“A Study to Assess the Effectiveness of Mindfulness- Based Stress

Reduction Programs in Improving Psychological wellbeing among Diabetes

Patients in Sharda Hospital, Greater Noida, Uttar Pradesh”

By
Ms. Istahil Osman Abdi
A dissertation submitted to
SCHOOL OF NURSING SCIENCE AND RESEARCH, SHARDA UNIVERSITY,
GREATER NOIDA
In partial fulfilment for the degree of

MASTER OF SCIENCE IN NURSING

Under The Guidance of:

Dr. T David Ratna Paul
Associate Professor
Mental health Nursing
School of Nursing Science and Research, Sharda University

Co-Guide
Ms. Niharika Tiwari
Assistant professor
Medical surgical Nursing
School of Nursing Science and Research, Sharda University

Sharda School of Nursing science and research

Year-2025

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 CHAPTER-1

INTRODUCTION

One of the biggest health issues facing people worldwide is diabetes mellitus. The modern way
of living (reduced physical activities exercise). The prevalence of this disease has increased
recently due to a number of variables, including increased stress. Being a chronic condition,
diabetes mellitus puts a lot of stress on the patient, and research has shown that certain
psychological illnesses, such anxiety and depression, are more common in these people.
Glycemic regulation is also negatively impacted by stress and mental health conditions. the
majority of patients, medication is not enough to control the disease and its associated
complications (Nikkhah, 2020 ).

According to (WHO, 2023). 422 million suffers DM worldwide by 2023. Indonesia has 19.5
million DM patients, which makes it the fifth most DM-affected country in 2021, according to
data from the International Diabetes Federation. By 2045, that number is expected to rise to 28.6
million (International Diabetes Federation, 2021). There were 21,992 cases of DM in 2020,
making it the tenth most common disease (Dinkes Lamongan, 2021). The Sukodadi Lamongan
Community Health Center's February 2023 HbA1c level analysis of DM patients revealed an
8.8% result, indicating that the patient's blood sugar control is still inadequate. Based on the
findings of (Mohamed et al.'s 2023). El-Radad et al. (2023) reported that only 5% of patients
with diabetes mellitus were able to effectively regulate their blood sugar levels.

Because of the condition, its care, and its complications, the majority of people with diabetes
mellitus have psychological issues. Patients may be highly at risk for depression if their
psychological issues are not adequately managed. Diabetes mellitus (DM) is a chronic condition
brought on by long-term endocrine metabolic abnormalities that interfere with insulin secretion
and/or activity, raising blood sugar levels (hyperglycemia). Diabetes is a complicated and
debilitating condition that will have detrimental effects on one's health if left untreated. Stress,
sadness, or diabetes distress are the primary psychosocial issues that DM patients deal with.
Diabetes-related psychological issues affect over 66% of people with type 2 diabetes, and they
are more likely to experience depression. Patients with type 2 diabetes can manage their

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condition on their own by changing their lifestyle, receiving treatment, and receiving
information. Changes in dietary and physical activity patterns after a diagnosis, knowledge of the
condition, and a lack of social support are just some of the difficulties and issues that diabetic
patients experience. physical, psychological, and social challenges strict treatment plans, low
motivation, a lack of knowledge about self-management, and a lack of empathy for patients are
some of the limitations to self-management. When DM patients don't control their diabetes well,
they may experience diabetes discomfort. (Arina Qona’ah1 3. M., 2023).

Mental health issues like stress, anxiety, and depression are also linked to diabetes. Diabetes
patients frequently experience high levels of chronic stress due to a variety of factors, including
feeling overburdened by the daily demands of diabetes management activities (such as blood
glucose monitoring, exercise, and healthy eating), worries about the long-term complications of
diabetes, and frustration with the unpredictability and uncontrollability of blood glucose levels
(Ellis et al., 2019). High stress levels are linked to a decrease in daily diabetic self-care
behaviors, which may raise blood glucose levels. The awareness that results from paying
attention to the present moment without passing judgement is known as mindfulness, and it is
fostered by the techniques used in MBSR. There is evidence that mindfulness protects mental
health Virginia Fisher, V. & Li, W. et al. (2023).

According to Guo et al. (2019), stress results in poor coping and self-management, a reduced
attention span, and a lack of innovative ideas. Stress may cause difficult to learn new things,
develop new abilities, and solve issues. Patients experiencing distress also likely to develop
harmful judgements, erroneous personal beliefs, and unrealistic goals and aspirations.
Mindfulness is one technique that can be used to help people with diabetes deal with
psychological issues. A set of mindfulness exercises called Mindfulness-Based Stress Reduction
(MBSR) is used to teach people how to direct their attention in the present moment without
judgement. MBSR helps persons with chronic conditions like diabetes to manage their worry and
tension.

