A STUDY TO COMPARE THE EFFECT OF TOPICAL

ANESTHETIC CREAM AND CUTANEOUS STIMULATION

ON AV FISTULA PUNCTURE RELATED PAIN AMONG
PATIENTS UNDERGOING HAEMODIALYSIS IN DISTRICT
HOSPITAL, TUMKUR.

PROFORMA FOR THE REGISTRATION OF SUBJECT FOR

DISSERTATION

SUBMITTED BY
MACDEEN DAVID

MEDICAL SURGICAL NURSING

2012 – 2014

AKSHAYA COLLEGE OF NURSING, IIND CROSS,

ASHOKA NAGAR, TUMKUR.

1
 RAJIV GANDHI UNIVERSITY OF HEALTH
SCIENCES, BANGALORE, KARNATAKA

PROFORMA FOR THE REGISTRATION OF SUBJECT

FOR DISSERTATION

1 NAME OF THE CANDIDATE : Ms. MACDEEN DAVID

AND ADDRESS 1 YEAR M Sc NURSING
AKSHAYA COLLEGE OF
NURSING, TUMKUR.
2. NAME OF THE INSTITUTION : AKSHAYA COLLEGE OF
NURSING
3. COURSE OF STUDY AND : 1 YEAR M Sc NURSING
SUBJECT MEDICAL SURGICAL NURSING
4. DATE OF ADMISSION : 15-06-2012
5. TITLE OF THE TOPIC : A STUDY TO COMPARE THE
EFFECT OF TOPICAL
ANESTHETIC CREAM AND
CUTANEOUS STIMULATION
ON AV FISTULA PUNCTURE
RELATED PAIN AMONG
PATIENTS UNDERGOING
HAEMODIALYSIS IN DISTRICT
HOSPITAL, TUMKUR.

2
6. BRIEF RESUME OF THE INTENDED WORK

INTRODUCTION

The kidneys are vital organs which perform an incredibly wide array of
functions for the body, most of which are essential for life. Some renal functions
have obvious logical and necessary connections to each other. Others seem to be
totally independent1. The kidney of humans contains roughly one million
nephrons. This number is already established during prenatal development; after
birth, new nephrons cannot be developed, and lost nephrons cannot be replaced.

Kidney diseases are occurring due to variety of reasons. Chronic Kidney

Disease (CKD) is a progression from health to illness which results in a
permanent failure of the excretory, regulatory and hormonal (metabolic)
functions of the kidney. CKD can be a slowly progressive disease over many
months or years, which results from the gradual loss of nephrons. The function
may be stable for prolonged periods of time and can be managed with
conservative management strategies. CKD is often asymptomatic in the early
stages and is often not diagnosed until sufficient impairment exists to retain
uremic toxins in the blood. Unfortunately the damage caused by CKD is
irreversible, unless the patient is managed appropriately, particularly at the early
stages, it can then be impossible to delay or even stop their CKD progressing to
later stages of established renal failure where the person will require Renal
Replacement Therapy (RRT) of some form to maintain life.1

Chronic kidney disease (CKD) is defined as kidney damage or glomerular

filtration rate (GFR) below 60 ml/min per 1.73 m2 for 3 months or more
irrespective of the cause. The Kidney Disease Outcomes Quality Initiative
(KDOQI) guidelines have classified CKD into five stages.

3
 The number of patients with chronic kidney disease (CKD), and the
subsequent need for renal replacement therapy (RRT), has reached epidemic
proportion and is anticipated to rise further. CKD affects approximately 10% of
the population worldwide and it is estimated that over 1.1 million patients, with
end stage renal disease (ESRD) currently require maintenance dialysis is
increasing at a rate of 7% per year. If the trend continues, by 2010 the number
will exceed 2 million. This figure excludes third world countries, where there is
less availability of, and access to dialysis services, so there is an underestimate of
the true demand. In United Kingdom the incidence of ESRD has doubled over
the last ten years and has now reached 101patients per million of population
(pmp). This is below the European and United States of America averages of
approximately 135 and 336 pmp respectively. Studies such as the NHANES
(National Health and Nutrition Examination Survey) which provided data on the
adult unselected population estimated that 4.7% of US adults had CKD stage 3 or
higher (defined as estimated glomerular filtration rate (eGFR)
<60ml/min/1.73m2). They also estimated that up to 11% of the general
population (19.2 million) has some degree of CKD.2

World Health Organization estimates that the diseases of the kidney and
urinary tract contribute to over 850000 deaths and over 15 million disability-
adjusted life years 10. In United States (US) alone, over 30 million people have
been diagnosed to have CKD and it is estimated that over 6, 00,000 will need
renal replacement therapy by 2010, costing US dollar 28 billion.11 It is estimated
that approximately one lakh new patients develop ESRD in India annually. This
suggests the possibility that the burden of CKD could be significant in India. 3

Considering the growing number of clients afflicted with CKD, the option
to prolong the life is limited to Renal Replacement Therapy (RRT) which includes
dialysis and kidney transplant. The Kidney Disease Outcomes Quality Initiative
(K/DOQI) guidelines recommend that patients with chronic kidney disease

