the postoperative period (Rolls et al. 2023; Greenwood 2024); however, this period may present challenges for learning, as patients often experience nausea, pain, and emotional distress in the early postoperative phase, which may adversely affect their ability to receive, process, and apply stoma care education. Additionally, the shorter hospital stays associated with minimally invasive surgery may limit the time available for in‐hospital training (Yiğitoğlu and Şendir 2021). A study by Wasserman and McGee (Wasserman and McGee 2017) reported that 29% of patients lacked basic knowledge of stoma supplies and care, and only 56% could independently empty and change their pouching system. Another study found that the absence of preoperative stoma site marking and consultation with a stoma care nurse significantly increased the risk of stoma‐related or peristomal complications (Zelga et al. 2021). In many clinical settings, particularly in Turkey, stoma site marking is performed before surgery, but practical training on stoma care is rarely offered. Because stoma care involves psychomotor skills (Parlak and Doğan 2014), effective education should provide opportunities for patients to practice care procedures before surgery and gain familiarity with stoma management. Although preoperative stoma education has been recommended, evidence regarding practical, hands‐on nursing interventions that enable patients to actively practice stoma care before surgery remains limited. Furthermore, little is known about whether such interventions can improve not only technical skills but also adaptation, anxiety, and satisfaction outcomes. Given the central role of nurses in preoperative stoma education and patient preparation, there is a need for innovative, patient‐centred educational approaches that can be readily integrated into routine nursing practice. This study was conducted to address this gap by developing and evaluating a wearable Stoma Care Training Belt designed to support preoperative stoma education. Its lightweight, flexible, and ergonomic design allowed patients to wear the belt during routine daily activities, thereby increasing familiarity with stoma management while facilitating preoperative skill acquisition.
2.1. Hypotheses
Patients who receive preoperative education using the Stoma Care Training Belt will have higher stoma care skill scores than patients who receive standard care alone.
Patients who receive preoperative education using the Stoma Care Training Belt will have higher stoma adjustment scores than patients who receive standard care alone.
Patients who receive preoperative education using the Stoma Care Training Belt will have lower anxiety scores than patients who receive standard care alone.
Patients who receive preoperative education using the Stoma Care Training Belt will report greater satisfaction with education than patients who receive standard care alone.
3. The Study
3.1. Aim and Objective
The aim of this study was to evaluate the effects of a newly developed wearable Stoma Care Training Belt, designed to provide hands‐on stoma care practice and preoperative experience with a pouching system, on stoma care skills, stoma adjustment, anxiety, and satisfaction with education among patients scheduled for intestinal stoma surgery.
3.2. Primary and Secondary Outcomes
The primary outcomes of this study were stoma care skills, stoma adjustment, and anxiety, assessed using the Stoma Care Skills Rubric, the Ostomy Adjustment Inventory–23 (OAI‐23), and the State Anxiety Inventory, respectively. Patient satisfaction with education, assessed using a Visual Analog Scale (VAS)–Patient Satisfaction Level, was considered the secondary outcome.
4. Methods
4.1. Design
The study was conducted as a two‐centre, two‐arm, parallel‐group randomized controlled trial. The trial was prospectively registered at ClinicalTrials.gov before participant enrolment and was reported in accordance with the CONSORT 2025 statement.
The study was conducted in the general surgery departments of two university hospitals between May 2024 and April 2025. The study compared stoma care skills, stoma adjustment, anxiety, and satisfaction with education between the intervention and control groups.
4.2. Outcome Measures
Data were collected using the Sociodemographic and Medical Data Form, the Stoma Care Skills Rubric, the Ostomy Adjustment Inventory–23 (OAI‐23), the State Anxiety subscale of the State–Trait Anxiety Inventory, and a Visual Analog Scale for Satisfaction with Education.
Outcome measures were assessed across five time points. The Stoma Care Skills Rubric and OAI‐23 were administered at discharge (T1) and on postdischarge days 5 (T2), 15 (T3), and 30 (T4); state anxiety was assessed preoperatively (T0), at discharge (T1), and on postdischarge days 5 (T2), 15 (T3), and 30 (T4); and satisfaction with education was assessed preoperatively (T0) and at discharge (T1). All follow‐up assessments were conducted face to face during routine clinical visits. These follow‐up time points (post‐discharge days 5, 15, and 30) were selected because they correspond to the routine postoperative follow‐up schedule for patients with intestinal stomas in the participating institutions and are consistent with common clinical practice in Turkey.