Practicing mindfulness is one strategy for diabetics to overcome psychological issues like stress.
The sub-discipline of mindfulness-based stress reduction is one of the concentration programs

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known as mindfulness-based programs (MBP). This approach, which involves regular medical
procedures, was introduced as an educational option that works well for those who are stressed
out or have mental health problems. The goal of this program is to assist clients in learning how
to handle with challenges in life. The psychological method of mindfulness-based stress
reduction is one that has been found to be effective in treating mental illnesses. Being mindful or
present-minded refers to "being conscious of motivations, attitudes, actions, and feelings in order
to better control and govern them." To be mindful is to focus. On emotions in three different
manners: (1) consciously present; (2) being in the current moment and (3) present without
passing judgement. More awareness and acceptance of the current reality result from this type of
focus. Since older adults frequently take a variety of medications, it's critical to find efficient
ways to lessen their reliance on pharmaceuticals. Research on many human subjects verified that
mindfulness practices are effective in reducing stress, anxiety, and depression. A number of
attempts have also been made to employ mindfulness-based practices for senior citizens (Ahmad
Reza Sayadi 1, 2022).

MBSR was created in 1979 by (Dr. Jon Kabat-Zinn) and his associates at the University of
Massachusetts Medical Center's Stress Reduction and Relaxation Program in a supervised
clinical setting, MBSR integrates mindfulness meditation and mild Hatha yoga. The goal of the
nonreligious MBSR approach is to develop a more acute, present-moment, nonjudgmental
awareness of experience. MBSR, which was first created to help patients manage their pain and
cope with the pressures of medical disease, has developed into a technique that is used to treat a
wide range of health issues as well as for general health and stress reduction.

MBSR is available at hospitals, clinics, and medical centres both domestically and overseas. It is
an 8-week course that lasts 2.5 hours per week and includes a one-day [Link] are
instructed in formal mindfulness meditation practices, such as sitting meditation, body-scan
meditation, and mild Hatha yoga that consists of basic poses and stretches. The program's main
goal is to help participants gradually become more observant of their surroundings by practicing
mindfulness meditation.

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Meditation's application as a mental health and medical intervention has increased dramatically
during the past three decades, moving beyond a purely religious and spiritual setting. Meditation
can be essentially characterised as the deliberate self-regulation of attention, and its practices can
be largely divided into two groups: those that focus on mindfulness and those that focus on
concentration. Mantras, which are repeated sounds or phrases, are used to focus attention during
transcendental meditation, an example of a concentrative technique. In contrast, mindfulness
practices emphasise developing a nonjudgmental present-moment awareness of both the inner
and outside worlds. Though meditation is fundamentally distinct in both approach and goal, both
forms are frequently linked to relaxation techniques. Meditation's general focus is on nonstriving
and nondoing rather than aiming for a condition akin to deep relaxation where physical tension is
[Link] Even while a state of physiological relaxation is attained, the practice's main
objective is to cultivate mental discipline that leads to a state of deeper awareness and movement
beyond reflexive thought.

In MBSR, mindfulness meditation helps practitioners develop a nonreactive, no evaluative,

moment-to-moment awareness from a purposefully nonjudgmental standpoint. While observing
their thoughts and feelings, participants are urged to let them go without passing judgement or
becoming sucked into [Link] promotes rapid passage of both positive and negative ideas and
feelings and can heighten awareness of the ways in which ideas, feelings, and actions impact
mental, emotional, and physical well-being. In addition to helping practitioners better notice,
comprehend, and integrate their own view of themselves and their surroundings, this may also
lessen distracting or ruminative [Link] A deeper understanding of the body and mind and
their potent interplay is also fostered by MBSR, which combines mindfulness meditation with
gentle yoga Robin, W. [Link]. (2009).

Meditation, in which participants concentrate on their breathing, physical sensations, or a

specific idea or phrase, is one technique that is frequently used to develop mindfulness. Research
on mindfulness's possible advantages for stress reduction, mental health, wellbeing, and
cognitive function is common. Mindfulness activities frequently include in therapeutic
treatments like mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress
reduction (MBSR). Developing the ability to successfully manage one's thoughts, emotions, and

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general psychological well-being is the goal of these interventions. Diabetes patients who
practice mindfulness can improve their insulin resistance, glycemic management, chronic pain,
and clinical symptoms of bowel dysfunction. Diabetes treatment should benefit from
mindfulness exercises (Hamasaki, 2023).

NEED OF THE STUDY

Diabetes is a chronic health condition that significantly impacts patients' physical and
psychological well-being. Patients with diabetes also face psychological issues. Several
researchers have focused their attention on the psychosocial aspects of diabetes in recent
decades. Previous research has demonstrated that individuals with diabetes experience stress,
anxiety, and depression symptoms. Diabetes has been linked to a doubled increased incidence of
anxiety and depression. Depression affects around 25% of people with diabetes. Stress and
depression cause people to isolate themselves and engage in less social engagement Sayadi A, et
al. (2020).

