PROFOMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION.

Mr. NAIR GIRISH GOPALAKRISHNAN.

I YEAR M.Sc. NURSING
MEDICAL AND SURGICAL NURSING
YEAR 2011-2013.

PADMASHREE COLLEGE OF NURSING

GURUKRUPA LAYOUT, NAGARBHAVI
BENGALURU-560072.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BENGALURU, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

0
 NAME OF THE Mr. GIRISH NAIR
1 CANDIDATE AND 1st year M.Sc. Nursing,
ADDRESS Gurukrupa layout,
Nagarbhavi.
Bangalore-560072.

2 NAME OF THE Padmashree College of

INSTITUTE Nursing, Bangalore.

3 COURSE OF THE 1st year M.Sc. Nursing,

STUDY AND SUBJECT Medical Surgical Nursing

4 DATE OF ADMISSION 8.6.2011

5 TITLE OF THE STUDY A study to assess the

effectiveness of local
refrigeration prior to AV fistula
puncture on pain related
responses among
haemodialysis patients in N.U.
Hospital, Bengaluru.

6. BRIEF RESUME OF THE INTENDED WORK

6.1 Introduction:
Pain is a complex multidimensional experience that causes suffering
and reduces quality of life. Internal association for the study of pain (IASP) defines
pain as “Unpleasant sensory and emotional experience associated with potential or
actual tissue damage or described in terms of such damage.” The degree of pain
tolerance differs from one person to another.

1
 Chronic kidney disease (CKD) is a progressive irreversible detoriation in
renal function in which body’s ability to maintain metabolic, fluid and electrolyte
balance fails. Most patients are in the final stage of CKD where the glomerular
filtration rate is less than 15ml/hr. Now it is emerging as a public health problem
globally1.

A study was conducted on national action plan for chronic kidney

disease. The World Health Report which was accepted in 2010 estimates that the
diseases of the kidney and urinary tract contribute to over 8,50,000 deaths and over 15
million disability-adjusted life years. Even this is considered an underestimate, due to
problems of CKD classification and limited data on CKD from small observational
studies from many developing countries including India or from personal experience
of nephrologists. Much less is known about earlier stages of CKD when symptoms
may be mild or neglected by patients or their caring physicians.

CKD is the most devastating medical, social and economic problem

for patients and their family of our country. With an estimated new cases of end stage
renal disease of 100 per million people in a year globally, there could be 1 lakh
patients from India. Most CKD patients reporting to tertiary care centers in India are
in the final stage where renal replacement therapy (RRP) in the only opinion at this
stage.

The availability of various renal replacement therapies helps in reducing

severity of symptoms and result in longer survival of ESRD patients. These patients
largely depend on haemodialysis and renal replacement therapy. They receive chronic
or maintenance dialysis therapy for the control of uremic and azotemic
manifestations2.

Cold application as a cutaneous stimulation technique is an

inexpensive nursing intervention that is advocated to minimize the pain in patients.
The effect of cutaneous stimulation is best explained through gate control theory
propose Melzac in 1965. According to this theory touch impulse by the A-fibers is the
impulse transmission in thick fibers (touch) can be increased, this selectively blocks
conduction in the thin fibers (pain) by closing a gate consisting of specific nerve cells
in dorsal horn of spinal cord. The impulse from cold application is also transmitted by
touch fibers3.

2
 The conduction rate of touch stimulus is more and it is the meridian
points, the large intestine meridian point are the acupressure points present in arms,
extending up to the nose. There are 20 large intestine meridian points. L14 is the point
present on the medial midpoint of the first metacarpal between 3 to 4mm of the web
of skin between thumb and forefinger on either hand. Its dominant users are to relieve
pain in arms, legs and scapula for reducing labor pain and rigidity of neck as a
treatment measure.

Vascular access is the vital lifeline for haemodialysis. The most

common vascular access types are arteriovenous fistula (AVF), arteriovenous graft
and venous catheter. According to national kidney foundation, dialysis outcome
quality initiative (DOQI), 2005 reported that AV fistula remains as a gold standard for
vascular access in haemodialysis patients. Once mature, the AV fistula has excellent
long term patency rates and rarely become infected. AV fistula can provide adequate
vascular access for over 20 years.

Pain during arteriovenous fistula cannulation remains a common

problem in hemodialysis patients. Thus, studies have shown that cryotherapy given on
the contralateral arm not having the AV fistula reduces the puncture pain in
hemodialysis patients. Therefore, the need for adopting alternative therapies such as
cryotherapy for effective pain management in hospital settings is becoming an
essential factor.

