Effect of self-care education on self-efficacy of patients with multiple sclerosis: a randomized clinical trial

Abstract

Background

Self-care education is one method used to reduce the complications of chronic diseases like Multiple sclerosis which affects self-efficacy. The present study evaluated the effect of self-care training by nurses on the self-efficacy of patients with multiple sclerosis.

Methods

This is a randomized clinical trial with pre-test/ post-test. The statistical population of this study included all patients with multiple sclerosis who were members of the Iranian Multiple Sclerosis Association, from whom 90 patients were selected and divided into two groups of intervention and control (n = 45 people in each group), through a table of random numbers. First, both groups completed the demographic information and Sherer's self-efficacy questionnaire. Then, a self-care empowerment program was delivered to patients in the intervention group. Eight weeks later, the self-efficacy questionnaires were completed again by both intervention and control groups. The data were analyzed using SPSS-22 statistical software.

Results

The mean self-efficacy score in the intervention group was (60.27 ± 8.63) and in the control group was (59.07 ± 6.84) before the intervention. After the intervention, a statistically significant difference was observed between the two groups regarding the mean self-efficacy scores (p = 0.004). The mean self-efficacy scores in the intervention and control groups were (63.73 ± 6.97) and (59.21 ± 6.23) after the intervention.

Conclusions

A Self-care training program can be used as one of the methods to improve self-efficacy in patients with multiple sclerosis.

Trial registration

The protocol of this clinical trial has been registered in the Iranian Clinical Trial Registration Center (registration code: IRCT20180914041036N1). Registered 18 January 2019- Retrospectively registered, date of first recruitment: 23 August 2017, https://www.irct.ir/.

Background

Multiple Sclerosis is one of the chronic inflammatory diseases of the central nervous system [1], which is caused when the body attacks the nerve cells of the immune system in the brain and spinal cord, disrupting the cells that produce the myelin sheath [2, 3]. This disease causes a wide range of symptoms, such as balance and coordination disorders, bowel and bladder dysfunction, vision disorders, speech disorders, pain, cognitive function disorders, sexual dysfunctions, and mood changes [4].

Studies have shown that Multiple Sclerosis occurs at a young age, usually between the ages of 20 and 40, and women are affected by this disease two to three times more than men [5]. According to the World Health Organization, there are about 3.5 million people with Multiple Sclerosis worldwide, and currently, more than 40,000 patients with Multiple Sclerosis have been identified in Iran [6].

Multiple Sclerosis has a profound effect on a patient's life. The affected people develop this disease at a young age when they must be active, form a family, and live a happy life. Therefore, Multiple Sclerosis has numerous and unpredictable complications that disrupt the lives of affected people. In this regard, self-efficacy is one component affected by chronic diseases, including Multiple Sclerosis [7].

According to Bandura's definition, self-efficacy is one’s trust and confidence in his/her abilities to perform a specific behavior [8]. Also, self-efficacy includes one’s trust and confidence in being able to perform self-care tasks in an optimal way [9]. In 2012, Riazi and colleagues reported that the level of self-efficacy is a predictor of health status in Multiple Sclerosis patients [10]. On the other hand, the study of Shakerdulaq et al. (2014) showed that patients with multiple sclerosis obtained lower mean scores in terms of self-efficacy compared to healthy people [11]. People with high self-efficacy believe that they can do something that increases their ability to change environmental events, while people with low self-efficacy believe that they cannot undertake important behavior [12, 13]. Self-efficacy is a valuable tool for nurses, and self-efficacy assessment and promotion can increase patient motivation in self-care [14].

Education is one of the most important parts of a chronic disease control program and helps patients to properly adapt to the disease complications. This training and support is usually done by nurses [15]. On the other hand, one of the characteristics of Multiple Sclerosis disease is that drug treatments are not effective in improving patient's conditions and quality of life. Drug treatment, along with self-care training and other rehabilitation techniques, is only used to reduce disability and increase patients' self-efficacy [16–18]. Epidemiological studies have also shown that self-care is one of the main factors in reducing fatigue and depression, and improving health-related quality of life in Multiple Sclerosis patients [19, 20].

