Studying the effect of structured ostomy care training on quality of life and anxiety of patients with permanent ostomy

Abstract

Patients with ostomy are faced with several physical, psychological, and social challenges and need to be prepared to overcome these challenges. Studies have shown that training plays an important role in helping patients to adapt with ostomy, live with it, and improve their psychological well‐being and quality of life (QOL). Therefore, the present study aimed to determine the effect of structured ostomy care training on QOL and anxiety of the patients with permanent ostomy. In this randomised clinical trial study, 60 eligible participants were recruited from the only ostomy clinic in Kerman, Iran. They were selected using a purposive sampling method and randomly assigned to either a control group that received routine ostomy care or an intervention group that attended oral and practical training and a question and answer session by a trained ostomy nurse and received an ostomy information booklet besides their routine care. Outcome variables were anxiety and QOL in general and its physical, mental, social, and spiritual dimensions in detail. By using the anxiety subscale of Hospital Anxiety and Depression Scale (HADS) and City of Hope‐quality of life [COH‐QOL], data were collected before and 2 months after intervention in both groups. Data were analysed by SPSS version 19 using χ², analysis of variance (ANOVA), independent t, and paired t test and multiple regression analysis. The results showed that the intervention group had significantly lower mean scores in anxiety (P = .001) and a higher mean score in overall QOL (P = .009) compared with the control group. The most significant increase was observed for psychological, social, and physical aspects, and the least was in the spiritual aspect, all of which improved after intervention. After controlling the effects of confounding variables such as age, ostomy period, and number of children, the structured training programme still had a positive effect on QOL. Structured ostomy care training, including face‐to‐face education and personal practice of using ostomy equipment, along with written material provided by the ostomy nurse specialist, may lead to an increase in the overall QOL and a decrease in the perceived anxiety level in patients. This type of training is not routinely delivered to ostomy patients in our health care setting, so it is feasible to prepare surgical wards and to educate nurses to work with their patients before and after ostomy creation. Furthermore, to ease patients' religious concerns, we recommend counselling, and the support of religious leaders in the Muslim community may play a key role to adaptation regarding religious matters after ostomy surgeries and alleviate patients' concerns.

1. INTRODUCTION

Living forever with stoma after suffering diseases is very complicated, and everyone may experience it differently.1 To our knowledge, while ostomy surgery may improve health‐related quality of life (QOL) by reducing disease burden, stoma patients' QOL in all aspects is impacted by this surgical procedure, which was created to save their lives.2

It is estimated that about 30 000 patients live with ostomy in Iran.3 In addition to the problems of chronic diseases such as cancer and inflammatory bowel disease (IBD), ostomy patients are deeply involved with problems, such as skin burns; ulcers; infection; and protrusion of intestine, stoma hernia, nutritional problems and psychological, social, occupational, marital problems; unemployment; and divorce. In some cases, it leads to social isolation, decrease in sexual activity, anxiety, depression, and sometimes suicide attempts.4 In this regard, Bahayi et al.5 showed that patients with colostomy or ileostomy had more anxiety symptoms and lower QOL than normal, healthy people.

The above‐mentioned problems are preventable by tailored ostomy care training, which results in improvement in QOL and decreasing anxiety of ostomy patients.4 Created stoma decreases the overall aspects of patients' QOL; to resolve this issue, education is very important for patients and their families.6 Structured patient education programmes that are directed to increase knowledge and focus on the psychological needs of stoma patients may improve their health‐related QOL.1 It is challenging to teach ostomy patients how to self‐care after operation, and they need support and counselling to learn how to integrate self‐ostomy care into daily activities.7This issue is more challenging when patients are Muslims because it interferes with their religious tasks, which require purity (ablution and ghusl). Moreover, a systematic review showed that the QOL in Muslim ostomy patients was lower than non‐Muslim patients.8 A study on QOL in Muslim ostomate patients demonstrated that standards of QOL in the Muslim population may be improved by proper education and management by stoma care nurses and physician's counselling.9 At the same time, some researchers proposed that it would be very practical to improve public health policies for stoma patients and for patients to be guided by nursing interventions during the pre‐operating period regarding: possible complications and impacts on body image, clothing, food, sexuality, interpersonal relationships, activities of daily living, and preparation for stoma self‐care,10 but other studies recommended that stomate patients may benefit from support groups in hospitals.11 In a systematic review about the effect of education on patients with stoma, the authors concluded that there is a need to test this effect in more controlled studies.1

We hypothesised that focused and structured education provided by a trained ostomy nurse compared with receiving routine care would affect the treatment outcomes of anxiety and QOL in ostomy patient. Therefore, we designed a two‐group randomised clinical trial to evaluate the effect of structured ostomy care training on the QOL and anxiety of patients with permanent ostomy.

