Rajiv Gandhi University of health

Sciences Bangalore, Karnataka

AN EXPERMENTAL STUDY TO EVALUATE THE EFFECTIVENESS OF AN

INTERVENTIONAL PACKAGE ON SELECTED PHYSIOLOGICAL AND
PSYCHOLOGICAL PARAMETERS AMONG CLIENTS UNDERGOING
HEMODIALYSIS IN SELECTED SETTING, BANGALORE.

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

SUBMITTED BY

B PRASAD JALLURI

M.SC. NURSING 1ST YEAR.

MEDICAL SURGICAL NURSING SPECIALTY

MANASA COLLEGE OF NURSING

KOLAR DIST, KARNATAKA

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1) NAME OF THE CANDIDATE AND ADDRESS: B PRASAD JALLURI

1ST YEAR M.SC. NURSING
MANASA COLLEGE OF
NURSING, BANGALORE ROAD
MALUR.KOLAR (DT.).

2) NAME OF THE INSTITUTION : MANASA COLLEGE OF

NURSIING, BANGALORE ROAD.
MALUR.KOLAR (DT.).

3) COURSE OF THE STUDY AND SUBJECT: 1ST YEAR M.Sc., NURSING

MEDICAL AND SURGICAL
SPECIALTY

4) DATE OF ADDMISSION TO THE COURSE : 25-10-2010

5) TITLE OF THE TOPIC : AN EXPERIMENTAL STUDY TO

EVALUATE THE EFFECTIVENESS
OF AN INTERVENTIONAL PACKAGE ON
SELECTED PHYSIOLOGICAL AND
PSYCHOLOGICAL PARAMETERS AMONG
CLIENTS UNDERGOING HEMODILYSIS IN
SELECTED SETTING, BANGALORE.
BRIEF RESUME OF THE INTENDED WORK

INTRODUCTION:
“Real life isn't always going to be perfect or go our way, but the recurring acknowledgement of what is
working in our lives can help us not only to survive but surmount our difficulties.”

Renal failure is a serious medical condition affecting the kidneys. When a person suffers from renal
failure, their kidneys are not functioning properly or no longer work at all. Renal failure can be a
progressive disease or a temporary one depending on the cause and available treatment options.
Acute renal failure occurs within hours to days when the kidneys lose their ability to remove waste
products and excess fluids from the body. The most common cause of this is reduced blood flow to the
kidneys, either from dehydration, surgery, a severe infection, or injury. When blood flow to the kidneys
decreases, waste products and excess fluids are not adequately removed from the body
Chronic renal failure is more serious than acute renal failure because symptoms may not appear until the
kidneys are extremely damaged. Chronic renal failure can be caused by other long term diseases, such
as diabetes and high blood pressure. Chronic renal failure can worsen over time, especially when the
problem has gone undiagnosed and treatment is delayed1
While healthy kidneys have several functions in the body, the most well-known job is to produce urine.
When kidney function goes below 10% to 15% kidneys are no longer able to filter the blood and make
urine. This causes toxins to build up in the body along with excess fluid. Fortunately, we live in a time
when there are treatments and medicines that can replace the functions of the kidneys and keep the body
alive
Hemodialysis is a new module of the Clinical Procedures package that provides features specific to
hemodialysis treatment. Hemodialysis allows you to collect hemodialysis treatment information from the
medical device, and manually enter treatment data into the application.
Meaning a treatment that replaces kidney function — is hemodialysis. Hemodialysis is a therapy that
filters waste, removes extra fluid and balances electrolytes (sodium, potassium, bicarbonate, chloride,
calcium, magnesium 2
Globally the incidence of end-stage renal disease (ESRD) is increasing worldwide at an annual growth
rate of 8%, far in excess of the population growth rate of 1.3%1. Nearly one million people are receiving
hemodialysis worldwide, 60% of whom are treated in five countries (USA, Japan, Germany, Brazil and
