Abstract
Background
While the care of the stoma poses a problem for individuals, the presence of complications, lack of stoma adjustment, and impaired quality of life can be more exhausting for patients, as well.
Methods
This thesis study was designed and conducted as a multicenter, randomised controlled intervention study with repetitive measurements in a pretest-posttest order. Patients, who underwent intestinal stoma in 5 hospitals, (one of which was private), in a city in the south-eastern Turkey between 20 March and December 31, 2021, participated in the study. Seventy-four patients, who were regarded eligible, were randomised and divided into experimental and control groups. A patient information form, the Stoma Complications Evaluation Form, the Stoma-Related Problems Form, the Ostomy Adjustment Inventory-23, and the Stoma Quality of Life Scale were used to collect data.
Results
Results of the study revealed a significant difference between the groups based on quality of life and stoma adjustment.
Conclusions
The nurse navigation programme not only increases the quality of life and stoma adjustment in patients with stoma but also reduces stoma complications.
Trial registration
ClinicalTrials.gov NCT05809661 (Registered: 30/03/2023). Retrospectively registered.
Supplementary Information
The online version contains supplementary material available at https://doi.org/10.1186/s12876-026-05073-0.
Keywords: Compliance, Complications, Nursing, Navigation Program, Stoma, Quality of Life
Background
The word “ostomy” originates from Greek word that means creating an opening from the hollow organ inside the body to the skin surface and stoma refers to its opening part. Intestinal stomas can be in the form of jejunostomy, ileostomy or colostomy [1, 2]. Although the primary cause of intestinal stoma procedure is colorectal cancer, it may also stem from diverticulitis, intestinal perforations, inflammatory bowel diseases like ulcerative colitis and Crohn’s disease, fistulas, traumas, and congenital diseases [3, 4].
Complications seen systematically or around the stoma, after the stoma is opened, adversely affect the patient’s stoma adjustment and quality of life [5, 6]. The stoma complications primarily include peristomal skin complications, stoma necrosis, stoma retraction, stoma stenosis, stoma prolapse, stomal hernia, and bleeding [7–10].
Stoma adjustment means reorganising, directing, and accepting difficulties in one’s life despite changing bodily functions [11]. The follow-up of the patients by the nurse after discharge and the continuation of education and counselling services facilitate the patient’s stoma adjustment [12]. Training and counselling service should be determined according to the needs of the patient and should be provided with appropriate methods (such as hospital appointments, remote support systems, phone calls, information messages, videos) [13].
The quality of life, which is expressed as an individual’s ability to perform physical, mental, and social functions, is significantly affected by the opening of the intestinal stoma [14, 15]. Patients need help, education, and counselling not only to learn stoma care, but also to adapt to changes in body image and loss of normal body function and enhance their quality of life [16]. There are study results showing that the quality of life of patients with stoma who receive continuous care, training and consultancy services by nurses in the post-discharge period are enhanced [3, 13, 16–18].
The patient navigation programme is an application that was first developed for cancer patients in the United States in the early 21st century [19, 20]. The purpose of this newly developed application is to help for individuals to understand the healthcare system and to travel comfortably in this system, together with the continuity of procurement of healthcare service by the individual [21]. Nurse navigation programme is an application that can help patients to understand their diseases and care for themselves in order to improve their self-sufficiency skills and reduce number of hospitalisations. Navigator nurses refers to nurses who perform the nurse navigation programme [22]. There are studies showing positive effects of nurse navigation programme on patients’ better understanding of the disease process, their adaptation to complex treatment practices, and reduction of side effects [23]. It is known that the nurse navigation programme, which is one of the continuous care applications, is used for obese individuals, chronic diseases, cancer screenings, and care of cancer patients and is a successful application [23–27]. The findings of the studies in which the nurse navigation programme was applied in stoma patients who had problems such as adjustment, impaired quality of life and stoma complications were not found. If the nurse navigation programme after discharge is used to maintain the education and counselling services of patients with stoma, to provide them with access to training materials, to solve their physical and psychosocial problems based on the changing patient needs, to help them receive remote support and to ensure their connection with the health institution, it may have the potential to be beneficial for patients experiencing problems such as poor adjustment, impaired quality of life, or stoma-related complications.
This study aims to examine how nurse navigation programme affects stoma adjustment, quality of life, and prevention of complications in patients with intestinal stoma. In this context, stoma adjustment, quality of life, and stoma-related complications were evaluated as study outcomes.
Method
Participants and sample size
The patients with intestinal stoma, who received treatment in the surgical clinics and an outpatient chemotherapy unit in five hospitals including one private hospital, two training and research hospitals and two state hospitals between March and December 2021, were included in the study. This study was carried out and reported based on the CONSORT guidelines. The inclusion criteria of patients were determined as being 18 years or older, being literate, having an intestinal stoma, having a stoma for a maximum of two months, having no vision-hearing problem, being able to use a smart phone, having the physical ability to replace the stoma bag on their own, and having no psychiatric disease. Patients were included in the study in the early postoperative period, once they were clinically stable and able to actively participate in the research process. Exclusion criteria were determined as withdrawing the research after agreeing to participate in the study, closing the stoma during the study, the patient’s death, and experiencing communication problems during the study.