One of the biggest health issues facing people worldwide is diabetes mellitus. Glycemic
regulation is negatively impacted by stress and mental health conditions. For glycemic control in
the majority of patients, a multidisciplinary strategy involving exercise, a balanced diet, and
stress reduction is necessary. A structured group program called mindfulness-based stress
reduction (MBSR) helps people feel less distressed. A multidisciplinary strategy that
incorporates stress management, a balanced diet, and physical activity is needed. In order to
regulate this, psychological and medicinal measures are implemented together. MBSR is a
structured group program designed to lower pain and suffering, increase mental health, and
reduce stress. In order to help patients, analyze and respond to stress in a constructive way rather
than a passive one, these trainings are designed to raise their awareness and acceptance of their
internal and external experiences. Over time, this approach leads to more effective health
behaviors and less emotional discomfort by promoting self-awareness and taking ownership of
personal decisions Ravari, A. et al. (2020).

The goal of this research is to evaluate how effectively diabetes patients' psychological well-
being is improved by mindfulness-based stress reduction programs. The study will specifically

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look into whether doing an MBSR program can help people with diabetes feel less stressed, have
better moods, and have better overall psychological health.

STATEMENT OF THE PROBLEM:

A Study to Assess the Effectiveness of Mindfulness-Based Stress Reduction Programs in

Improving Psychological Wellbeing Among Diabetes Patients in Sharda Hospital, Greater
Noida”

OBJECTIVES:

1. To assess the impact of mindfulness-based stress reduction programs on measures of

psychological status and quality of life among diabetes patients
2. To evaluate the effectiveness of a mindfulness-based stress Programs among diabetes
patients
3. To investigate the association between MBSR involvement in improving psychological
well-being among diabetes patients

OPERATIONAL DEFINITIONS:

 Assess: refers to the systematic process of evaluating or measuring the effectiveness of

Mindfulness-Based Stress Reduction (MBSR) programs in improving the psychological
well-being of diabetes patients.
 Effectiveness: refers to the outcome of mindfulness based stress reduction on diabetes
patients to reduce mental health problems.
 Mindfulness-Based Stress Reduction (MBSR): Mindfulness-Based Stress Reduction
(MBSR) refers to a structured therapeutic program designed to help individuals manage
stress, anxiety, and other psychological challenges through the practice of mindfulness.
 Psychological wellbeing: refers to the overall mental and emotional health of diabetes
patients.
 Diabetes: is a chronic metabolic disease that occurs when the body doesn't produce
enough insulin or can't use the insulin it produces properly

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HYPOTHESIS:

All hypothesis will be assessed at 0.05 level of significant

H01: Significant association will be there between the sociodemographic variables and the
effectiveness of mindfulness based stress reduction programs in improving psychological
wellbeing among diabetes patients

H02: There will be significant difference between the effectiveness of mindfulness-based stress
reduction programs in improving psychological wellbeing among diabetes patients.

ASSUMPTIONS OF THE STUDY:

Use of Mindfulness-Based Stress Reduction will improve mental health of diabetic patients

 Awareness of Mindfulness- Based Stress reduction is very important for diabetic patients

DELIMITATIONS OF THE STUDY:

Study participants confined to diabetic patients of Sharda Hospital, Greater Noida, Uttar Pradesh

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 CHAPTER-2

REVIEW OF LITERATURE

One of the most crucial stages in the research process is the review of the literature. It provides
an overview of the existing knowledge regarding a specific phenomenon. A literature review's
primary goal is to inform readers about previous research, as well as the concepts and
information that have been previously formed on a certain study subject. A review of the
literature is an explanation of the accomplishments and earlier studies on a phenomenon by
academics. Gives a summary of the discussion, the major authors, and the dominant theories and
hypothesis, what queries were posed, and what techniques and procedures were suitably and
practically

A review of the literature is described as a broad, comprehensive, systematic, and critical

analysis of research publications, unpublished scholarly print resources, audiovisual materials,
and private correspondence.

The literature review for the present study is organized and presented under following:

Sayadi A, et al. (2020) conducted an experimental study to assess the effect of mindfulness-
based stress reduction (MBSR) training on stress, sadness, anxiety, and serum cortisol levels in
older persons with type 2 diabetes (T2DM) during the COVID-19 pandemic. Participants in this
experimental study Accurate random sampling was used to select 56 adult patients with type 2
diabetes, and equal numbers of participants were after that assigned at random to the control and
intervention groups. The intervention group's members go through 8 mindfulness-based stress
reduction (MBSR) training sessions. There was no intervention given to the subjects in the
control group. Only 52 patients' data were gathered using the Depression Anxiety Stress Scale
(DASS-21) and a questionnaire about their demographics and medical conditions because 4
patients withdrew from the study. The Kolmogorov-Smirnov test, chi-square test, Fisher test,
independent samples t-test, and two-way ANOVA were used to analyze the data using SPSS18
software; the significance was p<0.05. Before, immediately after, and three months after the

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intervention, there were statistically significant differences (p<0.00001) in the mean scores of
anxiety, stress, depression, and cortisol levels in the intervention group.