Self-care activity is an active and practical process in which a person uses himself as a resource and protects his health independently without the help of others. Self-care includes performing some aspects of physical care and participating actively in the process of care [21]. Given the low level of self-care behaviors in patients with chronic diseases, one of the important challenges of the twenty-first century is the effective implementation of self-care behaviors in these patients and achieving desirable self-control [22]. Therefore, the goal of teaching self-care to patients is to help them gain more responsibility for self-care and adapt to the changes in their physical conditions [23], which ultimately leads to an improved quality of life for them.

Multiple Sclerosis often occurs in young people, and evidence indicates the growing trend of this disease in recent years. MS also has a destructive effect on the self-efficacy of affected patients. Nurses, as members of the healthcare team, are in direct contact with patients [24], and by providing health services, they can help patients follow up on the treatment, which reduces the frequency and duration of hospitalization as well as costs. On the other hand, teaching self-care to patients is one of the important goals of nurses. Considering the lack of an intervention study regarding the self-efficacy of MS patients in the Iranian population, the present study evaluated the effect of self-care training by nurses on the self-efficacy of patients with multiple sclerosis. This study was conducted with the hypothesis that the self-care training program affects the self-efficacy of patients with Multiple sclerosis.

Methods

This is a parallel randomized clinical trial (RCT) that was conducted on 90 patients with Multiple Sclerosis, referring to the Iranian Multiple Sclerosis Association in Tehran From August 23, 2017, to February 20, 2018, who were assigned to two groups, control, and intervention, by using a table of random numbers.

Entry criteria in this study included being 20–65 years old, having a definite diagnosis of Multiple Sclerosis based on the medical record, not being in the acute stage of the disease, living in Tehran, being able to read and write, and not being a member of a medical team, which was evaluated by the researcher.

Exclusion criteria included debilitating diseases such as cancer, Chronic Obstructive Pulmonary Disease, Parkinson's disease, Chronic kidney disease, etc. Based on the medical record, the death of patients during the study, and their unwillingness to continue the study.

In the Iranian Multiple Sclerosis Association, there are programs such as financial and spiritual support for patients and their families, informing the public about this disease, helping patients and disabled people to use services and medical care, helping to conduct research in this field, employment assistance for patients, and communication with domestic and foreign communities in order to identify and promote disease prevention methods.

After getting permission from the relevant organizations, first, a list of Multiple Sclerosis patients (25954 patients) was obtained, and from this list, 200 patients were selected by simple random sampling. Then their contact numbers were extracted from their medical records. The researcher, after introducing herself to patients, explained the objectives of the study and then invited them to participate in the study. In this way, 90 patients from 182 patients who met the inclusion criteria and consented to participate in the study were selected by simple random method. Necessary arrangements were made with the patients for face-to-face meetings, and the time of the first meeting was determined in the Multiple Sclerosis Association of Iran to complete the questionnaires in the pre-intervention phase. At the beginning of the study, questionnaires were completed by both the intervention and control groups. The questionnaires had a written consent form, and the patients signed the consent form before completing them.

The patients in the intervention group were divided into five groups of 9 people, and classes were held by the researcher for five two-hour sessions two days a week (Sundays and Wednesdays) with the patients’ consent at the Multiple Sclerosis Association of Iran (the content of training sessions is presented in Table 1). During the study, after the completion of each training course, a booklet containing the items taught previously was provided to the patients. After that, telephone follow-up was done by the researcher for 8 weeks, which included verbal encouragement, questions and answers, reinforcement of teachings, and better implementation of the self-care program, once a week for about 10 min based on the patient's needs. Telephone calls were made between 8 am and 8 pm on a certain date and time agreed upon by the researcher and the patients. In the present study, no intervention was carried out for patients in the control group during the study period and they followed the usual programs of the Multiple Sclerosis Association. After 8 weeks of intervention, patients in the two groups completed the questionnaires again. It should be noted that to comply with ethical principles at the end of the study, a copy of the training booklet was provided to patients in the control group.

Table 1.