4
(CKD) who reach an estimated glomerular filtration rate (GFR) of 15–30
mL/min/ 1.73 m2 (i.e. stage 4) need to be prepared for kidney replacement
therapy.4

Clinically, dialysis is a technique in which substances move from the blood

through a semi permeable membrane and into a dialysis solution (dialysate). It is
used to correct fluid and electrolyte imbalances and to remove waste products in
renal failure. The two methods of dialysis available are peritoneal. 4

Functional vascular access is needed for all extracorporeal dialytic

therapies dialysis and haemodialysis (HD). vascular access remains as the lifeline
for patients with end stage renal disease who need chronic intermittent
haemodialysis (HD) therapy. The ideal HD access should have a long length of a
suitable superficial vein for cannulation in two places more than 5 cm apart with
a sufficient blood flow for effective dialysis, usually in excess of 400 ml/min. A
vascular access should have good primary patency, have a low risk of
complications and side effects, and leave opportunities for further procedures in
the event of failure. Ideally, a first access should be an Arterio Venous (AV)
fistula placed peripherally at the wrist. However, upper arm and lower limb
access sites are increasingly used because the aging dialysis population, with
multiple co morbidities, has poor and diseased arm vessels that may be
unsuitable for the creation of a simple wrist fistula.

In the clinical set up intravenous injection is taken with needle of 22 gauge

imposes significant pain. For many patients the mere mention of the need for
insertion of an intravenous catheter invokes anxiety and dread. These emotions
may become exaggerated at times, triggering a vasovagal reaction. This reaction
can result in syncope, unresponsiveness, hypotension, and diaphoresis. Patient's
anxieties and fears concerning needles are real and may even prevent them from
seeking health care. Haemodialysis through AV fistula uses 14-16 gauge needles

5
in which patient has to suffer much pain with AV fistula puncture pain than with
intravenous injection. 5

6.1 NEED FOR THE STUDY

In India the projected number of deaths due to chronic diseases will rise
from 3.78 million in 1990 (40.4% of all deaths) to an expected 7.63 million in 2020
(66.7% of all deaths). Traditionally, health programs for prevention of chronic
diseases have mainly focused on hypertension, diabetes mellitus and
cardiovascular disease, however, the increase in the prevalence of chronic kidney
disease (CKD) progressing 6 to end-stage renal disease (ESRD) and the
consequent financial burden of renal replacement therapy (RRT). In both
developed as well as developing nations has highlighted the importance of CKD
and its risk factors. The CKD burden is increasing rapidly worldwide. At the end
of 2004, 1,783,000 patients worldwide were receiving treatment for ESRD, of
which 77% were on dialysis and 23% had a functioning renal transplant (RT), and
this number is increasing at a rate of 7% every year. If the current situation
prevails, the global ESRD population will exceed 2 million by the year 2010. The
average incidence of ESRD in developing countries is 150 per million populations
(pmp), which is lower than what is reported in the developed world.

All patients diagnosed as ESRD needed RRT. In developing countries such

as India, the management of end-stage renal disease (ESRD) is largely guided by
economic considerations. Haemodialysis (HD) is mainly a short-term measure to
support ESRD patients prior to transplant. The cost of peritoneal dialysis (PD) is
two times higher than that of HD, fewer than 2% of patients are started on PD.
Among the three RRT options available, renal transplant is the preferred mode,
as it is most costeffective and provides a better quality of life. But due to financial
constraints and nonavailability of organs, only about 5% of ESRD patients
undergo transplant surgery. Though the removal of organs from brain-dead

6
patients has been legalized, the concept of donation of organs from deceased
donors has not received adequate social sanction. Only 2% of all transplants are
performed from deceased donors. 6

Haemodialysis is not possible without vascular access. In case of patient

undergoing maintenance haemodialysis needed permanent vascular access, no
vascular access has exceeded the success and reliability of Arterio Venous Fistula
(AVF). Fistulas have the best overall patency rates and least number of
complications (e.g., thrombosis, infections) of all vascular accesses. To draw the
blood from fistula AVF needles are used. The needles used are 14 to 16 gauges
and are inserted into the fistula or graft to obtain vascular access. One needle is
placed to pull blood from the circulation to the HD machine, and the other needle
is used to return the dialyzed blood to the patient. The needles are attached via
tubing to dialysis lines. The insertion of large bore needle in to AV fistula causes
significant pain.

Application of topical anaesthetic cream is non invasive pharmacological

measures of pain management. A study conducted in 2001 to detect the minimal
application time of Eutetectic Mixture of Local Anaesthetic (EMLA). This study
was conducted in middle Tennese State University to determine the effects of 5
minute application of EMLA cream would have on a patient’s perception of
cannulation. This study compared pain perception between an experimental
group who received EMLA cream and a control group who received placebo.
Sample consisted of 40 males and females who underwent ophthalmic surgical
procedures. There were 20 subjects in each group when pain was investigated all
patient reported some level of pain following cannulation. There was a
significant difference between the two groups .The findings of this study
suggests that a 5 minute application of EMLA cream is adequate to decrease pain
associated with intravenous cannulation.7

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 Cutaneous stimulation is non invasive non pharmacological measure of
pain management by superficial heating or cooling of skin. These pain
management methods include cold packs and hot packs and should be used in
conjunction with exercise.