Based on previous studies [28, 29], minimum sample size was calculated 29 in G* Power Version 3.1.9.2 programme by determining Type I Error of 0.05 and Type II Error of 0.10. The sample size calculation was based on the between-group differences in quality of life and stoma adjustment scores reported in previous studies [28, 29]. A total of 74 patients (37 in each of experimental and control groups), were included in the study because of the possibility of loss of subjects during the study. The patients were assigned to the groups using the SPSS 23.0 statistical analysis programme through simple randomisation method. During randomisation, numbers from 1 to 74 were given for each patient. The given numbers were entered into the SPSS 23.0 programme. The SPSS programme randomly assigned 74 patients to the experimental and control groups. Randomisation was performed by a statistician who did not participate in the study and had no contact with the patients. The study was completed with 58 patients (30 in the experimental group, 28 in the control group) (Şekil 1). The study was conducted as a single-blind trial, in which the researcher was aware of group assignments, while randomization was performed by an independent statistician who had no contact with the participants.
Ethical considerations
This multicenter, randomised controlled study was retrospectively registered in the ClinicalTrials.gov database (NCT05809661) after its completion. The study was carried out by following the Declaration of Helsinki. Ethics approval dated 18.03.2021 and numbered 2021-29 was obtained from the Ethics Committee of the University. Institutional permission was obtained from the related university hospital (Permission No: E-9178672-010.99-43910). Permission was obtained from the provincial directorate of health to conduct the study in the state hospitals and the private hospital (Permission No: E-48230018-774.99). Each participant signed informed consent form.
Measurements
Patient information form
The researcher developed this form upon the related review [16, 28–30]. It has questions about some socio-demographic (age, gender, educational status, marital status, number of children, health insurance, income status, smoking status, alcohol status) and medical (presence of chronic disease, medical diagnosis, stoma type, receiving training on stoma care, stoma caregiver, bag change and empty frequency) characteristics of the patients. The English version of this researcher-developed form is provided in the Supplementary File.
Stoma complications evaluation form
The form developed by the researcher in accordance with the literature [28, 29, 31] was used to query and record a total of 14 stoma complications, including leakage, peristomal irritant dermatitis, bleeding, stoma stenosis, stoma retraction, stoma prolapse, parastomal hernia, stoma necrosis, stomal fistula, mucocutaneous separation, stoma hyperplasia, intestinal obstruction, and pain. The English version of this researcher-developed form is provided in the Supplementary File.
Ostomy adjustment inventory-23
The Ostomy Adjustment Inventory-23 (OAI-23) was developed by Simmons et al., in 2009 [32] to identify stoma adjustment of individuals with stoma. Karadağ et al., conducted its Turkish validity and reliability study in 2011 [33]. This self-assessment scale has 23 items and four subscales (acceptance, anxious preoccupation, social engagement, and anger). Each item is assessed in a 5-point Likert type scale ranging between 0 and 4 points. The lowest and highest scores of the scale are 0 and 92, respectively. A high score signifies that adjustment increases.
Stoma quality of life scale
The Stoma Quality of Life Scale (SQOL) was developed by Baxter et al., to determine the quality of life of individuals with stoma [34]. Karadağ et al., conducted its Turkish validity and reliability study in 2011 [33]. It has 19 items. The first two items (the first part) assess the individual’s satisfaction with his life instantly and monthly. 17 items in the second part are scored using a 5-point Likert type scale (ranging from one to five points as “Never”, “Rarely”, “Sometimes”, “Often”, and “Always”). These 17 items are grouped into three subscales; work/social function (6 items), sexuality/body image (5 items), and stoma function (6 items).
Training materials used in the study
Training booklet
A training booklet was prepared by the researcher based on the literature [35–37]. The training booklet enriched with visuals and containing the contact information of the researchers gives information about what is stoma, the structure of the digestive system, bag change, care and types, stoma complications, stoma emergencies, and daily life with stoma.
Training videos
The researcher shot 16 training videos for the patient educations. The videos were sent by phone to the patients in the experimental group regularly every week.
Phone calls
The most frequently used method of nurse navigation programme is phone calls [19]. The questions of the patients about the problems they experienced were answered by instant messaging, sharing stoma images or calling up. The patients were referred to appropriate hospital units (emergency clinic, surgical clinic, chemo-radiotherapy unit, etc.) according to their problems.
Implementation of the intervention
The nurse navigation programme was conducted by a researcher nurse experienced in stoma care. The programme included regular follow-up through phone calls, educational messages and videos, individualized counselling, and guidance tailored to patients’ needs.
Experimental group
The first interview: the patients were informed about the purpose of the study and signed informed consent form. All of the data collection tools were filled out. The practices made by the patients for stoma care and their problems were evaluated. The training requirement was determined. Their questions were answered. The training booklet was delivered to them. Their contact information was obtained and the contact information of the researcher (navigator nurse) was shared with them. They were told that they could call the navigator nurse, send a message to him/her, take a photo of the stoma and share it with his/her when necessary, when they had physical, social, and psychological problems in the stoma or in line with their changing needs. In the next 3 months, they were informed about the applications to be made within the scope of the study (phone calls, information messages and videos, guidance and appointment planning). Appointment was scheduled for the next interview in 3 months.