The above reviews suggest that there are number of alternative or non-
pharmacological nursing interventions which can be utilized for relieving pain in
patients. Hence, the researcher felt the need to conduct a study regarding the
effectiveness of application of cold therapy during AV fistula puncture and along with
it, to assess the changes in pain related responses during its application in
hemodialysis patients to alleviate their sufferings.

3
6.2 NEED FOR THE STUDY
Pain is an individual’s unique experience that may be difficult for the
clients to explain or describe and is often difficult for others to recognize, understand
and assess. There are different nursing interventional modalities that can be applied to
reduce the pain according to the condition of the patient. Cold application as a
cutaneous stimulation technique is an effective non-pharmacological intervention for
pain management. In this study researcher tries to find out its application in reducing
AV fistula puncture pain and its related responses among haemodialysis patients4.

The main type of AV fistula is radio-cephalic fistula, brachio-cephalic

fistula, and brachio-basilic fistula which are created in arm surgically by inserting
catheter into the arterial and venous part of the fistula for starting haemodialysis. In
addition to their suffering, severity of disease, patient are exposed to stress and pain
from approximately 300 punctures per year to their AV fistula with large bore
catheter for haemodialysis5.

The number of patients treated for end stage renal disease (ESRD) has
demonstrated continuous growth since the establishment of dialysis as a life
sustaining therapy and advances in organ transplantation. This growth in ESRD
patients is five times the world population growth (1.3%) and continues to grow
beyond all expectations showing no sign of reaching a steady state within next two
decades. Additionally, developments to provide a superior or financially viable
replacement therapy are not expected in the foreseeable future6.

The needle currently used for arterio-venous fistula puncture for

haemodialysis has a size of 14 to 16 gauge. The insertion of large size needle to
delicate walls of AV fistula leads to pain which is a significant cause of concern for
both children and adult on regular haemodialysis

Although AV- fistula puncturing cause pain, local anesthesia is not

frequently used due to concern of vasoconstriction, burning sensation, scarring and
infection. On an average patient on maintenance haemodialysis undergoes 10 AV-
fistula punctures a month and would continue to receive throughout their lifetime.

4
Until a successful renal transplant his or her comfort with the procedures is therefore
of at most importance for long term compliance with the treatment.

Studies have also shown that there are lot of changes associated with pain
which includes the blood pressure, body temperature and respiration. These
parameters play an important role and have to be thoroughly monitored during
hemodialysis. Thus, during the AV fistula puncture the researcher felt the need to
assess these pain related responses along with cold application, which is considered to
be a cutaneous stimulation technique.

Moreover, not so much emphasis was given on the pain related reponses
after AV-fistula puncture. So the researcher is interested in finding out the
effectiveness of local refrigeration on pre- procedural AV fistula puncture and its pain
related responses thereby alleviating their sufferings.

5
6.3 STATEMENT OF THE PROBLEM
A study to assess the effectiveness of local refrigeration prior to AV-fistula
puncture on pain related responses among haemodialysis patients in N.U. Hospital,
Bangalore.

6.4 OBJECTIVES OF THE STUDY

• To assess the effectiveness of local refrigeration during AV- fistula puncture

among hemodialysis patients.

• To assess the pain related responses among experimental group of

haemodialysis patients after AV-fistula puncture.

• To assess the pain related responses among control group of haemodialysis

patients after AV-fistula puncture.

• To compare the pain related responses among experimental group and control
group of haemodialysis patients after AV-fistula puncture.

• To associate the pain related responses of experimental and control group

with their selected demographic variables.

6.5 OPERATIONAL DEFINITIONS

a. Effectiveness:

It refers to the reduction in the level of pain at the AV-fistula site as

elicited by the investigator using subjective numerical rating scale and objective
checklist after the application of local refrigeration.

b. Local refrigeration:

Application of cold therapy on the contralateral arm, in between the web

of thumb and index finger in the form of ice cubes which is applied for 10 minutes
prior to AV fistula puncture and is continued throughout the puncture procedure.