2. MATERIALS AND METHODS

2.1. Design

The present study is a clinical trial in which two groups of ostomy patients were assessed pre‐ and post‐intervention.

2.2. Participants

The eligible participants were all patients with permanent ostomy regardless of their diagnosis, who referred to the sole ostomy clinic of southeast Iran in Kerman City. Power calculations showed that a sample size of 54 patients would have 80% power to detect an effect size of approximately 0.5 (α = 0.05). However, in order to increase the strength of the study, 60 patients were selected among others, and 30 were assigned to either the intervention or control group.

The inclusion criteria for patients were: age ≥ 18 years, having a permanent ostomy, at least 1 month since permanent ostomy surgery, and the ability to understand and complete the questionnaire.12 Exclusion criteria were suffering from anxiety and depression disorders diagnosed by physician, suffering from functional disorders in a way that they cannot take care of themselves, and anyone who gives up participation in the study for any reason (replaced with predetermined eligible ones). Finally, the list of eligible patients was prepared, and then, odd and even numbers were assigned to them by a person unaware of the study, with 60 patients selected to participate in the study; then, 30 people were randomly assigned to two intervention and control groups.

2.3. Instruments

2.3.1. COH‐QOL ostomy questionnaire

The questionnaire includes 90 questions in three parts. The first part includes 13 questions about demographic and disease properties. The second part includes 34 questions about the effect of ostomy on lifestyle with one‐word answers about job, insurance, sex, mental concerns, clothing, diet, routine ostomy care, and food groups. The third part includes 43 questions about the effect of ostomy on QOL related to physical, mental, social, and spiritual health dimensions of QOL. The questions in this part are scored on a Likert scale from 0 to 10, used to measure total score of QOL. A score of 0 shows the best QOL, and 10 shows the worst QOL in negative questions, while it is vice versa in positive questions. Therefore, inverted changes were applied for negative questions to determine a scoring range similar to positive questions, 0 for the worst and 10 for the best.3 In present study, the third part of the Persian version of the COH‐QOL Ostomy Questionnaire was used. Its validity and reliability were measured by Naseh et al3 in Iran. Reliability of the questionnaire was assessed using test‐retest and internal correlation tests. For test‐retest, the questionnaire was filled out by 10 patients with permanent ostomy, and then, it was filled out again by the same patients after 2 weeks. At the end, Cronbach's α and correlation coefficient for physical, mental, social, and spiritual dimensions of QOL were as follows: 0.95, 0.82, 0.88, 0.83, and 0.78, respectively.3 After obtaining the reliability of the COH‐QOL questionnaire, a decision was made to remove the second part of the questionnaire because of its length and the fatigue caused by responding to it.

2.3.2. HADS questionnaire

Anxiety subscale of HADS was also administered. The HADS was developed in 1983 by Zigmond and Snaith13 to define risk and levels of anxiety and depression, as well as to measure their intensity changes in patients. The scale has 14 items; 7 of them (odd numbers) measure anxiety, while the remaining 7 (even numbers) measure depression (31). All items are rated on a 4‐point scale, scored from 0 to 3, resulting in maximum subscale scores of 21 and an overall total score ranging from 0 to 42, with higher scores indicating greater levels of depression and anxiety. Kaviani et al14 investigated the scale validity and reliability in Iran. It had suitable validity, and the scale reliability based on Cronbach's α for subscales of depression and anxiety has been reported to be 0.70 and 0.85, respectively.

2.4. Intervention and data collection

The anxiety subscale of HADS was distributed among the patients. Based on the sample size, 60 patients who scored above 7 on the anxiety subscale of HADS were recruited to the study. After assigning the patients in the intervention and control groups, the participants completed the pre‐test questionnaires.