The second interview (3 months after the first interview): the patients were called up at least once a week. Illustrated informative messages and training videos were shared with them every week. Approaches/solution suggestions were shared with them based on the physical, psychological, social problems related to stoma and their changing needs, and they was referred. Guidance was provided on support resources and remote support. The navigator nurse assisted them in scheduling hospital appointments when necessary. The number and content of interviews and informing with them were recorded. A few days before the interview, they were called up and reminded of their appointment. At the end of the 3rd month, the researcher filled out the relevant forms with them. Training was given according to their training needs and their questions were answered. An appointment was scheduled for the next interview 3 months later.
The third interview (6 months after the first interview): the nurse navigation programme applications in the first 3 months continued. A few days before the interview, the patients were called up and reminded of their appointment. At the end of the 6th month, the researcher filled out again the relevant forms with them. Training was given according to their training needs and their questions were responded. The study was terminated.
Control group
The first interview: the patients were informed about the purpose of the study and signed informed consent form. All of the data collection tools were filled out. Their questions about stoma care were answered. Training booklet was handed down to them. An appointment was scheduled for the next interview 3 months later.
The second interview (3 months after the first interview): A few days before the interview, they were called up and reminded of their appointment. The relevant forms were filled out with them at the end of the 3rd month. Their questions about stoma care were answered. An appointment was scheduled for the next interview 3 months later.
The third interview (6 months after the first interview): A few days before the interview, the patients were was called up and reminded of their appointment. Ostomy Adjustment Inventory, Stoma Quality of Life Scale, and Stoma Complications Evaluation Form were filled out with them at the end of the 6th month. Training was given according to their training needs, and their questions about stoma care were answered. The study was terminated.
Statistical analysis
The data were analysed through the SPSS (Statistical Package for Social Sciences) for Windows Version 24.0 (SPSS Inc. Chicago, IL, USA). Among descriptive statistics numbers and percentages for variables determined by counting, and mean±standard deviation for variables determined by measurement were utilised. Shapiro-Wilk test was applied to test whether or not the data were normally distributed. Time, group, time* group interaction for scale scores were evaluated using the Generalized Estimating Equation (GEE) and LSD (Least Significant Difference) tests. Unstructured correlation structure was used to evaluate the covariance between repeated measurements. Partial eta squared (ω2) values were given to show the effect sizes. The correlations between. OAI-23 and SQOL and its subscales were analysed using the Pearson’s correlation coefficient. Pearson’s chi-square test and Fisher’s exact chi-square test were used to determine whether or not there was a difference between the groups in terms of qualitative variables. The value of p < 0.05 was accepted statistically significant.
Results
Characteristics of the participants
Table 1 illustrates the descriptive characteristics of the patients. 60% of the patients in the experimental group and 50% of the patients in the control group were male. The mean age of the patients was 50.90 ± 13.73 years, and approximately two-thirds of the patients in both groups were 45 years old or older. Almost all of the patients in both groups were married and most of them were primary school graduates. Almost all of the participants had health insurance and almost half of them had an income equal to their expenses. Approximately one third of them suffered from a chronic disease. Any statistically significant difference was not detected between the groups in terms of gender, age, marital status, educational status, health insurance, income status, chronic diseases, smoking and alcohol consumption (p > 0.05). Table shows the stoma-related characteristics of the patients. Colon cancer was present in 73.3% of the patients in the experimental group and 67.9% of the patients in the control group. All of the participants stated that they received training on stoma, and most of them received this training from a nurse. 100% of the control group and 93.3% of the experimental group had colostomy. In both groups, stoma care of approximately half of the patients was provided by their family members or caregivers. Approximately two-thirds of the participants changed the bags every day and emptied the bags at least three times a day. Any statistically significant difference was not detected between the groups in terms of the specified stoma characteristics (p > 0.05). The two groups were similar.
Table 1.