Italy) that constitute only 12% of world population
In India estimated in 48 hospitals. In the population screening 4712 subjects are with ESRD. Mean age
was 42.38±12.54 years, 56.16% were male. Thirty-seven were found to have chronic renal failure
(prevalence rate of 0.78%). If these data are applied to India's 1 billion populations there are ∼7.85 million
ESRD patients in India.
Estimate of incidence of ESRD at 100/million population/year and a population approaching 1.2 billion in
these two countries, an estimated 120,000 fresh patients are likely to reach ESRD
Demographic data from renal registries in 1996 showed that approximately 1,000,000 of ESRD patients
received RRT throughout the world and approximately 200,000 new patients started RRT
In KarnatakaAs of now, 187 patients have registered their names with the hospital for regular dialysis.
But, with the available staff, the hospital can offer service only to a few. As many as 45 patients regularly
undergo dialysis in private hospitals
There are around 20,000 patients undergoing dialysis there are around 170 government recognized
transplant centers in India, performing around 3500 transplants annually. The patients on CAPD number
less than 5000In India 34 to 240 per million populations which is in contrast to an incidence between 98
and 198 per year reported from ESRD registries3
A study done on Hemodialysis patients on an average of 25-year older than PD patients, demonstrated
more comorbid situations. HD patients experience worse nutritional status, lower hemoglobin
concentrations and lower residual renal function compared to PD patients. However, there is no significant
discrepancy in the observed serum albumin levels. The number of HD patients that died during the follow-
up period was around 239 while the number of PD patients was 72. Around 4.05% of HD patients were
transferred in PD after the follow-up while 23.1% of Peritoneal Dialysis patients transferred to
Hemodialysis. The two-year technique survival rate for HD patients was 96% and PD patients exhibit
74% survival rate. In the study during the periods between 3 to 12 months and 12 to 24 months, the
mortality rates of HD patients were higher than that of PD patients. 5
NEED FOR STUDY
Renal failure is a serious medical condition affecting the kidneys. When a person suffers from renal
failure, their kidneys are not functioning properly or no longer work at all. Renal failure can be a
progressive disease or a temporary one depending on the cause and available treatment options
Hemodialysis is the stage that you are on the threshold of needing renal replacement therapy (any form of
dialysis, or a kidney transplant). When this actually happens will depend on your symptoms and lab
results, but it will occur as you get close to 10% kidney function (by which time the special renal diet and
medications will no longer be enough to keep you healthy). You will be considered to be approaching
ESRD when you are under 30% kidney function (as measured by Glomerular Filtration Rate), and more
actively as you approach 20% kidney function.6
Worldwide Demographic data from renal registries in 1996 showed that approximately 1,000,000 of
ESRD patients received RRT throughout the world and approximately 200,000 new patients
In India At least one lakh(100,000) Indians suffer from renal failure and an average of 80 new cases per
million populations crop up every year it is estimated that in India, there are estimated 80,000 people with
severe renal failure, and the 650 dialysis units available are insufficient to support the need

