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Regulatory Requirements on Parenteral Dosage Forms – A Comparative Analysis of CDSCO (INDIA) and DDF (CAMBODIA)

Ashok Kumar P; Abdul Rakeeb M; Devika KN; Meghana Shree H; N Shilpa; Devaraj GS

Abstract

ABSTRACT Parenteral products enter directly into the bloodstream or other sterile body cavities; any failure in sterility or pyrogen control can therefore be fatal. India’s Central Drugs Standard Control Organization (CDSCO) and Cambodia’s Department of Drugs and Food (DDF) impose distinct—but increasingly convergent—regulatory frameworks to safeguard these medicines. Using document analysis of primary statutes, 2023-2025 draft amendments and technical guidance, this study compares nine domains: dossier structure, good manufacturing practice (GMP), quality control, labelling, pharmacovigilance, clinical data, timelines, user fees and intellectual-property protection. CDSCO’s reviewed Schedule M introduces ISO-class cleanrooms, media-fill twice yearly and real-time environmental monitoring, whereas DDF relies on ASEAN Common Technical Dossier (ACTD) and WHO-GMP while fast-tracking import licenses to bolster access. India mandates local bioequivalence (BE) for most generic injectables and endotoxin limits , while Cambodia grants BE waivers for well-established therapeutic classes to attract investment. Timelines average nine months in India and twelve in Cambodia, but Cambodian fees remain lower. Alignment opportunities include mutual GMP recognition and a shared e-submission portal. Findings assist manufacturers in dossier planning and support regulators in harmonizing approvals without flexible patient safety. Keywords: Parenteral products, DDF, ACTD, GMP, CDSCO

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RESEARCH ARTICLE Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 Please cite this article as: Poornima TS et al., Assessment of Effectiveness of Self-Instructional Module (SIM) on Knowledge Regarding Stress Management among Nursing Officers Working in ICU in Selected Hospital at Hassan” . American Journal of PharmTech Research 202 5 . Assessment of Effectiveness of Self-Instructional Module (SIM) on Knowledge Regarding Stress Management among Nursing Officers Working in ICU in Selected Hospital at Hassan” Poornima TS1*, Ravindra Kumar KV2, Kallesh B3, Somashekar ST3 1. Nursing Tutor, Sri Devaraj Urs College of Nursing, Kolar 563103. 2. Professor and HOD of Mental Health Nursing, Government College of Nursing, Hassan 573201. 3. Assistant Professors of Mental Health Nursing, Government College of Nursing, Hassan 573201. ABSTRACT Nursing is a highly demanding and stressful profession that requires the ability to cope with critically ill or dying clients and medical emergencies. Nurses often encounter tough situations that demand dedication, sound academic knowledge, clinical skills, and time management to complete multiple tasks effectively. Coping strategies and resilience are essential to maintain well-being and ensure quality patient care. The objectives of present works are To assess pre-existing knowledge regarding stress management among ICU nursing officers in a selected hospital at Hassan. To evaluate the effectiveness of a self-instructional module (SIM) on stress management. To determine the association between pre-test knowledge scores and demographic variables. An interventional one-group pre-test post-test pre-experimental design was adopted. Forty participants were selected using purposive sampling. Data was collected through a structured knowledge questionnaire. The SIM was administered after the pre-test, and the post-test was conducted after 7 days. Data was analyzed using descriptive and inferential statistics. The mean post-test knowledge score (72.18%) was significantly higher than the pre-test score (36%) (Paired t = 21.915, df = 39, p < 0.001). Pre-test knowledge levels were significantly associated with number of children. The study concluded that the self-instructional module was effective in improving knowledge regarding stress and its management among ICU nursing officers. Keywords: Effectiveness, SIM, Knowledge, Occupational stress, Management, Nursing officers. *Corresponding Author Email: [email protected] Received 22 September 2025, Accepted 05 October 2025 Journal home page: http://www.ajptr.com/ Poornima et. al., Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 141 www.ajptr.com INTRODUCTION “Worry and stress affects the circulation, the heart, the glands, the whole nervous system, and profoundly affects heart action.” Charles W. Mayo, M.D. Nursing is one of the largest health care professions, dedicated to nurturing and caring for individuals across all stages of the health care experience. Nurses provide 24-hour comprehensive care, comfort, and support in