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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)
RENJITHA S. A.
I YEAR M. Sc. NURSING
DR. M. V. SHETTY COLLEGE OF NURSING
VIDYANAGAR
MANGALORE – 575013.
2.
Name of the Institution
DR. M. V. SHETTY COLLEGE OF NURSING
VIDYANAGAR
MANGALORE – 575013.
3.
Course of Study and Subject
M. Sc. NURSING
OBSTETRICS AND GYNAECOLOGICAL
NURSING
4.
Date of Admission to the Course
15.07.2013
5.
Title of the study
A STUDY TO ASSESS THE EFFECT OF GARLIC PREPARATION
INTAKE
IN
PROMOTION
OF
BREASTFEEDING
AMONG
POSTNATAL MOTHERS IN A SELECTED RURAL COMMUNITY
AREA, AT MANGALORE.
1
6.
Brief resume of the intended work
6.1
Need for the study
Being a mother can be a frightening experience and a wonderful time. The
puerperium covers the 6-week period following birth, during which time the various changes
that occurred during pregnancy revert to the non-pregnant state. Physiological changes during
this time include mainly the lactation changes
Although lactation starts following delivery, the preparation for effective lactation
starts during pregnancy. There will be remarkable growth of both the ductal and
lobuloalveolar systems (mamogenesis). Milk secretion actually starts on 3rd or 4th postpartum
day. Around this time the breast become engorged, tense, tender, and feel warm. When the
oestrogen and progesterone are withdrawn following delivery, prolactin begins its milk
secretory activity in previous fully developed mammary gland. The secretary activity is
enhanced directly or indirectly by growth hormone, thyroxine, glucocorticoids and insulin
(lactogenesis). Discharge of milk from the mammary gland depends not only on the
contractile mechanism which expresses the milk from the alveoli in to the ducts
(galactokinesis). Prolactin appears to be the single most important galactopoietic hormone.
For maintenance of effective and continuous lactation, suckling is essential. It is not only
essential for the removal of milk from the glands, but it also cause the release of prolactin
(galactopoiesis).1
A healthy mother will produce about 500-800 ml milk a day to feed her infant with
about 500 KCal/day. This requires about 600 Kal/day for the mother which must be made up
from the mother’s diet or from her body store.1
Milk, in the form of colostrum, is present from about the fourth month of pregnancy
onward. At birth, the delivery of the placenta triggers a reduction in the woman’s
progesterone level that removes the inhibition of milk production and allows the elevated
levels of prolactin to function. Increased amounts of blood and lymph in the breast form the
nutrient for the milk production. These fluids cause the breast to become fuller, heavier, and
sometimes tender. As regular frequent breastfeeding progress, this normal fullness
diminishes. By about two week postpartum, when lactation is well established, the breast
2
become comfortably soft and pliable, even when they are full with milk. Regular, frequent
feeding will maintain this condition.2
Breastfeeding Promotion Network of India (BPNI) 2002, says, infants aged 0-5
months who are not breastfed have seven fold and five fold increased risk of death from
diarrhoea compared with infants who are exclusively breastfeed. At the same age, non
exclusive breastfeeding results in more than two fold increased risk of dying from diarrhoea.
Infants aged 6-11 months who are not breastfed also have been an increased risk of such
deaths.3
A UNICEF (2007) report states that India has close to 2.5 million children born every
year, out of these, 1.9 million are under-five, who die in a year. Among the decreased
children, 1.4 million children die just within one year and roughly one million children die
with in a month. Most of these deaths are associated with infant and young child malnutrition
and other preventable disease caused mainly due to poor care and inappropriate infant feeding
practices. Only 23.4 % newborn across the country begins breastfeeding within a hour of
birth. Early initiation of breastfeeding practices provides quality health care for children and
reduces their specific health problems. WHO also recommends for optimal infant feeding
practices to fight against malnutrition and promote child survival.4
A comparative study was conducted to determine the causative factors responsible for
failure of Breastfeeding in post-partum women in Military Hospital Rawalpindi in Pakistan.