Introductory Characteristics of the Patients and Stoma-Related Characteristics (n = 58)
| Introductory Characteristics of the Patients | Experimental Group (n = 30) | Control Group (n = 28) | Test | p | ||
|---|---|---|---|---|---|---|
| N | % | N | % | |||
| Gender | χ2 = 0.586a | 0.444 | ||||
| Female | 12 | 40.0 | 14 | 50.0 | ||
| Male | 18 | 60.0 | 14 | 50.0 | ||
|
Age (x̄±ss = 50.90 ± 13.73) (min = 18. max = 74) |
χ2 = 0.554a | 0.758 | ||||
| 18–45 | 11 | 36.7 | 9 | 32.1 | ||
| 46–58 | 9 | 30.0 | 11 | 39.3 | ||
| 59–74 | 10 | 33.3 | 8 | 28.6 | ||
| Marital Status | χ2 = 1.000b | 0.631 | ||||
| Married | 27 | 90.0 | 25 | 89.3 | ||
| Single | 3 | 10.0 | 3 | 10.7 | ||
| Education Status | χ2 = 3.603b | 0.082 | ||||
| Primary School | 23 | 76.7 | 17 | 60.7 | ||
| Middle School | 1 | 3.3 | 5 | 17.9 | ||
| High School | 5 | 16.7 | 5 | 17.9 | ||
| College | 1 | 3.3 | 1 | 3.6 | ||
| Health İnsurance Status | χ2 = 0.097b | 0.082 | ||||
| Yes | 29 | 96.7 | 23 | 82.1 | ||
| No | 1 | 3.3 | 5 | 17.9 | ||
| Income Status | χ2 = 0.085a | 0.771 | ||||
| Income less than expense | 16 | 53.3 | 16 | 57.1 | ||
| Income equals expense | 14 | 46.7 | 12 | 42.9 | ||
| Number of children | χ2 = 1.919a | 0.383 | ||||
| 0–2 | 6 | 20.0 | 8 | 28.6 | ||
| 3–4 | 15 | 50.0 | 9 | 32.1 | ||
| 5 and above | 9 | 30.0 | 11 | 39.3 | ||
| Smoking status | χ2 = 0.022a | 0.882 | ||||
| Yes | 7 | 23.3 | 7 | 25 | ||
| No | 23 | 76.7 | 21 | 75 | ||
| Alcohol use status | χ2 = 0.483b | 0.483 | ||||
| Yes | 0 | 0.0 | 1 | 3.6 | ||
| No | 30 | 100 | 27 | 96.4 | ||
| Presence of chronic disease | χ2 = 0.222a | 0.637 | ||||
| Yes | 10 | 33.3 | 11 | 39.3 | ||
| No | 20 | 66.7 | 17 | 60.7 | ||
| Medical diagnosis | χ2 = 0.210a | 0.647 | ||||
| Colon Ca | 22 | 73.3 | 19 | 67.9 | ||
| Other | 8 | 26.7 | 9 | 32.1 | ||
| Education about stoma | - | - | ||||
| Yes | 30 | 100 | 28 | 100 | ||
| No | 0 | 0.0 | 0 | 0.0 | ||
| The person providing the Stoma Training | χ2 = 0.473b | 0.272 | ||||
| Nurse | 24 | 80.0 | 25 | 89.3 | ||
| Medical firm | 6 | 20.0 | 3 | 10.7 | ||
| Stoma type | χ2 = 0.492b | 0.263 | ||||
| Colostomy | 28 | 93.3 | 28 | 100.0 | ||
| Ileostomy | 2 | 6.7 | 0 | 0.0 | ||
| Person who cares for stoma | χ2 = 0.218a | 0.897 | ||||
| Itself | 5 | 16.7 | 6 | 21.4 | ||
| Partner | 10 | 33.3 | 9 | 32.1 | ||
| Caregiver or family members | 15 | 50.0 | 13 | 46.4 | ||
| Bag emptying frequency | χ2 = 0.051a | 0.975 | ||||
| 3–4 times a day or more | 18 | 60.0 | 17 | 60.7 | ||
| 2–3 times a day | 6 | 20.0 | 5 | 17.9 | ||
| 1–2 times a day | 6 | 20.0 | 6 | 21.4 | ||
| Bag change frequency | χ2 = 1.612b | 0.464 | ||||
| Every day | 17 | 56.7 | 18 | 64.3 | ||
| Every other day | 6 | 20.0 | 7 | 25.0 | ||
| Once every 3–4 days | 7 | 23.3 | 3 | 10.7 | ||
a Pearson chi-square test, b Fisher’s exact chi-square test
Table 2 illustrates the stoma complications of the patients in both groups at the beginning and in the 3rd and 6th months. The most common complication at the beginning of the study was leakage, which was seen in 60.0% of the experimental group and 75.0% of the control group. The most common complication in the third month of the study was peristomal dermatitis, which was seen in 50.0% of the experimental group and 78.6% of the control group. The most common complication in the 6th month of the study was peristomal dermatitis, which was seen in 23.3% of the experimental group and 42.9% of the control group. Any statistically significant difference was not observed between the groups in terms of stoma complications at the beginning and in the 3rd and 6th months of the study (p > 0.05). Complications were analyzed separately for each category at the patient level, and patients could present more than one complication simultaneously.
Table 2.