In Chennai, the prevalence at the community level is 8600 per million populations (pmp) in the study
group and 13900 pmp in the control group. The second study based in Delhirevealed a prevalence of CKD
(serum creatinine more than 1.8 mg %) at 7852 pmp. The third study from Bhopal revealed an incidence
of 151 pmp suffering from end stage renal disease (ESRD). Do we have the resources and skill to handle
this ever increasing population of ESRD in India
There are around 20,000 patients undergoing dialysis at the centers. There are around 170 government
recognized transplant centers in India, performing around 3500 transplants annually. The patients on
CAPD number less than 5000
In India 34 to 240 per million population (pmp) which is in contrast to an incidence between 98 and 198
pmp per year reported from ESRD registries
Estimate of incidence of ESRD at 100/million population/year and a population approaching 1.2 billion in
these two countries, an estimated 120,000 fresh patients are likely to reach ESRD
In Karnataka the Nephrology Department of KIMS Hubli is one of the proud possessions of the Institute.
We have six updated Hemodialysis units. Which is used for regular renal patients, In addition to this, one
Hemodialysis Unit n an average about 200 patients are taken up for hemodialysis in a month.
It is estimated that some 1, 00,000 patients develop ESRD every year in India but 90 per cent
Bangalore has around 35 dialysis centers August alone has seen 140 patients visiting the center.4
The continued presence of troubling symptoms in hemodialysis clients such as fatigue, pain, infection,
stress, electrolyte imbalance require the health care professional to pursue some symptoms management
strategies which include excersice,dietry management, to reduce stress, pain and infection and to decrease
fatigue.to prevent stress in the clients undergoing hemodialysis stress reductionstrategies are used to
increase the quality of life by imitating some technique’s which can relieve stress7
The clients who are undergoing hemodialysis experience pain due to catheter insertion and
recurrentintersection which causes Sevier pain to relieve pain or to keep it from getting worse could be
done by reducing tension in the muscles so relaxation, massage and menthol preparations are used to
relieve pain
Massage is relives stress by providing relaxation to the body muscles.Massage or deep tissue massage
relaxes and acts as an important for the body to deeply relax.
Relaxation is the best method to relieve pain by reducing the tension in the muscleshelps to enhance
energy, reducefatigue, reducesstress, anxiety and also pain relief methods to work better
Menthol preparations relives pain when they are rub into the skin they increases blood circulation to the
affected area and it gives soothing feeling.
Hemodialysis results in high protein loss and so dietary modifications for hemodialysis patients include
high protein rich diet with high biological values such as eggs, lean meat etc. and also increase calorie
requirements to prevent muscle wasting and to prevent protein energy malnutrition
Lifestyle modifications in time changes modification in energy and stamina, modification in activity in
body changes is essential and has to be maintained to reduce pain, fatigue and relives stress and anxiety
and improve the nutritional status and prevent infections.9
The investigator was posted in dialysis unit as a part of requirement while pursuingunder
graduationprogramme and also as a clinical instructor so while caring the adult patients undergoing
hemodialysis investigator found they manifested with pain, fatigue, infection, stress and other
complications following hemodialysis this motivated instructor to do an experimental study to evaluate the
effectiveness of an interventional package on selected physiological and psychological parameters among
clients undergoing hemodialysis.
A prospective study was done to assess the infection rates were highest in hemodialysis patients with
temporary vascular access, compared with rates in those with permanent arteriovenous fistulae and
synthetic grafts. Most of the bacterial organisms isolated from the vascular access sites were gram-positive
cocci, with S. epidermidis accounting for 50% of the organisms. The rate of infection with gram-negative
bacilli was higher than in other reports. Our greater dependence on central venous catheters, due to local
factors, coupled with the immune-compromising comorbid conditions of our patients, may be contributory
to the pattern of infection reported. Delays in the creation of vascular grafts for hemodialysis access
should be avoided.10
A study was conducted in Hemodialysis patients on an average of 25-year older than PD patients,
demonstrated more comorbid situations. HD patients experience worse nutritional status, lower
hemoglobin concentrations and lower residual renal function compared to PD patients. However, there is
no significant discrepancy in the observed serum albumin levels. The number of HD patients that died
during the follow-up period was around 239 while the number of PD patients was 72. Around 4.05% of
HD patients were transferred in PD after the follow-up while 23.1% of Peritoneal Dialysis patients
transferred to Hemodialysis. The two-year technique survival rate for HD patients was 96% and PD
patients exhibit 74% survival rate. In the study during the periods between 3 to 12 months and 12 to 24
months, the mortality rates of HD patients were higher than that of PD patients11
Aprospective cohort study conducted on 205 Canadian hemodialysis (HD) patients describes the
prevalence, cause, severity, of pain in this population. A chart review for demographic and clinical data
was conducted, and patients completed a questionnaire that incorporated the Brief Pain Inventory,
followed by the McGill Pain Questionnaire. One hundred three patients (50%) reported a problem with
pain. Patients with pain had been on HD therapy longer (52.2 months) than those without pain (37.7
months). Causes of pain were diverse, and 18.4% of patients had more than a single cause of their pain.
Musculoskeletal pain was most common (50.5%) and equal in severity to pain associated with peripheral
neuropathy and peripheral vascular disease. Fifty-five percent of patients with pain rated their worst
episode in the previous 24 hours as severe.12