Qona’ah, A. & Pandin, M. et al. (2023) conducted a systemic review and meta-analysis to
determine how mindful therapies affect individuals with diabetes mellitus's psychological health
and ability to control their blood sugar levels. The study's preferred report items for Systematic
Review and Meta-analysis (PRISMA) guidelines were followed in the systematic review
method. The databases used in this systematic review are Google Scholar, Web of Science,
Science Direct, and Scopus. Participants in the study required to have type 2 diabetes for at least
six months, have HbA1C levels greater than 7, and had previously been tested for psychological
issues (diabetic distress, stress) using a questionnaire. Individuals who were medically diagnosed
with mental health issues were not included in the study. he patient's psychological issues,
particularly those involving poor self-management, can be controlled with mindfulness. MBSR
treatments improve the wellbeing of patients with type 2 diabetes by lowering stress, depression,
and anxiety scores with p < 0.05).

Fisher, V. & Li, W. et al. (2023) conducted a systemic review and meta-analysis of randomized
controlled trails study to evaluate the effect of mindfulness-based stress reduction (MBSR) on
diabetic patients' mental health, hemoglobin A1c (HbA1C), and mindfulness. narrative review on
Diabetes patients' mental health has improved with the use of clinically standardized
mindfulness-based stress reduction (MBSR) as an intervention. The study 718 individuals were
included in the tests, with sample sizes ranging from 38 to 110. There were 48 individuals with
type 1 diabetes, 474 with type 2 diabetes, 124 with type 1 or type 2 diabetes, 94 with diabetes
that was not identified, and 88 pregnant women with gestational diabetes. Three of the ten
included studies used standardized MBSR in its entirety (8-week sessions plus a full-day retreat).
The combined effect sizes the MBSR intervention showed a significant impact size on anxiety
(Hedges' g = −2.407, 95% CI [−3.631, −1.183], p =.000) and depression (Hedges' g = −1.110,
95% CI [−1.988, −0.232], p =.013), according to a comparison of the post-test scores for the
MBSR and control groups.

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Hamasaki, H.(2023) conducted a systemic review and data-analysis study to provide a summary
of the available data about the effect of mindfulness practices on diabetics' glycemic
management and make suggestions for further study. This review evaluated a total of five RCTs
(randomised controlled trials) meta-analyses and systematic reviews. The effectiveness of
mindfulness therapies on psychological outcomes was evaluated in three of the four systematic
[Link] or MBCT decreased depression ratings on a variety of assessments
(standardised SMD = 0.84, 95% CI 1.16 to 0.51, p < 0.0001) and enhanced the quality of life
mental health composite (MD = 7.06, 95% CI 5.19 to 9.03, p < 0.0001). further revealed that
mindfulness therapies decreased diabetes-related distress (MD = 5.81; 95% CI, 10.10 to 1.52, p =
0.008), stress (SMD = 0.53; 95% CI, 0.75 to 0.31, p < 0.0001), and depression (SMD = 0.56;
95% CI, 0.82 to 0.30, p < 0.0001). However,The included studies showed varying effects of
mindfulness therapies on anxiety. When comparing the intervention group to the control group,
two RCTs revealed a substantial decrease in anxiety, whereas three RCTs showed no significant
differences between the groups. Also showed that self-directed mindfulness meditation and
MBCT decreased anxiety (SMD = 0.41; 95% CI, 0.66 to 0.15, p = 0.002).

Abed, M. & Azadi, [Link] al. (2021) collected a quasi-experimental study with a pretest and
posttest to determine how mindfulness-based stress reduction (MBSR) training affects with the
emotions of type 2 diabetic patients' emotional expressiveness and fear of hypoglycemia (FOH).
This study done on the ll type 2 diabetes patients who visited Yazd Diabetes Centre in 2020
made up the statistical population. In order to choose forty men and women, carefully case and
control groups were assigned at random after sampling. For eight sessions, lasting two hours
each, the case group got MBSR teaching. as well as no interventions were given to the control
group. Affective Questionnaire on Expressiveness (EEQ) and the Fear of Hypoglycemia Data
collection was done using the HFS Survey. The ANCOVA results showed that MBSR training
significantly reduces the fear of hypoglycemia (P-value<0.0001) and improves emotional
expressiveness and its components (P-value<0.0001) in patients with type 2 diabetes (P-value<
0.035).