Comparison of Patients in the Experimental and Control Groups in terms of Stoma Complications (n = 58)
| Complications | Experimental Group (n = 30) |
Control Group (n = 28) | Test** | p | |||
|---|---|---|---|---|---|---|---|
| n* | % | n* | % | ||||
| Beginning | Peristomal dermatitis | 13 | 43.3 | 11 | 39.2 | χ2 = 1.630 | 0.898 |
| Peristomal bleeding | 3 | 10.0 | 4 | 14.3 | |||
| Leak | 18 | 60.0 | 21 | 75.0 | |||
| İnfection | 1 | 3.3 | - | - | |||
| Smell | 6 | 20.0 | 4 | 14.3 | |||
| 3 months | Peristomal dermatitis | 15 | 50.0 | 22 | 78.6 | χ2 = 11.006 | 0.201 |
| Peristomal bleeding | 3 | 10.0 | 5 | 17.9 | |||
| Retraction | 1 | 3.3 | - | - | |||
| Hernia | 2 | 6.7 | 6 | 21.4 | |||
| Leak | 9 | 30.0 | 14 | 50.0 | |||
| Prolapse | 3 | 10.0 | 2 | 7.1 | |||
| infection | 1 | 3.3 | - | - | |||
| Smell | 5 | 16.7 | 3 | 10.7 | |||
| 6 months | Peristomal dermatitis | 7 | 23.3 | 12 | 42.9 | χ2 = 7.693 | 0.360 |
| Peristomal bleeding | - | - | 2 | 7.1 | |||
| Retraction | 1 | 3.3 | - | - | |||
| Hernia | - | - | 5 | 17.9 | |||
| Leak | 5 | 16.7 | 9 | 32.1 | |||
| Prolapse | 3 | 10.0 | 3 | 10.7 | |||
| Smell | 2 | 6.7 | 3 | 10.7 | |||
* Each complication was evaluated separately at the patient level; therefore, a patient could be counted in more than one complication category, ** Chi-square test
Table 3 illustrates the variation of the generalised estimating equation analysis and OAI-23 subscale and total mean scores between and within the group. It was found that there was a statistically significant difference in OAI-23 subscale and total mean scores of the experimental group within each evaluation and between the groups (p < 0.05). No statistically significant difference was found in OAI-23 subscale and total mean scores of the control group (p > 0.05).
Table 3.
The Effect of Group, Time, and Group*Time Interaction on Total and Sub-Dimensional Scores of the Ostomy Compliance Scale (n = 58)
| Ostomy Compliance Scale and Sub-Dimensions | Measurement time | Experimental Group (n = 30) |
Control Group (n = 28) |
Time | Group | Group x Time | In-group (Experiment) |
In-group (Control) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Average ± sd | Average ± sd | Wald X 2 | p | ω 2 | Wald X 2 | p | ω 2 | Wald X 2 | p | ω 2 | p | p | ||
| Acceptance | Beginning | 17.86 ± 5.51 | 17.17 ± 6.36 | 31.428 | 0.001 | 0.120 | 20.565 | 0.001 | 0.151 | 13.407 | 0.001 | 0.065 | 0.001 | 0.351 |
| 3 months | 23.23 ± 4.84 | 17.71 ± 5.96 | ||||||||||||
| 6 months | 26.03 ± 4.02 | 18.64 ± 5.83 | ||||||||||||
| Anxiety/Worry | Beginning | 6.26 ± 3.07 | 6.10 ± 3.91 | 19.091 | 0.001 | 0.090 | 22.346 | 0.001 | 0.156 | 18.317 | 0.001 | 0.089 | 0.001 | 0.974 |
| 3 months | 9.90 ± 4.90 | 5.96 ± 3.60 | ||||||||||||
| 6 months | 12.33 ± 4.26 | 6.14 ± 4.27 | ||||||||||||
| Social Engagement | Beginning | 4.50 ± 2.92 | 4.42 ± 2.91 | 43.338 | 0.001 | 0.171 | 23.086 | 0.001 | 0.168 | 21.397 | 0.001 | 0.093 | 0.001 | 0.183 |
| 3 months | 9.00 ± 3.71 | 5.07 ± 3.52 | ||||||||||||
| 6 months | 10.80 ± 3.79 | 5.57 ± 3.89 | ||||||||||||
| Anger | Beginning | 2.50 ± 1.97 | 2.39 ± 1.83 | 8.744 | 0.013 | 0.051 | 8.460 | 0.004 | 0.064 | 7.544 | 0.023 | 0.032 | 0.001 | 0.733 |
| 3 months | 3.63 ± 1.80 | 2.71 ± 1.24 | ||||||||||||
| 6 months | 4.10 ± 1.70 | 2.53 ± 1.31 | ||||||||||||
| Total | Beginning | 36.26 ± 11.97 | 35.03 ± 15.03 | 32.698 | 0.001 | 0.146 | 27.422 | 0.001 | 0.188 | 19.722 | 0.001 | 0.096 | 0.001 | 0.456 |
| 3 months | 52.60 ± 15.14 | 36.57 ± 14.28 | ||||||||||||
| 6 months | 61.23 ± 13.57 | 38.07 ± 15.24 | ||||||||||||
Bold values indicate statistically significant p values (p < 0.05)
ω2: partial eta effect size
W: generalized estimating equation (GEE)
Wald X2: Wald chi-square
The change in the experimental group in terms of effect size was observed to be at moderate level (0.06 < ω2 < 0.14) in acceptance, anxious preoccupation, social engagement subscale and total adjustment; whereas, the change in anger subscale was at low level (ω2 = 0.032).
Table 4 shows intra-group and inter-group variation of SQOL subscale and total mean scores with generalised estimating equation analysis. There was a statistically significant difference in SQOL subscale and total mean scores of the experimental group in each evaluation and within the group and between the groups (p < 0.05). No statistically significant difference was determined in SQOL subscale and total mean scores of the control group (p > 0.05).
Table 4.