REVIEW OF LITERATURE
Review of literature related to hemodialysis:
A study conducted on Hemodialysis patients on an average of 10-year older than PD patients,
demonstrated more comorbid situations. HD patients experience worse nutritional status, lower
hemoglobin concentrations and lower residual renal function compared to PD patients. However, there is
no significant discrepancy in the observed serum albumin levels. The number of HD patients that died
during the follow-up period was around 239 while the number of PD patients was 72. Around 4.05% of
HD patients were transferred in PD after the follow-up while 23.1% of Peritoneal Dialysis patients
transferred to Hemodialysis. The two-year technique survival rate for HD patients was 96% and PD
patients exhibit 74% survival rate 13
The purpose of this study was to evaluate the impact of a fatigue management program on 25
hemodialysis patients regarding their level of fatigue and their rate of satisfaction towards knowledge. The
study took place inside a hemodialysis unit in a health care facility located in New Brunswick. This
research design was pre-experimental. The before-after design, with only one group of subjects, makes it
possible to compare the level of fatigue, as well as the rate of satisfaction towards pre- and post-program
knowledge. According to the results of our study, it seems that the subjects, after benefiting from a fatigue
management program, managed to significantly decrease their level of fatigue and gain satisfaction related
to the acquisition of knowledge. Even though our number of participants was small, our research supports
the idea that a fatigue management program can meet the need of fatigue management in this population.
The results of this study foresee the need to develop a fatigue management program in hemodialysis units
and to evaluate its effectiveness in the medium or long term in selecting quasi-experimental studies,
including a broader population of patients.14
A prospective study conducted for the period of 36 months. In the study were included 31 patients, which
are on chronic hemodialysis treatment. During this study, we are followed all complications, which
occurred at temporary, and permanent tunneled hemodialysis catheters. Complications have occurred in
terms of thrombotic problems, low blood flow, occurrence of infection. All patients are divided in two
groups, 16 patients with permanent and 15 patients with temporary catheters. In the course of the study
was analyzed blood flow and dialysis adequacy as well as complications and results was compared with
randomly selected 16 patients who hemodialysis treatment performed by artery venous fistula (AVF).
Two patients were lost to further follow-up to the end of the study. 26 patients at the end of the study had
functional catheters, while in the case of 3 patients the catheter was removed. Infection was found in 10
patients while thrombotic complications were observed in 27 cases regardless of catheter.15