6
c. Pain:

It is a subjective expression of discomfort perceived by the patient due to

the stimulation of nerve endings by the local tissue infiltrations as measured by the
visual analogue scale.

d. Pain related responses:

It refers to the changes in the vital parameters such as B.P., temperature,

pulse, and respiration which are monitored and then recorded using an objective
checklist after the AV fistula puncture.

e. AV-fistula (Arteriovenous fistula):

An arteriovenous fistula is an abnormal connection or passage way

between an artery and a vein. It may be surgically created for haemodialysis patients.

f. Haemodialysis:

It is a method for removing waste products such as creatinine and urea as

well as water from the blood when the kidneys are in a state of renal failure.

6.6 ASSUMPTIONS
1. Patients discomfort associated with frequent puncturing of AV-fistula can be
minimized by introducing some pain reducing strategies like local refrigeration.

2. Local refrigeration causes a cutaneous stimulation of nerve endings which is very

effective in alleviating pain in haemodialysis patients.

6.7 HYPOTHESES
H1 : There will be a significant difference in the post-test pain related responses
between experimental group and control group.

H2 : There will be a significant association of post-test pain related responses of

experimental group and control group with selected demographic variables.

7
6.8 REVIEW OF LITERATURE

The reviews of the study include-

➢ Reviews related to incidence and prevalence of end stage renal disease

(ESRD) and hemodialysis patients.

➢ Reviews related to effectiveness of cold application as a cutaneous stimulation

technique on haemodialysis patients in alleviating pain.

➢ Reviews related to changes in the pain related responses (BP, temperature

pulse, respiration) among haemodialysis patients
One of the most satisfactory assets of the literature search is the
contribution it makes to the knowledge, insight and general scholarship. Review of
literature is one of the key factors of designing and carries out a search on study in
any field, to make the study more empathetic and valid. It is extremely important for
the researchers to have an in depth knowledge of existing related literature; keeping
the facts in mind regarding the existing literature that was reviewed.

I. Reviews related to the prevalence of end stage renal disease (ESRD):

A descriptive study was done to know the enormity of chronic kidney
disease in Nigeria. CKD is emerging as a worldwide public health problem. The
World Health Report 2002 and Global Burden of Disease project reports show that
diseases of the kidney and urinary tract contribute to the global burden of diseases
with approximately 850,000 deaths every year and 15,010,167 disability-adjusted life
years. Globally, they represent the 12th cause of death and 17th cause of disability.
This may however be an underrepresentation of the contribution of CKD to global
burden of disease. Apart from the effect on kidney function per se, kidney damage is a
major determinant for the development of progression of accelerated atherosclerosis,
ischemic vascular disease, and cardiovascular death. The burden of CKD is therefore
not limited to its impact on demand of renal replacement therapy (RRT); it is
paralleled by the huge cost of provision of health care services for these patients7.

An evaluative study was conducted by the Dialysis Outcomes and Practice

Patterns Study (DOPPS) regarding vascular access performance against kidney
disease outcomes in Europe, United States, and Japan. The Kidney Disease Outcomes

8
Quality Initiative Guidelines for Vascular Access in hemodialysis patients
recommend native arteriovenous (AV) fistulae over AV grafts or catheters for
permanent vascular access. They recommend letting fistulae mature > or =1 month
before cannulation. The Dialysis Outcomes and Practice Patterns Study (DOPPS)
provide an unparalleled means to examine vascular access practice patterns and
guidelines internationally, with particular attention to associations with mortality risk.
The results of the study suggested that patients who receive nephrology care for over
30 days before starting dialysis have significantly higher chances of commencing via
AV fistula8.

A cross sectional study was conducted in Iran on causes of chronic renal

failure among Iranian hemodialysis patients. The study stated that over 1.1 million
patients are estimated to have ESRD worldwide, and an additional average of 7%
annual incidence of ESRD is seen in Middle- East countries, wherein an estimated 93
per million population is affected. About 1.6 million patients undergo renal
replacement therapy in which an approximate 95% of the haemodialysis patients have
AV fistulas on vascular site9.
II. Reviews related to effectiveness of cold application as a cutaneous
stimulation technique to relive pain:
An experimental study was conducted on the effect of cutaneous
stimulation on AV fistula puncture pain of haemodialysis patients. The study was
conducted to identify the effect of cutaneous stimulation on reduction of
arteriovenous fistula puncture pain on 45 haemodialysis patients. The instrument used
for this study was visual analogue pain scale as subjective pain measurement,
objective pain behavior checklist and Spielberger's Trait Anxiety Inventory as
intervening variables. Analysis of data was done by use of paired t-test, t-test,
ANOVA and Pearson’s correlation coefficient methods. The results showed that the
subjective pain scores of AV fistula puncture pain in experimental group with
cutaneous stimulation were lower compared to the control group3.