Patients in the surgical ward received only written material regarding ostomy, and there are few nurses qualified in ostomy care delivery, pre‐ and post‐operation. It was observed that most patients and their families are so worried, so they may not ask questions. In addition, nurses and physicians do not have enough time to open dialogue with them to elicit patients' special needs and concerns. According to this issue, patients in the control group only received, and were offered, written material and questions and answers, which are limited to those patients who are interested to know more, and prepared for surgery procedures as a routine care. In the intervention group, all eligible patients attended a one‐session training. A trained ostomy nurse (first author) provided structured oral and practical information about ostomy, working with patients to learn how to manage ostomy and perform self‐care, answering their questions, and evaluating their learning by asking questions, and at the end of session, patients received a training booklet including: information about caring for ostomy, sexual relationship, travel, diet, rituals, physical activities, sport, familiarity with ostomy equipment and how to use it, and common and uncommon side effects of ostomy and how to manage them. The booklet was prepared by the first author under the supervision of the research team and was validated by a general surgeon and a colorectal fellowship in the ostomy clinic.

After group assignment, patients in the intervention group were invited by the first author to participate in a single‐session practice training and workshop(2‐hour meeting) including information about properties of healthy skin and how to take care of the skin; measure pouch size; detach and empty the pouch; change the two‐piece pouches; prevent leakage; and how to use ostomy equipment (powder, belt, paste, and adhesive), which was explained and performed by an ostomy‐specialised nurse (first author), in addition to asking and answering questions and practicing/performing procedures for patients. Patients in the control group received routine care and did not receive any structured, integrated, and practical training. The post test (HADS and COH‐QOL questionnaires) was completed 2 months after intervention by the intervention and control groups.

2.5. Data analysis

Data were analysed by SPSS 19. Normality of the data was measured using the Shapiro‐Wilk test. The distribution of the data was normal. Descriptive statistics, such as frequency, percentage, mean, and SD, were used to describe the demographic characteristics of the research samples.

To assess homogeneity between the groups, the χ² test was used. Based on the normal distribution, parametric tests were used. To compare pre‐ and post‐intervention QOL and anxiety, a paired t test was used. Furthermore, a student's t test was used to compare the variables between the two groups. To compare QOL and anxiety scores according to the demographic factors (age, occupation, and education), independent t test and analysis of variance (ANOVA) were used.

Multiple regression analysis was used to study the effect of independent variables (structured ostomy care training, age, ostomy period, and number of children) on dependent variable (QOL or anxiety). The significance level was considered to be P < .05.

2.6. Ethical considerations

After obtaining ethical approval (IR.KMU.REC.1395.158) from the Ethics Committee of the Research Deputy of Kerman University of Medical Sciences, the researcher received the clinical trials code (IRCT 2016110224919) from the Iranian clinical trials (IRCT) registration system and then received a referral letter from the Razi Nursing and Midwifery Faculty to carry out the study and presented it to the head of the ostomy clinic in the southeast of Iran. Then, the research method, optional participation, and ineffectiveness of rejection from participation in the treatment process were explained sufficiently to the patients, in addition to assurances of their information's confidentiality. A written consent letter was also filled out by each patient.

The researchers accepted the responsibility to train the control group with a programme similar to the intervention group because of the positive effects of the presented training in this study on the QOL and anxiety of the intervention group patients.

3. RESULTS

3.1. Descriptive results

Results of the χ² test showed that both groups are homogenous (P > .05) but heterogeneous in terms of length of time of being ostomate (P = .001) (Table 1).

Table 1.