primary, secondary, and tertiary settings. The profession is highly demanding and stressful, requiring strong knowledge, skills, dedication, and effective time management to handle critically ill patients, emergencies, and challenging situations while maintaining resilience.1 Nurses often experience occupational stress when job demands exceed their abilities and available resources, leading to emotional and physical exhaustion. Prolonged exposure to such stress can cause burnout—a condition marked by reduced physical and emotional well-being, loss of selfworth, and developing a cynical attitude toward patients and colleagues.2 Nursing is ranked among the top 40 most stressful professions in the United States, largely due to high-stress demands in healthcare. Caring for dying patients is a significant stressor, as nurses frequently encounter death and are expected to maintain professional composure, despite the emotional impact. The nature of nursing exposes them to death-related stress more than most other professions.3 Occupational stress occurs when job demands exceed a nurse’s abilities and resources, causing physical and emotional strain. Nurses, particularly in elder care settings, face stressors such as patient agitation, heavy workloads, and patient-related difficulties. Prolonged exposure can negatively affect physical and psychological health, including irritability, anxiety, and fatigue, which in turn impact quality of life—a multidimensional concept encompassing physical and mental well-being. Identifying these stressors is essential to develop interventions that reduce occupational stress among nurses.4 Nursing care is central to nurses’ clinical practice, aiming to provide high-quality services that improve patient and societal outcomes. As key members of healthcare teams, nurses are ethically and legally accountable for the quality of care they deliver. Quality nursing care encompasses meeting patients’ physical and psychosocial needs, ensuring patient satisfaction, fostering trust, and maintaining effective communication. Continuous improvement of care quality is a major challenge for nurse managers, requiring services to be effective, efficient, and economical.5 ICU nurses experience higher stress than those in other wards due to heavier workloads, longer patient contact, and multiple roles in interventions and care. Most nurses are female and also Poornima et. al., Am. J. PharmTech Res. 2025;15(05) ISSN: 2249-3387 www.ajptr.com 142 manage roles as mothers, spouses, and homemakers, making prolonged work stress detrimental to patient care. Effective stress management—through techniques like cognitive restructuring, relaxation, time management, anger control, problem-solving, and communication skills—is essential. Maintaining nurses’ mental and psychological well-being in ICU settings is critical for delivering efficient and high-quality clinical care.5 Personnel are vital assets in any organization, and occupational stress significantly affects their health and performance. ICU nurses face particularly high and persistent stress due to complex work environments, heavy workloads, sophisticated equipment, urgent care demands, and professional responsibilities, as well as interpersonal and management-related challenges. This frequent exposure increases the risk of work-related injuries, burnout, job dissatisfaction, functional disorders, and physical and psychological health problems. Maintaining a healthy nursing workforce is essential for both their well-being and quality patient care.6 NEED FOR THE STUDY It’s not about perfect. It’s about EFFORT. And when you bring that effort every single day, that’s where TRANSFORMATION happens. -Jillian Michaels “Reality is the leading cause of stress amongst those in touch with it” - Jane Wagner Global Stress has become a pervasive and chronic condition due to global uncertainties, constant media exposure, and the ongoing drive for advancement, competitiveness, and a better lifestyle. This “stress epidemic” affects individuals, organizations, and health professionals, prompting the search for strategies to manage its widespread impact.7 Work experiences can impact family life, and family dynamics can affect work, creating a conflict that negatively influences psychological health. High work-family conflict among nurses reduces job satisfaction, professional effectiveness, and commitment, while increasing stress and affecting physical, mental, and psychological well-being.8 About 30% of the workforce in developed countries experiences occupational stress, with even higher rates in developing nations. In the U.S., absence due to stress is nearly four times higher than that from illness or nonfatal injuries. Health professionals, particularly nurses, face greater stress due to demanding work conditions, teamwork requirements, and 