4.2.1. Sociodemographic and Medical Data Form
This researcher‐developed form collected sociodemographic and medical characteristics, including age, sex, and the indication for stoma formation, based on the relevant literature (Basim and Argun 2021; Dalmolin et al. 2017; Bulkley et al. 2018; Wasserman and McGee 2017). For the education variable, “Literate” was defined as individuals who were able to read and write but had not completed any formal educational program, whereas “Primary school” referred to individuals who had completed primary school education. The form was completed for all patients in both the intervention and control groups during the preoperative period.
4.2.2. Stoma Care Skills Rubric
The Stoma Care Skills Rubric, developed by İncesu and Ulupınar (İncesu and Ulupınar 2022), comprises 23 items representing the essential steps of stoma care. Higher scores indicate better stoma care skills. The developers indicated that the rubric could be used in nursing education, patient education, and stoma‐related research; therefore, it was used without modification. Patients were assessed by direct observation while independently performing stoma care procedures, and their performance was scored according to the original criteria.
This rubric was used to evaluate patients in both groups at four time points: at T1, T2, T3, and T4. Internal consistency was high across all time points, with Cronbach's alpha values of 0.94 at T1, 0.97 at T2, 0.95 at T3, and 0.97 at T4. Permission to use the Stoma Care Skills Rubric was obtained from the developer prior to the study.
4.2.3. Ostomy Adjustment Inventory‐23
The OAI‐23 was adapted to Turkish by Karadağ et al. (Karadağ et al. 2011). It comprises 23 self‐report items, with higher scores indicating better adjustment. In this study, the inventory was administered at T1, T2, T3, and T4. The internal consistency of the instrument was supported with Cronbach's alpha values of 0.76 at T1 and 0.91 at T2, T3, and T4. Permission to use the OAI‐23 was obtained from the authors of the Turkish validation study.
4.2.4. State Anxiety Inventory
The 20‐item State Anxiety subscale of the State–Trait Anxiety Inventory was used to assess participants' current anxiety at T0, T1, T2, T3, and T4. Higher scores indicate greater state anxiety. The Turkish version was validated by Öner and Le Compte (Öner and Le Compte 1985). In the current study, the scale's internal reliability was strong, with Cronbach's alpha values of 0.91 at T0, 0.95 at T1, 0.88 at T2, 0.93 at T3, and 0.93 at T4. Permission for the use of the scale was obtained prior to the initiation of the study.
4.2.5. Visual Analog Scale (VAS) for Satisfaction With Education
Satisfaction with education was measured using a 0–10 VAS, where 0 indicated “not at all satisfied” and 10 indicated “completely satisfied.” The scale was administered immediately after the preoperative education session (T0) and again at hospital discharge (T1) to participants in both groups.
4.3. Sampling and Recruitment
Participants were randomly assigned to the intervention or control group in a 1:1 ratio using computer‐generated block randomization. The random allocation sequence was generated using the Sealed Envelope online randomization program. A coin toss was used to assign Group A and Group B to the intervention and control conditions. A total of 170 participants were allocated across 17 blocks of 10 participants each.
Due to the nature of the study, participant blinding was not feasible. The randomization list was generated before participant enrolment and was accessible only to the principal researcher responsible for group assignment. To minimize bias, different individuals were responsible for intervention delivery, data collection, data entry, and statistical analysis. In addition, statistical analyses were performed using coded group assignments.
4.4. Sample Size and Power
An a priori power analysis was conducted using G*Power version 3.1.9.7. The power analysis was based on the OAI‐23 scores reported by Pouresmail et al. (Pouresmail et al. 2019) (intervention group: X̄=64.60, SD = 16.74; control group: X̄=58.17, SD = 13.07). Based on these values, the effect size was calculated as Cohen's d = 0.44. Assuming a two‐sided significance level of α = 0.05 and a statistical power of 80%, the required sample size was estimated to be 81 participants per group. Allowing for an anticipated attrition rate of 5%, 85 participants were included in each group, resulting in a planned sample of 170 participants. No outcome data were missing among the 170 randomized participants; therefore, no imputation was performed, and all randomized participants were included in the analyses. The study process was conducted in accordance with CONSORT 2025 guidelines and is shown in Figure 1.
FIGURE 1.
CONSORT 2025 participant flow diagram.
4.5. Population and Sample
The population of the study consisted of adult patients scheduled to undergo bowel stoma surgery in the general surgery departments of two university hospitals between May 2024 and April 2025. The sample included patients who met the eligibility criteria and agreed to participate in the study.
4.6. Inclusion and Exclusion Criteria
Eligible participants were adults aged 18 years or older who were scheduled to undergo their first colostomy or ileostomy, were able to speak and understand Turkish, and were conscious, oriented, and able to cooperate with the study procedures. Patients were excluded if they had a diagnosed psychiatric or psychological disorder, a physical limitation that prevented them from performing stoma care, such as loss of an upper limb, or previous knowledge of or training in stoma care. Withdrawal criteria included refusal to perform postoperative stoma care, voluntary withdrawal, death, transfer to another hospital, development of a major postoperative complication, failure to complete the data collection instruments, or inability to complete follow‐up.