The Effect of Group, Time, and Group*Time Interaction on Stoma Quality of Life Scale Total and Sub-Dimensional Scores (n = 58)
| Stoma Quality of Life Scale and its Sub-Dimensions | Measurement time | Experimental Group (n = 30) |
Control Group (n = 28) |
Time | Group | Group x Time | In-group (Experiment) |
In-group (Control) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Average ± sd | Average ± sd | Wald X 2 | p | ω 2 | Wald X 2 | p | Wald X 2 | p | ω 2 | Wald X 2 | p | Wald X 2 | ||
| Satisfaction | Beginning | 58.50 ± 21.62 | 65.17 ± 22.79 | 22.652 | 0.000 | 0.059 | 5.447 | 0.020 | 0.049 | 16.029 | 0.001 | 0.069 | 0.003 | 0.009 |
| 3 months | 56.00 ± 28.08 | 41.25 ± 26.65 | ||||||||||||
| 6 months | 74.83 ± 22.94 | 48.92 ± 28.91 | ||||||||||||
| Work/Social Function | Beginning | 28.75 ± 26.92 | 26.04 ± 25.42 | 22.819 | 0.001 | 0.088 | 27.578 | 0.001 | 0.184 | 18.312 | 0.001 | 0.089 | 0.001 | 1.001 |
| 3 months | 46.80 ± 25.34 | 21.27 ± 20.16 | ||||||||||||
| 6 months | 63.61 ± 19.20 | 26.04 ± 22.72 | ||||||||||||
| Sexuality/Body İmage | Beginning | 49.16 ± 23.65 | 34.67 ± 22.51 | 25.097 | 0.001 | 0.128 | 30.353 | 0.001 | 0.202 | 11.160 | 0.004 | 0.060 | 0.001 | 0.242 |
| 3 months | 68.88 ± 22.63 | 37.64 ± 21.97 | ||||||||||||
| 6 months | 76.38 ± 18.22 | 45.08 ± 23.13 | ||||||||||||
| Stoma Function | Beginning | 45.83 ± 19.12 | 39.28 ± 21.80 | 22.480 | 0.001 | 0.113 | 42.394 | 0.001 | 0.259 | 5.806 | 0.055 | 0.032 | 0.001 | 0.082 |
| 3 months | 68.83 ± 21.72 | 44.28 ± 23.08 | ||||||||||||
| 6 months | 76.50 ± 16.66 | 45.53 ± 22.49 | ||||||||||||
| Total | Beginning | 49.09 ± 10.43 | 41.69 ± 15.65 | 30.274 | 0.001 | 0.085 | 29.244 | 0.001 | 0.238 | 19.777 | 0.001 | 0.066 | 0.001 | 0.757 |
| 3 months | 59.30 ± 22.57 | 37.14 ± 20.69 | ||||||||||||
| 6 months | 73.23 ± 16.18 | 42.90 ± 20.81 | ||||||||||||
Bold values indicate statistically significant p values (p < 0.05)
ω2: partial eta effect size
W: generalized estimating equation (GEE)
Wald X2: Wald chi-square
The effect size showing the time-dependent change of the application in the experimental group was moderate in work/social function and sexuality/body image subscales and overall quality of life (0.06 < ω2 < 0.14), while the change in stoma function subscale was at low level (ω2 = 0.032).
Table 5 shows the correlations between OAI-23 and SQOL mean scores. A positive and highly significant correlation was found between total scores of OAI-23 and SQOL (r = 0.714; p < 0.01). A positive and low-level significant correlation was found between scores of SQOL satisfaction subscale and OAI-23 anger subscale (r = 0.245; p < 0.05). A positive and low-level significant correlation was detected between SQOL work/social function subscale and OAI-23 total score (r = 0.749; p < 0.01) and acceptance subscale score (r = 0.736; p < 0.01).
Table 5.
The Relationship Between Ostomy Adjustment Scale and Stoma Quality of Life Scale Mean Scores (n = 58)
| Experimental Group | SQOL Total |
SQOL Satisfaction |
SQOL Work/Social Function |
SQOL Sexuality/Body İmage |
SQOL Stoma Function |
OAI-23 Acceptance |
OAI-23 Anxious Preoccupation |
OAI-23 Social Engagement |
OAI-23 Anger |
OAI-23 Total |
|---|---|---|---|---|---|---|---|---|---|---|
|
SQOL Total |
1 | |||||||||
|
SQOL Satisfaction |
0,806* | 1 | ||||||||
|
SQOL Work/Social Function |
0.801* | 0.523* | 1 | |||||||
|
SQOL Sexuality/Body İmage |
0.758* | 0.422* | 0.730* | 1 | ||||||
|
SQOL Stoma Function |
0.711* | 0.270** | 0.642* | 0.655* | 1 | |||||
|
OAI-23 Acceptance |
0.639* | 0.409* | 0.736* | 0.614* | 0.557* | 1 | ||||
|
OAI-23 Anxious Preoccupation |
0.698* | 0.486* | 0.676* | 0.576* | 0.573* | 0.788* | 1 | |||
|
OAI-23 Social Engagement |
0.678* | 0.410* | 0.681* | 0.622* | 0.654* | 0.743* | 0.781* | 1 | ||
|
OAI-23 Anger |
0.453* | 0.245** | 0.456* | 0.352** | 0.417* | 0.509* | 0.539* | 0.584* | 1 | |
|
OAI-23 Total |
0.714* | 0.452* | 0.749* | 0.630* | 0.627* | 0.914* | 0.929* | 0.890* | 0.663* | 1 |
Bold values indicate statistically significant p values (p < 0.05)
*p < 0.01; **p < 0.05
r = 0.00 (No relation), r = 0.01–0.29 (Low relation), r = 0.30–0.70 (Moderate relation), r = 0.71–0.99 (High relation), r = 1.00 (Excellent relation)
Discussion
The nurse navigation programme significantly improved stoma adjustment and quality of life in patients with stoma. Although no statistically significant difference was found in complication rates, lower rates were observed in the experimental group.