A comparative study was conducted on ice massage and transcutaneous

electrical stimulation, a comparison of treatment for low-back pain. It has recently
been shown that ice massage of the web between the thumb and index finger produces
significantly greater relief of dental pain than a placebo control procedure. The results
indicate that ice massage is an effective therapeutic tool, and appears to be more
effective than TES for some patients. Evidence that cold signals are transmitted to the
spinal cord exclusively by A-delta fibers and not by C fibers suggests that ice massage

9
provides a potential method for differentiating among the multiple feedback systems
that mediate analgesia produced by different forms of intense sensory input10.

An experimental study was conducted on effect of cryotherapy on

arteriovenous fistula puncture-related pain in hemodialysis patients. Pain during
arteriovenous fistula (AVF) cannulation remains a common problem in hemodialysis
(HD) patients. This study was undertaken to assess the effect of cryotherapy on pain
due to arteriovenous fistula puncture in hemodialysis patients. A convenience sample
of 60 patients (30 each in experimental and control groups) who were undergoing
hemodialysis by using AV fistula was assessed in a randomized control trial. The
objective and subjective pain scores were found to be significantly (P = 0.001)
reduced within the experimental group with the application of cryotherapy. This study
highlights the need for adopting alternative therapies such as cryotherapy for effective
pain management in hospital settings11.

A comparative study was performed on chronic renal patients in

whom the effect of application of cold compress as compared with the use of topical
anesthetics before the punch of fistula-arteriovenous to minimize pain. This study
effectively is a theoretical discussion with the intent to present the best solution for
the treatment of pain in the puncture of the AVF. Concluded with the research in
scientific articles, the appropriate protocol by nurses in the application of cold
compress or the administration of analgesic medication, require a more theoretical
basis12.
An experimental study was conducted on relief of dental pain by ice
massage on hand. Patients suffering from acute dental pain were treated with ice
massage of the web between the thumb and index finger of the hand on the same side
as the painful region. Control groups received tactile massage alone or with explicit
suggestion that the massage was intended to alleviate their pain. Changes in pain
intensity produced by the procedures were measured with the McGill Pain
Questionnaire. Ice massage decreased the intensity of the dental pain by 50% or more
in the majority of patients. The fact that cold signals are transmitted to the spinal cord
exclusively by A-delta fibers and not by C fibers provides a potential method for
differentiating the various feedback systems that mediate analgesia produced by
different forms of intense sensory input. Ice massage provides a simple method for the
palliative control of pain in dental clinics13.

10
 An experimental study was conducted on ice massage for the reduction
of labor pain. The use of ice massage of the acupressure energy meridian point large
intestine 4 (LI4) to reduce labor pain during contractions. LI4 is located on the medial
midpoint of the first metacarpal, within 3 to 4 mm of the web of skin between the
thumb and forefinger. Participants noted a pain reduction mean on the VAS of 28.22
mm on the left hand and 11.93 mm on the right hand. The post delivery ranked MPQ
dropped from number 3 (distressing) to number 2 (discomforting). The study results
suggest that ice massage is a safe, noninvasive, non-pharmacological method of
reducing labor pain14.

A pilot study was conducted to ascertain the effects of ice massage on

neuropathic pain in persons with AIDS. The purpose of this pilot study was to
examine the effects of ice massage to reduce neuropathic pain and improve sleep
quality and to determine the feasibility of a larger study. The three treatments
consisted of ice massage, dry-towel massage, and presence. Consecutive sampling
was used to select 33 persons with AIDS who had neuropathic pain. The results of the
study showed that there was a decrease in pain intensity over time with both the ice
massage and towel massage, suggesting that the intervention has some clinical
benefit15.

An evaluative study was conducted on the cooling, analgesic, and

rewarming effects of ice massage on localized skin. More importantly, the onset of
skin analgesia and its duration were evaluated. Sixteen normal subjects participated in
four testing sessions, two of which were control session. A thermistor unit with
probes monitored skin temperature and a standardized pain-evoking stimulus was
used to verify analgesia. Analgesia was elicited by the ice massage only after the
localized region had been cooled to, and maintained below, 13.6 degrees Celsius.The
results showed that ten-minute ice massage was an effective procedure in achieving
analgesia and, thus, may be sufficient to permit therapeutic exercise of selective
painful condition for approximately three minutes immediately following
application16.