24-hour patient care. A study in Sweden found that over 80% of nurses reported higher stress levels than other professionals.6 Poornima et. al., Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 143 www.ajptr.com Work-related stress among nurses is a major global concern. A study in the United States revealed that 93% of nurses experienced high stress levels, while in China, 68.3% reported high occupational stress. In Iran, 63.47% of nurses experienced stress, and in Saudi Arabia, 34.7% suffered from work-related stress. Dobnik M reported a 56.5% prevalence of occupational stress among nurses in Slovenia, while Maphangela T found that 74% of nurses in Gaborone clinics had experienced occupational stress. In Ethiopia, nurse workload remains high due to staff shortages, with studies showing that 37.8% to 66.2% of nurses experience work-related stress.9 A survey conducted in Wuhan city revealed that nurses working in intensive care units experienced poor communication among colleagues and feelings of loneliness. Many reported decreased appetite or indigestion (59%), fatigue (55%), sleep disturbances (45%), nervousness (28%), frequent crying (26%), and even suicidal thoughts (2%). The study also found that younger nurses without prior experience in caring for critically ill patients faced a greater psychological crisis.10 Due to the high demands of the healthcare profession, the health status of nurses is expected to be better than that of the general population. However, several studies have shown that many nurses are unhealthy. Zapka et al. reported that 13.6% of nurses had high blood pressure, 21.5% had high cholesterol, and 65.4% had a body mass index (BMI) over 25. Most nurses were not engaging in regular exercise, and 1 in 10 used negative coping strategies such as tobacco consumption. Similarly, Bhatia et al. found that the prevalence of work-related stress among nurses was 87.4%, with 32.2% experiencing severe or extreme stress.1 A survey conducted in Turkey aimed to assess the levels of depression, anxiety, and burnout among intensive care unit nurses. The findings revealed that 53.3% of nurses experienced burnout, and 27% were exhausted and required professional help. A moderately significant positive correlation was found between anxiety and burnout as well as depression and burnout. The researchers emphasized the need to protect nurses’ mental health to enhance both quality of care and work productivity.11 A moderate level of stress, known as “eustress,” acts as a motivating force and is considered normal and beneficial. However, when stress becomes intense, continuous, and repetitive, it turns into “distress,” leading to physical illness and psychological disorders, thereby diminishing quality of life.¹² Occupational stress can arise from various factors such as poor working conditions, excessive workload, shift duties, long working hours, role ambiguity, role conflict, and poor interpersonal relationships at work. A survey among registered nurses in the United States revealed that 59% found their job highly stressful and felt burned out.12 Poornima et. al., Am. J. PharmTech Res. 2025;15(05) ISSN: 2249-3387 www.ajptr.com 144 Studies by Abdi and Shahbazi and Rahmani et al. on intensive care unit (ICU) nurses revealed that 49.2% experienced high levels of occupational stress related to their work environment. Analysis across six stress dimensions showed that stress prevalence ranged as follows: workload (25– 27.4%), incompetence (26.3–54.1%), dichotomy (40.5%), role range (31.3–62.5%), role responsibility (33.3–48.9%), and physical environment (48.4–54.2%).6 A study conducted in Tehran, Iran, analyzing 16,000 COVID-19 cases, reported that the mortality rate in ICU and CCU was 62.7% among confirmed cases and 52.2% among suspected cases. Nurses and physicians, being on the frontline of the pandemic, experienced significant anxiety, fear, and stress due to the virus’s high transmissibility and widespread prevalence.3 A study on perceived stress among 310 nurses in Jordan revealed that ICU, CCU, and ER nurses experienced the highest levels of stress, while medical and surgical nurses reported the lowest stress levels. Such high stress can negatively impact patient care and safety, particularly for ICU patients. The study emphasized that nurse managers and policymakers should closely monitor this issue and investigate the underlying causes of elevated stress.12 Research Methodology Research methodology is a systematic way of solving research problems. It involves defining the problem, formulating hypotheses, selecting data collection methods, and applying statistical techniques for analysis. Methodological decisions affect the validity and credibility of study findings. This chapter describes the methodology adopted to evaluate the effectiveness of a SelfInstructional