It was determined that the stoma-associated complications experienced by the participants in both groups were similar, and the most common complications were peristomal dermatitis and leakage. In the literature, it is stated that the most common stoma complications include peristomal skin complications and leakage. Altınbaş [31] conducted a systematic review including 15 studies prospectively evaluating stoma complications of patients with repeated observations and reported that stoma complications primarily included peristomal dermatitis, peristomal skin irritation, leakage, and allergic reactions. Similarly, other related studies reported that the most common stoma complications were peristomal skin complications and dermatitis [5, 9, 10, 38].
No study was found showing the effectiveness of nurse navigation programme in preventing complications in patients with intestinal stoma. In the systematic review conducted by Rodrigues et al., [39] on clinical outcomes of the navigation programme applied by nurses in oncology patients, they determined that in studies including gastrointestinal cancer patients, nurse navigation programme provided continuity of care and symptom control. Joo and Liu [23] provided counselling to a group of cancer patients with the nurse navigation program and reduced their symptoms. In this study, 73.3% of the patients had colon cancer, which can be considered similar to the studies mentioned. Although not under the name of nurse navigation programme, it was revealed that stoma-related complications were significantly reduced in intervention studies in which patients with stoma were followed up after discharge [3, 40, 41].
The results of the present study revealed that OAI-23 subscale and total mean scores of the patients in the experimental group increased significantly in the 3rd and 6th months and there was a statistically significant difference between the groups. The change in the experimental group in terms of effect size was at moderate level in acceptance, anxious preoccupation, social engagement subscales and overall OAI-23, while the change in anger subscale was at low level.
Despite the training provided by the stoma nurses in the hospital, patients experience problems with stoma adjustment in the first months after discharge [28]. Continuation of follow-up, training, and counselling services by the nurse after discharge facilitates the patient’s stoma adjustment [12]. Training and counselling service should be determined according to the needs of the patient and should be given with appropriate methods (such as hospital appointments, remote support systems, phone calls, information messages, videos) [13]. In this study, a training booklet containing information about the products used in stoma care, stoma care and bag change, things to consider in daily life activities, stoma-related complications and emergencies was delivered to patients in both groups during the first interview. Although both groups were given a training booklet, the fact that the patients in the experimental group had higher stoma adjustment than the control group showed that the continuity of follow-up and care was effective. Making phone calls with the patients in the experimental group at least once a week for 6 months, sharing illustrated information messages and training videos every week, and being able to get counselling by calling the navigator nurse when the patients need it are assessed as important practices that contribute to the increase in stoma adjustment.
It can be asserted that the changes in the mood of the patients due to stoma were effective in the low change in the anger subscale of OAI-23. It can be recommended that navigator nurses working with patients with stoma should work in cooperation with psychologists in identifying and correcting the emotional problems of patients.
In the control group, OAI-23 subscale and total mean scores showed a slight increase in the 3rd and 6th months, as well. This insignificant increase showed that patients adapted to live with a stoma over time; however, they needed long-term follow-up, training and counselling, as in the nurse navigation programme, in order to have a higher level of adjustment.
In this study, it was found that SQOL subscale and total mean scores of the experimental group increased significantly in the 3rd and 6th months, and there was a statistically significant difference between the groups. The effect size showing the time-dependent change of the application made to the experimental group was detected at moderate level in work/social function and sexuality/body image subscales and overall SQOL, while the change in stoma function subscale was at low level.
One of the most important factors in enhancing the quality of life of patients is that the patient gains the ability to perform stoma care on his own. The earlier the patient can take care of their stoma after stoma surgery, the better the quality of life [42, 43]. In this study, it was determined that the rate of the patients who performed their own stoma care was very low, and stoma care was generally provided by spouses/family members/caregivers in the first evaluation. However, limitation of this study is that the rate of patients who performed stoma care themselves was not questioned in the evaluations made in the 3rd and 6th months. Therefore, it was not possible to evaluate changes in patients’ self-care abilities over time.