A comparative study was conducted to determine the effects of two non –

pharmacologic pain management methods for intramuscular injection pain in
children. Ninety samples were chosen randomly and were divided into groups,
the first group received distraction and second group received cold therapy and
the third group received routine care. Oucher scale was used to measure the pain
intensity .Average pain intensity in local cold therapy, distraction and control
group was 26.3, 34.3 and 83.3 respectively. The finding of the study shows that
cold therapy has significant effect on pain reduction.

Investigator during his clinical experience in dialysis unit observed that

patients undergoing haemodialysis through AV fistula reported severe pain
during AV fistula puncture. Local anaesthetic injection at the puncture site can be
used to reduce the pain but patients are not willing to take local anaesthetic
because it also causes significant pain while puncturing. Further it causes
bruising sensation and vaso constriction. Oral analgesics are another alternative,
but many of them are Non Steroidal Anti Inflammatory Drugs (NSAIDs) which
are nephrotoxins. So for these patients non invasive methods of pain relief are
most useful. Cutaneous stimulation and topical anaesthetic cream are non
invasive pain relief measures, which has an effect on AV fistula puncture related
pain. So study to compare the effect of topical anaesthetic cream and cutaneous
stimulation on AV fistula puncture related pain will be helpful to identify the
better option.8

6.2 REVIEW OF LITERATURE

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 Review of literature is a key step in the research process. A review of
literature is comprehensive and covers all relevant research and supporting
documents in print. Literature review is essential to locate similar or related
studies that have already been completed which helped the investigator to
develop deeper insight into the problem and gain information on earlier studies.
Review of literature is a systematic identification, location, scrutiny and
summary of written materials that contain information on research and the
problem.

The literature reviewed related to the present study is and presented under
the following headings

 AV fistula as a vascular access in haemodialysis

 AV fistula Puncture related pain in haemodialysis
 Effect of topical anaesthetic agent in reduction of pain
 Effect of Cutaneous stimulation in reduction of pain

AV fistula as a vascular access in haemodialysis

Haemodialysis is a life saving treatment for patient with chronic kidney

disease. Before beginning haemodialysis treatment, a person needs an access to
their bloodstream, called vascular access. The access allows the patient’s blood to
and from the dialysis machine at a large volume and high speed, so that toxins
waste and fluid can be removed. The two most common vascular accesses are AV
fistula and AV grafts (AVGs).

A retrospective study was conducted in Seoul, Korea to compare the

efficacy of AVF, AVG, Fore Arm Basilica Vein Transposition (FBVT) AVF . The
study was conducted among 389 patients (300 radial-cephalic AVFs and 89
brachial-cephalic AVFs). Of those, the cephalic AVFs were superior in primary

9
patency when compared with the FBVT. The study findings reveal that all AVFs
were superior to the AVG in patency, function and complications. Patency was
also affected by age and the presence of previous access.The investigator point
out that there were no infectious complications in the AVF; however,
seroma/hematoma developed. In comparison with AVG, FBVTs showed
significantly fewer thrombosis and infection (p < .001) The disadvantages of the
AVF include a longer surgical procedure, longer time to maturation, possible
vein damage, and wound problems in comparison with the AVG creation. The
rationale for FBVT in reference to the AVG are patency rates, which were
comparable to that of AVG, infectious complication is less in FBVT than AVG,
the use of the basilic vein in an AVF may contribute to the development of the
upper arm basilic vein, which would then be utilized for AVF when the FBVT
fails, a forearm AVG can be the next option without sacrificing the vessels that
could be used for AVF.9

A prospective randomized hospital based study conducted among 73

Chronic hemodialysing patients (48 males and 25 females) in Gezira Hospital For
Renal Disease And Surgery, Saudi Arabia from January to July 2007 revealed that
the man age of patient was 43.9 (ranging from 18 to 72). Seventy one (97.3%) of
the patients had been dialysed before creation of AVF and 67 (91.8%) of the study
subjects 18 undergone with temporary access. All patients (n=73) had a native
AVF as a permanent vascular access. A primary radio-cephalic AVF was created
in 78.1 % of patients, cubital fossa in 20.5%; one case had left snuff AVF (1.4%).
Percentage of AVF maturation reported in 67.1% of the cases within the first six
week and 9.6 % of the cases AVF never matured. Failure rate of AVF occurred in
only 26% cases, due to thrombosis in 20.5 %( n=15) and aneurysm in 5.5% of the
cases. 10