The educational content of training sessions

Session	Content
1	Prevention of defecation disorders including: bladder training, pelvic floor muscle exercises, habitual defecation training using Kerd and Valsalva maneuvers, diet to prevent constipation, sufficient exercise and movement, regulation of fluid intake
2	Prevention of mobility disorders, weakness and muscle cramps and imbalance, including relaxation and coordination exercises, how to use mobility aids, introduction and use of canes and walkers, hot shower
3	Getting rid of fatigue includes: The relationship between MS and fatigue, The most effective ways to prevent fatigue, Proper sleep, planning regular and tolerable sports, fluid intake, prioritizing tasks, energy conservation methods and designing the living environment appropriately, Appropriate weight, Attention to internal hours
4	spiritual care training includes methods of increasing self-confidence, proper relationship with family and surrounding people, increasing hope and encouraging participation in social activities, use of music, doing new activities, visualization, Remembering positive memories and good experiences, positive thinking

The data collection tools in this study included the following:

A researcher-made personal information questionnaire with two parts: demographic characteristics (age, gender, marital status, place of residence, education, occupation, and economic status) and disease characteristics (duration of disease, frequency of disease recurrence, first symptom of the disease and the most important disabling problem), which was used to measure the demographic and disease characteristics of the participants.

Sherer’s general self-efficacy questionnaire was designed in 1982. This scale, which is intended to evaluate general self-efficacy, has 17 questions and each question is based on a 5-option Likert scale that ranges from completely disagree to agree. Questions 1, 3, 8, 9, 13, and 15 are scored from 5 to 1 respectively (reversed question), and questions 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are scored from 1 to 5. Thus, the highest self-efficacy score on this scale is 85 and the lowest is 17 [25]. To measure the construct validity of the general self-efficacy scale, Arabian et al. (2013), correlated the scores obtained from this scale with the measures of several personality traits (Rotter's internal and external control scale, personal control subscale, Marlowe and Crowne’s social degree scale [1960] and Rosenberg's interpersonal competence scale), and predicted the correlation between the self-efficacy scale and the dimensions of personality traits (0.61 and at significant level of 0.5) to be moderate, confirming its desired structure. Also, the reliability coefficient of the scale was 0.76, using the Guttmann test's halving method) and its Cronbach's alpha coefficient was 0.79 [26]. Moreover, in the study of Fasanghari et al. [27], the correlation coefficient of the test–retest was reported as 0.75 [27].

The necessary sample size for this study was calculated at a confidence level of 95% and a test power of 80% [28], taking into account the probability of sample loss. Thus, 45 people were considered for each group, and the sampling was done using a simple random method by the researcher. Then, the participants were divided into two intervention (45 people) and control (45 people) groups by someone else (not the researcher) and through a Table of random numbers. Sampling was done in a one-way blind manner, so the person taking the sample did not know about the allocation of samples to the intervention or control group.

$$n=\frac{(z_{1-_{}^{\alpha }\left./,_2^{}\right)}^{}+z_{1-\beta })_{}^2\times ({\sigma }_1^2+{\sigma }_2^2)}{d^2}$$

$$z_{0.975}=1.96$$

$$z_{0.8}=0.84$$

$$\mathrm{d}=6$$

$${\sigma }_1=10$$

The collected data were entered into SPSS-22 software to be analyzed using descriptive statistics (frequency distribution table, mean, and standard deviation) and inferential tests (Chi-square, paired t-test, independent t-test, and ANCOVA).

Ethical considerations

The code of ethics (IR.TUMS.FNM.REC.1396.2939) for this study was obtained from the joint ethics committee of the Faculties of Nursing & Midwifery and Rehabilitation of Tehran University of Medical Science. Informed consent was obtained from all participants. The confidentiality and privacy of the information were respected regarding personal data protection.

Trial registration

The protocol of this clinical trial has been registered in the Iranian Clinical Trial Registration Center (registration code: IRCT20180914041036N1). Registered 18 January 2019- Retrospectively registered, date of first recruitment: 23 August 2017, https://www.irct.ir/.

Results

Out of 200 patients with Multiple Sclerosis, 18 patients were excluded from the study (1 due to his activity in the field of medical sciences, 6 due to not living in Tehran, 4 due to suffering from other debilitating diseases, and 7 due to lack of consent). Also, one person in the intervention group was excluded from the study due to lack of consent to participate in the training sessions, and three people in the control group were excluded from the study due to lack of consent to complete the questionnaires in the post-intervention phase. Finally, the remaining participants (n = 86) were divided into two intervention (n = 44) and control (n = 42) groups through a table of random numbers (Fig. 1).

