Impact of Educational Self-Ecacy Enhancement Program on Quality of Life, Pain Management, Self-Eciency Behaviors and Its Impact of Satisfaction among Adults Diabetic Patients with Peripheral Neuropathy Pain: A Randomized Control Trial

Background: Peripheral neuropathy pain is common among adult diabetic patients worldwide. Lifestyle behavior modication such as proper diet and exercise, quitting smoking, weight control and regular follow up, as well as enhancement of self-ecacy among adult diabetic patients can be helpful in managing peripheral neuropathy pain and, therefore, improving their quality of life and satisfaction. Aims: This study aims to investigate educational self-ecacy enhancement program's impact on pain management, self-eciency behaviors, quality of life and satisfaction among adult diabetic patients with peripheral neuropathy pain. Materials and Methods: This randomized controlled study was conducted between October and March 2020 at the Jordanian Ministry of Health settings, where 72 adult diabetic patients with peripheral neuropathy pain were randomly assigned into research group (n = 36) or control group (n = 36), after obtaining ethical approval and informed consents. An educational self-ecacy enhancement program was implemented in the research group only. The instrument used for data collection consisted of Demographic Data Form, Diabetes Pain Intensity Scale, Self-Ecacy Scale, Quality of Life Questionnaire (EQ-5D) and Patient Satisfaction Questionnaire. Results: Statistically signicant improvements in pain levels (p = 0.020), self-ecacy score (p = 0.000), quality of life scores (p = 0.000) and best imagined health status (p = 0 .000) were found among research group participants. Furthermore, multiple-linear regression models showed that the implementation of educational self-ecacy enhancement program signicantly increased the explained variance of self-ecacy scores (R 2 = 0.746, p = 0.000) and quality of life scores (R 2 = 0.746, p = 0.000). At the end of implementation, research group participants showed a high overall satisfaction levels (4.33 out of 5). Conclusion: The ndings suggest that an educational self-ecacy enhancement program is effective in modifying adult diabetic patients’ lifestyle, enhancing self-ecacy behaviors, managing peripheral neuropathy pain, improving quality of life and satisfaction among adult diabetic patients. It is, therefore, recommended to expand the implementation of this program among adult diabetic patients with peripheral neuropathy pain.


Introduction
Diabetic peripheral neuropathy pain (DPNP) is one of the most popular and complex chronic diseases [1][2][3]. The American Pain Society (APS) de nes DPNP as an emotional and unpleasant experience related to acute or potential tissue damage or described in terms of such damage. The nature of peripheral neuropathy pain is characterized by aching, burning, or shooting [4]. A study in the UK by Hall and colleagues (2013) estimated the incidence of DPNP at 15.3 cases per 100,000 person-years in the primary care population in 2002 and increasing to 27.2 cases per 100,000 people in 2005 [5]. Roughly, more than 11% of patients with diabetic peripheral neuropathy worldwide are suffering from DPNP [6].
Usually, DPNP is reported to interfere with daily living activities, mood, mobility, social relations and work. Moreover, impaired patients' health could hurt the patients' quality of life (QoL). Having DPNP causes higher societal and health care costs compared to diabetes without neuropathic pain 6 . Also, glycemic blood level plays an important role in the DPNP onset and development and although drug therapy and rehabilitation cause relative improvements and control of hemoglobin glycosylated (HbA1c), they are very important in the prevention of the disease complications [7][8][9][10].
Self-care behaviors of DPNP patients can alleviate severe symptoms; enhance pain management, clinical outcomes and quality of life; and reduce further hospitalizations [7,8,[10][11][12][13][14][15]. Several factors can affect the patients' self-care including the behavior and self-e cacy of an individual [16][17][18][19]. Self-e cacy re ected the main principle of social cognition on the theory that was originally proposed by Bandura. Self-e cacy behaviors are described as one's belief in her/ his capabilities to ful ll expectations and tasks to reach the goals [20]. Furthermore, it should be noted that education plays an important role in enhancing and improving the function of an individual's behavior.
In order to guide positive change in DPNP patients' self-care behavior, educational programs are developed and implemented, such as educational self-e cacy enhancement program, which plays an important role in improving health outcomes of DPNP patients. Namely, implementing an educational self-e cacy enhancement program may lead to improvements in patients' pain management, self-e ciency behaviors, quality of life and satisfaction.
To the date of writing this study, the prevalence of DPNP has been scarcely studied in Jordan. Also, an educational self-e cacy enhancement program has not been implemented on DPNP patients in Jordan. The signi cance of this study lies in the potential of testing this program's effectiveness in improving Jordanian DPNP patients' pain management, self-e ciency behaviors, quality of life and satisfaction for the rst time. Ultimately, testing the effectiveness of the educational self-e cacy enhancement program can inform future research and practice in DPNP management in Jordan.
Therefore, this study aims to investigate educational self-e cacy enhancement program's impact on Jordanian DPNP patients' pain scores, self-e ciency behaviors, quality of life scores and satisfaction. To achieve the study's aim, the following four research questions were addressed: Is implementing an educational self-e cacy enhancement program effective in improving pain scores among adult Jordanian DPNP patients? Is implementing an educational self-e cacy enhancement program effective in improving self-e ciency scores among adult Jordanian DPNP patients? Is implementing an educational self-e cacy enhancement program effective in improving QoL scores among adult Jordanian DPNP patients? And what is the level of program satisfaction among adult Jordanian DPNP patients who received an educational self-e cacy enhancement program?

