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A STUDY TO ASSESS THE EFFECTIVENESS OF PLANNED TEACHING PROGRAMME ON KNOWLEDGE REGARDING
CORD BLOOD BANKING AMONG STAFF NURSES IN SELECTED HOSPITALS AT BANGALORE
M.Sc. Nursing Dissertation Protocol Submitted to
Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore
By
Ms.JAKHA LEENU.M
M.Sc Nursing 1st Year
2012-2014
Under the Guidance of
HOD, Department of OBG Nursing
Nightingale College of Nursing
Guruvanna Devara Mutt,
Near Binnyston Garden,
Magadi Road,
Bangalore-560023
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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 (in
block letters)
MS.JAKHA LEENU.M
Ist YEAR M.Sc NURSING
NIGHTINGALE COLLEGE OF NURSING,
GURUVANNA DEVARA MUTT,NEAR
BINNYSTON GARDEN,MAGADI
ROAD.BANGALORE.-23
2: Name of the Institution NIGHTINGALE COLLEGE OF NURSING
MAGADI ROAD
BANGALORE.
3: Course of Study and Subject M. Sc. NURSING
OBG NURSING
4: Date of Admission to the Course 01/05/2012
5: TITLE OF THE STUDY:
“A STUDY TO ASSESS THE EFFECTIVENESS OF PLANNED
TEACHING PROGRAMME ON KNOWLEDGE REGARDING CORD
BLOOD BANKING AMONG STAFF NURSES IN SELECTED HOSPITALS
AT BANGALORE.”
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6
BRIEF RESUME OF THE INTENDED WORK
6.0 INTRODUCTION:
“A baby is God’s opinion that life should go on’’Carl Sandburg
Umbilical cord or funiculus umbilicalis is a long cord like structure, extending
from fetus to the placenta. It acts as a lifeline between placenta and fetus by providing oxygen
and nutrients to fetus and disposing waste products. Cord blood contains hematopoietic stem
cells, progenitor cells which can form red blood cells, white blood cells and platelets. Cord
blood banking consists of the collection, processing, and cryopreservation of the remaining
blood within the umbilical and placental circulation following the birth of a child and
typically prior to placental delivery. A cord blood bank is a facility which stores umbilical
cord blood for future use.1
Cord blood collection happens after the umbilical cord has been cut and is extracted
from the fetal end of the cord, diverting up to 75+/-23ml from the neonate. It is usually done
within 10minutes of giving birth. After the health care provider draws the cord blood from the
placental end of the umbilical cord, the placenta is couriered to the stem cell laboratory,
where it is processed for additional stem cells. An adequate cord blood collection requires
atleast 75ml in order to ensure that there will be enough stem cells to be used for a
transplantation .Before the cord blood is stored for later use, it undergoes viral testing
including tests for HIV and Hepatitis B and C and tissue typing. It will also be examined for
nucleated cell count, cell viability, blood group antigen (ABO &Rh), molecule cluster
(CD34), and bacterial and fungal growth.1
After the collection, the cord blood unit is shipped to the lab and processed and
then cryopreserved. There are many ways to process a cord blood unit, some processing
methods separate out the red blood cells and remove them, while others keep the red blood
cells. The unit is processed, a cryopreservant is added to the cord blood to allow the cells to
survive the cryogenic process.After the unit is slowly cooled to -90degree C,it can then be
added to a liquid nitrogen tank which will keep the cord blood unit frozen at -196degree
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C.The slow freezing process is important to keep the cells alive during the freezing process.
Although many cryopreservation strategies suggest using dimethylsulfoxide(DMSO),slow or
controlled rate cooling and rapid thawing.1
A study to conduct the methods of cord blood collection and separation for
haematopoietic progenitor cells among health personnels. This study aimed to investigate the
level of knowledge on methods of umbilical cord blood collection and separation methods. A
structured questionnaire method was adopted for this study. Health personnels were surveyed
(n=150) with the response rate of 40%.The results of this study shows that majority of health
personnels are faced difficulties during collection and separation methods.2
Cord blood stem cells are used in the treatment of several life-threatening
diseases. It plays an important role in the treatment of blood and immune system related
genetic diseases, cancers and blood disorders like leukemia, Hodgkin’s lymphoma and sickle
cell anaemia. The use of cord blood stem cells are in the application of regenerative medicine.