Fig. 1.

Diagram of the study sampling steps

The demographic characteristics of patients are presented in Table 2. Except for having supplementary health insurance (p = 0.001), and the first symptoms of the disease (p = 0.001), other characteristics of patients in the two groups had the same distribution, and the two groups were homogeneous. The average age of the patients in the intervention and control groups was 38.05 years and 40.83 years, respectively. In the intervention group, 52% of the patients were male, and in the control group, 55% of the patients were female. Most of the people in both groups were married and had an average economic status.

Table 2.

Demographic characteristics of in Multiple Sclerosis patients in the intervention and control groups

Demographic variable		Intervention group	Control group	P-value
		Mean (%)	Mean (%)
Age (years)	Below 30	3 (6)	6 (14)	P = 0.08
	30–39	26 (59)	13 (31)
	40–49	9 (20)	16 (38)
	above 50	6 (15)	7 (17)
Duration of disease (years)	0–5	6 (14)	9 (21)	P = 0.35
	5–10	7 (16)	8 (19)
	10–15	14 (32)	12 (29)
	15–20	11 (25)	9 (21)
	20 and more	6 (14)	4 (10)
Gender	Male	23 (52)	19 (45)	P = 0.51
	Female	21 (48)	23 (55)
Marital status	Single	18 (41)	10 (24)	P = 0.23
	Married	44 (55)	30 (71)
	Divorced	2 (4)	2 (5)
Education level	Below diploma	5 (11)	3 (7)	P = 0.67
	Diploma	15 (34)	17 (43)
	University	24 (55)	20 (50)
Occupation	General laborer	4 (9)	2 (5)	P = 0.90
	Office worker	16 (36)	14 (33)
	Housekeeper	10 (23)	13 (31)
	Student	3 (7)	1 (2)
	Retired	4 (9)	4 (10)
	Unemployed	4 (9)	5 (12)
	Others	3 (7)	3 (7)
Economic status	Poor	12 (27)	14 (33)	P = 0.71
	Moderate	24 (55)	22 (52)
	Good	8 (18)	6 (15)
Health insurance	Yes	44 (100)	40 (95)	P = 0.24
	No	0 (0)	2 (5)
Supplementary insurance	Yes	22 (50)	7 (17)	P = 0.001
	No	22 (50)	35 (83)
Income adequacy	Yes	19 (44)	19 (45)	P = 0.92
	No	24 (56)	23 (55)
First symptom of disease	Vision impairment	18 (40.9)	8 (19)	P = 0.001
	Lack of balance	4 (9.1)	12 (29)
	Movement disorder	4 (9.1)	16 (38)
	Sensory disorder	15 (34.1)	2 (5)
	Others	3 (6.8)	4 (9.5)
Number of hospitalization	None	18 (42)	26 (60)	P = 0.17
	Once	14 (32)	11 (26)
	Twice	7 (16)	2 (5)
	More than twice	5 (12)	3 (7)
Number of disease relapse	None	16 (36)	27 (64)	P = 0.06
	Once	12 (27)	7 (17)
	Twice	9 (20)	3 (7)
	More than twice	7 (16)	5 (12)
Debilitating problem	Fatigue	12 (27)	7 (18)	P = 0.06
	tiredness	11 (25)	4 (11)
	Muscle stiffness	11 (25)	4 (11)
	Vision impairment	3 (7)	6 (16)
	Lack of balance	7 (16)	11 (29)
Other diseases	Yes	10 (23)	18 (43)	P = 0.07
	No	34 (78)	24 (57)
Taking other medications	Yes	9 (20)	16 (38)	P = 0.072
	No	35 (80)	26 (62)
Smoking	Yes	16 (38)	10 (24)	P = 0.16
	No	26 (62)	32 (76)
Getting support from other family members	Yes	18 (42)	9 (21)	P = 0.06
	No	25 (57)	33 (79)

As the results show, The mean score of self-efficacy in the intervention group was 60.27 before the intervention and 63.73 after the intervention, and there was a statistically significant difference in this regard (p = 0.001).

After the intervention, there was a statistically significant difference between the two intervention and control groups regarding the mean self-efficacy scores (p = 0.004). The effect size for self-care education with adjusting the Supplementary insurance and First symptom of the disease was 0.108 (Table 3).