4.7. Procedures
4.7.1. Development of the New Stoma Care Training Belt
This new Stoma Care Training Belt was conceptualized and prototyped by the researchers (HÖC and MY) to address the lack of effective preoperative training methods that allow patients not only to practice stoma care skills but also to experience living with a stoma pouch before surgery (see Figure 2). The training belt was a wearable device specifically designed to enable patients to safely practice stoma care procedures on their own bodies without direct adhesive application to the skin. Unlike commercially available ostomy training models, which are primarily intended for demonstration and short‐term skills training, this belt was designed to be lightweight, flexible, and comfortable enough to be worn during the preoperative period. By allowing patients to wear the belt during daily activities, the intervention was intended to increase familiarity with stoma management while supporting hands‐on skill acquisition. In addition, eliminating the need for repeated adhesive use minimized the risk of skin irritation and potential surgical site complications.
FIGURE 2.
The Stoma Care Training Belt: (a) unfolded; (b) folded; and (c) positioned on a participant.
The training belt was made from biocompatible EVA foam (3 mm thickness) and adjustable Velcro straps, offering flexibility, comfort, and ease of application. The material is lightweight, non‐abrasive, and suitable for use with stoma accessories such as pastes and baseplates. The modular design included interchangeable cut‐outs representing ileostomy and colostomy sites. These simulated stoma areas can be adjusted based on the patient's actual stoma type. Two versions of the belt were evaluated. Version A used wider 5‐cm Velcro straps to improve stability, whereas Version B used narrower 4‐cm straps to improve patient comfort based on feedback from the initial usability testing.
A pilot usability study was conducted with eight patients to assess comfort, functionality, and realism. All pilot participants described the belt as soft and lightweight and reported that it facilitated practice. Additionally, feedback was gathered from the nurse responsible for training patients, focusing on the belt's ability to hold stoma materials, ease of removal, and ease of applying stoma paste. Most participants preferred Version B because it was easier to handle and apply. Based on the combined feedback, the belt design was refined. Patients included in the pilot phase were not enrolled in the main study.
4.7.2. Implementation of the Stoma Care Training Belt Intervention
4.7.2.1. Standard Clinical Care
All patients included in the study received routine preoperative and postoperative care provided by the surgical unit. As part of the standard clinical care protocol, stoma site marking was performed preoperatively for patients scheduled to undergo bowel stoma surgery. Additionally, a specialist stoma care nurse provided verbal information on stoma characteristics, stoma equipment, and basic care procedures. The use of educational materials and stoma care equipment was demonstrated to the patients and all questions were addressed to ensure adequate understanding. In standard clinical care, patient education was provided verbally during the preoperative period. During the postoperative period, patients were provided with education on the proper management and care of their stoma. During the postoperative period, all patients received standard clinical care from certified stoma care nurses. Standard postoperative care included assessment of stoma function, evaluation of the peristomal skin, monitoring for stoma‐related complications, supervision and reinforcement of pouch management skills, and individualized counselling according to patient needs. During scheduled outpatient follow‐up visits, additional education and support were provided when necessary.
4.7.2.2. Intervention Group
Patients in the intervention group participated in a structured training session using the Stoma Care Training Belt in addition to standard clinical care training. Training began on the day of hospital admission, prior to surgery, and was delivered by a certified stoma care nurse who was a member of the research team. All sessions were conducted by the same nurse to ensure accuracy and consistency of the intervention.
During each session, the belt was applied to the abdominal area either directly over the skin or over clothing, according to the participant's preference. The nurse then demonstrated each stoma care step in accordance with the Stoma Care Skills Rubric. Participants practiced the procedures under supervision at least twice or until they demonstrated adequate confidence and proficiency. Each session lasted approximately 60–90 min.
Following the session, participants were allowed to continue wearing the belt during the preoperative period, allowing them to experience performing daily activities while wearing a stoma pouch, such as walking, sitting, and bathing. In the postoperative period, patients were encouraged to manage their stoma care independently when they felt physically and psychologically ready, and nursing support was provided throughout the process. No adverse effects related to the intervention were observed.
4.7.2.3. Control Group
Patients in the control group received standard clinical care training from the surgical unit before and after surgery, and no additional intervention was provided to the control group.
4.8. Data Collection
Data were collected through participant interviews and direct observation. Sociodemographic and medical characteristics were obtained during the preoperative period using the Sociodemographic and Medical Data Form. Stoma care skills were assessed by direct observation while patients independently performed stoma care procedures, whereas stoma adjustment, anxiety, and satisfaction outcomes were collected using the corresponding patient‐reported outcome measures. All outcome data were collected at the predefined assessment points described above using standardized data collection procedures.