Module (SIM) on stress management among nursing officers working in ICU at Hassan Institute of Medical Sciences, Hassan. It includes research design, setting, population, sample, tool development, validity, reliability, pilot study, data collection and data analysis plan. Research approach A Quantitative Evaluative Research Approach was used. Evaluation research assesses the success of a program, practice, or policy. Research design The study adopted a one group pre-test and post-test pre-experimental design, represented as: O1 – Pre-test knowledge assessment  X – Intervention (SIM on stress management)  O2 – Post-test knowledge assessment (on 8th day) Variables  Independent variable: Self-Instructional Module (SIM)  Dependent variable: Knowledge of nursing officers regarding stress management. Poornima et. al., Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 145 www.ajptr.com  Extraneous variables: Age, sex, marital status, experience, income, previous knowledge, health status, etc. Setting and population The study was conducted at HIMS Hospital, Hassan. Target population was nursing officers working in ICU. Sample and sampling technique A sample of 40 nursing officers was selected using non-probability purposive sampling.  Inclusion criteria: ICU nursing officers present and willing to participate  Exclusion criteria: Nursing officers not present during data collection Development of SIM The SIM was developed through literature review and expert consultation. Content covered:  General information on stress  Predisposing factors and stressors  Occupational stress, causes, signs, and symptoms  Effects of stress  Work–family balance  Coping strategies and unhealthy practices Tool development A Structured Knowledge Questionnaire was developed with:  Section I: 11 items on demographic data  Section II: 40 questions on knowledge (5 aspects of occupational stress and management) Scoring:  Inadequate: ≤20 (≤50%)  Moderate: 21–30 (51–75%)  Adequate: 31–40 (76–100%) Validity: Reviewed by 10 experts; modifications made as per suggestions. Reliability: Tested using split-half Karl Pearson’s correlation, yielding r = 0.99, indicating high reliability. Pilot study Conducted from 04-04-2024 to 13-04-2024 on 5 nursing officers. Post-test mean score (96.6%) was significantly higher than pre-test (40%), proving feasibility of the study. Data collection procedure  Pre-test (O1): Knowledge assessed using questionnaire (45 minutes). Poornima et. al., Am. J. PharmTech Res. 2025;15(05) ISSN: 2249-3387 www.ajptr.com 146  Intervention (X): SIM administered on same day.  Post-test (O2): Conducted on 8th day (40 minutes). Data analysis  Descriptive statistics: Frequency, percentage, mean, mean percentage, SD.  Inferential statistics:  Paired ‘t’ test → effectiveness of SIM  Chi-square test → association between knowledge and demographic variables RESULTS AND DISCUSSION Presentation of the data To begin with, the data was entered in a master sheet for tabulation and statistical processing. In order to find the relationship, the data was tabulated, analyzed and interpreted by using descriptive and inferential statistics. The data is presented under the following headings. Section I: Analysis of demographic characteristics of respondents under study. Section II: Analysis of pre-test and post-test knowledge scores of respondents and effectiveness of self-instructional module. 1. Analysis of pre-test knowledge scores. 2. Analysis of post-test knowledge scores. 3. Effectiveness of self-instructional module on knowledge scores of whole tests. 4. Effectiveness of Self-instructional Module area wise knowledge scores. Section Ⅲ: Analysis of association between demographic variables with pre-test knowledge scores. Section-1: Socio-demographic characteristics of respondents under the study The data from the Table 1 shows the following findings: 1. Majority of the subjects (55%) were in the age group of 31-40 years followed by 32.5% in the age group of less than 30 years and remaining 12.5% of them were in the age group of 41-50 years. (Figure-1). 2. Majority of the participants (77.5%) were females and remaining 22.5% were males. (Figure-2). 3. Majority (75%) of the respondents belonged to Hindu religion and remaining 25% of them were belonged to Christian. (Figure-3). 4. Majority (57.5%) of the respondents were belonged to nuclear family, 37.5% of them to joint family and remaining 5% of the respondents to single parent family. (Figure-4). Poornima et. al., Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 147 www.ajptr.com 5. Majority (90%) of the respondents was married while 10% of them were unmarried. (Figure -5). 6. Majority (65%) of the respondents professional qualification was GNM, 15% of them BSc (N), 15% of them are PBBSc (N) and remaining 5% are MSc(N) qualified. (Figure-6). 