Table 3.

Numerical indicators of self-efficacy in Multiple Sclerosis patients before and eight weeks after the intervention in the two intervention and control groups, as well as significance test

Self-efficacy	Intervention	Control	aResults of Ancova
	Mean (SD)	Mean (SD)
Before intervention	60.27 (8.63)	59.07 (6.84)	p = 0.388
8 weeks after intervention	63.73 (6.97)	59.21 (6.23)	p = 0.004 ${\mathrm{\eta }}^2=0.108$
Results of paired t-test	t =—3.11 df = 43 P = 0.001	t = −0.17 df = 41 P = 0.52

^aANCOVA test with adjusting the Supplementary insurance and First symptom of disease 

${\mathrm{\eta }}^2$ = partial eta-squared = Effect sizes: 0.01 = small; 0.06 = moderate; 0.14 = large

Discussion

The present study was conducted with the aim of determining the effect of self-care on the self-efficacy of patients with multiple sclerosis. The findings of the present study showed that the mean score of self-efficacy in the intervention group increased more than the control group after the intervention.

The average self-efficacy score in the intervention group eight weeks after the intervention was significantly higher than the control group, which shows that an effective educational intervention based on self-care can play a significant role in improving the self-efficacy of MS patients. Many studies have also recommended self-care training as one of the most effective factors in the rehabilitation of patients with various disabilities [29–31]. On the other hand, several studies showed a positive correlation between self-efficacy and self-care behaviors, indicating that improving self-efficacy makes patients put more effort into self-care behaviors such as diet control, medication compliance, physical activity, and weight management strategies and improves health outcomes [28, 32]. Therefore, it is important to address the methods that lead to improved self-efficacy in these patients. Higher self-efficacy is associated with less depression, anxiety, sleep disorders, pain, and fatigue and with better physical and mental health. As a result, these patients seek information related to self-care and illness to achieve adaptation to the situation, improve their control over the situation and have high self-efficacy [33].

O'Hara and colleagues (2002) conducted a single-blind clinical trial study on 278 patients with Multiple Sclerosis to evaluate the effectiveness of a professionally guided self-care program for the management of MS in the community. The results of this study showed that patients in the intervention group obtained better scores than the control group in terms of mental health status (p = 0.04), and self-efficacy (p = 0.04), showing a higher level of self-independence [34]. The results of this study are consistent with the findings of the present study.

In line with the results of the present study, Masoudi and colleagues (2008) in a clinical trial study, trained Multiple Sclerosis patients for three months (eight training sessions) based on the patient's educational needs, using Orem’s self-care model. Using the evaluation scale for physical dimensions of quality of life, the patients were evaluated before and three months after the intervention. The results showed that the average physical dimensions of quality of life of the Multiple Sclerosis patients in the intervention group improved more than the control group after the intervention. In this study, patients understood that with self-care, they can improve different aspects of their quality of life and be self-efficient [35].

Many studies have been conducted with different methods in recent years to increase the rehabilitation of these patients. Conducting group interventions to increase self-efficacy [36, 37], sports training [38, 39], psycho-educational intervention to improve quality of life [40], practical interventions to increase walking speed in patients with movement disorders [39], and training self-care methods to control stress, anxiety and improve the mental dimensions of quality of life [41, 42] are examples of these studies. The results of most of these studies indicate that self-care training is effective in reducing physical and mental problems of Multiple Sclerosis patients.

In this regard, Share et al. (2021) in a semi-experimental study with a pre-test/post-test design, investigated the effectiveness of cognitive behavioral therapy on the self-efficacy, pain, fatigue, life expectancy, and depression of 68 patients with multiple sclerosis. Training sessions were held once a week for two months. The results showed that after participating in the cognitive-behavioral therapy sessions, the level of self-efficacy, pain, and life expectancy increased in the intervention group, and the level of depression and fatigue decreased. These results are in line with the findings of the present study [43]. In addition, Akbari et al. (2024) investigated the effect of progressive muscle relaxation techniques on the self-esteem and self-efficacy of 100 patients with multiple sclerosis in a clinical trial study. The intervention group was subjected to progressive muscle relaxation and deep breathing techniques using the Jacobsen method. The results showed that immediately after the intervention, the mean score of self-esteem in the intervention group increased, although there was no statistically significant difference between the two groups in this regard (P = 0.083). However, 4 weeks after the intervention, a statistically significant difference was observed between the intervention and control groups in terms of the mean score of self-esteem (P = 0.012). Also, a statistically significant difference was observed in the mean score of self-efficacy in the control and intervention groups immediately after and 4 weeks after the intervention (P < 0.001) [44]. The results of this study are also consistent with the findings of the present study.