Demographic characteristics of patients with permanent ostomy

Variables		Intervention group		Control group		χ²	P
		N	%	N	%
Gender	Female	16	26.7	11	26.7	1.7	.19
	Male	14	23.3	19	31.7
Age	Less than 56 years old	18	30	11	18.3	0.16	−1.43
	More than 56 years	12	20	19	31.7
Number of children	Less than 4 children	14	23.3	14	23.3	0.75	−4.87
	More than 4 children	16	26.7	16	26.7
Level of Education	Illiterate	12	20	9	15	0.66	.70
	Under the diploma	11	18.3	13	21.7
	Diploma and higher	7	11.7	8	13.3
Economic situation	Weak	16	26.7	12	20	1.07	.3
	Medium	14	23.3	18	30
Marital status before the ostomy	Single/widow/divorced	5	8.3	2	3.3	1.45	.42
	Married	25	41.7	28	46.7
Marital status at the moment	Single/widow/divorced	5	8.3	5	8.3	0.001	1
	Married	25	41.7	25	41.7
Type of ostomy	Permanent colostomy	22	36.7	24	40	0.37	.54
	Permanent ileostomy	8	13.3	6	10
Reason for stoma creation	Colon or Rectum Cancer	21	35	19	31.7	0.30	.78
	Other Cancers	5	8.3	7	11.7
	Other	4	6.7	4	6.7
Length of time of being ostomate	Less than 22 months	25	41.7	4	6.7	0.36	.001
	More than 22 months	5	8.3	26	43.3

3.2. Quality of life

According to the results of the independent t test, there is no significant difference between mean scores of QOL pre‐intervention between two groups (P = .10), whereas a post‐intervention comparison showed significant differences between two groups (P = .009); the intervention group exhibited positive significant changes (Table 2). Moreover, according to the results of the paired t test, mean scores of QOL and its dimensions in the intervention group increased significantly after the intervention compared with the pre‐intervention. However, in the control group, no significant improvement was observed in the mean score of QOL in the second assessment (P = .79) (Table 3).

Table 2.

Comparing mean score for anxiety and quality of life (QOL) between groups in patients with permanent ostomy

Variables		Before intervention				After intervention
	Group	Mean	SD	t test	P	Mean	SD	t test	P
Physical health	Intervention	45.56	10.53	−2.19	0. 33	61.93	9.89	3.33	0.002
	Control	46.93	11.94			51.16	14.46
Psychological health	Intervention	32.83	13.74	−2.04	0.87	64.00	9.46	−0.15	0.046
	Control	64.00	76.97			66.20	77.32
Social relationship	Intervention	42.16	12.58	0.29	0.13	62.00	10.73	0.11	0.022
	Control	49.00	20.90			52.90	18.20
Environmental	Intervention	29.23	11.55	0.43	0.66	41.96	11.52	3.03	0.004
	Control	27.83	13.15			32.43	12.77
Total QOL score	Intervention	144.8	34.07	−2.40	0.10	229.9	83.3	1.65	0.009
	Control	185.7	84.9			202.7	38.3
Anxiety	Intervention	13.40	4.23	2.31	0.24	11.06	2.26	0.3	0.001
	Control	10.62	3.55			10.26	3.45

Table 3.

Pre‐ and post‐intervention mean score for anxiety and quality of life in patients with permanent ostomy

Variable	Intervention	Intervention group				Control group
		Mean	SD	Paired t test	P	Mean	SD	Paired t test	P
Physical health	Pre	40.56	10.53	10.69	.04	46.93	11.94	−2.19	.07
	Post	61.93	9.89			51.16	14.67
Psychological health	Pre	32.83	13.74	10.91	.005	62	11.14	−0.15	.25
	Post	64	9.46			66.20	8.65
Social health	Pre	42.16	12.58	8.88	.17	49	20.90	−1.53	.92
	Post	62	10.73			52.90	18.20
Spiritual health	Pre	29.23	11.55	12.14	.83	27.83	13.15	0.43	.33
	Post	11.52	41.96			32.43	12.77
Total QOL score	Pre	144.8	34.07	14.10	.001	185.7	84.9	1.56	.79
	Post	229.9	83.3			202.7	83.3
Anxiety	Pre	13.40	4.23	−10.6	.001	11.06	3.55	2.31	.85
	Post	10.62	2.26			10.26	3.45

Results obtained from regression analysis showed that the effect of structured ostomy care training on QOL score was still significant considering the confounding variables such as age, length of time of being ostomate, and number of children (Table 4).

Table 4.