Dual Sil Kim, Sung Wan Kim et al conducted a comparative study to

evaluate the vascular patency rates and incidence of interventions in autogenous

10
arteriovenous fistulas and grafts. A total of 166 vascular access operations were
performed in 153 patients between December 2002 and November 2009 were
selected as the participants. Thirty seven cases were excluded due to primary
access failure and loss of follow-up. One group of 92 autogenous arterioveous
fistulas and the other group of 37 arteriovenous prosthetic grafts were evaluated
retrospectively. Primary and secondary patency rates were estimated using the
Kaplan-Meier method. Study results showed that primary patency rate (84%,
67%, 51% vs. 51%, 22%, 9% at 1, 3, 5 year; p=0.0000) and secondary patency rate
(96%, 88%, 68% vs. 88%, 65%, 16% at 1. 3, 5 year; p=0.0009) were better in
autogenous fistula group than prosthetic graft group. Interventions to maintain
secondary patency were required in 23% of the autogenous fistula group
(average 0.06 procedures/patient/year) and 65% of prosthetic graft group
(average 0.21 procedures/patient/year). So the autogenous fistula group had
fewer intervention rate than prosthetic graft group (p=0.01). The risk factor of
primary patency was diabetus combined with ischemic heart disease and the
secondary patency’s risk factor was age. Autogenous arteriovenous fistulas
showed better performance compared to prosthetic grafts in terms of primary &
secondary patency and incidence of interventions. 11

Coburn MC and Carney WI Jr conducted a study to compare patency and

complication rates between basilic vein and polytetrafluoroethylene (PTFE) for
brachial arteriovenous fistulas (AVF) for long-term haemodialysis. All basilic
vein and PTFE brachial AVF constructed between March 1988 and April 1993
were retrospectively reviewed. After construction of life-tables, log-rank testing
was used to compare the primary patency rate of basilic vein AVF (n = 59) with
the primary and secondary patency rates of PTFE AVF (n = 47). Complication
rates were calculated for each type of fistula and compared by use of chi-squared
testing. The result finding shows that primary patency rate for basilic vein AVF
(90%) was superior to that of PTFE AVF (70%) at 1 year (p < 0.01), and at 2 years

11
(86% vs. 49%, p < 0.001). Complications occurred two and a half times more
frequently in the PTFE group than in the basilic vein group (p < 0.05). Basilic vein
AVF provided superior patency rates and lower complication rates compared
with PTFE AVF.12

AV fistula Puncture related pain in haemodialysis

Pain is one of the most common complaints made by patients during their
time in hospital and one of the important causes of fear in patients who are to
undergo a procedure during hospitalization. Pain is a complex, multidimensional
experience. For many people, it is a major problem that causes suffering and
reduces quality of life. Pain is one of the major reasons that people seek health
care.

Figueiredo A E, Viegas A, Monteiro M And Poli-De-Figueiredo C E

Conducted research into pain perception with arteriovenous fistula cannulation
in patients with endstage renal failure (ESRF) undergoing haemodialysis (HD).
The finding shows that ESRF patients are repeatedly exposed to stress and pain
fro approximately 300 punctures per year to their arteriovenous fistula (AVF).
Repeated AVF punctures lead to a considerable degree of pain, due to the calibre
and length of the bevel of fistula needles. Pain is a sensitive, emotional and
subjective experience. The objective of this study was to measure pain associated
with AVF needling. The analogue visual scale (AVS) divided into 10 equal parts
(0 indicating lack of pain, and 10 unbearable pain) was used. Patient’s
perceptions were measured in three different HD sessions. Pain was considered
mild during AVF needling. The buttonhole technique caused a mean degree of
pain of 2.4 (+/-1.7), compared to 3.1 (+/-2.3) using the conventional ropeladder
technique. Although without reaching a statistically significant difference,
diminished pain was associated with the buttonhole technique. 13

12
 A study conducted by Crespo Montero R, Rivero Arellano F, Contreras
Abad MD, Martinez Gomez A and Fuentes Galan MI among 48 haemodialysis
patients with autologous arteriovenous fistula to evaluate the effect of needle
bevel position on the degree of pain and damage to the skin covering the vein, in
an arteriovenous fistula puncture. After AV fistula puncture, the patient was
asked about the degree 22 of pain perceived by means of an analogue visual scale
and a descriptive verbal scale. When the needle was removed, the length of the
cut made by the puncture was measured. The perceived pain assessed by
analogue visual scale was greatest when the needle was punctured with the bevel
facing upwards rather than downwards (median: 3 versus 2, p<0.003). The prick
in the skin was greater when the puncture was made with the bevel facing
upwards (19.7 +/- 5.6) rather than downwards (16.2 +/- 3.8, p<0.0001). It is
concluded that Arterio Venous fistula puncture with the bevel facing downward
significantly reduces the degree of pain and the skin lesion at the point of
puncture, without increasing the number of punctures. 14

Effect of topical anesthetic agent in reduction of pain

A study revealed that eutectic mixture of local anaesthetics (EMLA)

contains 2.5% lidocaine and 2.5% prilocaine in an oil and water emulsion found
to give effective, safe analgesia on normal and diseased skin. It is used for
numerous medical and surgical procedures, such as anaesthesia for superficial
surgery, split-thickness skin grafts, venipuncture, argon laser treatment,
epilation, and debridement of infected ulcers. Other indications have included
use in postherpeutic neuralgia, hyperhidrosis, painful ulcers, and inhibition of
itching and burning. Study also revealed that EMLA should ideally be applied to
the desired area for at least 1 hour under an occlusive dressing.