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Xia, T. & Lopes, S. et al. (2022) Conducted a single-arm, mixed methods study to test the
effectiveness of applying a low-dose mindfulness-based stress reduction (MBSR) treatment in a
therapeutic context to patients with diabetes. The group-based low-dose MBSR intervention was
administered in four waves, with each wave lasted 8–10 hours in 8 sessions spread across 6–8
weeks. A recruiting rate of 55.9% was achieved with 19 out of 34 eligible people. The attrition
rate was 26.3% among the 19 registered participants, as 4 of them left after baseline data
collection and did not attend any sessions, and 1 of them attended one session but did not
complete post-intervention data collection. Of the 15 individuals who attended at least one
session, 80.0% attended at least five sessions, and 46.7% attended all sessions.
A qualitative examination of 11 participants revealed that 90.9% of them had a good overall
experience with the intervention. Significantly lower levels of depression (mean reduction =
5.04, SD = 7.66, p = 0.02), flexibility exercise participation (42.86% vs. 85.71%, p = 0.01), and
glycosylated haemoglobin (HbA1c) (mean reduction = 1.43%, SD = 2.54%, P=0.03) at post
intervention.

Sasikumar, S. Padmapriya, S. (2020) concentrated a true experiment with pre-test, post-test

design study to investigate the positive benefits of MBSR therapy on 138 type 2 diabetics'
HbA1C, blood pressure, BMI, stress, depression, and mindfulness. Participants were split into
two groups at random: the intervention group and the control group. Participants in the
intervention group received MBSR for 8 weeks, while the control group did not receive any
intervention. Every participant in both groups got their standard medical care. Before and after
six weeks following the intervention, dependent variables were measured. At the tenth week, a
follow-up was conducted. According to the study's findings, MBSR improved the intervention
group's HbA1C, blood pressure, BMI, stress, depression, and mindfulness. The mean pre-test
stress score for the intervention group was 18.39, which was higher than the post-test stress score
of 13.65. The control group's mean post-test stress score was 18.73, while the intervention
group's was 13.65. he intervention group's mean post-test depression score was lower (12.88)
than that of the control group (18.38). Plus, the control group's mean post-test depression score
(18.49) was higher than that of the intervention group (12.88). the pre-test group (48.06) and the

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post-test group (60.64). The post-test mindfulness score was greater for the intervention group
(60.64) than for the control group (48.32). To determine if the groups were homogeneous based
on their baseline clinical and demographic characteristics, the chi-square test was used (p>0.05).
Software called Statistical Package for Social Sciences (SPSS) 16.0 was used to complete the
task.

Xia,T. Yang, Y. Li, W. et al. (2020) focused a systemic review and meta-analysis to provide a
summary of the newest studies on the benefits of meditation for people with type 2 diabetes.
After searching and filtering the papers for duplicates, removing pointless titles and abstracts,
and examining entire texts, two independent researchers chose the studies that met the criteria.
21 studies met the inclusion criteria. Researchers analysed the study findings using RevMan
5.3.0, which was made available by the Cochrane Collaboration. Since the meta-analysis only
contained continuous data, they reported the data as mean ± standard deviation. then computed
the standardised mean difference (SMD) to get the 95% confidence interval (CI) and two-sided P
value. The analysis data consisted of the entire case data. The I2 value and the 2 test were used to
quantify the +e degree of heterogeneity. They conducted subgroup analysis based on the
following criteria: region (Asia versus non-Asia), control type (nonexercise versus other active
exercises), type of meditation movement (Tai Chi/Qigong versus Yoga), duration (>3 months
versus ≤ 3 months), and total sample size (>60 versus ≤ 60). If required, we also conducted a
sensitivity analysis. To see if treatment effects varied among subgroups, a test for the interaction
between the therapy and subgroups was conducted.A P value of ≥0.05 was considered as an
interaction, meaning that there was no significant difference in the effect of treatment between
subgroups.

Ravari, O. & Mousavi, S. et al. (2019) conducted A randomized controlled clinical trial study
to Evaluate how mindfulness meditation affects type 2 diabetes patients' mental health and
glycaemic management referred to Imam Ali Comprehensive Urban Health Center in Isfahan, a
central city in Iran, in 2019. A total of 108 patients with type 2 diabetes were chosen, and they
were randomized into two groups: the intervention group undergo (12 weeks of MBSR program)
and the control group (regular care). Before and 13 weeks after educational programs,

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depression, anxiety, and stress scores pertaining to the Depression, Anxiety, and Stress Scale - 21
questionnaire as well as levels of fasting blood sugar (FBS) and haemoglobin A1C (HbA1C)
were measured and analysed using independent t-test, paired t-test, Mann–Whitney U–test, and
Chi-square. The MBSR group's means of HbA1C, FBS, and stress, anxiety, and depression
evaluations all significantly improved after the intervention. The mean change in all outcome
variable scores was significant between the two groups, with the exception of FBS levels.