The results of multiple regression analysis on the effect of significant variables on anxiety and quality of life

Variables	B	SE	Beta	t	P
Age	−6.28	11.49	−0.058	0.54‐	.58
Gender	2.97	11.71	0.027	0.25	.8
Number of children	−6.50	5.20	−0.11	−1.25	.216
Length of time of being ostomate	−21.32	40.15	−0.19	−1.38	.172
Structured training	68.16	11.7	0.62	6.15	.000

3.3. Anxiety

According to the results of the t test, there is no significant difference between mean scores of anxiety pre‐intervention between two groups (P = .24), whereas a post‐intervention comparison showed significant difference between the two groups (P < .001) (Table 2).

According to the results of the paired t test, when the patients' pre‐ and post‐intervention mean scores for anxiety were evaluated, it was determined that patients' mean score for anxiety had significantly decreased in the intervention group (P < .001), whereas in the control group, there was no significant difference in patients' pre‐ and post‐intervention mean scores of anxiety (P = .85) (Table 3).

Multiple regression analysis showed that the effect of structured ostomy care training on anxiety score was still significant considering the confounding variables, such as age, length of time of being ostomate, and number of children (Table 4).

4. DISCUSSION

The results of this study indicated that structured ostomy care training reduced anxiety and improved QOL and its dimensions in patients with permanent ostomy. These findings are consistent with previous studies that evaluated the effect of training activities, stress management programme, and supportive interventions on anxiety and QOL and their dimensions in patients with permanent ostomy.1, 8, 15, 16, 17

Danielsen and Rosenberg1 found that training activities increasing knowledge and focusing on the social and psychological needs of ostomy patients can improve their QOL. Furthermore, stress management programmes can reduce stress, depression, and anxiety and enhance stress management knowledge and perceived relaxation in stoma patients.16 In general, training interventions in ostomy patients may have positive effects on their QOL, some social‐psychological skills, and self‐management.17

The postoperative period can trigger symptoms of stress, anxiety, and depression in patients with ostomy because it is a transitional period that requires adjustment to the new physical condition.16 The nurse to patient ratio in Iran is contrary to the global standards, so patients are hardly assessed for the stress and anxiety they may experience before and after the surgery or receive face‐to‐face and structured training during their hospitalisation. After discharge, ostomy clinics are the sole source for patients to receive suitable training tailored to their needs, but not all patients attend these centres because of the lack of information, awareness, or even transportation. According to the aforementioned information, patients should be prepared about their disease and obtain practical advice for living with stoma before, during, and after operation by a trained nurse to alleviate their concerns and improve their QOL. The design and implementation of appropriate training and supportive interventions, especially in the initial months after ostomy surgery, can help patients to adapt to their appearance and maintain their social interactions.8 Ostomy‐specialised nurses can train and support patients, encourage them to take care of ostomy, increase self‐efficacy, and thus increase the QOL of ostomy patients.18

According to the results of this study, the anxiety level and the mean score of all dimensions of QOL improved after the intervention, and mental, physical, social, and spiritual health had the most improvement. Soad et al7 concluded that educational guidelines had a positive effect on improving awareness (knowledge and practices) and self‐efficacy among patients with permanent colostomy. Psychological problems of patients who had ostomy included a change in the perception of the body, decreased self‐esteem, impairment of sexual functions, emergence of problems in alignment with the spouses, and various psychiatric disorders, including depression in the forefront.5

Generally, patients' adaptation to ostomy during the first days after surgery is lower because of the severe conditions of surgery and deformed appearance, but they will adapt more with passing time, and their mental health will also increase. In the present study, the recovery period of the patients after surgery was passed, and training about colour of the ostomy and the skin around it, determining its size, and cutting the adhesive causes more acceptance and adaptation of patients with ostomy and facilitates taking care of it; this resulted in the increase in mean score of mental health. Nurses play an important role in presenting such interventions, and these effects can encourage patients to participate in the training programmes.17

In light of the current study results, patients' physical health concerns were significantly diminished after the intervention. By learning and following nutritional tactics in order to control some ostomy‐related concerns such as: bad smell, sound, gas, constipation, diarrhoea, etc., such problems declined, and the mean score of physical health was increased. Ben Fatma et al19 stated that technical training by skilled trainers can improve some of problems related to pouch leakage and skin irritations. Soad et al7 found that training has a positive effect on the awareness, knowledge, and self‐efficacy of permanent colostomy patients, in addition to a significant reduction of anxiety, side effects, and skin problems after surgery.