It is used in children with type1 diabetes mellitus, cardiomyopathy and cerebral palsy etc.3
An International Cord Blood Transplant Registry conducted a study on cord
blood banking for hematopoietic stem cell transplantation. This study indicated that human
umbilical cord blood contains hematopoietic stem cells for transplantation to cure children
and adults with leukemia and other fatal marrow disorders.4
The FDA (Food and Drug Administration)governs the collection, processing,
storage, labeling, packaging and distribution of cord blood stem cells. There are two different
standards which can apply: cGTP(Current Good Tissue Practices)and cGMP(Current Good
Manufacturing Practices). cGTP standards apply to the collection, processing and storage of
human cells, tissues and cellular/tissue-based products and are regulated by the centre for
Biologics Evaluation and research .All us cord blood banks must be complaint with cGTP
standards. cGMP standards apply to the manufacture of a product that is considered a drug.
How one determines whether a bank must be complaint with cGMP standards is based upon
the product that they manufacture. If a cord blood bank manufactures cord blood stem cells
that are overly manipulated or the cells are used in a different basic biologic function that
product is regulated as a drug and both cGTP and cGMP standards would apply.5
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India’s first public cord blood bank is Jeevan Blood Bank and Research
Centre(Chennai).The various private cord blood bank found across India are Life cell
India(Chennai,Mumbai,Hyderabad,Bangalore,Ludhiana,Ahmedabad,Delhi,Cochin),Asia cryo
cell private limited (Chennai& Bangalore),Reliance Life Sciences Pvt.Ltd(Mumbai),
Cryobanks international (Patna)&Rotary Narayana Tissue Bank and Stem cell research
centre(Bangalore).6The average charge to preserve cord blood for a period of 21 years is
Rs.70,000 to Rs.84,000 which can also be paid in divided rents of Rs.3500 per month and
further storage demands Rs.2000 per year.7
6.1 NEED FOR STUDY:“Believe that life is worth living and your belief will help create the fact’’
William James
Placenta is an organ within the uterus which connects embryo to the wall of
the uterus and provide nourishment, eliminates waste and exchange respiratory gases of the
embryo.8
Since this placenta was considered as medical waste and was discarded. Then
came a period when researchers found that it can be used for preparation of cosmetics and
now found that this is a source of precious primitive hematopoietic stem cells and progenitor
cells that can reconstitute the hematopoietic system in patients with malignant and non
malignant disorders treated with myeloablative therapy. 9Bone marrow Transplantation was
the major source for such conditions since 1960’s.The major issues concerned with bone
marrow transplantation are average length of time for searching the donor, low availability of
HLA matched donor and higher incidence of viral infection (90%) etc .10
The cord stem cells have many significant advantages over other sources.
Umbilical stem cells is the freshest and youngest stem cells, more tolerant to tissue mismatch,
do not have DNA mutation that adult stem cells may develop overtime, avoids ethical debate
and it is a biological health insurance for donor future off springs. 14 Cord blood stem cells
may be useful for the siblings, parents or cousins if there is an adequate Human leukocyte
Antigen (HLA) match.11
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Umbilical cord blood has been approved for use by the Food and Drug
Administration (FDA)and other authorities since the late 1980’s.The first umbilical cord
blood transfusion cured a blood cancer in 1988,when French researchers took umbilical cord
blood from a newborn and gave it to a five year old sibling who had Fanconi’s anaemia, a
severe type of anaemia that causes skeletal defects. Over 1000 cord blood transfusions have
been successlly performed in the United States. Every year nearly 9,000 Americans die who
are waiting for stem cell transplantation.12
Survey of European blood marrow transplantation activity (2006)states that
hematopoietic stem cell transplantation should focus on use of cord blood products and in
2006 there were 25,050 hematopoietic stem cells transplantation from 605centers in 43
participating countries.12In India about 30,000 individuals each year are diagnosed with
conditions that could be treated with a bone marrow transplantation. A study found that
children who received cord blood transplant from closely matched sibling were 59% less
likely to develop graft versus host disease. In Karnataka more then 3,000 patients have now
been treated with cord blood stem cells and 400-500 new patients receives
treatmentannually.13
A study to conduct the uses of cord blood among pregnant mothers. The
result of this study was 67% of women would agree to store cord blood for research
purposes,39%for gene therapy, and 33%for drug manufacturing investigations.13 Recent
research has shown that umbilical cord blood stem cells have similar powers and health
promoting benefits as do embryonic stem cells. Advances are being made each day in
providing greater safety to the patient. Keeping in view the findings seen in scientific
literature, the present study is intended to assess the knowledge of cord blood banking among
staff nurses.14
Some of the common misconceptions about cord blood banking are (1) doctors
would never treat the child with his or her own blood stem cells because it would contain the
disease; (2) no family history of cancer or disease, will ever need their banked cord blood are
so low that people shouldn’t bother doing it; (3) cord blood is not being used yet in medical
treatments; (4) cord blood collection takes important blood away from the baby; (5) the cord
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stem cell may not remain useful after long-term storage.14
With stem cell therapy proving to be the emerging treatment for the future, cord
blood is one of the cheapest alternatives. Stem cell transplantation facilities are increasing in
India but for optimal utilisation of these facilities, it is important to create concept awareness.