4.9. Statistical Analysis
Data were analysed using SPSS (SPSS Inc., Armonk, NY, USA) version 25.0. Descriptive statistics were reported as frequencies, percentages, means, and standard deviations. Independent‐samples t‐tests were used to compare continuous variables between the two groups when the normality assumptions were met. Paired‐samples t‐tests were used for within‐group comparisons involving two time points. Outcomes assessed at three or more time points were analysed using mixed‐design repeated‐measures ANOVA. Bonferroni‐adjusted significance thresholds were used to interpret the separate between‐group comparisons conducted at each time point. When the sphericity assumption was violated, Huynh–Feldt corrections were applied to the Stoma Care Skills Rubric and OAI‐23 analyses, and the Greenhouse–Geisser correction was applied to the state anxiety analysis. All tests were two‐sided, and a p value of less than 0.05 was considered statistically significant.
4.10. Ethical Considerations
This study was approved by the Ethics Committee of Ankara University (approval date: 05 March 2024; approval number: 19). All participants received written and verbal information about the study and were given adequate time to consider participation. Written informed consent was obtained before enrolment. The trial was conducted in accordance with the principles of the Declaration of Helsinki and reported in compliance with the Consolidated Standards of Reporting Trials (CONSORT) 2025 guidelines.
5. Results
Participant sociodemographic and medical characteristics are presented in Table 1. The mean age of the participants was 54.78 ± 11.88 years. No statistically significant between‐group differences were observed in baseline sociodemographic or clinical characteristics (p > 0.05).
TABLE 1.
Sociodemographic and medical characteristics of the patients (n = 170).
| Intervention group (n = 85) Mean ± SD | Control group (n = 85) Mean ± SD | Total Mean ± SD | Test | p | |
|---|---|---|---|---|---|
| Age | 54.45 ± 11.69 | 55.11 ± 12.13 | 54.78 ± 11.88 | ‐0.360 a | 0.719 |
| n (%) | n (%) | n (%) | |||
| Gender | |||||
| Male | 30 (35.3) | 41 (48.2) | 71 (41.8) | 2.926 b | 0.087 |
| Female | 55 (64.7) | 44 (51.8) | 99 (58.2) | ||
| Marital status | |||||
| Married | 71 (83.5) | 61 (71.8) | 132 (77.6) | 3.389 b | 0.066 |
| Single | 14 (16.5) | 24 (28.2) | 38 (22.4) | ||
| Level of education | |||||
| Literate | 1 (1.2) | 2 (2.4) | 3 (1.8) | 0.488 b | 0.921 |
| Primary school | 24 (28.2) | 23 (27.1) | 47 (27.6) | ||
| High school | 28 (32.9) | 30 (35.3) | 58 (34.1) | ||
| University degree or higher | 32 (37.6) | 30 (35.3) | 62 (36.5) | ||
| Employment status | |||||
| Working | 34 (40.0) | 36 (42.4) | 70 (41.2) | 0.097 b | 0.755 |
| Not working | 51 (60.0) | 49 (57.6) | 100 (58.8) | ||
| Perceived income level | |||||
| Low | 29 (34.1) | 25 (29.4) | 54 (31.8) | 1.332 b | 0.514 |
| Moderate | 55 (64.7) | 57 (67.1) | 112 (65.9) | ||
| High | 1 (1.2) | 3 (3.5) | 4 (2.4) | ||
| Social insurance | |||||
| Yes | 84 (98.8) | 82 (96.5) | 166 (97.6) | 0.621 c | 0.310 |
| No | 1 (1.2) | 3 (3.5) | 4 (2.4) | ||
| Presence of additional chronic disease | |||||
| Yes | 51 (60.0) | 55 (64.7) | 106 (62.4) | 0.401 c | 0.527 |
| No | 34 (40.0) | 30 (35.3) | 64 (37.6) | ||
| Indication for stoma formation | |||||
| Digestive system diseases | 83 (97.6) | 79 (92.9) | 162 (95.3) | 0.277 c | 0.139 |
| Other diseases | 2 (2.4) | 6 (7.1) | 8 (4.7) | ||
Independent‐samples t‐test.
Chi‐square test.
Fisher's exact‐test.
At T1, T2, T3, and T4, mean Stoma Care Skills Rubric scores were significantly higher in the intervention group than in the control group. The main effects of group effect (F = 251.017), time effect (F = 194.579), and group‐by‐time interaction (F = 15.144) were also statistically significant, indicating that skill scores changed over time and followed different trajectories in the two groups (p < 0.05) (Table 2; Figure 3).
TABLE 2.