7. Majority (67.5%) of the respondents have 1-10 years of professional experience and remaining 32.5% have 11-20 years of professional experience. (Figure-7). 8. Majority (52.5%) of the respondents have one child, 25% are have two children, 20% of them don’t have child and remaining 2.5% of them are have more than two children. (Figure-8). 9. Socio-economic status of majority (42.5%) of the respondents was Rs. 15000-25000/ month, while 37.5% of them had an income of Rs. 10000-15000, 12.5% of them had Rs. 25000-35000 and remaining 7.5% of them had an income above Rs.35000. (Figure-9). 10. Majority (55%) of the respondents has some previous knowledge regarding stress and its management, and remaining 45% of respondents has no previous knowledge. (Figure-10). 11. Majority (90%) of the respondents were not suffering from any medical/psychological disorders and remaining 10% were suffering. (Figure-11). Table 1: Classification of study participants by socio-demographic variables. Sl. No Socio demographic variables Categories N=40 Frequency % 1 Age in a year Less than 30 13 32.5% 31 - 40 22 55% 41 - 50 5 12.5% 51 - 60 0 0% 2 Gender Male 9 22.5% Female 31 77.5% Transgender 0 0% 3 Religion Hindu 30 75% Christian 10 25% Muslim 0 0% Others 0 0% 4 Type of family Marital status Nuclear family 23 57.5% Joint family 15 37.5% Single parent family 2 5% Extended family 0 0% 5 Marital status Married 36 90% Unmarried 4 10% Others 0 0% 6 Professional Qualification GNM 26 65% BSc(N) 6 15% PBBSC(N) 6 15% MSc(N) 2 5% Poornima et. al., Am. J. PharmTech Res. 2025;15(05) ISSN: 2249-3387 www.ajptr.com 148 PHD 0 0% 7 Years of professional experience 1 - 10 years 27 67.5% 11 - 20 years 13 32.5% 21 - 30 years 0 0% More than 30 years 0 0% 8 Number of children Nil 8 20% One 21 52.5% Two 10 25% More than two 1 2.5% 9 Socio economic status Rs.10,000 - 15000/month 15 37.5% Rs.15000 - 25000/month 17 42.5% Rs.25000 - 35000/month 5 12.5% More than Rs.35000/month 3 7.5% 10 Previous knowledge about stress and its management Yes 22 55% No 18 45% 11 Suffering from any medical / psychological disorders No 36 90% Yes 4 10% Figure 1: Classification of study participants by their age in years. Poornima et. al., Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 155 www.ajptr.com Figure 14: Classification of Respondents of Post-test Knowledge level on Stress and its management. Effectiveness of Self-Instructional Module on Knowledge scores of Whole test Table 6 and figure 16 depicts the overall pretest mean knowledge scores of respondents on stress and its management was 36% and post-test mean was 72.18% with an enhancement of 36.18% mean knowledge score. The calculated paired ’t’ test value (t=21.915*) is greater than the table value at 0.05 level of significance which indicates that there is a significance difference between pre-test and post-test knowledge scores of whole test of respondents. Hence the stated research hypothesis H1 is accepted. It was concluded that the Self-Instructional Module was effective in increasing the knowledge of nursing officers regarding Stress and its management. Table 6: Over all pre-test and post-test mean knowledge scores on stress and its management. (N=40). (s)= significant at 0.05 level t (0.05, 39df) =2.042 0% 57.50% 42.50% 0% 10% 20% 30% 40% 50% 60% 70% Inadequate Moderate Adequate Respondents(%) Knowledge Level Mini mum Maxi mum Ran ge Mea n Mean % Std. Deviati on Coefficien t of varianc e Paired t test value Pretest 7 24 17 14.4 36% 4.229 29.37% 21.915(s) P<0.0001 Df=39 Posttest 20 37 17 28.87 72.18% 3.155 10.92% Enhancement 4 24 20 14.47 36.18% 4.361 10.90% Poornima et. al., Am. J. PharmTech Res. 2025;15(05) ISSN: 2249-3387 www.ajptr.com 156 Figure.16: Over all Pre-test, Post-test and Enhancement Mean Knowledge scores on stress and its management. The above table reveals aspect wise pre-test and post-test knowledge scores on stress and its management. In the aspect wise knowledge regarding general information about stress the mean % in pretest was 38.611% and in post-test was 75.833% with the enhancement of 37.22%. Which is significant (t=13.505*) at 0.05 level of significance. In the aspect wise Predisposing Factors of Stress mean % in the pre-test was 35.833% and in posttest was 69.72% with the enhancement of 33.88% which is significant (t=14.104*) at 0.05 level of significance. In the aspect wise Indicators, signs and symptoms of stress the mean % in the pretest was 33.125% and in post-test was 68.75% with the enhancement of 35.62% which is significant (t=15.380*) at 0.05 level of significance. In the aspect wise Affects of occupational stress the mean % in the pretest was 33.75% and in posttest was 67.5% with the enhancement of 33.75% which is significant (t=9.458*) at 0.05 level of significance. In the aspect wise Coping strategies and unhealthy ways of stress management the mean % in the pretest was 37% and in post-test was 75.75% with the enhancement of 38.75% which is significant (t=21.777*) at 0.05 level of significance. The overall mean percentage in pre-test was 36%, and post-test was 72.187% with the enhancement of 36.18%, which is significant (t=21.915*) at 0.05 level of significance. However the enhancement of knowledge found to be higher in knowledge regarding Stress and Its Management. 