Considering the importance of educational interventions for Multiple Sclerosis patients, some limitations must discussed for the implementation of these interventions. Therefore, the importance of personal factors (such as level of disability, walking restrictions, fatigue, fear and apprehension, self-efficacy, and self-confidence) and environmental factors (such as cultural-ethnic acceptability, social-demographic factors, lack of necessary facilities and space to perform exercises, lack of patient follow-up and contradictory training by specialists) should be considered in the design of interventional measures [45, 46].

Considering the homogeneity of the two groups in terms of demographic variables and the elimination of the effect of confounding variables, it can be concluded that the self-care education method for MS patients can improve the self-efficacy of these patients; therefore, the research hypothesis is accepted. Since MS affects all aspects of these patients' lives, including self-efficacy; it seems that the use of methods such as self-care education is essential for these patients. Taking multiple medications, the need to have a special diet, acquiring skills to adapt to the disease, and physical and mental complications have put these patients in need of self-care education by nurses. Improving the self-efficacy of these patients through self-care education can lead to improved health, improved mental health, reduced hospitalization, reduced treatment costs, the use of individual abilities, and adaptation to the disease. On the other hand, implementing a standard self-care program (not just in the form of a pamphlet used in medical centers) increases patients' ability to take care of themselves, their independence, and empowerment, which reduces patients' dependence on doctors, nurses, and family.

The strengths of this study include adherence to all principles of clinical trials, including randomization, use of a control group, and allocation concealment, as well as careful design and use of valid instruments. The limitations of the present research are: the lack of motivation of the samples to participate in the training sessions; the psychological states of the samples during the training sessions; and the individual indifference of the samples towards improving their health status, which may affect the results. The influence of other sources of information on the control and intervention groups should also be taken into account, as the researcher couldn't control these limitations. The small sample size and the use of the self-report method were other limitations of this research. In future longitudinal and comparative studies, efforts should be made to identify the factors and interventions effective in improving the self-efficacy of these patients. Further studies with a larger sample size and longer follow-up are recommended to investigate the effect of this intervention.

Conclusions

The results of the present study showed that educational interventions are an effective factor in increasing the self-efficacy of patients with multiple sclerosis. Considering that the current treatments for multiple sclerosis patients do not significantly improve their condition, and to make the treatments more effective and reduce the psychological and social effects of multiple sclerosis on patients, we recommend self-care training for these patients. These interventions can be used in the routine care of patients based on their needs by nurses to promote self-efficacy, and rehabilitation centers can also use this intervention for the rehabilitation of MS patients. We also suggest that educational packages based on the results of this study (in the four areas of prevention of movement disorders, prevention of excretory disorders, prevention of fatigue, and training in mental and emotional care) be prepared and used for patients referring to the Multiple Sclerosis Association and medical centers because we believe that these training packages will improve the self-care of multiple sclerosis patients and ultimately increase their self-efficacy.

Authors’ contributions

ZR: Concepts, Design, Definition of intellectual content, Manuscript preparation, Manuscript editing, Manuscript review, Data analysis, Statistical analysis. MS: Concepts, Design, Definition of intellectual content, Literature search, Clinical studies, Experimental studies, Data acquisition, Manuscript preparation, Manuscript editing, Manuscript review, Guarantor. SN: Concepts, Design, Definition of intellectual content, Manuscript editing. SH: Data analysis, Statistical analysis, Manuscript preparation, Data acquisition. RK: Concepts, Literature search, Manuscript preparation, Manuscript editing, Manuscript review.

Funding

This study was financially supported by the Tehran University of Medical Sciences.

Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

The code of ethics (IR.TUMS.FNM.REC.1396.2939) for this study was obtained from the joint ethics committee of the Faculties of Nursing & Midwifery and Rehabilitation of Tehran University of Medical Science informed consent was obtained from all participants.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.