Comparison of stoma care skills, stoma adjustment between groups across follow‐up time points (n = 170).
| Outcome Measures | Intervention group (n = 85) | Control group (n = 85) | Mean difference (95% CI) | ||
|---|---|---|---|---|---|
| Mean ± SD | Mean ± SD | Test a | p b | ||
| Stoma Care Skills Rubric | |||||
| T1 | 30.52 ± 6.25 | 8.63 ± 9.03 | 18.359 | < 0.001 | 21.89 (19.53–24.24) |
| T2 | 34.38 ± 7.93 | 14.71 ± 11.56 | 12.927 | < 0.001 | 19.67 (16.66–22.67) |
| T3 | 39.64 ± 5.09 | 21.10 ± 11.41 | 13.675 | < 0.001 | 18.54 (15.86–21.21) |
| T4 | 40.69 ± 9.26 | 27.15 ± 10.46 | 8.931 | < 0.001 | 13.54 (10.54–16.53) |
| Test c /p | 43.41/< 0.001 | 208.74/< 0.001 | |||
| Time effect d | F = 194.579, p < 0.001, ηp2 = 0.537 | ||||
| Group effect | F = 251.017, p < 0.001, ηp2 = 0.599 | ||||
| Group × time interaction d | F = 15.144, p < 0.001, ηp2 = 0.083 | ||||
| Ostomy Adjustment Inventory‐23 | |||||
| T1 | 49.30 ± 8.56 | 36.75 ± 8.49 | 9.590 | < 0.001 | 12.55 (9.96–15.13) |
| T2 | 56.07 ± 6.58 | 38.67 ± 9.27 | 14.104 | < 0.001 | 17.40 (14.96–19.83) |
| T3 | 62.32 ± 6.85 | 41.64 ± 9.29 | 16.510 | < 0.001 | 20.68 (18.20–23.15) |
| T4 | 69.61 ± 5.63 | 48.21 ± 9.18 | 18.303 | < 0.001 | 21.40 (19.09–23.70) |
| Test c /p | 281.21/< 0.001 | 82.67/< 0.001 | |||
| Time effect e | F = 322.731, p < 0.001, ηp2 = 0.658 | ||||
| Group effect | F = 291.160, p < 0.001, ηp2 = 0.634 | ||||
| Group × time interaction e | F = 28.429, p < 0.001, ηp2 = 0.145 | ||||
Abbreviations: CI, confidence interval; SD, standard deviation; T1, discharge day; T2, postdischarge day 5; T3, postdischarge day 15; T4, postdischarge day 30; ηp2, partial eta squared.
Independent sample t‐test.
Because between‐group comparisons were conducted separately across multiple follow‐up time points for each outcome, Bonferroni‐adjusted significance thresholds were considered when interpreting these comparisons (Stoma Care Skills Rubric and Ostomy Adjustment Inventory‐23: α = 0.0125).
Repeated‐measures ANOVA for within‐group change over time.
Because Mauchly's test indicated a violation of the sphericity assumption (W = 0.768, χ2 = 44.077, p < 0.001), the Huynh–Feldt correction was applied in the repeated‐measures analyses.
Because Mauchly's test indicated a violation of the sphericity assumption (W = 0.713, χ2 = 56.319, p < 0.001), the Huynh–Feldt correction was applied in the repeated‐measures analyses.
FIGURE 3.
Mean Stoma Care Skills Rubric scores (a) and Ostomy Adjustment Inventory–23 scores (b) by group and follow‐up time point.
The intervention group again scored significantly higher mean OAI‐23 scores than the control group at T1, T2, T3, and T4 (p < 0.05). The results of repeated measures ANOVA also indicated statistically significant changes over time in both groups (p < 0.05), with the intervention group showing consistently greater improvement (group effect F = 291.160, time effect F = 322.731, group‐by‐time interaction F = 28.429, p < 0.05) (see Table 2, Figure 3).
As shown in Table 3, there was no significant between‐group difference in anxiety scores at T0 (p > 0.05). At T1, T2, T3, and T4, mean anxiety scores were significantly lower in the intervention group than in the control group (p < 0.05). The change over time within each group was also statistically significant (p < 0.05). In addition, the intervention group showed a different pattern of change in anxiety over time (group effect F = 246.898, time effect F = 333.912, group‐by‐time interaction F = 53.232, p < 0.05).
TABLE 3.