Fifty patients at post-natal gynaec ward were attended in the study. Patients were divided into
two groups of 25 each. Those patients who were exclusively breastfeeding their babies were
included in group-II while group-I included those patients who were not breastfeeding their
babies at all. Patient’s demographic data was entered on questionnaire and factors. The most
important causative factor responsible for failure of breastfeeding in group-I were noted
down. The mothers in group-II were enquired about that problem. Data was analyzed by
using computer software program SPSS version 11. The study shown that as compared to
group-II causative factors involved in failure of lactation in group-I were pain at operated site
10, insufficient milk production 9, breast abscess 4 and failure of proper counseling.5
A study was conducted in relationship between maternal perception of insufficient
milk and breastfeeding confidence using the breastfeeding self efficacy scale. Two hundred
3
and sixty-two mothers were the sample and the data has collected using a structured
questionnaire. The findings of the study showed that although most mothers intended to
exclusively breastfeed, less than 40% were doing so at 4 weeks of postpartum. Among the
mothers using formula, 73% cited perceived insufficient milk as the primary reason for
supplementation or completing discontinuing breastfeeding. Mothers’ perception of
insufficient milk at 4 weeks postpartum was significantly related to breastfeeding selfefficacy in hospital in the immediate postpartum period (‘r’ value is 0.45 and p <0.001.) The
study revealed that breastfeeding self efficacy explained 21% of the variance in maternal
perceptions of insufficient milk and the contribution was independent of socioeconomic
variables.6
Besides the influence of medication on breast milk, mothers often are concerned about
an inadequate quantity of breast milk. Many patients will attempt to increase the quantity of
breast milk production by taking herbs and foods called galactogogues. These substances
increase milk supply, usually by increasing prolactin to initiate the breast milk let-down
reflex or oxytocin to aid in breast milk ejection. Commonly used galactogogues include
blessed thistle, chaste tree fruit, fennel, fenugreek, garlic, goat's rue, and thistles. Categorized
as major galactogogues, they are the primary herbs used as galactogogues and are commonly
used alone.7
A subsequent study confirmed that infants attached to the breast longer than usual
when their mothers started taking garlic. Garlic has been used as a galactogogue in India.
Garlic's odour is transmitted to breast milk, which may increase infant sucking time acutely
and might enhance the breastfed infant's food choices in the long term. Garlic has a long
history of use as a food and medicine and is "generally recognized as safe" (GRAS) as a food
flavouring by the US Food and Drug Administration, including during lactation. Limited
scientific data found that a few days of oral garlic supplementation caused no adverse effects
in nursing mothers or infants. From these findings the investigator felt the need for selecting
the present study.
4
6.2
Review of literature
Human milk is not just a complex mixture of substances that best meets the nutritional
requirements of the infant. It is a food that varies in flavour because selected volatiles from
the mother's diet are transmitted to her milk. Like the milk of other mammals, the flavour of
human milk is altered when lactating women eat sulphur-containing foods such as garlic.
When human milk is flavoured with garlic, the infants breast-feed longer and suck more
overall than they do when this flavour is absent, at least under conditions in which the
mothers have been ingesting bland diets for several days.8
The study was conducted using a self-administered questionnaire validated through
two pilot studies. Participants were 18 years or older, breastfeeding or had breastfed in the
past 12 months. Participants were recruited from various community and health centres, and
through advertising in newspapers. Simple descriptive statistics were used to summarise the
demographic profile and attitudes of respondents, using the SPSS statistical software. A total
of 304 questionnaires from eligible participants were returned (27.2% response rate) and
analysed. Amongst the respondents, 59.9% took at least one herb for medicinal purposes
during breastfeeding, whilst 24.3% reported the use of at least one herb to increase breast
milk supply. Most commonly used herbs were fenugreek (18.4%), ginger (11.8%), dong
quasi (7.9%), chamomile (7.2%), garlic (6.6%), and blessed thistle (5.9%). The majority of
participants (70.1%) believed that there was a lack of information resources, whilst 43.4%
perceived herbal medicines to be safer than conventional medicines. Only 28.6% of users
notified their doctor of their decision to use herbal medicine(s) during breastfeeding; 71.6%
had previously refused or avoided conventional medicine treatments due to concerns
regarding safety of their breastfed infants8.