Review of literature related to pain

A study conducted to examine the relationship between moderate to severe chronic pain and depression,
insomnia, and the desire to withdraw from dialysis in HD patients. In a cross-sectional study of 205
Canadian HD patients, patients completed a questionnaire that included the Brief Pain Inventory, Beck
Depression Inventory, and the Pittsburgh Sleep Quality Index. One hundred and three patients (50.2%)
reported chronic pain and 85 (41.4%), moderate to severe pain. There was a higher prevalence of
depression in patients with moderate or severe chronic pain compared to patients with mild or no pain
(34.1% vs. 18.3%, odds ratio [OR] = 2.31,P = 0.01). Severe irritability, anxiousness, and inability to cope
with stress were all more common in patients with pain compared to patients without pain (P < 0.001).
There was a higher prevalence of insomnia in patients with moderate or severe chronic pain compared to
patients with mild or no pain (74.7% vs. 53.0%, OR = 2.32, P = 0.02). Although consideration of
withdrawal from dialysis was significantly associated with moderate or severe pain compared to no or
mild pain (46% vs. 16.7%, P < 0.001), death due to withdrawal from dialysis was not.16
A prospective cohort study was conducted on 205 Canadian hemodialysis (HD) patients describes the
prevalence, cause, severity, of pain in this population. A chart review for demographic and clinical data
was conducted, and patients completed a questionnaire that incorporated the Brief Pain Inventory,
followed by the McGill Pain Questionnaire. One hundred three patients (50%) reported a problem with
pain. Patients with pain had been on HD therapy longer (52.2 months) than those without pain (37.7
months). Causes of pain were diverse, and 18.4% of patients had more than a single cause of their pain.
Musculoskeletal pain was most common (50.5%) and equal in severity to pain associated with peripheral
neuropathy and peripheral vascular disease. Fifty-five percent of patients with pain rated their worst
episode in the previous 24 hours as severe.17
A study conducted on the cutaneous stimulation is an independent nursing intervention used in various
painful conditions, and is explained by gate control theory. This study was aimed at identifying the effect
of cutaneous stimulation on reduction of arteriovenous fistula puncture pain of hemodialysis patients. One
group repeated measurement posttest research was designed. Forty-five hemodialysis patients who
received arteriovenous fistula puncture regularly in hemodialysis units of an attached D hospital to K
University have been studied from August 16 to 21, 1993. First the arteriovenous fistula puncture pain of
control period was measured, and then the arteriovenous fistula puncture pain of experimental period
(with cutaneous stimulation) was measured.18
Review of literature related to infection
Aconducted study shows that PICCs used in high-risk hospitalized patients are associated with a rate of
catheter-related similar to conventional CVCs placed in the internal jugular or subclavian veins (2 to 5 per
1,000 catheter-days), much higher than with PICCs used exclusively in the outpatient setting
(approximately 0.4 per 1,000 catheter-days), and higher than with cuffed and tunneled Hickman-like
CVCs (approximately 1 per 1,000 catheter-days). A randomized trial of PICCs and conventional CVCs in
hospitalized patients requiring central access is needed. Our data raise the question of whether the growing
trend in many hospital hematology and oncology services to switch from use of cuffed and tunneled CVCs
to PICCs is justified, particularly since PICCs are more vulnerable to thrombosis and dislodgment, and are
less useful for drawing blood specimens. Moreover, PICCs are not advisable in patients with renal failure
and impending need for dialysis, in whom preservation of upper-extremity veins is needed for fistula or
graft implantation.19
A prospective study conducted on bloodstream infection to specific type of intravascular device (e.g.,
central venous port). Mean rates of IVD-related BSI were calculated from pooled data for each type of
device and expressed as BSIs per 100 IVDs (%) and per 1000 IVD days. prospective studies in which
every IVD in the study cohort was analyzed for evidence of infection by microbiologically based criteria,
show that all types of IVDs pose a risk of IVD-related BSI and can be used for benchmarking rates of
infection caused by the various types of IVDs in use at the present time. Since almost all the national
effort and progress to date to reduce the risk of IVD-related infection have focused on short-term no
cuffed CVCs used in intensive care units, infection control programs must now strive to consistently apply
essential control measures and preventive technologies with all types of IVDs20
Review of literature related to stress
Astudy conducted to describe the treatment-related stressors of in center hemodialysis patients, to identify
relationships between stressors and selected demographic and illness variables, and to identify changes in
stressors over time. Data were collected at two points in time, 3 months apart. The data were obtained
from 86 patients in 2 inner-city Midwest dialysis units. Structured interviews were conducted using one
open-ended question and the Hemodialysis Stressor Scale. The greatest stressors were fluid limitations,
the length of dialysis, and vacation limitations. There was a consistent trend for almost all stressors to
become more intense over time, with some specific stressors increasing significantly. Patients new to
dialysis and those with more education had relatively more stressors. 21
A study was conducted to investigate the effects of pomegranate juice (PJ) consumption by hemodialysis
patients on the changes in oxidative stress and the incidence of infections, cardiovascular events and
mortality rate in patients with end stage renal failure is substantially higher than in the general population,
and deaths are mainly attributable to cardiovascular diseases and infections. There is accumulating
evidence that supports the role for oxidative stress in damaging the immune system and in the
pathogenesis of cardiovascular diseases in hemodialysis patients, therefore ant oxidative treatment, which
will reduce oxidative stress, may be beneficial.22
A study conducted to investigate the causes and effects of nursing stress in the hospital environment. It
was hypothesized that the sources and frequency of stress experienced by nursing staff were functions of
the type of unit on which they worked, levels of training, trait anxiety, and socio demographic
characteristics. It was also hypothesized that high levels of stress would result in decreased job
satisfaction and increased turnover among the nursing staff. Data were collected from 122 nurses on 5
patient care units of a private, general hospital using a Nursing Stress Scale developed for this study, the
IPAT Anxiety Scale, the Job Description Index, and personnel records. Analysis of variance, profile
analysis, and path analysis were used to analyze these data. Three major sources of stress were identified
work load, feeling inadequately prepared to meet the emotional demands of patients and their families,
and death and dying 23