Comparison of anxiety and satisfaction with education between groups across follow‐up time points (n = 170).
| Outcome Measures | Intervention group (n = 85) | Control group (n = 85) | Test a | p b | Mean difference (95% CI) |
|---|---|---|---|---|---|
| Mean ± SD | |||||
| Mean ± SD | |||||
| State Anxiety Inventory | |||||
| T0 | 51.60 ± 8.35 | 53.97 ± 7.44 | −1.959 | 0.052 | −2.37 (−4.77 to 0.01) |
| T1 | 38.49 ± 6.30 | 52.50 ± 7.62 | −13.049 | < 0.001 | −14.01 (−16.13 to −11.89) |
| T2 | 35.97 ± 4.31 | 49.47 ± 6.14 | −16.507 | < 0.001 | −13.49 (−15.10 to −11.88) |
| T3 | 33.75 ± 4.25 | 45.98 ± 5.00 | −17.167 | < 0.001 | −12.23 (−13.64 to −10.82) |
| T4 | 30.10 ± 2.73 | 43.23 ± 5.41 | −19.954 | < 0.001 | −13.12 (−14.43 to −11.82) |
| Test c /p | 231.73/< 0.001 | 95.63/< 0.001 | |||
| Time effect d | F = 333.912, p < 0.001, ηp2 = 0.667 | ||||
| Group effect | F = 246.898, p < 0.001, ηp2 = 0.597 | ||||
| Group × time interaction d | F = 53.232, p < 0.001, ηp2 = 0.242 | ||||
| VAS for Satisfaction with Education e | |||||
| T0 | 9.00 ± 1.04 | 5.02 ± 1.99 | 16.242 | < 0.001 | 3.97 (3.49–4.45) |
| T1 | 9.80 ± 0.48 | 6.80 ± 1.47 | 17.871 | < 0.001 | 3.00 (2.66–3.33) |
| Test f /p b | −8.34/< 0.001 | −7.03/< 0.001 | |||
Abbreviations: CI, confidence interval; SD, standard deviation; T0, preoperative assessment; T1, discharge day; T2, postdischarge day 5; T3, postdischarge day 15; T4, postdischarge day 30; VAS, visual analog scale; ηp2, partial eta squared.
Independent sample t‐test.
Because between‐group comparisons were conducted separately across multiple follow‐up time points for each outcome, Bonferroni‐adjusted significance thresholds were considered when interpreting these comparisons (State Anxiety Inventory: α = 0.010; VAS‐Patient Satisfaction Level: α = 0.025).
Repeated‐measures ANOVA for within‐group change over time.
Because Mauchly's test indicated a violation of the sphericity assumption (W = 0.298, χ2 = 200.169, p < 0.001), the Greenhouse–Geisser correction was applied in the repeated‐measures analyses.
For satisfaction with education, T0 refers to the assessment conducted immediately after the preoperative education session.
Paired samples t‐test.
Satisfaction with education increased significantly from T0 to T1 in both groups and was significantly higher in the intervention group at both assessments (see Table 3).
6. Discussion
Patient education is essential to enable individuals with a stoma to perform self‐care independently and to adapt successfully to their new condition (Khalilzadeh Ganjalikhani et al. 2019; Guo et al. 2023). Stoma education should be continuous, beginning in the preoperative period and extending through the postoperative phase and beyond hospital discharge (Wang et al. 2018). However, the postoperative recovery process is often accompanied by pain, nausea, and emotional distress, which may limit patients' ability to receive, retain, and apply educational information or to adapt effectively to their stoma (Yiğitoğlu and Şendir 2021; Sun et al. 2018). For this reason, hands‐on stoma care education provided during the preoperative period is considered particularly beneficial. The findings of the present study demonstrated that patients in the intervention group, who received preoperative education using the Stoma Care Training Belt, achieved significantly higher stoma care skill scores at all follow‐up time points compared with those in the control group. In this study, stoma care skills improved over time in both groups; however, patients in the intervention group consistently achieved higher skill scores throughout all follow‐up assessments. Notably, patients who received the Stoma Care Training Belt intervention attained substantially higher stoma care skill levels by the time of discharge, indicating that they had acquired many of the required stoma care skills before accumulating substantial postoperative experience with a stoma. In contrast, the gradual increase observed in the control group likely reflects learning through routine care and lived experience over time. These findings are consistent with those of Yeo and Park (Yeo and Park 2023), who reported that preoperative education significantly enhanced self‐care knowledge and competence among first‐time stoma patients. Similarly, Koç et al. (Koc et al. 2023) found that preoperative stoma education improved patients' self‐care abilities. Similarly, Yiğitoğlu et al. (Toğluk Yiğitoğlu et al. 2025) reported higher self‐efficacy and stoma adjustment scores among patients who received mobile application–based stoma education compared with those who received booklet‐based education, further supporting the value of interactive educational approaches over information‐only methods.