Study Design
This study employed a randomized, controlled study design, where adult Jordanians with DPNP were randomly assigned to one of two groups; a research or control group. Study participants in the research group received an educational self-e cacy enhancement program; whereas those in the control group did not. Both study groups participants have been tested for pain at the beginning and the end of the study. Also, self-e ciency behaviors, quality of life scores and satisfaction were tested in both groups at the end of the study and comparisons of these outcomes were carried out to test the impact of educational self-e cacy enhancement program implementation on these outcomes between the two groups.

Setting and Sample
Data collection took place in three Jordanian Ministry of Health (MoH) hospitals. Each of these hospitals regularly receives diabetic complications referrals from other MoH hospitals and hospitals from other health sectors in Jordan, such as the private and educational sectors. The reference population of this study was all adult Jordanian DPNP patients who visited or were referred to MoH hospitals. Data collection took place during the period from Oct 14, 2019 -Mar 14, 2020. Inclusion criteria for selecting the study sample included being an adult Jordanian (aged The total sample size was 72 adult DPNP patients, 36 of them were randomly assigned to each of the research and control groups.

Research Instruments
A ve-part assessment tool package was utilized for data collection. The ve parts were: (1) demographic data developed by researchers. (2) the Diabetes Self-E cacy Scale (DSES), a tool introduced by the Stanford Self-Management Resource Center (SMRC) in 2009, which includes eight items rated along a ve-point Likert scale (from 1 = to corresponded to never self-e cacy to 5 = to very good self-e cacy) [21]. Scores ranged from 0 to 10 and higher scores were correlated with better self-care. Al-Amer et.al performed reliability and validity (2016) in Jordan and was taken into consideration. The DSES was translated into Arabic, with the revised scale of Cronbach's alpha that was 0.81 [22]. (3) a Quality-of-Life Scale entitled EQ-5D [23]. This standardized instrument includes four domains that measure the QoL: anxiety/depression, usual activities, mobility and self-care. The overall score was 1= perfect health and 0= dead [23]. The researcher translated the EQ-5D and two professional academic instructors-working in the eld of nursing -to ensure the consistency of inquiring the information while interviewing the patients. The Jordanian EQ-5D validity and reliability researches were performed by Abu-Shennar et.al. in 2020. The revised scale of Cronbach's alpha 0.88 [24]. (4) Pain Intensity Scale, where each patient was asked to point to the number that represents the intensity of his current pain experience. According to our authors in the current research, responses were rated on a scale from 0 to 10 were less than or equals to 3 indicating mild pain, four-seven indicating moderate pain and eight-ten indicating severe pain. (5) the patient satisfaction questionnaire to assess and measure the program e ciency and effectiveness and education tools. The satisfaction scale consists of ten items, which was prepared by the researchers. According to the authors, responses were rated on a scale from one to ve where one = never, two = low, three = moderate, four = good and ve = very good; to determine whether further training is required during the education program in sessions.
To test the ve-part assessment tool's usability, pilot research was conducted on 10% of sample members before the beginning of the study. According to the results of the pilot study, some necessary edits and revisions were made to the assessment tool.

Intervention Program
The educational self-e cacy enhancement program is specially designed for adult DPNP patients. The educational tools included demonstrative pictures, a booklet, videotapes were prepared and the programs were organized. The researchers prepared this program based on the relevant literature [2.3,10-12,25] and it involved four sessions of self-e cacy enhancement and rehabilitation for each patient group. After all, the educational tools and program developed by three specialized persons (three professionals: one with a Ph.D. in nursing, one in medicine and one with a Ph.D.in pharmacy & toxicology specializes), were reviewed and approved, following the below content: Information about diabetes mellitus and DPNP.
Diabetes complications; prevention of through self-care.
Compliance with medication, diet and exercises.
Self-monitoring and regular follow-up.