Kitamoto Y etal studied the effect of dermal anaesthetic patch on venous

cannulation of blood-access among haemodialysis patients. Aqueous gel of 10%
lidocaine base with 3% glycyrrhetinic acid monohemiphthalate disodium was

13
applied for 60 minutes to the skin of the patients. Degree of pain was expressed
as a pain score. Analgesic effect of the lidocaine gel was evaluated in 16 patients
in a placebocontrolled, double-blind, cross-over design by comparing the gel
with lidocaine with a placebo gel without lidocaine. The mean pin-prick pain
score (1.0 0.5) in the lidocaine gel patch (n = 16) was significantly lower than that
(2.3 0.3) in the placebo gel patch (P < 0.01). In 8.8% of the patients, blood pressure
was elevated after venous cannulation, but this tendency was modified by
dermal patch anesthesia with the lidocaine gel. Plasma concentration of lidocaine
was under the detection limit of assay 0.05 micrograms/mL) after dermal patch
anaesthesia in six subsequent dialysis treatments.15

Watson AR, Szymkiw P, Morgan AG studied on the use of a local

anaesthetic cream (EMLA) for arteriovenous fistula cannulation was compared to
placebo in a double-blind randomised manner in 26 patients undergoing chronic
haemodialysis who were currently using injections of lignocaine. Investigators
found that The EMLA cream was highly effective compared to placebo (P <
0.001) on visual analogue and verbal rating scales as well as ease of venepuncture
(P < 0.01). It also gave more pain relief and improved the ease of venepuncture
compared to lignocaine injections. Patients expressed a strong preference for the
EMLA cream, which has advantages that outweigh the cost and convenience
factors.16

A research study by Mc Phail to investigate the analgesic effect of an

anaesthetic (lidocaine/prilocaine) cream when used to alleviate pain from the
insertion of haemodialysis needles. The study took place over a 12-month time
frame with a total of seven patients participating in the study. Before the patient
entered the study, an assessment was made by the nursing staff as to the degree
of pain and/or anxiety experienced by the patient in relation to needling.
Patients were instructed regarding application of the cream. Investigators have
found this cream to be an effective topical anaesthetic in preventing pain and

14
alleviating anxiety associated with needling. All patients involved in the study
have expressed the desire to continue use of the cream. Use of this topical
anaesthetic could also have great ramifications for paediatric dialysis,
venipunctures and other procedures requiring topical anaesthesia. 17

A study was conducted at the Paediatric Haemodialysis service of the

Paediatric Department of Padua University, Italy to evaluate the efficacy of
EMLA cream (containing a eutectic mixture of local anaesthetic) and cutaneous
stimulation in controlling pain due to arteriovenous fistula cannulation in
teenagers undergoing chronic haemodialysis. The study was conducted in two
phases, one prospective, the other a blind randomized trial; it involved six
teenagers, aged 12-18 years. Pain was measured using the visual analogue scale,
indirect evaluation by nurses and a fourcategory verbal rating scale. Results
shows that the EMLA cream might be effective in controlling cannulation-related
pain but emotional factors, such as uncontrolled fear and stress, can interfere
with the global efficacy of the analgesic approach.15

Effect of Cutaneous stimulation in reduction of pain

The Nursing Interventions Classification (NIC) defined cutaneous

stimulation as stimulation of the skin and underlying tissues for the purpose of
decreasing undesirable signs and symptoms such as pain, muscle spasm, or
inflammation. Cutaneous stimulation also referred to as peripheral technique,
describes any form of stimulation of the skin with the goal of pain relief. There
are many different methods of cutaneous stimulation such as pressure, massage,
heat, cold, vibration, and TENS (Transcutaneous Electrical Nerve stimulation).
These methods are superficial forms of treatment that the nurse in practice is
qualified to give.18

15
 Kubsch SM studied on the effect of cutaneous stimulation on pain
reduction among 50 patients (38 adults, 12 children) admitted in emergency
department. The objectives of the study were evaluating the effectiveness of a
specific protocol of cutaneous stimulation, developed by the researchers, in
reducing pain levels in emergency department patients. Another objective was to
determine the effect of cutaneous stimulation on blood pressure and heart rate.
Potential factors that could influence the dependent variables such as age,
gender, educational level, location of pain, and site of cutaneous stimulation also
were tested. The design used for the study was one group pre-test post-test
experimental design. The investigator measured variables before and after
intervention in all subjects. Results revealed that following cutaneous
stimulation, subjects reported significantly reduced pain, and demonstrated
reduced heart rate, and blood pressure readings. The location of pain
significantly influenced heart rate and diastolic blood pressure but not pain level.
The most effective site of cutaneous stimulation was contra lateral to the pain and
variables like age, gender and educational level had no significant affect. The
results of this study provide empirical evidence that cutaneous stimulation
effectively reduces pain, heart rate, and blood pressure in emergency department
patients. The intervention of cutaneous stimulation has solid utilization potential
and could be easily incorporated into standard emergency department
procedures.18