Previous studies have also shown that information provided during the preoperative and postoperative periods may be difficult for patients to process and retain, often resulting in misunderstanding or poor retention (Yiğitoğlu and Şendir 2021). Therefore, practical training—particularly for psychomotor skills such as stoma care—should be delivered using methods that enhance retention and skill acquisition. Although gradual improvement in stoma care abilities over time is expected, offering earlier opportunities to develop these skills may help prevent complications and facilitate more rapid adaptation. In the absence of adequate education, patients may remain unprepared, potentially leading to complications that require hospital readmission (Millard et al. 2020). Overall, the findings of the present study support the effectiveness of preoperative, hands‐on stoma education, particularly when delivered using the Stoma Care Training Belt, in enhancing skill development and promoting independent stoma care.
Beyond the technical aspects of care, the physical and psychological consequences of the underlying disease, surgical intervention, and stoma formation have a profound impact on patients' daily lives (Abdelmohsen 2020; Basim and Argun 2021). Nurses play a pivotal role in facilitating patients' adaptation through education, counselling, and support for self‐care during the perioperative period (Heidari‐Beni et al. 2022). In this study, ostomy adjustment scores were consistently higher in the intervention group, with improvements observed in both groups over time. Although existing literature has largely focused on the effects of postoperative education on adjustment to a stoma (Pouresmail et al. 2019; Heidari‐Beni et al. 2022), evidence regarding the impact of preoperative training remains limited. Notably, Zganjar et al. (Zganjar et al. 2022) demonstrated that preoperative education among patients undergoing radical cystectomy significantly improved both stoma adjustment and quality of life, supporting the relevance of early educational interventions. The importance of fostering self‐efficacy is also emphasized by Karaçay et al. (Karaçay et al. 2020), who highlight that promoting autonomy in stoma care supports long‐term psychosocial adaptation. Higher levels of stoma‐related self‐efficacy have been associated with greater independence in self‐care and better adjustment to life with a stoma (Pouresmail et al. 2019). Because adaptation may take time, healthcare providers should assess individual perceptions and needs early on and tailor interventions to build confidence and self‐care ability. The Stoma Care Training Belt may support this process by enabling patients to visualize, experience, and practice stoma care before surgery, thereby facilitating skill acquisition and stoma adjustment and promoting greater independence in postoperative self‐care. The improved adaptation observed in the intervention group may be attributed to enhanced stoma care skills, greater self‐care competence, greater independence in stoma management, and greater confidence gained through repeated hands‐on practice before surgery.
The process of stoma formation is also associated with significant psychosocial challenges, including anxiety, depression, poor body image, reduced self‐esteem, and social stigma (Heidari‐Beni et al. 2022). Preoperative stoma education has been shown to reduce anxiety levels and facilitate earlier acquisition of care skills (Harris et al. 2020). In this study, anxiety scores were significantly lower in the intervention group from discharge through postdischarge day 30, whereas no significant between‐group difference was observed before surgery. Few studies have specifically evaluated the effect of preoperative stoma training on anxiety.
These findings are consistent with those of Koç et al. (Koc et al. 2023) and Harris et al. (Harris et al. 2020), who reported lower anxiety among patients who received preoperative stoma education. Anxiety can impair attention, memory, and learning, thereby hindering patients' ability to process stoma care instructions (Harris et al. 2020; Kizilbash et al. 2002). Structured education prior to surgery may reduce anxiety, promote engagement, and facilitate earlier mastery of care routines, as demonstrated by the outcomes of this study. The reduction in anxiety observed in the intervention group may be related to increased familiarity with stoma care procedures, greater preparedness for self‐care, and earlier mastery of stoma management skills.
Patient satisfaction is a key indicator of healthcare quality and reflects patients' perceptions of the care they receive and how effectively healthcare services meet their needs and expectations (Cui et al. 2025). Although various educational approaches have been proposed to improve satisfaction and clinical outcomes in stoma care, the most effective method has yet to be clearly established (van der Storm et al. 2024). The present study demonstrated significantly higher satisfaction levels among patients in the intervention group, suggesting that preoperative, hands‐on training has a positive influence on the educational experience. While previous studies have shown that nursing interventions are associated with increased satisfaction among patients with a stoma (van der Storm et al. 2023; Su et al. 2021), relatively few have specifically examined the influence of preoperative education on patient satisfaction. The findings of the current study indicate that providing patients with practical skills, increasing preparedness for self‐care, and facilitating early adaptation to stoma care may collectively contribute to greater satisfaction with education.
6.1. Strength and Limitations
Strengths of this study include its randomized controlled design and complete participant follow‐up. Several limitations should also be considered. First, participants were recruited from two university hospitals affiliated with the same institution, which may limit the generalizability of the findings to other clinical settings and populations. Second, participants could not be blind because of the nature of the intervention, creating a potential risk of performance and response bias.