Kian, A. & Vahdani, B. et al. (2018) carried on a randomized clinical trial to determine how a
mindfulness-based stress reduction (MBSR) intervention affects type 2 diabetic patients'
glycaemic control and emotional regulation. For this randomised controlled study, 60 people
with type 2 diabetes were gathered from an outpatient clinic at Imam Hospital in Iran. The
control group continued receiving treatment as usual, while the intervention group engaged in
eight MBSR sessions. As two indicators of glycaemic management, fasting blood sugar and
HbA1c were measured. The General Health Questionnaire (GHQ-28), the Hamilton Depression
Rating Scale (HDRS), and the Hamilton Anxiety Rating Scale (HARS) were used to assess
overall mental health, depression, and anxiety, respectively. Every assessment was carried out at
baseline and as a follow-up after eight weeks and three months. All outcome measures, including
FBS, HbA1C, HARS, and HDRS scores, were significantly lower in the MBSR intervention
group than in the control group (p < 0/05). In conclusion. MBSR significantly improved the
glycaemic control and emotional well-being of type 2 diabetic patients.

Ni, Y. Ma, L. Li, J. (2021) Carried on a systemic review and meta-analysis to determine how
MBI affects diabetics' psychological outcomes and glycemic control. From the beginning to
October 2019, searches were conducted across six databases: Pubmed, Embase, CINAHL,
Cochrane, Web of Science, and PsycINFO. There were both type 1 and type 2 diabetes
randomised controlled studies using MBI. A third reviewer served as an arbitrator while two
authors separately collected significant data and evaluated the possibility of bias. Additionally,
sensitivity analysis and subgroup analyses were performed. Eligibility criteria were met by 841
participants in 8 studies. According to a meta-analysis, MBI has a moderate effect size in
lowering stress (standardised mean difference -0.53, 95% CI -0.75 to -0.31) and depression
(standardised mean difference -0.56, 95% CI -0.82 to -0.30) while also slightly improving

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glycosylated haemoglobin (HbA1c; -0.25%, 95% CI -0.43 to -0.07) and diabetes-related distress
(-5.81, 95% CI -10.10 to-1.52). Subgroup studies revealed that individuals with baseline HbA1c
levels less than 8% and follow-up times longer than six months experienced larger HbA1c
decreases. There were conflicting results about anxiety. The significant heterogeneity for
depression (I2 = 16%; P = 0.31) was partially explained by a study with a longer intervention
duration (>8 weeks), but not the significance or the direction of the impact (SMD -0.65, 95% CI
-0.83 to -0.47; P < 0.00001). A study that used compact to administer the intervention explained
all of the significant variability in diabetes-related distress (I2 = 0% kept the effect's direction
and significance same (MD -7.44, 95% CI -11.58 to -3.29; P = 0.0004), but did not alter its
significance (P = 0.43).

Takavoli, Z. Zahrani, H. (2018) used an experimental study to investigate at the effects of

mindfulness-based stress reduction therapy on type 2 diabetic patients' problems with emotion
regulation and glycaemic control. study using pre- and post-tests in control and treatment groups.
34 type 2 diabetes patients, both male and female, with at least a high level of education were
chosen and placed into two groups at random: control (N=17) and treatment (N=17).Both groups
attended a pre-test phase using the Cognitive Emotion Regulation Questionnaire (CERQ) and a
Glucometer to measure their patients' blood sugar levels. The treatment group received
instruction in a mindfulness-based stress reduction technique for eight two-hour sessions, held
once a week. Both groups then completed the post-test. Multivariate analysis of covariance and
SPSS software version 20 were used to analyse the collected data. the MANCOVA results for a
comparison of the two groups' methods to emotion control. All emotion regulation subscales,
with the exception of catastrophising, reveal a significant difference between the intervention
and control groups (P>0.05), as indicated which normalises the impact of synchronous factors
(sex, education, age, and pre-test) on the dependent variable.

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Ngan, H. Chong, Y. et al. (2020) carried on a systemic review and meta-analysis to review how
mindfulness and acceptance-based therapies affect the glycaemic level and diabetic distress in
people with type 2 diabetes who live in the community. From begin till June 2020, seven
electronic databases (in Chinese and English) were thoroughly searched. Two reviewers
independently carried out data extraction and methodological quality assessment utilising the
Grading of Recommendations, Assessment, Development, and Evaluations standards.
The effects of acceptance and commitment therapy, mindfulness-based cognitive therapy,
mindfulness-based stress reduction, and self-directed mindfulness practice were investigated in
nine RCTs with a total of 801 participants. Most patients (mean age: 50–66 years, average
disease duration: 4–10 years) in the analysed RCTs had worse than ideal diabetes management
(HbA1c >7.0%, 53 mmol/mol).The therapies significantly decreased HbA1c (mean difference,
MD = −0.35, 95% CI: −0.67, −0.04; p = 0.03) and diabetic distress (standardised mean
difference, SMD = −0.37, 95% CI: −0.63, −0.12; p < 0.01) up to one month after the intervention
when compared to controls. However, the therapies for diabetes distress and HbA1c were varied,
and the underpowered studies might have resulted in overestimation.

