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SUBMITTED BY
B PRASAD JALLURI
BANGALORE KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
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
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
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
4. Physiological parameters
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
DELIMITATION
INCLUSION CRITERIA
The clients affected with severe complications like infection, severe electrolyte
imbalance, and uremia.
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.
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
Control group - 25
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.
Variables:
Projected outcome - The study helps the clients undergoing hemodialysis to maintain the normal
level of physiological and psychological parameters.
LIST OF REFERENCES:
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
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)
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
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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
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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
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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).
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
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)