36% 72.18% 36.18% 0% 10% 20% 30% 40% 50% 60% 70% 80% Pre-test Post-test Enhancement MEAN SCORES(%) KNOWLEDGE Poornima et. al., Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 157 www.ajptr.com The calculated paired’t’ test values based on pre-test and post-test knowledge scores of all the aspects were more than the table value(2.042) at 0.05 level of significance with 39 degrees of freedom. It indicates that there is a significant difference between pre-test and post-test knowledge score. Hence the stated null hypothesis H0 is rejected and the research hypothesis H1 is accepted. Table.7 & Figure 17 reveals the aspect wise mean pre-test and post-test knowledge score on stress and its management, highest enhancement (38.75%) in mean percentage is obtained in the aspect of "Coping strategies and unhealthy ways of stress management", followed by 37.22% enhancement in the aspect of "General information about stress", 35.62% in the aspects of "Indicators, signs and symptoms of stress", 33.88% in the aspect of “Predisposing factors of stress” and 33.75% in the aspect of “Affects of occupational stress”. The overall enhancement was 36.18%. The calculated paired’t’ test values based on pre-test and post-test knowledge scores of all the aspects were more than the table value at 0.005 level of significance with 39 degree of freedom. It indicates that there is a significant difference between pre-test and post-test knowledge scores in all aspects. Table 8 & Figure 18 depicts that in pre-test 34% of respondents had inadequate knowledge, 15% of them had moderate knowledge and none of them had adequate knowledge. In post-test none of them had inadequate knowledge, 57.5% had moderate knowledge and 42.5% had adequate knowledge. Which indicates that Self-instructional Module was effective. Table 7: Aspect wise Mean and Mean% of pre-test, post-test, and Enhancement knowledge scores among nursing officers working in ICU. (N=40) Aspects Mean Mean% Calculated Paired t-test value Pretest Post test Enhancement Pretest Post test Enhancement Aspect I: General information about stress 3.475 6.825 3.35 38.611% 75.833% 37.22% 13.505 (S) P<0.001 df=39 Aspect Ⅱ: Predisposing factors of stress 3.225 6.275 3.05 35.833% 69.72% 33.88% 14.104(S) P<0.001 df=39 Aspect Ⅲ: Indicators, signs and symptoms of stress 2.65 5.5 2.85 33.125% 68.75% 35.62% 15.380 (S) P<0.001 df=39 Aspect IV: Affects of occupational stress 1.35 2.7 1.35 33.75% 67.5% 33.75% 9.458 (S) P<0.001 df=39 Aspect V: Coping strategies and unhealthy ways of stress management 3.7 7.575 3.875 37% 75.75% 38.75% 21.777(S) P<0.001 df=39 Poornima et. al., Am. J. PharmTech Res. 2025;15(05) ISSN: 2249-3387 www.ajptr.com 158 OVERALL 14.4 28.875 14.475 36% 72.187% 36.18% 21.915 (S) P<0.001 df=39 (S)Significant at 5% level, t (0.05, 39df) = 2.042 Figure 17: Aspect wise mean pre-test and post-test knowledge scores on Stress and its management. Section III: Association between demographic variables and pre-test knowledge level on stress and its management. Table 9 Association between pre-test level of knowledge of study participants and their sociodemographic variables and calculated χ2 values. The calculated χ2 values with regard to the sociodemographic variables viz. Age in years (χ2=4.020), Gender (χ2=2.049), Religion (χ2=0.261), Type of family (χ2=2.671), Marital status (χ2=0.349), Professional qualification (χ2=3.801), Years of professional experience (χ2=0.807), Socio economic status (χ2=3.153), Previous knowledge about stress and its management (χ2=0.388), suffering from any medical/psychological disorders (χ2=0.784), were less than the table value at 0.05 level of significance. Hence the stated null hypothesis Ho is accepted and the research hypothesis H2 is rejected with regard to these socio demographic variables and pretest level of knowledge of study participants. But the calculated χ2 values with regard to Number of children (χ2=14.849) was more than the table value at 0.05 level of significance at respective degrees of freedom and hence were statistically significant. Hence the stated null hypothesis H0 is rejected and the research hypothesis H2 is accepted with regard to the number of children pretest level of knowledge of study participants. (Figures 19). 