A Study showed that natural Menthol (l-menthol, natural menthol derived from peppermint oil)
diminishes one’s perception of pain in a dose-dependent manner. In one study researchers found that the
subject’s pain threshold was increased when higher concentrations of l-menthol were applied centrally or
peripherally.

Scientists from the Departments of pharmacology of the University of Florence (Florence, Italy), and
from the Department of Pharmacology of Natural Substances and General Physiology (Rome, Italy)
investigated the analgesic properties of and menthol and observed the presence of stereo selectivity
menthol (natural menthol derived from peppermint oil) was able to increase the pain threshold whereas
menthol (synthetic menthol) was completely devoid of any analgesic effect. Scientists from Centre for
Neuroscience Research and Membrane Biology Group, Centre for Integrative Physiology, Edinburgh,
United Kingdom, came to similar conclusions in their experiments with and menthol: Concentration-
dependent effects on pain threshold were observed in both studies.
The results indicated that menthol is endowed with analgesic properties mediated through a selective
activation of?-opioid receptors and Group II/III metabotropic glutamate receptors
the ant nociception induced by (-)-menthol (l-menthol) was comparable to that exhibited by morphine.
Topical analgesic products with 10% menthol are more potent and produce greater pain relief than other
products concentration with lower menthol24

A Conducted studies have shown the effectiveness of massage therapy in reducing stress and millions of
people avail themselves to the services of massage therapists to treat stress. Using massage to reduce
stress is natural and safe and unlike some forms of alternative therapies, massage therapy is a proven
discipline within the medical community with scientific evidence supporting the use of massage for stress
management. Massage therapy is a proven, non-invasive way to reduce chronic stress levels in the body
A conducted study showed the effect of massage over a 5-week period on 24 randomized chronic low
back pain sufferers. After receiving two 30-minute treatments per week for the duration of the study, the
massage group reported less pain, depression, anxiety, and improved sleep.
A conducted study on massage therapy and its effect on stress reduction. After examining 25 different
studies, the team concluded that single treatments improved stress-related conditions and longer-term
benefits were apparent in blood pressure, but they were unable to prove longer-term stress-related benefits
for massage.25
Dietary and life style modifications
Dietary and lifestyle modifications are recommended for prevention complications among hemodialysis
clients in the general population. Recommends lifestyle modifications as initial therapy in newly
diagnosed in hemodialysis patients and as adjuvant therapy in persons on medications. Apart from
physical activity, most lifestyle recommendations are nutrition-based and include (1) reduction of dietary
sodium consumption to <100 mmol/d (2.4 g/d); (2) weight loss (for overweight and obese persons) and
weight control (for non-overweight); (3) moderation of alcohol intake (≤2 drinks per day for men and ≤1
drink/day for women); and (4) adoption of the Dietary Approaches to Stop Hypertension.26

A cross sectional study of 50 patients with end stage renal disease, who were on chronic and chronic
hemodialysis (CHD=25), was done for level of stress and stress coping ability. These patients belonged to
different socio-economic background. A modified structured questionnaire was used to compare the mean
stress and coping ability between CPD and CHD patients. The results showed that the overall mean stress
score in the CHD patients was higher (78.3%) than in CPD patients (43.3% p<0.001). Coping ability
score for CHD patients was 51.9% as compared to CPD patients (60.9% p<0.001).27

A Study conducted on patient’s adjustment to chronic illness has often focused on the understanding of
physical and psychological variables, which influence health outcomes. As treatment0 is a long-term
process, patients have to use strategies to manage their illness. Lev and Owen concluded that patients with
a sense of confidence in their ability to perform self-care behaviors are more likely to actually perform
these tasks.13Thus, individuals with high levels of self-care are better able to manage their ESRD.
According to Orem, self-care is a0 ‘‘human regulatory function’’ based on an individual’s capability to
perform his or her own care28

Reduction in dietary sodium intake lowers blood pressure in CKD (Strong). Clinical and experimental
studies clearly show that sodium handling by the kidney is altered in CKD, and that sodium retention has
a major role in hypertension in CKD.281d the primary mechanism appears to be expansion in
extracellular fluid (ECF) volume.282 Dietary sodium restriction is recommended to reduce ECF volume
expansion and lower blood pressure. Based on the results of the DASH and DASH-Sodium Trials, the
Work Group recommended that most individuals with CKD should reduce sodium intake to less than 100
mmol/d (2.4 g/d). Further reduction in sodium intake to <50 mmol/d (<1.2 g/d) might lower blood
pressure further, but may be more difficult to achieve.29

A study conducted on the optimal level of dietary protein intake to slow the progression of CKD and
maintain protein nutritional status is not known. The DASH diet has a protein content (18% protein;
approximately 1.4 g/kg/d) that is higher than the recommended daily allowance (US-RDA) for healthy
adults (0.80 g/kg/d) and exceeds NKF-K/DOQI guidelines for CKD Stage 3 (0.75 g/kg/d) and CKD Stage
4 (0.60 g/kg/d).The K/DOQI recommendations are based on observations that reduced dietary protein
intake reduces the generation of nitrogenous wastes and inorganic ions, which can lead to uremia. In
addition, post analyses from the Modification of Diet in Renal Disease 30
STATEMENT OF THE PROBLEM

An experimental study to evaluate the effectiveness of an interventional package on selected

physiological and psychological parameters among clients undergoing hemodialysis in selected
setting, Bangalore

Objectives of the study

1. To assess the pre interventional level of physiological and psychological parameters

among the clients undergoing hemodialysis in experimental group.
2. To assess the pre interventional level of physiological and psychological parameters among
the clients undergoing hemodialysis in control group.
3. To evaluate the effectiveness of the interventional package on psychological parameters
among the clients undergoing hemodialysis in experimental group.
4. To co relate on psychological parameters among the clients undergoing hemodialysis in
experimental group.
5. To co relate on psychological parameters among the clients undergoing hemodialysis in
control group.
6. To assess the mean improvement score in psychological parameters with selected
demographical variables among the clients undergoing hemodialysis in experimental group.
7. To assess the mean improvement score in psychological parameters with selected
demographical variables among the clients undergoing hemodialysis in control group.