Shukla, R. Gupta, M. et al. (2021) used a randomized controlled study to determine how MM
affects glycaemic control and quality of life in individuals with T1D. The study included thirty-
two persons with type 1 diabetes (mean age 23.8 ~ 6.6 years; mean duration of diabetes 12.7 ~
6.2 years; 15 men, 46.9%) in total. A total of thirty-two persons with type 1 diabetes were
randomly assigned to the control and intervention (meditation) groups. Both at baseline and six
months during the intervention, the glycaemic control and quality of life were evaluated. The
mean blood glucose level in the control group (222.4 ~ 77.8 against 182.6 ~ 52.0; p = 0.007) and
the intervention group (215.3 ~ 50.1 versus 193.2 ~ 31.8; p = 0.008) improved statistically
significantly at the end of six months. In addition, the intervention group's overall diabetic
distress score decreased significantly (1.6 ~ 0.3 vs 1.3 ~ 0.3; p = 0.003), whereas the control
group showed no change (1.6 ~ 0.7 versus 1.7 ~ 0.4; p = 0.762). The intervention group showed
a statistically significant increase in the health and functioning domain (p = 0.023).

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Reza, M. Shabani, J. (2024) conducted an experimental research with pre-test and post-test
study to investigate how effectively stress-reduction-based mindfulness group training affects
type 2 diabetics' emotional self-regulation and self-care. A sample of 36 individuals was selected
for the purpose of the research. The participants were assigned to a control group and an
experimental group at random. Over the course of eight weeks, the experimental group received
mindfulness group classes focused on stress reduction in eight two-hour sessions, while the
control group received no training. The two groups took completed Tobert and Glasso's (2000)
self-care questionnaire and Hoffman and Kashdan's (2010) emotional self-regulation
questionnaire before and after the educational sessions. The multivariate evaluation of
covariance test was used to analyse the data. The results have shown that stress-reduction-based
mindfulness group training can increase life expectancy and emotional self-regulation scores in
individuals with type 2 diabetes (P: 0.0005).

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 CHAPTER-3

METHODOLOGY

Methodology is the most important part of any research study which enables the researcher to
form the blue print for the study undertaken. Research methodology involves the systemic
proceeding by which the researcher starts from the time of initial identification of the problem to
its final conclusion.

In the present study, the investigator intended to assess the effectiveness of mindfulness based-
stress reduction on diabetes.

This chapter deals with the brief description of steps undertaken by the investigator for the study.
It includes research approach, research design, setting of the study, population, the sample and
sampling techniques, sample size, sampling criteria, variables, method of data collection,
development and description of the tool, procedure of data collection and plan od data analysis.

Research Approach

Research approach involves in the research methodology is the strategy to examine the
phenomenon being studied using either an unstructured (qualitative) or structured (quantitative)
method, or a combination of the two (quantitative qualitative integrated approach). Decisions
about the use of randomization, variable manipulation, and control are assisted by the research
methodology. Additionally, determining whether control groups are present or not for
comparison is helpful.
A quantitative research approach will be used for this study.

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Research Design

The research design is the comprehensive strategy that describes the techniques and steps for
collecting and evaluating the information required for a study. It is used as a blueprint for
carrying out a research study, including the explanation of the research methodology, study
setting, sampling size, sampling technique, instruments, and data collection and analysis
procedures to answer certain research questions or test research hypotheses. It is the overall
strategy the researcher has for addressing the research questions or applying the research
hypotheses to the test.
This study will use Pre-experimental research design (one group pre-test post-test design). This
provides comparison between one group of subjects before and after treatment. Pre-experimental
study is very simple and convenience to conduct in natural settings. This design does not have
randomization and control group like quasi-experimental study.

Setting

Research setting is the physical, social, or experimental environment in which research is carried
out. The setting of this study is Sharda Hospital, Greater Noida. Uttar Pradesh, where diabetes
patients are enrolled. The study will be conducted within the Hospital environment.

population

The population is the sum of all the units that a researcher is interested in. in other words, The
population is the set of people or objects to which study findings are intended to be applied.
The participants of this study will be diabetes patients from Sharda Hospital. The selection
criteria will include patients those did not get formal education. Participants will be assigned to
the treatment.

Target population: A target population is the total number of individuals or items that fit a
particular set of requirements. The researcher wants to draw conclusions about a particular
occurrence (or phenomena) based on the sum of all the examples involving that phenomenon.