The mean score of the patients' social health significantly increased after the intervention in the present study. Sport activities, presence in society, travelling, stress in family, personal relations, and having intimate relationships with others are negatively affected in ostomy patients and reduces the patients' social health.20 Akbulut21 stated that, by proper nutrition, diet, and taking care of ostomy, the patient can prevent the bad smell caused by accumulation of excreta in the pouch, which affects one's mental image and prevents him or her from having relationships and presenting in society, which leads to the patient's isolation. This finding was consistent with Danielsen and Rosenberg1 who found that patients' education about ostomy could promote their social functioning 3 and 6 months after the intervention. Negative feelings, such as anxiety, depression, and anguish, arise concomitantly with concerns about social life and insecurity when ostomate wants to reintegrate to previous social roles and functions. Thus, health professionals should recognise and assist/encourage patients in their efforts to reduce such concerns by providing professional support for the development of instrumental, expressive, and social skills. The ability to perform the care of the stoma and the skin around the stoma, the competence to identify problems and complications, and the search for appropriate physical and psychosocial solutions should be primarily achieved.10

From the patients' perspective, among QOL dimensions, the lowest mean score belonged to the “spiritual health” domain. Muslims believe in the necessity of purity for entering holy places and performing religious practices, and ostomy is contrary to their beliefs. As all patients who participated in the present study were Muslim, the spiritual health score was less affected by intervention. A systematic review on QOL concluded that Muslim patients had lower QOL compared with other religions.8 In a study in Egypt on QOL in ostomate patients, results showed that there is a clear relationship between the impact of stoma on religious rituals and quality of life. In Islamic faith, praying in the mosque has advantage over praying alone in the house. The majority of Muslim ostomates in the above‐mentioned study do not pray in the mosque for fear of smell. Moreover, a significant number of Muslim ostomates cannot perform Hajj because stoma interferes with their ability to travel.22 Lack of purity to perform religious tasks such praying or Hajj, which is an obligation for them, is the main problem of Muslim ostomate,8 and this issue is not resolved by training and education primarily. These reasons may be the most effective factors why the spiritual aspect of QOL was not improved after our intervention. However, some studies demonstrated that, if effective psychological counselling by the religious leaders is available, the spiritual aspect of QOL in ostomate patients will remain high. They further emphasise that Muslim religious leaders probably better counsel their followers about religious matters, and they have greater influence and control over the followers than doctors, nurses, and psychologists.23

The study had a number of limitations, including the low number of participants and no participants' blindness. It is suggested that future studies be conducted on more samples with blindness.

5. CONCLUSION

In the present study, it was observed that, after receiving structured, face‐to‐face training, along with a question and answer session followed by the provision of a take‐home guide booklet by a ostomy nurse specialist, anxiety of the patients in the intervention group decreased, and their QOL improved significantly compared with the control group that received routine care. Most patients referred to ostomy clinics after the surgery as they are not appropriately prepared regarding ostomy care, so a recommendation is made that these clinics have the facilities to provide such structured training by nurse specialists to patients, also involving their families to support them in order to enhance their QOL. In our community, religious leaders are able to impress people effectively, so to improve the QOL using methods besides the timely nursing interventions, religious leaders can play a role to relieve patients' spiritual concerns regarding purity and religious tasks and promote their spiritual aspect of QOL.

CONFLICT OF INTEREST

The authors did not receive any sponsor's help in the design, methods, subject recruitment, data collections, analysis, and preparation of paper or have any personal relationships with other people or organisations that could inappropriately influence (bias) their work.

AUTHOR CONTRIBUTIONS

All authors contributed to the concept, design, analyses, interpretation of data, and drafting of manuscript or revising it critically for important intellectual content.

Khalilzadeh Ganjalikhani M, Tirgari B, Roudi Rashtabadi O, Shahesmaeili A. Studying the effect of structured ostomy care training on quality of life and anxiety of patients with permanent ostomy. Int Wound J. 2019;16:1383–1390. 10.1111/iwj.13201