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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1
Name of the candidate and
address
ANUMOL K. V.
(in block letters)
ADYAR
SAHYADRI COLLEGE OF NURSING
MANGALORE-575007.
2
SAHYADRI COLLEGE OF NURSING
Name of the institution
ADYAR
MANGALORE-575007
3
M. Sc. NURSING
Course of the study and subject
MEDICAL SURGICAL NURSING
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Date of admission to the course
5
Title of the study
A
COMPARATIVE
01.06.2010
STUDY
TO
ASSESS
THE
EFFECTIVENESS OF HOT FOMENTATION VERSUS
COLD
COMPRESS
IN
REDUCING
INTRAVENOUS
INFILTRATION AND PAIN AMONG PATIENTS IN A
SELECTED HOSPITAL AT MANGALORE, KARNATAKA.
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Brief resume of the intended work
6.1
Need for the study
Intravenous infusion has become an indispensable component in medical
therapy. It is used to correct electrolyte imbalances, to deliver medications, for blood
transfusion or as fluid replacement to correct dehydration. In spite of its therapeutic
effects the most frequently encountered problems are infiltration and extravasation.
Unfortunately, they are so common, that they are sometimes overlooked or not
addressed as soon as they should be, or else they can produce debilitating effects1
A study conducted by infusion nursing society on incidence of intravenous
catheter complications in the hand and forearm reported that 67 patient had
developed intravenous catheter complication in a hospital over a three year period in
which 56 minor complications and 11 major complications. In 68% of minor
complications, the patients were aged 50 years or older and 68% were women in
which minor complications comprised 26 intravenous infiltrations and 23 cases of
thrombophlebitis. The most common complication of peripheral venous cannulation
is infiltration which results in an inflammatory reaction, and is manifested as pain,
swelling, and erythema that may prolongs the duration of hospital stay. Therefore,
nurses are in a pivotal position to manage infiltration through effective nurseinitiated intervention that are economical in both nursing times and resources. In the
past, drugs have been the conventional methods to alleviate pain and swelling, but in
many instances, medications themselves do not provide optimal results. The
modality of hot and cold compression have a very appropriate role in the treatment
of almost all injuries involving soft tissues involves pain, possible bleeding and a
leakage of fluid from damaged tissues into the area.2
A comparative study was conducted in Pune on effectiveness of hot
fomentation versus cold compress for reducing intravenous infiltration. The sample
size was sixty patients (30 for hot fomentation and 30 for cold compress) with mild
to moderate degree of infiltration stayed in hospital for 8-14 days and data was
analysed by using descriptive and inferential statistics. Findings prove that the pretreatment mean score of degree of infiltration was 7.1667 reduced to 0.7071 on the
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third day of treatment with hot fomentation. In cold compress pre-treatment mean
score 6.9333 reduced to 0.70571. The study concluded that both hot fomentation and
cold compress are effective in treatment of intravenous therapy related infiltration3.
In contrast, a study was conducted on effectiveness of warm versus cold
applications of intravenous infiltrations at Health Science Centre, New York.
Differences in pain intensity, surface area measurements of induration and erythema,
and interstitial fluid volume when warm versus cold applications were randomly
made to an intentional intravenous infiltrate of 5 ml of a designated solution were
examined. Three solutions were used: 0.5 saline, normal saline, and 3% saline.
Study was done with 18 samples .There was induration and erythema was no
difference in remaining infiltrate when 0.5 saline or normal saline were used, but a
significant (p<0.001) difference was found with 3% saline. Pain intensity did not
differ by treatment but a significant (p<0.005) difference was found by solution,
with 3% saline producing the greatest difference. Erythema was absent with all
solutions. Surface induration was affected by solution and decreased overtime
(p=0.001) .There was no effect of warmth or cold on surface area induration4.