6.2. Recommendations for Future Research
To enhance the generalizability of the findings, future studies should be conducted as multicentre randomized controlled trials with larger and more heterogeneous samples.
Long‐term follow‐up studies are needed to more comprehensively evaluate the effects of the Stoma Care Training Belt, particularly its sustained impact on stoma adjustment, complication rates, and quality of life.
To better understand the psychosocial dimensions of the intervention, associations between the effects of the intervention and psychosocial variables such as anxiety, depression, body image, and social adjustment should be examined in greater detail.
Subgroup analyses and targeted intervention studies should be conducted to assess its effectiveness in different patient populations (e.g., older adults and individuals with low health literacy).
To determine its contribution to healthcare systems, the cost‐effectiveness of the intervention and its impact on nursing workload should be evaluated.
Finally, the integration of the training belt with digital health technologies (e.g., mobile applications and telehealth) should be explored to evaluate the effectiveness of hybrid education models.
7. Conclusions
This study demonstrated that preoperative education using the Stoma Care Training Belt is a feasible nursing intervention for patients undergoing ostomy surgery. Participants who received belt‐assisted training had higher stoma care skill and adjustment scores, lower postoperative anxiety, and greater satisfaction with education than those who received standard care alone. Integrating structured, hands‐on practice into routine preoperative nursing education may facilitate earlier skill acquisition, strengthen self‐care competence, and support adjustment to life with a stoma. The Stoma Care Training Belt may therefore provide nurses with a practical, patient‐centred tool for promoting independent stoma management after discharge.
8. Clinical Impacts
The Stoma Care Training Belt was developed as a wearable tool for preoperative stoma education.
Patients who received belt‐assisted training had higher stoma care skill and adjustment scores, lower postoperative anxiety, and greater satisfaction with education than patients who received standard care alone.
The belt provides nurses with a practical method for delivering supervised, hands‐on stoma care training before surgery.
Integrating the belt into routine preoperative nursing education may support earlier skill acquisition, greater self‐care independence, and smoother postoperative adjustment.
Author Contributions
All authors made substantial contributions. H.Ö.C. contributed to the project administration; resources; funding acquisition; conceptualization; investigation; writing – original draft; methodology; visualization; writing – review and editing. M.Y. contributed to the Project administration; funding acquisition; investigation; writing – original draft; writing – review and editing. İ.M.G. contributed to the formal analysis; visualization; writing – review and editing. S.U. contributed to the conceptualization; data curation; investigation, A.D., contributed to the writing – review and editing. Ş.E. contributed to the conceptualization; investigation. A.B.E. contributed to the supervision; investigation, writing – review and editing. E.Ş. contributed to the investigation, writing – review and editing.
Funding
This study was supported by the Scientific and Technological Research Council of Türkiye (TÜBİTAK) through the 1002 Rapid Support Program [grant number 323S432].
Disclosure
Although the journal recommends fewer than 25 references, a total of 34 references were included in this manuscript to ensure a comprehensive and balanced discussion of the study findings. Given the multidimensional nature of the study—encompassing clinical, behavioural, and psychosocial outcomes—additional references were necessary to adequately contextualize the results within the existing literature. Care was taken to include only the most relevant and up‐to‐date sources to support the scientific rigour and clarity of the manuscript. We ask for your understanding.
Statistics
The authors have checked to make sure that our submission conforms as applicable to the Journal's statistical guidelines described here.
The statistics were checked prior to submission by an expert statistician (GülengülATİK‐gulengulatik@hotmail.com).
Ethics Statement
This study was approved by the Ethics Committee of Ankara University (approval date: 05 March 2024; approval number: 19). All participants received written and verbal information about the study and were given adequate time to consider participation. Written informed consent was obtained before enrolment. The trial was conducted in accordance with the principles of the Declaration of Helsinki and reported in compliance with the Consolidated Standards of Reporting Trials (CONSORT) 2025 guidelines.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Data S1: CONSORT 2025 checklist.
Acknowledgements
The authors gratefully acknowledge the financial and scientific support of the Scientific and Technological Research Council of Türkiye (TÜBİTAK) under the 1002—Rapid Support Program (Grant number: 323S432). The authors also thank all patients who voluntarily participated in this study.
Öner Cengiz, H. , Yüksekkaya M., Gönenç İ. M., et al. 2026. “Effect of a Stoma Care Training Belt on Stoma Care Skills, Adjustment, Anxiety and Satisfaction in Intestinal Stoma Patients: Randomized Controlled Study.” Nursing Open 13, no. 7: e70713. 10.1002/nop2.70713.
The researcher (Hatice Öner Cengiz, Mehmet Yüksekkaya, İlknur Münevver Gönenç and Ayten Demir) does not work at the hospital where the study was conducted.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data S1: CONSORT 2025 checklist.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.