Results of the studies that did not use a nurse navigation programme in the literature, but which were similar in some aspects in terms of the application, have also revealed an enhanced quality of life. In the study conducted by Xia [16] with continuous care model, it was indicated that the quality of life of patients with stoma enhanced in the first three months after discharge. Zhang et al., [13] applied a hospital-family holistic care model based on the use of mobile technology to patients with permanent stoma and stated that their quality of life enhanced. Parchami Iraqi and Ahmadi [18] provided an enhancement in the quality of life of patients with permanent colostomy, to whom they provided phone counselling for 16 weeks. In their systematic review examining how telephone monitoring affected patients with permanent colostomy, Semi et al., [44] stated that the application provided an enhancement in the quality of life. Taylan and Aksoy [6] provided phone counselling to patients with stoma for the first 10 weeks after discharge and reported that their quality of life and social adjustment improved significantly. In this study, weekly phone calls that we implemented for 6 months within the scope of the nurse navigation programme, sharing illustrated information messages and training videos every week, and the fact that patients can get counselling by calling up the navigator nurse when they need it are considered as practices that contribute to an enhancement in stoma-related quality of life.
In the present study, a positive and highly significant correlation was found between OAI-23 and SQLS total scores. As the patients’ stoma adjustment increased, their quality of life enhanced. Another significant result was that there was a positive and highly significant correlation between SQLS work/social function subscale and OAI-23 total score and acceptance subscale score. As the patients’ stoma adjustment increased and they accepted stoma, the quality of life enhanced in their work/social function subscale. Similar results were found in some studies examining stoma adjustment and quality of life [3, 6, 45].
Another aspect of the nurse navigation programme applied within the scope of this study was its implementation during the coronavirus pandemic. The fact that patients who had difficulty in reaching hospitals and healthcare personnel, especially nurses during the pandemic, easily reached the navigator nurse by phone and received counselling on the issues they need ensured the continuation of care. Ferrua et al., [46] applied the nurse navigation programme to cancer patients for 6 months during the pandemic period, showed positive results in symptom management and supportive care as a result of tele-monitoring with the mobile phone application, and reported that hospitalisations and emergency admissions significantly reduced. In this study, the nurse navigation programme was conducted by a researcher nurse who had received training and had experience in stoma care, rather than a certified stomatherapy nurse. This reflects the current clinical practice in the study setting. However, whether structured programmes delivered by specialized stomatherapy nurses may lead to different outcomes can be explored in future studies.
Conclusions
The results of this multicenter randomised controlled study revealed that the nurse navigation programme provided a highly significant increase in stoma adjustment and quality of life of patients with stoma. However, although there was no significant difference in the incidence of stoma-related complications, the findings do not provide sufficient evidence that the programme reduces complication rates.
Recommendations
In the light of the results of the study; it is recommended.
To conduct studies in which the nurse navigation program is applied in providing continuous care, follow-up and counselling services to patients with stoma after discharge and to evaluate the results with different dimensions,
To apply the nurse navigation program to different chronic conditions that affect the stoma adjustment and quality of life of the patients and to assess the results,
To assess the results of the nurse navigation program application using qualitative research methods,
To provide nurses with training on the nurse navigation program and introduce the application examples from abroad,
To put nurse navigation programs into practice in necessary units of health institutions,
To plan studies evaluating the cost dimension of the nurse navigation program,
To make long-term follow-ups of patients with stoma.
Limitations
The findings of this study were limited to patients with stoma who were followed up and treated in the related hospitals. The rate of patients who cared for stoma themselves was not questioned in the evaluations in the 3rd and 6th months, planned operations were postponed due to the pandemic process, stoma was opened only for emergency cases and this situation was not questioned during data collection, only the contact information of the patients was obtained, the contact information of their relatives was not taken, and the communication was interrupted from time to time due to problems in communication technology, all of which can be assessed as the limitations of the study.
Supplementary Information
Acknowledgements
The authors express their special thanks to all participants who participated in this study.
Abbreviations
- OAI-23
Ostomy adjustment inventory-23
- SQOL
The stoma quality of life scale
Authors’ contributions
GY: Conceptualization, Methodology, Software, Data curation, Writing- Original draft preparation, Visualization, Investigation, Supervision, Software, Validation, Writing- Reviewing and Editing. NT: Conceptualization, Methodology, Writing- Original draft preparation, Visualization, Investigation, Supervision, Software, Validation, Writing- Reviewing and Editing.
Funding
No external funding.
Data availability
Not applicable. This manuscript does not report data generation or analysis.
Declarations
Ethics approval and consent to participate
This multicenter, randomised controlled study was registered in the clinical trials database (NCT05809661). The study was carried out by following the Declaration of Helsinki. Ethics approval dated 18.03.2021 and numbered 2021-29 was obtained from the Non-invasive Ethics Committee of the Hasan Kalyoncu University. Institutional permission was obtained from the related university hospital (Permission No: E-9178672-010.99-43910). Permission was obtained from the provincial directorate of health to conduct the study in the state hospitals and the private hospital (Permission No: E-48230018-774.99). Each participant signed informed consent form .
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
This article is derived from the doctoral dissertation of Gülistan Yurdagül entitled “Nurse Navigation Programme on Stoma Adjustment, Quality of Life, and Prevention of Complications in Patients with Stoma.”
Some of the results of this study were presented as an oral presentation at the International Congress of Medical and Health Sciences Studies held in Ankara on 13-14 December 2022.
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Supplementary Materials
Data Availability Statement
Not applicable. This manuscript does not report data generation or analysis.