Some studies shows that hot and cold application is very effective in
reducing intravenous infiltration at the same time others shows there is no effect.
Since it is contradictory to nursing practice investigator felt that there is a need to be
check the effectiveness of hot fomentation versus cold compress in reducing
intravenous infiltration.
6.2 Review of literature
A comparative study was conducted in Pune on effectiveness of hot
fomentation versus cold compress for reducing intravenous infiltration. The sample
size was sixty patients (30 for hot fomentation and 30 for cold compress) with mild
to moderate degree of infiltration stayed in hospital for 8-14 days and data was
analysed using descriptive and inferential statistics. Findings prove that the pretreatment mean score was 7.1667 reduced to 0.7071 on the third day of treatment
with hot fomentation. In cold compress pre-treatment mean score 6.9333 reduced to
3
0.70571. The study concluded that both hot fomentation and cold compress are
effective in treatment of intravenous therapy related infiltration3.
An interventional study was conducted in Mangalore on effectiveness of
nursing interventions (ichthammol glycerine, thrombophob, hot fomentation) on
patients with phlebitis related to peripheral intravenous infusion. The sample consist
of 45 subjects and three treatment was administered to 15 patients for three days two
times a day. The collected data were analysed by using ANOVA and t test. The
study concluded that treatment with warm ichthammol glycerine dressing was most
effective ,pre treatment score 7.67 reduce to 1.47 on the third post treatment day
with warm ichthammol glycerine5.
A study was conducted in West Bengal on effectiveness of four modalities
(hot fomentation, glycerine magnesium sulphate application, ichthamol magnesium
sulphate and ichthamol belladonna) of nursing interventions evaluated. Tool
included the demographic data to know the sample characteristics, phlebitis
measurement chart, observation check list and visual analogue scale. The pre test
mean pain score related to peripheral IV infiltration were 61.23 and post test mean
pain scores were 13.27 in treatment with ichthamol belladonna dressing with hot
fomentation which was found to be most effective out of all the 4 interventions.
Thus the study concluded that ichthamol belladonna dressing with fomentation was
effective6.
An interventional study was conducted in Mangalore on effectiveness of ice
packs versus thrombophob gel for reducing iv infiltration in patients admitted in
paediatric wards. The study was conducted on 40 samples (20 for thrombophob gel
group and 20 for ice cube group) selected using purposive sampling technique. The
infiltration was assessed by using modified infiltration scale. The results showed that
before the treatment, majority (65%) of patients had grade two infiltration after the
treatment with thrombophob and 100% of patient’s infiltration had reduced to grade
one infiltration. In group two majority (80%) had grade two infiltration after the
treatment with ice cube 100% had grade one infiltration. The study concluded that
both thrombophob gel and ice pack are effective in reducing intravenous infiltration
among paediatric patients7.
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A comparative study was conducted in Portland on the effect of warm and
cold application on resolution of phlebitis. The sample was composed of 18 healthy
adult volunteers. The findings reveals that application of warm to sites of iv phlebitis
produced faster resolution of extravasation than did cold application at a significance
difference (F=14.38,p<0.001)8.
A comparative study was conducted at monarch university on effect of
elevation, warmth and cold on phlebitis .Nursing interventions used to treat
intravenous phlebitis generally included application of warmth and cold, elevation.
The study concluded that effect of warmth versus cold on phlebitis shown that
warmth is better than cold in decreasing the symptoms or speeding re-absorption of
the infiltrate9.
6.3
Problem statement
A comparative study to asses the effectiveness of hot fomentation versus
cold compress in reducing intravenous infiltration and pain among patients admitted
in a selected hospital at Mangalore, Karnataka.
6.4
Objectives of the study
The objective of the study are:

To assess the degree of infiltration before and after intervention in both
groups as assessed by standardised infiltration scale.

To assess the pain before and after intervention in both groups as assessed by
numerical pain scale.

To determine the effectiveness of hot fomentation on intravenous infiltration
and pain.

To determine the effectiveness of cold compress on intravenous infiltration
and pain.
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
To compare the effectiveness of hot fomentation versus cold compress on
intravenous infiltration and pain.

To find association between pre-test score of infiltration and pain with
selected demographic variables.
6.5
Operational definitions
Effectiveness: Effectiveness means capability of producing some effect
(Wikipedia).
In this study, effectiveness refers to the extent to which the hot
fomentation and cold compress in reducing intravenous infiltration and pain
as measured by infiltration measurement scale and numerical pain scale
respectively.
Hot fomentation: A preparation of hot moist material applied to any parts of
the body to increase local circulation, alleviate pain or soften the skin
(Oxford Dictionary).
In this study, hot fomentation refers to application of gauze pad
soaked in hot water (40-450C) to area of infiltration for the duration of 15
minutes twice a day in the morning and evening for three days.
Cold compress: Cold compress is a local moist cold application made out of
folded layers of gauze, lint piece or old soft linen, wring out of cold or ice
water or in some evaporating lotion applied to the required area (Sister
Nancy).
In this study cold compress refers to the application of ice cube
covered by gauze to the area of infiltration for the duration of 15 min twice a
day in the morning and evening for three days.
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Intravenous infiltration: Infiltration refers to escape of escape of fluid in to
the subcutaneous tissues due to the dislodgement or malfunctioning of the
cannula characterized by swelling, pain or itching, burning, skin that is cool
to the touch or discoloration (Whaley and Wong, 2006) .
In this study, infiltration refers to the infusion site with features of
swelling, pain or, skin is cool to touch or discoloration.
Pain: Pain is a feeling of distress, suffering or agony, caused by stimulation
of specialized nerve endings (Bailliere’s Nurse’s Dictionary).
In this study, pain refers to subjective feeling of discomfort measured
by scores of numerical pain scale.
Patient: Patient refers to a person receiving or registered to receive medical
treatment (Wikipidea).
In this study, patient refers to a male or female admitted with age
group of 25-40 years receiving peripheral intravenous infusion with the signs
of infiltration.
6.6
Assumptions
The study assumes that:

Patients on intravenous therapy are at risk for developing infiltration.

Hot and cold applications inducing vasodilation and vasoconstriction
respectively there by reducing intravenous infiltration.
6.7
Delimitations

The study is delimited to a period of one month.

The study is delimited to adults of age group 25-40 years.

Only limited to selected hospital in Mangalore.
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6.8
Hypotheses (All hypotheses will be tested at 0.05 level of significance)
H1:
There will be a significant reduction in infiltration and pain among patients
after application of hot fomentation
H2:
There will be a significant reduction in infiltration among patients after the
application of cold compress.
H3:
There will be a significant difference in infiltration and pain among those
who receive hot fomentation and those who receive cold compress.
H4:
There will be significant association between pre-test scores of infiltration
and pain with selected demographic variables.
7.
Materials and methods
7.1
Source of data collection
The data will be collected from patients with IV infiltration in selected
hospital at Mangalore.
7.1.1
Research design
Quasi-experimental
Time series design
Group I:
R
O1 X1 O2 X1 O3 X1 O4
Group II:
R
O1 X2 O2 X2 O3 X2 O4
O1:
Observation made before the intervention
O2:
Observation on the first day of intervention
O3:
Observation on the second day of intervention
O4:
Observation on the third day of intervention
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X1:
Hot fomentation
X2:
Cold compress
Group I:
Patients receiving hot fomentation
Group II:
Patients receiving cold compress
R:
Randomisation
7.1.2
Setting
The study will be conducted in medical surgical wards on selected hospital at
Mangalore.
7.1.3
Population
Population includes patients with signs and symptoms of intravenous
infiltration admitted in selected hospital at Mangalore.
7.2
Method of data collection
7.2.1
Sampling procedure
The samples for the study will be selected by purposive sampling technique.
7.2.2
Sample size
The sample for the study would comprise of 60 patients (30 hot fomentation
groups and 30 cold compress groups) who are having intravenous infiltration and
pain as assessed by standardized infiltration measurement scale and numerical pain
scale.
7.2.3
Inclusion criteria for sampling
Patients who are:

In the age group of 20-40 years, both male and female, receiving peripheral
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intravenous infusion with signs of infiltration.