A study was conducted on nursing approaches to non-pharmacological

pain control. The nurse may make a significant contribution to pain control by being
able to offer a variety of non-pharmacological methods of pain relief that the patient

11
may use in combination with the more traditional methods of analgesia or local
anaesthesia. Recent research supports some of the older methods of non-
pharmacological pain control such as distraction, especially humor; relaxation using
the patient's own memory of peaceful events; and cutaneous stimulation, especially
use of cold. Cutaneous stimulation may even be effectively used at sites other than the
site of pain17.

An evaluative study was carried out to assess the effect of local

application of cold or heat for relief of pricking pain. Electrical stimulation was
applied to the antebrachium or brachium of subjects as an artificial pricking pain, and
skin blood flow (BF) and skin conductance level (SCL) at the fingertip were
measured. Pain sensation was evaluated using the visual analog scale. Application of
cold to the stimulation site using an ice-water pack reduced BF and SCL responses
and pain sensation. Application of heat using a hot water bottle caused a significant
increase in pain sensation and enhancement of BF and SCL responses. These results
suggest that application of cold promotes relief of pricking pain sensation and
suppression of autonomic responses, and that application of heat has no such effect18.

An experimental study was conducted regarding the effect of cold

application in combination with standard analgesic administration on pain and anxiety
during chest tube removal in patients who had undergone cardiac surgery. A single-
blinded randomized design was used in this study. Ninety patients aged 18-74 years,
hospitalized in the intensive care unit (ICU), who had a chest tube for duration of at
least 24 hours, were used for this convenience sample.There was no statistically
significant difference in McGill Melzack Pain Questionnaire scores or in change of
anxiety level between the three groups. Results showed that cold application reduced
patients' intensity of pain due to CTR but did not affect anxiety levels or the type of
pain. Cold application is recommended as a pain-relieving technique during CTR19.

III. Reviews related to changes in the pain related responses (BP, temperature
pulse, respiration) among haemodialysis patients:
A retrospective observational cohort study was done related to
circadian variations in body temperature during hemodialysis. Body temperature
changes during HD were categorized by dialysis shifts. Patients with morning shifts
(n = 1064), afternoon shifts (n = 730) and evening shifts (n = 210) were compared.
The intra-dialytic change in blood pressure (BP) was significantly related to changes
in intra-dialytic body temperature irrespective of the study month. The result of the

12
study stated that both pre-dialytic body temperature as well as changes in body
temperature is significantly related to the timing of the dialysis shifts, in phase with
the circadian body temperature rhythm. Due to the relationship between body
temperature changes and changes in intra-dialytic BP, these findings might be of
additional relevance in the pathogenesis of intra-dialytic hypotension20.
A descriptive study was conducted at the Division of Nephrology,
Department of Medicine, University of Texas Health Science Center at San Antonio
regarding body temperature regulation during hemodialysis in long-term patients. The
changes in the dialysate temperature can raise or lower body temperature because the
blood is returned to the patient in thermal equilibrium with the dialysate. Continuous
monitoring of blood temperature allows the practitioner to make pre-emptive changes
in dialysate temperature because a small change in body temperature can have
enormous cardiovascular implications. The results suggested that improvement in the
hemodialysis procedure is to use devices that allow continuous monitoring of arterial
and venous blood temperatures and adjust the dialysate temperature automatically,
keeping the patient, not the dialysate, isothermic21.
A comparative study was conducted across nine European countries
related to the effects of control of thermal balance on vascular stability in
hemodialysis patients. One hundred sixteen HD patients were enrolled, and 95
patients completed the study. During thermoneutral dialysis energy flow rate 6 of 12
treatments (median) were complicated by hypotension, whereas during isothermic
dialysis, the median decreased to 3 of 12 treatments (P < 0.001). Systolic and diastolic
blood pressures and heart rate were more stable during the latter procedure.
Isothermic dialysis was well tolerated by patients. Results show that active control of
body temperature can significantly improve intradialytic tolerance in hypotension-
prone patients22.
A comparative study was conducted at the Department of Internal
Medicine, Division of Nephrology, University Hospital Maastricht, Maastricht,
Netherland regarding control of core temperature and blood pressure stability during
hemodialysis. Fourteen HD patients with a history of IDH were studied. Central blood
volume (CBV), BP, skin temperature, heart rate variability low and high frequency
was recorded. The results suggested that CT increased during thermoneutral and
remained respectively stable and decreased during isothermic and cooling. IDH may
be slightly improved by cooling compared with the isothermic approach, possibly
because of improved maintenance of CBV. The hemodynamic effects of mild blood
cooling should be balanced against a potentially higher risk of cold discomfort23.
A descriptive study was published in the Journal of the American society
of nephrology associated with Management of Blood Pressure in Hemodialysis
Patients. There is convincing evidence in the general population that hypertension is
associated with increased cardiovascular mortality and morbidity, and that its control
can reduce these adverse consequences. Observational studies in the hemodialysis
population have demonstrated that hypertension is also associated with adverse
consequences in these patients, especially with longer-term follow-up. Thus blood
pressure (BP) varies significantly in hemodialysis patients depending upon the time
taken during pre-dialysis, post-dialysis, or inter-dialytic24.
A descriptive study done in Montpellier, France was published in The
New England Journal of Medicine. The study signifies the seasonal changes in blood
pressure in 53 patients with end stage renal disease undergoing haemodialysis. The