At present, lack of awareness about the huge potential to be gained from the storage of cord
blood stem cells and highly technical nature of the process is the key reason for a small
customer base in the country.11
Even several misconceptions, ignorance and inadequate knowledge on cord
blood banking are prevalent among the healthcare providers. Increased awareness levels
among the healthcare providers, especially the staff nurses about the concept and strong
legalised and less commercialised environment can work positively towards making cord
blood banking an integral part of Indian healthcare. Hence, the researcher felt the need to
improve the knowledge of staff nurses on umbilical cord blood banking by administering a
planned teaching programme.
6.2 REVIEW OF LITERAURE:
“Review of literature is a critical summary of research on topic of interest
often prepared to put a research problem in a context or as the basis for an implementation
projects.’’
The review of literature is an integral component of any study or research
projects. It enhances the depth of knowledge and inspire a clear insight in to the crux of
problem. Literature review throws lights on studies and findings reported about the problems
under study.
A study conducted on transplantation of unrelated donar umbilical cord blood for
non malignant diseases in Taiwan among 45 patients. This study results shows that incidences
of neutrophil engraftment were 88%, platelet engraftment was 82%,GVHD 42%,five years
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overall survival 88% and disease free survival 77.1% respectively.15
A study conducted on umbilical cord blood collection and separation for
haematopoietic progenitor cell banking.25 samples were assessed. Recoveries of nucleated
cell count, total progenitors and CD34-positive cells in the buff coat were 90%,88% and
100% respectively. The result of this study shows that cord blood can be effectively readily
available blood banking techniques.11
A study was conducted on assessment of feasibility of related cord blood
collecting, the appropriateness of storage and the final suitability for transplantation.
63families were enrolled n this study. A total of 72 cord blood units were collected and stored
for 64 patients. HLA-typing was carried out for 34 donor-recipient couples and most unit
(72%)mismatched with the related patients. About 60% of collections had acceptable for
transplantation. In that only 21% of units had suitable for transplantation. Appropriateness of
related cord blood banking for parents should be further investigated and cost-effective
guidelines policies should be provided. The result shows that banking of related cord blood
unit is an important resource then, this public service should be supported and enhanced. 16
A study was conducted on impact of donor and collection related variables on
product quality in ex-utero cord blood banking. This study aimed to evaluates the role of
selected donor and collection related variables. Retrospective review was performed of cord
blood units collected ex-utero. This study shows that donor selection and collection technique
modifications may improve product quality.17
A study was conducted on impact of intra partum factors on umbilical cord
blood stem cell banking. Cord blood samples were obtained from 102 normal full term
deliveries for the banking of stem cells. Fluorescence activated cell sorting was used to
measure CD34+cell numbers. Statistical analysis was undertaken using Pearson correlation
test and multiple regression analysis. The result shows that some intra partum factors have an
impact on the characteristics of collected cord blood cells. Stress during delivery may
influence the number of haematopoietic cells, through altered cytokine production. This
knowledge may facilitate the selection of optimal cord blood samples for unrelated banking
and the early discarding of suboptimal cord blood samples thus resulting in the saving of
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costs related to expensive further processing.18
A study was conducted in Calcutta on placental umbilical cord whole blood
transfusions. The sample consisted of 62 patients from nine years of age, of whom 32 were
suffering from varying stages and grades of malignancy. The remaining 30 patients included
patients suffering from thalassemia major, aplastic anaemia, systemic lupus erythematous,
chronic renal failure, rheumatoid arthritis, ankylosing spondylitis, and a geriatric group of
patients with benign prostatic hypertrophy. One hundred and seventy-four units of umbilical
cord whole blood was collected aseptically from the umbilical vein after caesarean section in
standard paediatric blood transfusion bags, after the removal of the baby from the operative
field and after confirming the stable condition of the mother. It was concluded that it also has
the advantage of a higher oxygen carrying capacity of foetal haemoglobin in addition to many
growth factors and other cytokine filled cord blood plasma along with its hypoantigenicity.19
A study was conducted in USA to overcome the barriers to umbilical cord
blood transplantation. The study results showed that there has been marked increase in the
utilisation of umbilical cord blood transplantation (UCBT) in recent years, especially in the
paediatric population. However graft failure, delayed engraftment, and profound delay in
immune reconstitution led to significant morbidity and mortality in adults. It was concluded
that the ability to transplant across Human Leucocytic Antigen (HLA) disparities, rapid
procurement time and decreased graft versus host disease (GVHD) seen with unit cord blood
transplant made it a promising stem cell source and while barriers existed, consistent progress
was being made to overcome them.20
A study was conducted in Coimbatore to evaluate the effectiveness of planned
teaching programme on umbilical cord stem cell collection, preservation and utilization.