Enjezab B, Khoushbin A, Bokaei M and Naghshin N perform research to

determine the effect of Hoku point ice massage on labour pain. Participants of
this clinical trial study were 60 pregnant women, who satisfy the inclusion
criteria. Participants were randomly divided to two groups of thirty, each. i.e.
into Control Group=only touch of Hoku point and Case group= ice massage of
Hoku point. This procedure was done for thirty minutes. Labour pain of subjects
was measured by visual analogue scale before and after the procedure. There

16
was no statistical difference between the gestational age, parity and age of the
two groups. Results showed that reduction of labour pain by ice massage of
Huko point was statistically significant (P<0.001). Study suggests that
Acupressure is a non-invasive, simple and cheap method of relieving pain and
the study confirms its effect on reduction of labour pain. This method is therefore
applicable in delivery rooms.17

In Delhi a quasi experimental study was conducted to assess the effect of

cryotherapy on pain due to AV fistula puncture in haemodialysis patients. A
convenience sample of 60 patients (30 each in experimental and control groups)
who were undergoing haemodialysis by using AV fistula, was assessed in a
randomized controlled trial. Objective and subjective pain scoring was done on
two consecutive days of haemodialysis treatment (with cryotherapy for the
experimental group and without cryotherapy for the control group). In
experimental group ice massage was 33 done between the thumb and index
finger of the hand not having the AV fistula before the procedure. The study
shows that the objective and subjective pain scores were found to be significantly
reduced (P<0.001) within the experimental group with the application of
cryotherapy.18

6.3 STATEMENT OF THE PROBLEM

“A STUDY TO COMPARE THE EFFECT OF TOPICAL ANESTHETIC
CREAM AND CUTANEOUS STIMULATION ON AV FISTULA PUNCTURE
RELATED PAIN AMONG PATIENTS UNDERGOING HAEMODIALYSIS IN
DISTRICT HOSPITAL, TUMKUR”.

6.4 OBJECTIVES OF THE STUDY

1. Assess AV fistula puncture related pain among patients undergoing
haemodialysis.

17
 2. Assess the effect of topical anaesthetic cream on AV fistula puncture
related pain among patients undergoing haemodialysis
3. Assess the effect of cutaneous stimulation on AV fistula puncture related
pain among patients undergoing haemodialysis
4. Compare the effect of topical application of anaesthetic cream and
cutaneous stimulation on AV fistula puncture related pain among patients
undergoing haemodialysis
5. Find the association of AV fistula puncture related pain with selected
variables among patients undergoing haemodialysis

6.5 OPERATIONAL DEFINITIONS

Effect: it is the change in severity of AV fistula puncture pain after topical

application of anaesthetic cream and cutaneous stimulation among patients
undergoing haemodialysis.

AV fistula puncture related Pain: It is the perception of discomfort in the AV

fistula during venipuncture of AV fistula among patients undergoing
haemodialysis as measured by numerical pain rating scale.

Topical Anaesthetic cream: It is the eutectic mixture of Lidocaine 2.5% and

Prilocaine 2.5%, which is applied on an area of 20-25 cm2 around AV fistula
venipuncture site 60 minutes before the procedure and covered with polythene
sheet.

Cutaneous stimulation: It is the application of ice cubes (2X1.5) cm wrapped in

gloves on the web between thumb and index finger of the hand not used AV
fistula (contra lateral) for a time period 10 minutes.

18
AV fistula: It is the fistula of the upper extremity currently used for
haemodialysis which can be radio cephalic, radiobasilic or brachiocephalic.

Patient undergoing haemodialysis: A person with chronic kidney disease who is

undergoing maintenance haemodialysis through AV fistula.

Selected variable: The variables selected for the present study include age,
gender, and duration of HD through current AV fistula.

6.6 HYPOTHESES

H1: There is significant difference in the mean score of AV fistula puncture

related pain among patients undergoing haemodialysis with and without
application topical anaesthetic cream as measured by Numerical Pain
rating Scale

H2: There is significant difference in the mean score of AV fistula puncture

related pain among patients undergoing haemodialysis with and without
cutaneous stimulation as measured by Numerical Pain rating Scale.

H3 :. There is significant difference in the mean score of AV fistula

puncture related pain between application of topical anaesthetic agent and
cutaneous stimulation among patients undergoing haemodialysis.

H4: There is significant association of AV fistulas puncture related pain

with selected variables.

6.7 ASSUMPTION
Venipuncture of AV fistula among patients undergoing haemodialysis is
associated with varying level of pain

19
6.8 VARIABLES UNDER STUDY

Independent variables
The independent variables of the study were cutaneous stimulation and
application of the topical anaesthetic cream.

Dependent variable
Dependent variable of the study was AV fistula puncture related pain.

6.9 DELIMITATION
The study is limited to
 The investigator could not control the extraneous factors like physical and
psychological factors which can influence pain perception.
 Generalization is limited due to small sample size use of non probability
sampling technique.