Implementation
The intervention program was implemented for the research group during the period Oct 14, 2019 -Mar 14, 2020, as follows: Research group: Pre-tests of the outcomes through face-to-face structured interviews were performed with the research group participants individually. These interviews took place in the three MoH hospitals whilst participants waited in their turn in the follow-up clinic visits. In addition to the Numeric Pain Rating Scale (NRS), the interviews also collected data on demographics, QoL (EQ-5D) and Self-E cacy for Diabetes Questionnaire (DSES).
Educational sessions were performed. The intervention is consisting of small groups (eight to ten patients) of structured educational sessions for the enhancement programs on the quality of life of adult DPNP diabetic patients. The educational sessions were one hour to 90 minutes. Training booklets and PowerPoint presentations were used for educating the participants.
A review was repeated in this phase of the mentioned material and an educational booklet was handed to the research group which comprised the material presented in the four-session period.
The evaluation of the self-e cacy training program on DPNP among adult diabetic patients is carried out after three months of the education enhancement program. The Numeric Pain Rating Scale (NRS), Self-E cacy for Diabetes Questionnaire (DSES), Quality of Life Questionnaire (EQ-5D) and Patient Satisfaction Questionnaire were implemented.

Control Group:
Pre-tests of the outcomes through face-to-face structured interviews were performed with the research group participants individually. These interviews took place in the three MoH hospitals whilst participants waited in their turn in the follow-up clinic visits. In addition to the Numeric Pain Rating Scale (NRS), the interviews also collected data on demographics, QoL (EQ-5D) and Self-E cacy for Diabetes Questionnaire (DSES). No educational sessions were conducted in this group.

Statistical analysis
Statistical Package for Social Sciences (SPSS, version 25) was utilized for statistical analysis of results. Sample characteristics were tested using descriptive statistics, such as frequencies and percentages in categorical variables, means and standard deviations (±SD) for continuous variables and Chi-square and Independent-Sample T-Tests were respectively used to compare the two groups in terms of demographic characteristics. To answer the rst research question, Paired-Samples T-Test was used. To answer the second and third research questions, both Paired-Samples T-Tests and multiple-linear regression models were used and to answer the fourth research question, descriptive statistics, such as frequencies and percentages in categorical variables, means and standard deviations (±SD) for continuous variables were used. The Spearman's Rank-Order Correlation Coe cient (Spearman's Rho) measures the direction and strength of the correlation among the two variables were used. In the inferential statistics of Paired-Samples T-Test, multiple-linear regression models and Spearman's rho correlation coe cients model, a p-value < 0.05 was considered to be statistically signi cant.

Ethical Considerations
Data were collected after approval by the ethical committee in the Jordanian Ministry of Health and Near East University (N.E.U). We have got approval from SMRC to apply the DSES as all rights were reserved and reproduced. The data was used for scienti c inquiries only. Since the research was based on data obtained from structured questionnaires and medical records, no harm to adult DPNP diabetic patients was expected. Verbal consent was obtained from study participants before data collection and they were guaranteed information con dentiality.

Sample Characteristics
In this randomized controlled study, the results of the participants' demographic characteristics revealed that the ages mean was 60.9 years of the control group and 66.3 years of the research group. More than half of the participants were male in both groups (control group: 63.9%, research group: 75%). 38.9% of the control group participants and 33.3% of the research group participants had a bachelor's degree or higher. All of the patients in both groups reported non-adherence to the diet regimen and were non-compliant to physical activity. Also, 30.6% of the control group participants and 38.9% of the research group participants were current smokers. The mean body mass index (BMI) (Kg/m2) was 39.44 among the control group participants and 37.59 among the research group participants. Also, the mean monthly family income in the control group was JD 385.3 and among the research group was JD 338.5. None of the aforementioned demographic characteristics was found to be signi cantly different between the two groups, indicating an effective random assignment of group members (Table 1).

Pre-education Evaluation
The results of the pre-educational evaluation of the entire sample (N = 72) and the pain levels of the patients in a pre-educational evaluation, revealed that the mean score of the participants was 6.68 out of 10. The overall selfe cacy score was 1.60 out of 5, while the scores for self-e cacy questions were 1.  Table 2).