Operational definitions

1. Effectiveness
It is the outcome of the interventional package in terms of physiological and
psychological parameters among clients undergoing hemodialysis

2. interventional package
It is the planned schedule package that includes relaxation techniques (progressive
muscle relaxation, rubbing the skin with menthol preparations, massage (back
massage)

3. Psychological parameters

It includes psychological measures for stress.

4. Physiological parameters

It includes the measure of level of fatigue, pain, malnutrition.

 Hypotheses

H01 - There will not be a significant difference between pre interventional and post interventional
level of physiological and psychological parameters
H02 - There will not be a significant correlation between physiological and psychological
parameters
H03 - There will not be a significant association in the mean improvement score of physiological
and psychological parameters with selected demographical variables

ASSUMPTIONS

1) The selected physiological and psychological parameters in the clients

undergoing hemodialysis may be altered.
2) The interventional package may enable to maintain normal level of
physiological and psychological parameters in the clients undergoing
hemodialysis.

DELIMITATION

The study is determined to

 A period of 4 weeks
 50 clients undergoing hemodialysis at Bangalore institute of Nephro
Urology

INCLUSION AND EXCLUSION CRITERIA

INCLUSION CRITERIA

A) Clients with age group of 35- 50 years.

B) The clients undergoing hemodialysis.
C) The clients who can understand and speak English.
EXCLUSION CRITERIA

The clients affected with severe complications like infection, severe electrolyte
imbalance, and uremia.

MATERIALS AND METHODS

SOURCE OF DATA
A standard scale will be used for the assessment of the level of pain, level of fatigue by using interview
and observation techniques.

METHODS OF DATA COLLECTION

Research design -True experimental pretest and posttest design will be used
Settings - The study will to be conducted in Dialysis unit, Bangalore institute of nephro urology

Population - Patients who are undergoing hemodialysis in Bangalore

institute of nephron and urology.
Sample design - Simple random sampling technique.

Sample size - Experimental group - 25

Control group - 25

Tool -After extensive review of literature investigator selected

thestandard tools.

A) Consists of demographical characters of clients undergoing

hemodialysis such as age, sex, complicationsand history of
hemodialysis.
B) General health assessment (structured observational checklist
including diet and life style behavior)
Stress – Edin burg scale
Pain scale – visual analog scale
Fatigue assessment scale – piper fatigue scale.

Collection of data - Data will be carried out in the experimental and the
control group using the socio demographic profile and standard scale and tools
and structured observational check list used to assess the physiological and
Psychological parameters in experimental and control group.
Method of data analysis -Data will be analyzed using inferential and
descriptive statistics.

Duration of data collection -4 weeks.

Variables:

Dependent variables - Selected physiological and psychological parameters.

Independent variables - Interventional package.

Projected outcome - The study helps the clients undergoing hemodialysis to maintain the normal
level of physiological and psychological parameters.

Does the study require any investigations or interventions to be conducted on

Patients or other humans or animals? Yes

Has ethical clearance been obtained from concern authorities? Yes

LIST OF REFERENCES:

1) Introduction no renal failure: Brunner and Siddhartha’s Textbook of Medical-Surgical Nursing

Suzanne C. O'Connell Smeltzer (Author), Brenda G. Bare (Author 10th edition Lippincott Williams
& Wilkins; Tenth edition (July 12, 2003)(introduction to renal failure)
2) Brunner and Siddhartha’s Textbook of Medical-Surgical Nursing, 11th Edition
Publisher: Lippincott Williams & Wilkins; 11th Updated edition (December 12, 2006)Introduction
on hemodialysis

3) Global statistics and its incidence in ESRD: according to WHO global statistics and incidence in
ESRD &hl=en&as_sdt=0, 5&as_vis=1

4) Global statistics and its incidence in hemodialysis: according to WHO Indian statistics and
incidence in hemodialysis &hl=en&as_sdt=0

5) Termorshuizen ET (2003) demonstrated comorbid situations (worse nutritional status, HB levels

and renal function) Tn. Assoc. Am. Phys., 28:51, 1913

6) Text book of medical surgical nursing 5th edition book published by Scott Porath & Kathie
Somers(renal replacement therapy)
 7) Lippincott's Review Series, Medical-Surgical Nursing Ray A. Hargrove-Huttel (Author)
Lippincott Williams & Wilkins (January 15, 2001) (troubling symptoms in hemodialysis clients
such as fatigue, pain, infection stress, electrolyte imbalance)
8) Eve Adamson, Elizabeth Scott, M.SARS1010; located in Eureka Springs, AR(massage, relaxation
and menthol preparations)

9) Review of hemodialysis for nurses and dialysis personnel. 7th ed. St. Louis, Missouri: Elsevier
Mosby; 2005.(life style modifications)

10) Hemodialysis by Abdulla AL rubaish.Philosophical Transactions of the Royal Society in London.