Thirty health professionals were involved in the study. The study results showed that post-test
score (mean: 39.62.57) was higher than that of pre-test score (mean: 13.233.88).It is
concluded that planned teaching programme was effective in enhancing the knowledge of
health professionals regarding umbilical cord stem cell collection, preservation and
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utilisation.21
A study was conducted in Brazil to evaluate bio antioxidants in cryopreservation
of umbilical cord blood using cryo-protectants and low concentrations of dimethylsulphoxide.
Umbilical cord blood was processed and subjected to cryopreservation in solutions containing
different concentrations of dimethylsulphoxide, bioantioxidants and disaccharides. The study
results showed that antioxidants, principally catalase, performed greater preservation of
CD34+ cells, CD123+ cells, colony forming units, and cell viability all post- thawed,
compared with the standard solution of cryopreservation. The study was concluded that the
addition of catalase improved the cryopreservation outcome.22
A study was conducted in New Delhi to assess the knowledge and attitudes of
pregnant women with regard to collection, testing and banking of cord blood stem cells. Data
was collected from 650 pregnant women using questionnaire. The study results showed that
more than half (70%) reported poor or very poor knowledge about cord blood banking. Many
of respondents (68%) thought that physicians should talk to pregnant women about the
collection of cord blood, and they wanted to receive information about this topic from
healthcare professionals or prenatal classes. Most of women would elect to store cord blood
in a public bank and a much smaller portion (14%) would elect private banking. The study
has concluded that most women in this study supported the donation of cord blood to public
cord blood bank for potential transplantation and research.23
A study was conducted in Thailand to evaluate the collection system and
processing of umbilical cord blood donation. A comparison of three cord blood collection
methods, namely, hanging method after delivery of the placenta, aspiration from in-utero
placenta, and the third method is aspiration from in-utero placenta with the help of syringe
assisted aspiration were adopted. The study results showed that the third method was the best
collection method, but it require more trained personnel and involved a complicated
procedure.24
A study was conducted in USA to evaluate the state of the art of unrelated donor
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umbilical cord blood transplantation for the treatment of haematologic malignancies and
discussed the current issues associated with the use of this haematopoetic stem cell source.
The study findings showed that in contrast to the very high transplant-related mortality
associated with early experience of umbilical cord blood transplantation (UCBT), recent
series have been associated with comparable survival to that of human leucocyte antigen-
matched unrelated donor transplantation in children with similarly promising results in adults
with the use of double-unit grafts. In addition, utilisation of reduced intensity conditioning
regimens has been successful extending access to patients unsuitable for myeloablation. It
was concluded that improved transplant outcomes are now making umbilical cord blood
transfusion a rival to unrelated donor transplantation for the treatment of haematologic
malignancies.25
6.3 STATEMENT OF THE PROBLEM:
“A STUDY TO ASSESS THE EFFECTIVENESS OF
PLANNED TEACHING PROGRAMME ON KNOWLEDGE
REGARDING CORD BLOOD BANKING AMONG STAFF
NURSES IN SELECTED HOSPITALS AT BANGALORE”.
6.4 OBJECTIVES OF THE STUDY:
To assess the knowledge of staff nurses regarding cord blood banking.
To determine the effectiveness of planned teaching programme by comparing pre test
and post test knowledge scores.
To find out the association between pre test and post test knowledge scores with
selected demographic variables.
6.5 HYPOTHESIS:
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H1: The mean post test knowledge scores of staff nurses after administration of planned
teaching programme will be significantly higher than their pre test knowledge scores.
H2: There is a significant association between the pre test and post test knowledge
scores of staff nurses with selected demographic variables.
6.6 OPERATIONAL DEFINITIONS:
Assess: It refers to the way of finding the knowledge of the staff nurses regarding cord blood
banking.