13
monthly mean values for blood pressure, pulse, and body weight in relation to the
monthly values for temperature, relative humidity, and atmospheric pressure recorded
in Montpellier, France were analysed. The maximal monthly temperature varied from
10°C in the winter to 31°C in the summer, and the minimal monthly temperature from
1 to 20°C. The result of the study stated that patients with end-stage renal disease
treated with hemodialysis, blood pressure varies seasonally, with higher values in the
winter and lower values in the summer25.
A study was conducted regarding hemodialysis induced respiratory
changes at Tyne Newcastle upon Tyne, UK. Eight patients receiving maintenance
haemodialysis were studied under six different dialysis protocols, comprising
Cuprophan and polyacrylonitrile membranes, each used with dialysate containing 40
mmol/l acetate, 30 mmol/l acetate or bicarbonate (35 mmol/l). The respiratory
exchange ratio decreased by 25% as a result of decreases in lung CO2 excretion when
using acetate. Transfer factor declined by 40% for Cuprophan compared with 14%
with polyacrylonitrile (P<0.01). It was concluded that amelioration of hypoxemia may
be achieved by the use of bicarbonate, but its cause is multifactorial, with
contributions, from hypoventilation secondary to dialyzer CO2 losses and pulmonary
dysfunction due to leucostasis26.

7. MATERIALS AND METHODS

7.1 SOURCE OF DATA

All the haemodialysis patients admitted in the nephrology unit of N.U.

hospital, Bengaluru.

7.2 METHODS OF COLLECTION OF DATA

i. RESEARCH DESIGN

14
 The research design selected for the study is basic experimental design-
the After Only or Post-test Only design.

ii. VARIABLES

Independent variable
Local refrigeration (cold application) as an intervention during AV fistula
punctures in hemodialysis patients.
Dependent variable
Pain related responses of hemodialysis patients after AAV fistula puncture.
Demographic variables
Age, sex, occupation, economical status, marital status, type of family,
duration of illness, duration of treatment, dietary pattern, exercise.

iii. SETTING
The study will be conducted in N.U. Hospital, Bengaluru. The setting has been
chosen to perform the study, considering the feasibility of conducting the study and
availability of samples.

iv. POPULATION
All the haemodialysis patients admitted in the dialysis unit of N.U. hospital.

v. SAMPLE
The sample of 80 patients who fulfill the inclusion criteria will be selected as
sample out of which 40 subjects will be allocated for experimental group and 40
subjects will be allocated for control group of haemodialysis patients.

vi. CRITERIA FOR SELECTION OF SAMPLES

Inclusion Criteria

• Patients who have AV-fistula and undergoing haemodialysis.

• Patients who are willing to participate in the study.

Exclusion criteria

• Patient with neurological disorders who is not able to perceive pain.

• Patients who are receiving analgesics such as opioid analgesics group.

• Patients who have radiational injuries.

15
vii. SAMPLING TECHNIQUE
The sampling technique used will be probability sampling technique under which
simple random sampling will be used where the investigator will select samples using
the lottery method.

viii. TOOL FOR DATA COLLECTION

The tool for data collection includes the following-

Section A: To assess the demographic variables which includes- Age, gender,

occupation, economical status, marital status, type of family, duration of illness,
duration of treatment, dietary pattern, exercise.