6.10 PILOT STUDY

After getting the permission from institutional ethics committee and
permission from authorities concerned, a pilot study will be conducted among
patients in dialysis unit of District Hospital Thumkur. The purpose of the study
is to find out the feasibility of conducting study and design on plan of statistical
analysis. The findings of the pilot study samples will not be included in main
study.

7.0 MATERIALS AND METHODS

A written permission will be obtained from the concerned hospital
authority prior to the onset of the study, the purpose of the study and method of
data collection will be explained to the participants and informed consent will be
taken, confidentiality will be assured to all subjects to get their co-operation. Data
will be collect from 30 patients who are undergoing maintenance haemodialysis

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in the dialysis unit of District hospital at Tumkur. At the end, subjects will be
thanked for their co- operation during the study.

7.1 SOURCE OF DATA

Data will collected from patient’s who are undergoing maintenance

haemodialysis unit of District hospital at Tumkur.

 RESEARCH DESIGN
The design selected for the study is one group pre test post test design. The
same group of patients are repeatedly assessed for pain intensity and the
effectiveness of the intervention.

O1—O2—O3 —T1O4—T2O5—T3O6 —O7—O8—O9—C1O10—C2O11—C3O12.

O—Observation.
T—Topical application local of anaesthetic cream.
C—Cutaneous stimulation.
O1—O2—O3 Pain assessed with AV fistula puncture on three consecutive
haemodialysis process.
T1O4—T2O5—T3O6 AV fistula puncture related pain with topical application of
anaesthetic cream on three consecutive haemodialysis process.
O7—O8—O9 Pain assessed with AV fistula puncture on three consecutive
haemodialysis process between intervention Cutaneous stimulation and Topical
application of anaesthetic cream.
C1O10—C2O11—C3O12 AV fistula punctures related pain with cutaneous
stimulation on 3 consecutive haemodialysis process.

 RESEARCH APPROACH
Quasi experimental approach is adopted for the study. The sample selected
the study are subjects undergoing maintenance haemodialysis through Arterio-

21
Venous fistula. The same subjects are assessed for their basic pain, with
cutaneous stimulation and with application of topical anaesthetic cream. It is
measured by Numeric Pain Rating Scale.

 RESEARCH SETTING
The study will be conducted in dialysis unit of District hospital, Tumkur.

 POPULATION
Population of the study consists of patients with chronic kidney disease under
going maintenance haemodialysis.

 SAMPLE SIZE
The sample consists of 30 patients who are undergoing maintenance
haemodialysis in dialysis unit of District hospital, Tumkur.

SAMPLING TECHNIQUE
Non probability purposive sampling technique will be used in the study.
The investigator will select sample from the population as per inclusion criteria.
The sample size is 30 patients who receive maintenance haemodialysis through
AV fistula.

 SAMPLE CRITERIA
Sample consists of 2 criteria

 Inclusion Criteria
Patients with chronic kidney disease undergoing haemodialysis who are
 willing to participate in the study
 between age group of 20years- 65 years
 undergoing HD through AV fistula more than 6 times.

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 Exclusion Criteria
Patients with chronic kidney disease undergoing haemodialysis who are:
 having any injury, peripheral vascular disease and connective tissue
disorder
 having diabetic neuropathy.
 having psychiatric or neurological problem.
 altered level of consciousness.
 suffering from pain of other origin than AV fistula
 on analgesic medication

7.2 METHOD OF THE DATA COLLECTION

The method for data collection consists of interview and self reporting.
Patients who are waiting for dialysis are interviewed to collect data regarding
sociopersonal and clinical information. Self reporting technique is used to assess
the AV fistula puncture related pain using Numerical Pain Rating Scale.

 TOOL FOR DATA COLLECTION

Tools needed for data collection are divided into following categories

Tool 1: Interview schedule

PartA: Interview schedule for collecting socio personal data: Part A consist of 6
items including age, gender, education, religion, marital status and employment
status
Part B: Interview schedule for collecting clinical data: Part B consist of 3 Items
including duration of haemodialysis currently using AV fistula and site of AV
fistula.

Tool 2: Numerical Pain Rating Scale

It is the Numerical pain rating scale to assess pain intensity. It is one of the
standardized tools for quantifying pain intensity which consist of a scale with
values ranging from zero to ten. On this scale 0 means no pain, 1-3 means mild

23
pain, 4-6 means moderate pain and 7- 10 severe pain. Patients marked a tick on
the scale to indicate how strong their pain during AV fistula puncture

 METHODS OF DATA ANALYSIS & INTERPRETATION

The data will be organized, tabulated and analyzed by using descriptive and
inferential statics. The data will be planned to present in the form of tables and
figures.

 DESCRIPTIVE STATISTICS:
Frequency ,mean ,mean percentage , & standard deviation of described
demographic variable.

 INFERENTIAL STATISTICS:
Paired "t" test to compare the intensity of pain between pretest and
posttest.
Non parametric chi square [x2] test will be used to find out the association
between selected variables for intensity of pain.