38.61% 35.83% 33.12% 33.75% 37% 75.83% 69.72% 68.75% 67.50% 75.75% 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% I II III IV V Mean scores(%) Knowledge Aspects Pre test Post test Poornima et. al., Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 159 www.ajptr.com Table 8: Classification of Respondents on Pretest and Post-test Knowledge level on Stress and its management. N=40 Level Scores Percentage Pre-test Post test Pre-test Post test Inadequate 1 - 20 <50% 34 0 85% 0% Moderate 21 - 30 50 - 75% 6 23 15% 57.5% Adequate 31-40 >75% 0 17 0% 42.5% Total 40 40 100% 100% Figure.18: Classification of Respondents on Pre-test and Post-test Knowledge level on Stress and its management. Table 9: Association between pre-test level of knowledge of study participants and their socio-demographic variables. Sr no Socio demographic variables Categories Pretest level of knowledge Calculate d chi square value D f P value Inadequate Moderate N % N % 1 Age in years Less than 30 9 22.5 4 10 4.020 (NS) 2 0.133 31 - 40 20 50 2 5 41 - 50 5 12.5 0 0 51 - 60 0 0 0 0 2 Gender Male 9 22.5 0 0 2.049 (NS) 1 0.152 Female 25 62.5 6 15 Transgender 0 0 0 0 3 Religion Hindu 25 62.5 5 12.5 0.261 (NS) 1 0.609 Christian 9 22.5 1 2.5 Muslim 0 0 0 0 Others 0 0 0 0 4 Type of family Nuclear family 21 52.5 2 5 2.671 (NS) 2 0.263 Joint family 11 27.5 4 10 Single parent family 2 5 0 0 Extended family 0 0 0 0 85% 15% 0%0% 57.50% 42.50% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Inadequate Moderate Adequate Respondents(%) Knowledge Level Pre test Post test Poornima et. al., Am. J. PharmTech Res. 2025;15(05) ISSN: 2249-3387 www.ajptr.com 160 5 Marital status Married 31 77.5 5 12.5 0.349 (NS) 1 0.554 Unmarried 3 7.5 1 2.5 Others 0 0 0 0 6 Professional qualification GNM 20 50 6 15 3.801 (NS) 3 0.283 BSc(N) 6 15 0 0 PBBSc(N) 6 15 0 0 MSc(N) 2 5 0 0 PHD 0 0 0 0 7 Years of professional experience 1 - 10 years 22 55 5 12.5 0.807 (NS) 1 0.369 11 - 20 years 12 30 1 2.5 21 - 30 years 0 0 0 0 More than 30 years 0 0 0 0 8 Number of children Nil 2 5 3 7.5 14.849 (S) 3 0.0019 One 19 47.5 2 5 Two 10 25 0 0 More than two 0 0 1 2.5 9 Socio economic status Rs.1000015000/month 11 27.5 4 10 3.153 (NS) 3 0.368 Rs.1500025,000/ month 15 37.5 2 5 Rs.25,000-35000/ month 5 12.5 0 0 More than Rs.35000/month 3 7.5 0 0 10 Previous knowledge about stress & its management Yes 18 45 4 10 0.388 (NS) 1 0.533 No 16 40 2 5 11 Suffering from any medical/psychological disorders No 30 75 6 15 0.784 (NS) 1 0.375 Yes 4 10 0 0 (NS)= NOT SIGNIFICANT (S) = SIGNIFICANT AT 0.05 LEVEL Figure 19: Association between Number of children and Pretest Knowledge level on Stress and its management 5% 47.50% 25% 0% 7.50% 5% 0% 2.50% Nil One Two More than two Respondents(%) Number of children Inadequate Moderate Poornima et. al., Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 161 www.ajptr.com It is concluded that, pre-test knowledge level of respondents are significantly associated with only number of children and no significant association with other variables. This chapter discusses the major findings of the study in relation to similar studies. The study aimed to assess the effectiveness of a Self-Instructional Module (SIM) on knowledge regarding stress and its management among 40 nursing officers working in ICU at a selected hospital in Hassan. A one-group pre-test and post-test pre-experimental design was used. Data were collected using a Structured Knowledge Questionnaire. The SIM was implemented after the pre-test, and post-test was conducted on the 8th day to evaluate its effectiveness. Findings are discussed under the following sections: Section I: Demographic Characteristics  Age: 55% were 31–40 years, 32.5% <30 years, 12.5% 41–50 years.  Gender: 77.5% females, 22.5% males.  Religion: 75% Hindu, 25% Christian.  Family type: 57.5% nuclear, 37.5% joint, 5% single-parent.  Marital status: 90% married, 10% unmarried.  Professional qualification: 65% GNM, 15% BSc Nursing, 15% PBBSc, 5% MSc Nursing.  Experience: 67.5% had 1–10 years, 32.5% had 11–20 years.  Children: 52.5% had one child, 25% two children, 20% none, 2.5% more than two.  Income: 42.5% Rs. 15,000–25,000, 37.5% Rs. 10,000–15,000, 12.5% Rs. 25,000–35,000, 7.5% > Rs. 35,000.  Previous knowledge of stress management: 55% had some knowledge, 45% had none.  Medical/psychological disorders: 90% reported none, 10% reported disorders. Section II: Existing Knowledge Regarding Stress Management Pre-test results revealed 85% of nursing officers had inadequate knowledge, 15% had moderate knowledge, and none had adequate knowledge. This indicates that most nursing officers lacked sufficient knowledge regarding stress management. These findings are consistent with a similar study among pediatric nurses in Nagercoil, which also reported low knowledge levels regarding stress management techniques. Section III: Effectiveness of Self-Instructional Module  Pre-test mean knowledge: 36%  Post-test mean knowledge: 72.18% (increase of 36.18%) Poornima et. al., Am. J. PharmTech Res. 2025;15(05) ISSN: 2249-3387 www.ajptr.com 162  Post-test results: 57.5% moderate knowledge, 42.5% adequate knowledge, none inadequate.  