Post-education Evaluation
As shown in Table 3, a dependent-sample t-test was conducted to assess the improvements in the overall NRS score, QoL scores and self-e cacy scores among the study group members (N=36). The results revealed that the study group members have shown a statistically signi cant improvement in their NRS scores (t-test = 5.694, p = 0.02), QoL overall scores (t-test = 176.242, p = 0.000) and self-e cacy overall score (t-test = 386.545, p = 0.000).
Furthermore, statistically signi cant improvements in every subdomain (mobility, self-care, activity, discomfort and depression) of the QoL instrument and in every question (Q1 through Q8) of the self-e cacy instrument were observed.
In order to assess the impact of educational intervention on self-e cacy score, a two-step multiple linear regression model (Table 4) was conducted on the whole sample (N=72), where self-e cacy score was entered as the dependent variable and age, gender, income and type of treatment were entered in the rst step as independent factors. The results of the rst step of the multiple linear regression model showed that the combination of age, gender, income and type of treatment were unable to signi cantly explain variance in self-e cacy score (Step 1 ANOVA F (df) = 0.253 (4) , p = 0.906) and the percentage of explained variance of step 1 of the model was very small (Step 1 R 2 = 0.034). However, after adding the educational intervention in the second step of the multiple linear regression, the model became statistically signi cant (Step 2 ANOVA F (df) = 16.448 (5) , p = 0.000) and the percentage of explained variance in self-e cacy score noticeably increased (Step 2 R 2 = 0.746). The statistically signi cant improvement in the multiple linear regression model's percentages explained variance (R 2 ) indicates that the implementation of the educational intervention signi cantly improves self-e cacy scores among adult diabetic patients with DPNP.
Similarly, to assess the impact of educational intervention on QoL score, a two-step multiple linear regression model ( Table 5)  In order to test the mutual correlation between outcome variables, Spearman's rho correlation coe cients between pain score, self-e cacy score and QoL score were conducted both in the pre-educational and post-educational evaluation. In pre-educational evaluation, none of the three outcomes was found to have a statistically signi cant correlation with the others. Whereas in the post-educational evaluation, the correlation was found statistically signi cant between self-e cacy score and QoL score (Spearman's rho = -0.759, p = 0.000), but pain score's correlation with self-e cacy score and QoL score was not statistically signi cant (Table 6).
Finally, results showed that the satisfaction score mean of the research group participants was 4.33 (±0.67) at the end of the implementation, indicating a high level of satisfaction upon the completion of the educational program intervention (Table 7).

Discussion
The results of this randomized controlled study, which was conducted to investigate the impact of educational selfe cacy enhancement programs on pain management, self-e ciency behaviors, quality of life and satisfaction among adult DPNP diabetic patients, revealed the educational self-e cacy enhancement program was effective.

Self-e cacy
In a pre-educational evaluation of the self-e cacy behaviors, results of the patients' evaluation levels revealed that the self-e cacy behaviors scores mean for both participant's groups were showing low levels. These results were concordant with those from other epidemiological researches [7,8,[10][11][12][13][14][15], where patients with DM had signi cantly lower self-e cacy behaviors than those without DM. This might be attributed to the association with lower levels of self-e cacy behaviors by lower knowledge of the patients about the disease with uncontrolled of the complications and poor self-management skills practicing, which lead to the negative feedback that was frequently implemented among DPNP patients.
In our research, the research group participants who attended the educational self-e cacy enhancement program reported a positive enhanced self-e cacy behavior by comparing the posttest and pretest mean. The essential ndings of this research suggest the importance of incorporating self-e cacy enhancing interventions in diabetes self-e cacy (DSE) programs, emphasizing the requirement to build con dence for a given self-management behavior such as a portion of the health care providers communication or a component of a counseling, educational and skill-building program that can enhance the likelihood of maintaining the preferred outcomes of DPNP. Diabetes nurse educators and other health care providers need to develop effective methods for promoting self-management among adult Jordanian individuals. Also, recent results analysis has reported that in the followup intervention, health-related improvements were obtained from self-management programs. The selfmanagement methods increase participants' symptom self-management, knowledge and other self-management behaviors such as testing blood glucose, weight control, self-e cacy and aspects of health status management, very effectively [26]. Many clinical researches con rm the effect of the educational self-e cacy enhancing program interventions in DSE programs among T2DM patients [7,8,[10][11][12][13][14][15].