Patients who are willing to participate in the study.

Patients who are on IV fluid therapy irrespective of whether medicated or
non-medicated.

Patients who are conscious and well oriented.
7.2.4
Exclusion criteria for sampling

Clients with moderate and severe dehydration.

Clients with central venous infusion.

Clients on chemotherapy.

Clients who developed phlebitis.
7.2.5
Instruments used

Demographic proforma.

Standardized infiltration measurement scale.

Numerical pain scale.
7.2.6
Data collection method

The investigator will obtain formal permission from the selected institution.

The purpose of the study will be explained to the patients and informed
written consent will be obtained from them.

Infiltration and pain measurement is done using standardized infiltration
measurement scale and numerical pain scale respectively.

Samples for Hot fomentation and cold compress will be assigned randomly
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by lottery method.

Hot fomentation will be applied to 30 subjects for 15 minutes twice a day for
three days.

Cold compress will be applied to another 30 samples for 15 min twice a day
for three days.

After each intervention post-test will be conducted using the infiltration
measurement scale and numerical pain scale.
7.2.7
Data analysis plan

Demographic data and observational record will be analysed using
descriptive statistics.

Effectiveness of intervention will be analyzed by using paired ‘t’ test and
independent ‘t’ test.

Chi-square will be used to find out association between pre-test infiltration
and pain with selected demographic variables.
7.3
Does the study require any investigation to be conducted on patients or
other humans or animals (if so, please describe briefly)
Yes. In this study researcher has to apply hot fomentation or cold compress
on patients with infiltration.
7.4
Has ethical clearance been obtained from your institution in case of 7.3?

Yes, permission will be obtained from concerned authorities of selected
institutions.

Informal written consent will be obtained from participants.
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8.
LIST OF REFERENCES
1.
Intravenous therapy. [online]. 2010 [cited 2010 Sep 25]; Available from:
URL:http://www.answers.com/topic/content.
2.
Fabian B. Intravenous complication: infiltration. Journal of Intravenous
Nursing 2000 Jul;23(4):229-31.
3.
Anjum S. Hot fomentation versus cold compress for reducing intravenous
infiltration. Nursing Journal Of India 2007 Nov;xcviii(11):253-4.
4.
Tompkins L, Roboson L, Szevrenj N. Effect of warm and cold applications
on the resolution of IV infiltrations. Journal of Infusion Nursing 1993;(3):10.
5.
Joseph J. Effectiveness of nursing interventions on patients with phlebitis
related to peripheral intravenous infusion. Honours (thesis) submitted to
Rajiv Gandhi University of Health Sciences, Bangalore; 2009.
6.
Biswas D. A study to compare the effect of selected nursing interventions on
patients with phlebitis related to peripheral intravenous infusion in selected
hospital of Kolkata, West Bengal. Health Action 2005.
7.
Vishwambaran N. Effectiveness of thrombophob versus ice application in
reducing iv infiltration.
Honours (thesis) submitted to Rajiv Gandhi
University of Health Sciences, Bangalore; 2009.
8.
Hastings MT, Tompkins J .Effect of warm and cold applications on
resolution of IV phlebitis. Journal of Clinical Epidemiology 1993
Jun;16(3):171-2.
9.
Yucha CB. Effectiveness of elevation, warmth and cold on phlebitis.
[online]. 1998. Available from: URL:http:/www.springerlink.com/content.
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8.
Signature of the candidate
9.
Remarks of the guide
10.
Name and designation of (in block letters)
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12.
PROF. RAJA A.
HOD
MEDICAL SURGICAL NURSING
SAHYADRI COLLEGE OF NURSING
MANGALORE
10.1
Guide
10.2
Signature
10.3
Co-guide (if any)
10.4
Signature
11.1
Head of the department
11.2
Signature
12.1
Remarks of the Chairman and Principal
12.2
Signature
PROF. RAJA A.
HOD
MEDICAL SURGICAL NURSING
SAHYADRI COLLEGE OF NURSING
MANGALORE
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