Section B: Subjective numerical rating scale and observation checklist to assess the
pain related responses.

ix. DATA COLLECTION PROCEDURE

Data collection is the gathering of information needed to address the problem. After
taking the permission from the Medical Director of N.U. hospital and also the Nurse
Manager for conducting the main study, the data collection will be done in 3 phases-

Phase I

The investigator will apply local refrigeration (cold application) over the
web of thumb and index finger on the contralateral arm of the hand not having the AV
fistula (LI4 meridian point) for 10 minutes prior to the puncture and would continue
applying till the end of AV fistula puncturing procedure.

Phase II

The investigator will assess the post test pain of patients belonging to
experimental group and control group using subjective numerical rating scale and
observational checklist to evaluate the pain related responses (B.P., Temperature,
Pulse, and Respiration) after local refrigeration.

x. PLAN FOR DATA ANALYSIS

The data collected will be analysed by means of descriptive and inferential
statistics.

▪ Descriptive statistics

16
 Frequency, percentage distribution, mean and standard deviation will be used to
assess the pain related responses of haemodialysis patients of experimental
and control groups.

▪ Inferential statistics
a. Wilcoxon’s test:
It will be used to compare the post test scores of pain relaed
responses in both experimental and control group of hemodialysis
patients.

b. Mann Whitney U test:

` It will be used to compare between groups.

xi. PROJECTED OUTCOME

This study will enable the researcher to know the variation in the level of
pain in experimental and control group of haemodialysis patients during the process
of AV fistula puncture with and without local refrigeration on the contralateral arm at
the LI4 meridian point.

7.3 Does the study require any investigation or intervention to be conducted on

the patients or other human or animals?

Yes. This study requires an intervention using cold application on the

contralateral arm between the web of thumb and index finger of the hand not having
the AV fistula for a period of 10 minutes before the fistula puncturing procedure of
haemodialysis patients.

7.4 Has ethical clearance been obtained from your institution?

Yes. The permission has been obtained from the concerned authorities of N.U.
hospital, Bengaluru. The ethical committee clearance report obtained from our
institution has been enclosed.

17
18
8. LIST OF REFERENCES

1) Lewis JB, Bosch JP, Levey AS. Chronic kidney disease (CKD). NICE Clinical
Guideline.2008 September.
http://www.patient.co.uk/doctor/Chronic-Kidney-Disease-and-its-Management.htm

2) Shyam.C. K.V. Dakshina Murty, V. Sreenivas, Rapur Ram. Chronic kidney

disease: Need for national action plan. Indian J Med Res.2007 April; 125(4):498-
501.

3) JS Park, Taehans Kanho. The effects of cutaneous stimulation on AV fistula

puncture pain of hemodialysis patients. 1994, 33(1-2). 37-51.

4) Margo Mc Caffery. Nursing approaches to non- pharmacological pain control.

International Journal of Nursing Studies. Volume 27, 1990. 1-5.

5) Figueiredo AE, Viegas A, Monteiro M, Poli-de-Figueiredo CE. Research into pain

perception with arteriovenous fistula cannulation.J Ren Care. 2008 December:
34(4): 169-72.

6) Stefan Moeller, Simona Gioberge and Gail Brown. Global review of patients
treatment modalities and development trends of ESRD patients.2001.

7) Ifeoma Ulasi and Chinwuba.K. Ijoma. The enormity of chronic kidney diseae in
Nigeria. Journal of tropical medicine. Volume 2010, Article ID 501957.

8) Rayner H.C, Besarab. A, Brown WW, Disney A, Saito. A, Pisoni RL. Vascular
access results from Dialysis Outcomes and practices patterns study (DOPPS).
American Journal of Kidney Diseases.2004 November; 44(5 suppl.2). 22 -26.

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9) Leila Malekmakan, Sezaneh Haghpanah, Maryam Pakfetrat, Alireza Malekmakan,
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9. Signature of the Candidate :

10. Remarks of the guide : This study is feasible and has the

implication in reducing the pain

& pain related response in

haemodialysis patients

11.1 Name and Designation of :

the guide

11.2 Signature :

11.3 Co-guide :

11.4 Signature :

11.5 Head of the Department : Dr. Fathima. L, Principal

11.6 Signature :

12.1 Remarks of the Principal : The study is relevant &

appropriate to the field of

nursing & specialty chosen

12.2 Signature :

22