Statistical significance: Calculated t-value = 21.915*, greater than t-table value 2.042, indicating SIM was effective.  Similar studies also reported significant improvement in knowledge after SIM implementation among nurses and other professional groups, such as bank employees. Section IV: Association Between Demographic Variables and Pre-Test Knowledge  Significant association was found only for number of children (χ² = 14.849 > χ² table value).  No significant association was found for age, gender, religion, family type, marital status, qualification, years of experience, socioeconomic status, previous knowledge, or medical/psychological disorders.  This aligns with other studies, which found limited demographic variables affecting stress or knowledge levels, except income, experience, or working hours in some cases. Section V: Hypotheses Testing H1: There is a significant difference between preand post-test knowledge scores. Pre-test: 36%, Post-test: 72.18%, t = 21.915* > 2.042. Conclusion: H1 accepted; SIM significantly improved knowledge. H2: There is a significant association between pre-test knowledge and demographic variables. Only number of children showed a significant association (χ² = 14.849*). Other variables showed no significant association. Conclusion: H2 accepted for number of children; rejected for all other variables. CONCLUSION The study assessed the knowledge of nursing officers on stress management through a SelfInstructional Module (SIM). The module covered stress, predisposing factors, signs and symptoms, effects, coping strategies, and unhealthy management methods. Findings revealed that:  Knowledge was inadequate before SIM.  Post-test scores showed significant improvement.  SIM is an effective teaching strategy.  It helps nursing officers recognize stress early and seek mental health support. Limitations  Small purposive sample limits generalization.  No control over extraneous variables between preand post-test. Poornima et. al., Am. J. PharmTech Res. 2025; 15(05) ISSN: 2249-3387 163 www.ajptr.com  Knowledge retention was not assessed. Recommendations  Replicate with a larger sample and control group.  Compare government and private nursing officers.  Explore other teaching strategies.  Extend training duration and provide more in-depth content. Implications  Education: Integrate stress management in nursing curricula to improve knowledge and attitudes.  Practice: Nurses can promote stress prevention and coping strategies in hospitals, schools, and communities.  Administration: Plan continuing education programs, allocate resources, and evaluate effectiveness.  Research: Further studies are needed to improve stress management training and practical application in nursing education. REFERENCES 1. Sharma SK, Rani R. Nurse’s role and stress management in health care settings. Int J Nurs Educ Res. 2018;6(2):155–159. 2. Maslach C, Leiter MP. Understanding the burnout experience: recent research and its implications for psychiatry. World Psychiatry. 2016;15(2):103–111. 3. Health and Safety Executive. Stress in nursing: occupational risks and implications. Washington, DC: HSE; 2019. 4. McVicar A. Workplace stress in nursing: a literature review. J Adv Nurs. 2003;44(6):633– 642. 5. Donabedian A. The quality of care: how can it be assessed? JAMA. 1988;260(12):1743– 1748. 6. Gidron Y, Zwas DR, Shapiro Y. Occupational stress and health: a review of the literature. Int J Stress Manag. 1999;6(2):89–109. 7. Quick JC, Henderson DF. Occupational stress: preventing suffering, enhancing well-being. Int J Environ Res Public Health. 2016;13(5):459. 8. Allen TD, Herst DE, Bruck CS, Sutton M. Consequences associated with work-to-family conflict: a review and agenda for future research. J Occup Health Psychol. 2000;5(2):278– 308. Poornima et. al., Am. J. PharmTech Res. 2025;15(05) ISSN: 2249-3387 www.ajptr.com 164 9. Dobnik M, Maletič M, Skela-Savič B. Work-related stress factors in nurses at Slovenian hospitals – a cross-sectional study. Zdr Varst. 2018;57(4):192–200. 10. Cai H, Tu B, Ma J, Chen L, Fu L, Jiang Y, et al. Psychological impact and coping strategies of frontline medical staff in Hunan between January and March 2020 during the outbreak of COVID-19 in Hubei, China. Med Sci Monit. 2020;26:e924171. 11. Azoulay E, De Waele J, Ferrer R, Staudinger T, Borkowska M, Povoa P, et al. Symptoms of burnout in intensive care unit specialists facing the COVID-19 outbreak. Ann Intensive Care. 2020;10(1):110. 12. McVicar A. Workplace stress in nursing: a literature review. J Adv Nurs. 2003;44(6):633– 42. AJPTR is  Peer-reviewed  bimonthly  Rapid publication Submit your manuscript at: edito[email protected]