Pain
Results of a pre-educational evaluation of the patients' pain levels, showed that the majority of the participants in both groups were having different intensities of pain ranging from moderate to severe. According to a cohort research conducted in the U.K. by Abbott et al. (2011), the results revealed that the painful symptoms occurred in 60% of patients with severe neuropathy and 26% of patients without neuropathy [27]. According to pain intensity, in a cross-sectional research that was conducted by Van Acker et al (2009), 61% of patients had moderate-intensity pain [28]. While a research from the same region was conducted in French by Bouhassira et. al (2013) using the NRS revealed that 76.2% of patients are having moderate to severe intensity pain [29]. The difference in the reported neuropathic pain characteristics from all over the world can be related to different populations of the researches and the different screening tools that are used to assess DPNP.
In our research, the research group participants who attended the educational self-e cacy enhancement program reported better pain management as perceived by comparing the pretest and posttest means showing improvement after exposure to the educational program. Foot care, control of HbA1c% and exercise and lifestyle behaviors affect diabetes multiuse patients in their good pain management, according to most researches [28][29][30][31].

Quality of Life
In a pre-educational evaluation, results showed that the quality of life scores mean was showing a low QoL level.
Also, the results of the research revealed that most DPNP participants have reported a problem in discomfort, mobility, usual activity, self-care and anxiety or/and depression. These results of this research were concordant with those from other epidemiological researches, where DPNP patients had signi cantly lower QoL than those without DPNP. For example, according to a research by Davies et al. (2006), they found that patients who developed DPNP had poorer quality of life [30]. Similar results were found in a research by Van Acker et al (2009). The results revealed that DPNP patients were more likely to report problems in mental alterations and physical activities than those without DPNP, which may account for their lower QoL scores [28]. In a more recent research conducted in France, the results showed that DPNP was associated with disturbances in sleep, depression and higher anxiety levels [29]. Another recent research that agrees with the results of our research was performed in South Africa. In this research, the results reported that DPNP has a negative impact on QoL [31].
This research found that the research group participants who attended the educational self-e cacy enhancement program reported a positive impact on QoL. This nding was consistent with the relevant researches [32][33][34][35][36][37][38]. On the contrary, data obtained from a research in Saudi Arabia showed that results were not signi cantly associated with the effect of the educational program and QoL among T2DM diabetic patients [39]. Similarly, a research was conducted in Taiwan failed to show any signi cant association between the effect of the educational program and QoL among T2DM patients [40]. However, the variation in magnitude between these ndings and others may be attributed to either the characteristics of the research's participants or the differences in sample size.

Patient Satisfaction
Patient satisfaction means that a score of the research group participants showed a high level of satisfaction from educational intervention. Numerous clinical researches con rm the effect of the educational self-e cacy enhancing program interventions in high levels of satisfaction among diabetic patients [16][17][18][19]. Therefore, conscientious steps to improve patient engagement and satisfaction are vital for improving the quality of patient care and conveying the important message that healthcare providers are respected and valued as persons.
Limitations Some limitations may be recognized regarding the conduction of this research. Although the focus of this research was to investigate DPNP among adult patients, data collection lacks identifying if patients were taking pain pharmacological and non-pharmacological therapies.

Conclusion And Recommendations
This research found that the self-e cacy enhancement program had a positive impact on DPNP patients' satisfaction, QoL, self-e ciency behaviors and pain levels. Consequently, in order to promote patients' self-care behaviors, it is crucial to improve their self-e cacy behaviors and modi cation of lifestyle and behavioral changes such as appropriate diet, encouragement to stop smoking, reduce weight, exercise and regularly visit treating   Self-e cacy overall score (out of 5) 1.60 (±0.36) Self-e cacy Q1 score (out of 5) How con dent do you feel that you can eat your meals every 4 to 5 hours every day, including breakfast every day?
1.39 (±0.73) Self-e cacy Q2 score (out of 5) How con dent do you feel that you can follow your diet when you have to prepare or share food with other people who do not have diabetes?
1.57 (±0.60) Self-e cacy Q3 score (out of 5) How con dent do you feel that you can choose the appropriate foods to eat when you are hungry (for example, snacks)?
1.51 (±0.65) Self-e cacy Q4 score (out of 5) How con dent do you feel that you can exercise 15 to 30 minutes, 4 to 5 times a week?
1.73 (±0.66) Self-e cacy Q5 score (out of 5) How con dent do you feel that you can do something to prevent your blood sugar level from dropping when you exercise?
1.50 (±0.58) Self-e cacy Q6 score (out of 5) How con dent do you feel that you know what to do when your blood sugar level goes higher or lower than it should be?
1.74 (±0.73) Self-e cacy Q7 score (out of 5) How con dent do you feel that you can judge when the changes in your illness mean you should visit the doctor?