1854; 144:177–228.A prospective study was done to assess the infection rates in hemodialysis.

11) Nelson et AL(1992)Tn. Assoc. Am. Phys(A study was conducted in Hemodialysis patients
regarding mortality rates in hemodialysis) 28:51, 1913

12) Moreover Churchill et al (2002). Geneesk. Gids.( A prospective cohort study conducted on 205
Canadian hemodialysis clientsdescribes the prevalence, cause, severity, of pain in this population)
21:1944

13) Termorshuizen the association of intradialytic parenteral nutrition administration with survival in
hemodialysis patients. Am J Kidney Dis (A study conducted on Hemodialysis patients on an
average of 10-year old to demonstrate worse nutritional status, lower hemoglobin concentrations).
1994; 24(6):912-20.

14) Laupacis A, Muirhead N, Keown P, Wong C. Astudy to evaluate the impact of level of fatigue and
knowledge in patients on hemodialysis. 1992; 60(3):302–306.

15) Murtagh FE, Addington-Hall J, Higginson IJ. The study on complications occurred during
hemodialysis a systematic review. Adv. Chronic Kidney Dis. 2007; 14(1):82–99
.
16) Sara N. Davidson. Study to examine the relationship between moderate to severe chronic pain and
depression in hemodialysis patients 13:1307–1320, 2002

17) Johnson JL a prospective study was conducted on hemodialysis patients describes the prevalence,
cause, severity of pain Analgesia mediated by the TRPM8 cold receptor in chronic neuropathic
pain. Curr Biol 2006; 16: 1591e1605

18) Meininger.J States, 2000. Semin Dial. 2002; 15:162-171.a study conducted on the cutaneous
stimulation to relieve pain.
19) Dennis.G study conducted on high risk hospitalization associated with catheter related infections
Int 1999; 56:1–17
20) Anaissie E, Samonis G, Kontoyiannis D, CostertonJ, Sabharwal U Journal of Antimicrobial
Chemotherapy. 1999; 44(Suppl A):31-36. to Strategies for preventing central venous catheter
(CVC)-related bloodstream infection

21) Austin JK Nursing Research, identify relationships between stressors and selected demographic
and illness variables stressors in hemodialysis patients 2005,19 (3A: 415)

22) Claudio Ronco. A studied on Effects of pomegranate juice (PJ) consumption by hemodialysis
patients on the changes in Oxidative stress in hemodialysis. Q J Med 1994; 87: 679−683

23) West Lafayette. Sources and frequency of stress experienced by nursing staff 9:182–187, 1991

24) Eccles R. studied on Menthol and related cooling compounds. J Pharm Pharmacol. 1994;46:618–
630

25) Fortina F, Agllata S, Ragazzoni E, et al. A Conducted studies have shown the effectiveness of
massage therapy in reducing stress (1999; 51:85–87).

26) Lippincott's Review Series, Medical-Surgical Nursing Ray A. Hargrove-Huttel (Author)

Lippincott Williams & Wilkins (January 15, 2001) (Dietary and lifestyle modifications).

27) Larzelere MM, Jones GN. Stress and Health. Primary Care: Clinics in Office Practice.(A cross
sectional study of 50 patients with end stage renal disease was done for level of stress and stress
coping ability) 2008;35(4):839-856

28) Hammerfald K, Grau M, et al. Persistent effects of cognitive-behavioral stress management on

cortisol responses to acute stress in healthy subjects-A randomized controlled trial. Psycho neuron
endocrinology. 2005 Sep 22; epub ahead of print.

29) Cohen HW, Hailpern SM, Fang J, Alderman MH: Reduction in dietary sodium intake lowers blood
pressure in CKD 119: 275 e277–e214, 2006

30) Mary Ann Hogan (Author),2nd Edition Margaret M. Gingrich (Author), Mary Jean Ricci
(Author), Penny Overby (Author) Prentice Hall(December 25, 2006) (study conducted on the
optimal level of dietary protein intake)