 TIME AND DURATION OF THE STUDY

The time and duration of the study will be limited to 6 weeks as per the
guidelines of the university.

7.3 DOES THE STUDY REQUIRE AND INVESTIGATION OR

INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER
HUMAN OR ANIMAL?
Yes, structured program will be conducted on patients undergoing
maintenance haemo dialysis.

7.4 HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR

INSTITUTION?

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 Yes, the pilot study and the main study will be conducted after the
approval from the research committee of Akshaya College of nursing, Tumkur.
Permission will be obtained from the concerned head of the institution. The
purpose and details of the study will be explained to the study subjects and an
informed consent will be obtained from them. Assurance will be given to the
study subjects on the confidentiality and anonymity of the data collected from
them.

25
8.0 LIST OF REFERENCES

1. Douglas C, Eaton John P, Pooler. Vanders Renal Physiology seventh edition,

New York:Mc Graw Hill publishers; 2009.
2. Jurgen Floege, Richard J, Johnson, John Feehally. Comprehensive clinical
nephrology. 4th edition. St. Luois: Elsiviers publishers; 2010.
3. Althea Mahon, Karen Jenkins. Chronic kidney disease stage 1-3 A guide to
clinical practice. European Dialysis and Trained Nurses
Association/European Renal Association;2007.
4. KDOQI Clinical Practice Guidelines for Chronic Kidney Disease:
Evaluation,Classification, and Stratificationpart . [internet] available from
http://www.kidney.org/professionals/kdoqi/guidelines_ckd/p4_class_g1.h
tm.
5. Coresh J, Astor BC, Greene T, Eknoyan G, Levey A. Prevalence of chronic
kidney disease and decreased kidney function in the adult US population:
Third national health and nutrition examination survey. Am J Kidney Dis.
2003; 41 (1): 1-12.
6. Lysaght MJ. Maintenance dialysis population dynamics: current trends and
longterm implications. J Am Soc Nephrol 2002; 13: 37-40.
7. Xue J, Ma J et al. A forecast of the number of patients with end-stage renal
disease in the United States to the year 2010. J Am Soc Nephrol 2001; 12:2753-
2758.
8. The Renal Association. UK Renal Registry. The sixth annual report 2004.
Available from http://www.renalreg.com/Reports/2004.html.
9. Anandarajah S, Tai T, de Lusignan S, Stevens PO, Donoghue D, Walker M,
Hilton S. The validity of searching routinely collected general practice
computer data to identify patients with chronic kidneydisease (CKD) : a
manual review of 500 medical records. Nephrol Dial Transplant 2005; 20,
(10) :2089-2096

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10. World Health Organization. Burden of disease project available from http://
w w w. w h o . i n t / h e a l t h i n f o / s t a t i s t i c s / b o d g b d 2 0 0 1 / e n
/index.html. Accessed in September 2004.
11. Grassmann A, Gioberge S, Moeller S, Gail B . ESRD patients in 2004: global
overview of patient numbers, treatment modalities and associated trends.
Nephrol Dial Transplant 2005; 20: 2587–2593.
12. Reddy KS, Shah B, Varghese C, Ramadoss A. Responding to the threat of
chronic diseases in India. Lancet 2005; 366 :1744-9.
13. Shyam C, Dakshina Murty KV, Sreenivas V, Rapur R. Chronic kidney disease:
Need for a national action plan. Indian J Med Res. 2007;125: 498–501.
14. Clinical Practice Guidelines and Clinical Practice Recommendations 2006
Updates Hemodialysis Adequacy Peritoneal Dialysis Adequacy Vascular
Access. Available from http://www.kidney.org / professionals / kdoqi / pdf
/ 12- 50-0210_JAG_DCP_Guidelines-VA_Oct06_SectionC_ofC.pdf.
15. Kleiber C, Sorenson M, Whiteside K, Gronstal BA, Tannous R. Topical
anesthetics for intravenous insertion in children: a randomized equivalency
study. 2002 Oct;110(4):758-61.
16. Weinstein, SM. Plumer's Principle & Practice of Intravenous Therapy.
Philadelphia, Lippincott, 1993.
17. Smith M, Gray M, Ingram, Jewkes DA .Double –blind comparison of topical
lignocaine -prilocaine cream (EMLA) and lignocaine infiltration for arterial
cannulation in adults. The British Journal of anesthesia; 1990: 65(2): 240-42.
18. Figueiredo AE, Monterio M, Poli-de-Figuerido CE. Research into pain
perception with arteriovenous fistula (avf) cannulation. Journal of Renal Care.
2008 Dec; 34(4):169-72.

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9. SIGNATURE OF THE CANDIDATE :

10. REMARKS OF THE GUIDE :

11. NAME AND DEISGNATION OF THE :

11.1 GUIDE :

11.2 SIGNATURE :

11.3 CO-GUIDE :

11.4 SIGNATURE :

11.5 HEAD OF THE DEPARTMENT :

11.6 SIGNATURE :

12.1 REMARKS OF THE PRINCIPAL :

12.2 SIGNATURE :

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