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The target population of this study include both male and female diabetes patients of Sharda
Hospital, Greater Noida, Uttar Pradesh.

Accessible population: It is the total of conditions that meet specified criteria and can be used as
research subjects. The accessible population of the study will consist of diabetes patients from
Sharda Hospital who meet the inclusion criteria for participation in the study.

Sample

A sample is a representative unit of a target population that researchers will work with during
their investigation. In other words, a sample is a subset of the population that researchers or
investigators have decided to include in their study.
The sample for this study will be selected from the accessible population of diabetes patients in
Sharda Hospital, Greater Noida, Uttar Pradesh.

Sampling Technique

The process of choosing a representative portion of the target population to represent the
complete population is known as sampling. The process of selecting a sample that accurately
reflects the features of the population it is taken from is known as sampling technique.
even though there are many different sampling methods and techniques, they can be broadly
divided into two groups: probability sampling techniques and non-probability sampling
approaches.
The sampling technique of this study is purposive sampling technique

Sample size

In this study the sample size will be 60 diabetes patients. The sample will recruit from Sharda
Hospital.

Variables

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Variables are characteristics or attributes, like weight or height, that might have many values.
variables are Qualities, attributes, or characteristics of individuals, objects, or circumstances that
change or vary.

Independent variables: Variables those that the researcher intentionally changes or modifies,
also called manipulated variables. The independent variable in this study is Mindfulness-Based
Stress Reduction Programs.

Dependent variables: are variables that changes when the researcher manipulates the
independent variable. The dependent variable of this study is diabetes patients.

Sampling criteria

Inclusion criteria for sampling:

1. Patients with diabetic mellitus
2. 18+ old patients
3. Patients who did not get any formal education of MBSR
4. Patients who willing to participate the study

Exclusion criteria for this study are:

1. Patients with other chronic diseases

2. Younger than 18 years
3. Patients who not willing to participate the study

METHOD OF DATA COLLECTION:

Method refers to the way or mode of gathering data, while data collection is a precise systemic
gathering of information relevant to the research process. Since the study was primarily
concerned with assess the effectiveness of mindfulness based-stress reduction among diabetes
patients, the researcher planned to collect the information from subject through questionnaire.

A questionnaire is a paper and pencil instrument that a research subject is asked to complete as
instrument was provided.

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Development of the tool

A modified DASS21-Scale was prepared to assess the level of stress, anxiety and depression
among diabetes patients.

Description of the tool

As per expert’s suggestions the tool was prepared, the final tool consist of two sections

 Section A: Socio-demographic data

 Section B: DASS21 Scale
 Section-A consists of 7 on personal demographic data of the subjects those are:
Age, Gender, Education, Marital status, Occupation, Family history, Duration of
diabetes.
 Section-B consists of 3 parts Part-D and part-A as well as Part-S. Part-D consisted
of 7 questionnaires to assess the level of depression and part-A consisted of 7
questionnaires to assess the level of anxiety as well as Part-S consisted of 7
questionnaires to assess the level of stress.

Score interpretation

A scoring system was developed for the items were divided into three criteria for three stages.
(depression, anxiety, stress).

Depression Anxiety Stress

Normal 0-9 0-7 0-14

Mild 10-13 8-9 15-18

Moderate 14-20 10-14 19-25

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 Severe 21-27 15-19 26-33

Extremely severe 28+ 20+ 34+

Intervention

Data collection procedure

The figure shows the data collection procedure in Sharda School of Nursing science and
Research paramount importance as it allows us to capture unique insights from an
underrepresented demographic. These insights are crucial from a comprehensive understanding
of present research.

The data collection procedure is the core upon which our research insights were built and
developed as per the study objectives. Before the data collection, we established meaningful
collections within the school communities, which involved building trust, explaining the research
objectives. All participants provided informed consent before included in the study. The
assessment tools which were used in the study were standardized and can be used by any health
care professionals and available for the public domain.

Sample setting IEC approval necessary

identification Targets
Community approval

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 Data collection and
Assessment and Pilot Testing developing interventions
Sampling

Data screening and Data analysis and

Data entry interpretation
cleaning

Statistical analysis
Statistical analyses summarized continuous variables as means with standard deviations and
categorical variables as frequencies and percentages. Paired t-tests assessed the effectiveness of
the mindfulness based-stress reduction intervention among diabetes patients. Statistical
significance set at p< 0.05, and all analyses were performed using IBM SPSS Statistics.

Ethical considerations:
Ethical approval was obtained from Sharda University Ethics Committee. All participants
provided written consent after indicating that they fully understood the objective of the study.

Summary:
This chapter deal with the research methodology including research approach and design,
research setting, sample, sampling technique, sampling criteria and data collection procedure,
ethical considerations.

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