Effectiveness: It refers to gain in knowledge scores achieved by staff nurses regarding cord
blood banking after administration of PTP.
Knowledge: Knowledge means the scores obtained through planned teaching programme
on cord blood banking.
Planned Teaching Programme (PTP):It is a formal and specific teaching developed
for staff nurses regarding cord blood banking in the duration of 45 minutes.
Cord Blood Banking: It consists of the collection, processing and cryopreservation of the
remaining blood within the umbilical and placental circulation following the birth of a child.
Staff Nurses: It refers to all registered G.N.M, B.Sc and P.B.B.Sc, qualified professionals
working in selected hospitals, Bangalore.
6.7 ASSUMPTIONS:1. The staff nurses may have some knowledge regarding cord blood bank.
2. Adequate knowledge on cord blood banking improves saving of cord blood.
6.8 DELIMITATIONS:1. A data collection period of 4-6 weeks.
2. A sample size of 50 staff nurses.
3. Staff nurses who are working in selected hospitals at Bangalore, Karnataka.
6.9 PROJECTED OUTCOME:
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7
This study will promote the knowledge of staff nurses regarding cord blood banking.
MATERIALS AND METHODS:
7.1 SOURCE OF DATA:
Data will be collected from staff nurses working in selected hospitals at
Bangalore, Karnataka.
7.1.1RESEARCH DESIGN:
Research design is a blue print for conducting the study that maximizes control
over factors that could interfere with the validity of the findings. A pre experimental one
group pre test and post test design is planned for the research study with manipulation.
7.1.2 RESEARCH APPROACH: The research approach is evaluative.
7.1.3 SETTING:
This study will be conducted in selected hospitals at Bangalore.
7.1.4 POPULATION:
The population for the present study comprises of all staff nurses working in
selected hospitals at Bangalore, Karnataka.
7.1.5 SAMPLE SIZE: The sample size of this study is 50 Staff nurses.
7.1.6 SAMPLING TECHNIQUE: Non probability convenience sampling technique will be used.
7.2 CRITERIA FOR SAMPLE SELECTION:
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7.2.1 INCLUSION CRITERIA: 1. Nurses with professional qualification for G.N.M, B.Sc(N)and P.B.B.Sc.
2. Staff nurses who are willing to participate in the study.
7.2.2 EXCLUSION CRITERIA:
1. Nurses who are in administrative post.
2. Staff nurses who have attending seminar regarding cord blood banking.
7.2.3. INSTRUMENTS INTENDED TO BE USED:
SELECTION OF TOOL:
This consists of two parts
Part 1: consists of demographic variables.
Part 2: questionnaire will be used to assess and reassess the knowledge level.
QUESTIONNAIRE:
1.General information about cord blood banking.
2.Collection,cryopreservation,benefits and methods of cord blood banking.
SCORING PROCEDURE:
For knowledge assessment
If answer is correct-1
If answer is wrong-0
SCORING INTERPRETATION:
Good:- 75-100%
Average:- 50-75%
Poor:- below 50%
7.2.4. DATA COLLECTION METHOD:
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Data will be collected from 50 staff nurses working in selected hospitals at Bangalore by
using structured self administered questionnaire.
7.2.5. DATA ANALYSIS PLAN :
It includes descriptive and inferential statistics.
Descriptive statistics: The descriptive statistics analysis includes percentage,
frequency ,mean, standard deviation.
Inferential statistics: It includes parametric test and non parametric test.
Parametric test: paired t-test
Non parametric test: chi-square test
7.3. HAS THE ETHICAL CLEARANCE BEEN OBTAINED
FROM YOUR INSTITUTION? Yes, ethical clearance will be obtained from the research committee of Nightingale
College of Nursing.
Consent will be taken from the selected hospitals and permission will be obtained
before the collection of data.
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22. .Kumaraswamy S, Muthulakshmi P. Umbilical cord stem cell collection, preservation,
and utilisation. Nightingale Nursing Times 2010 Apr;6:16-17.
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9.SIGNATURE OF THE CANDIDATE
10.REMARKS OF THE GUIDE
11. NAME AND DESIGNATION OF (IN BLOCK LETTERS)
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11.1 GUIDE
11.2 SIGNATURE
11.3 CO-GUIDE
11.4 SIGNATURE
11.5 HEAD OF DEPARTMENT
11.6 SIGNATURE
1212.1 REMARKSOF THE
PRINCIPAL
12.2 SIGNATURE
19