The study investigated whether prior consumption of garlic by nursing mothers
modifies their infant's behaviours during breast-feeding when the mothers again consume
garlic. Three groups of mother-infant dyads were studied. The groups differed in the type
(placebo or garlic) or the timing of capsule ingestion by the mothers and, consequently, in the
amount and recency of exposure their infants had to garlic-flavoured milk during an
experimental period. Each mother-infant pair was observed during two 4-h test sessions. The
first session occurred at the beginning of the experimental period, when the mothers ingested
5
placebo capsules; the second occurred at the end of the experimental period, when they
ingested garlic capsules . During test sessions, the infants fed on demand and were weighed
before and after each breast-feeding to determine the amount of milk ingested, and their
behaviours during breast-feeding were monitored by videotape. The results demonstrated an
effect of prior experience with garlic in mother's milk. The infants who had no exposure to
garlic volatiles in their mothers' milk during the experimental period spent significantly more
time breastfeeding after their mothers ingested garlic capsules compared with those infants
whose mothers repeatedly consumed garlic during the experimental period. Moreover, the
former group of infants spent significantly more time attached to their mothers' breasts during
the 4-h test session in which their mothers ingested the garlic compared with the session in
which she ingested the placebo.9
A study randomized nursing mothers to receive garlic capsules or placebo for 3 days
before testing with a single capsule as in the study above. Infants who received garlic in the
milk for the first time spent 30% more time nursing than after placebo. Infants who had been
previously exposed to garlic in milk did not spend more time nursing after subsequent garlic
exposure in milk. The authors interpreted the results of these studies as having a positive
effect on infants' later food choices (i.e., being less "picky" about foods).8
In two studies conducted by the same investigators, capsules containing 1.5 g of garlic
extract were given to nursing mothers. In the first experiment, 8 mothers receive a garlic
capsule or placebo once daily in a crossover fashion. Garlic-naive infants whose mothers
ingested garlic capsules spent more time (33 v/s 27 minutes) attached to the nipple during the
time period of 1.5 to 3 hours after garlic ingestion when garlic odour in milk was maximal
than in those whose mothers received a placebo; however, total number of nursing or total
amount of milk ingestion did not differ between groups.10
In 1994 study in lactating mice evaluated the effects on xenobiotic metabolizing
enzymes in mouse pups from garlic administered to the mother. The lactating mice received
either 200 or 400 mg/kg of crushed fresh garlic diluted in a volume of 0.1 mL of water for 14
or 21 days postpartum. Significant hepatic enzyme changes were measured in both the dams
and pups, but the clinical significance of the changes is unknown.8
6
A study published in 1991 examining the effect of garlic on the odour of breast milk
and the nursling's behaviour. Eight women, all exclusively breast-feeding their 3- to 4-month
old infants, were the subject. None of the women was a regular user of garlic and their
consumption of other sulphur-containing foods was limited before and during the study. In
addition to breastfeeding, milk samples were also collected from the women every hour for 4
hours. They were given either placebo or garlic (1.5 g of garlic extract) capsules on alternate
days. A sensory panel of 11 judges, all screened for normal olfactory function, were able to
consistently detect the odour of garlic from paired samples of expressed milk (treated and
untreated) with a peak effect at 2 hours. It also appeared that the nursing infants detected the
garlic odour because when the mother had ingested garlic capsules, the infants attached to the
breast for significantly longer periods of time and sucked more. Although not significant, the
infants also tended to consume more milk, but consumption may have been limited by the
amount of milk available to the infant.8
Forty women who complained of an insufficient milk supply at 5 days postpartum
were given a combination herbal supplement as 2 capsules of Lactare 3 times daily. Each
capsule contained wild asparagus 200 mg, ashwagandha (Withania somnifera) 100 mg,
fenugreek 50 mg, licorice 50 mg, and garlic 20 mg. By day 4 of therapy, no infants required
supplementary feeding. Infants were weighed before and after each feeding on the fifth day of
maternal therapy to determine the amount of milk ingested. On the day of the test weighing,
infants' milk intake averaged 388 ml, and the fluid and caloric intake was considered
adequate.8
Mothers given placebo or 1.5 g of garlic in capsules once daily extracted about 20 ml
of breast milk every hour for 4 hours after garlic ingestion. A panel of 11 men and women
who were blinded to maternal product ingestion rated the perceived odour of garlic in each
sample. Garlic odour was most strongly perceived at 2 hours after maternal garlic ingestion.
The odour remained equally perceptible at 3 hours after ingestion in some mothers' milk.8
The study was conducted using a self-administered questionnaire validated through
two pilot studies. Participants were 18 years or older, breastfeeding or had breastfed in the
past 12 months. Participants were recruited from various community and health centres, and
through advertising in newspapers. Simple descriptive statistics were used to summarise the
7
demographic profile and attitudes of respondents, using the SPSS statistical software. A total
of 304 questionnaires from eligible participants were returned (27.2% response rate) and
analysed. Amongst the respondents, 59.9% took at least one herb for medicinal purposes
during breastfeeding, whilst 24.3% reported the use of at least one herb to increase breast
milk supply. Most commonly used herbs were fenugreek (18.4%), ginger (11.8%), dong
quasi (7.9%), chamomile (7.2%), garlic (6.6%) and blessed thistle (5.9%). The majority of
participants (70.1%) believed that there was a lack of information resources, whilst 43.4%
perceived herbal medicines to be safer than conventional medicines. Only 28.6% of users
notified their doctor of their decision to use herbal medicines during breastfeeding; 71.6%
had previously refused or avoided conventional medicine treatments due to concerns
regarding safety of their breastfed infants11.
This study was to evaluate whether consumption of maternal herbal tea containing
fenugreek had any effects on breast milk production and infants' weight gain pattern in the
early postnatal period. Sixty-six (66) mother-infant pairs were randomly assigned to 3 groups.
Group 1 (n=22) consisted of mothers who were receiving herbal tea containing fenugreek
every day. Group 2 (n=22) and group 3 (n=22) were assigned as placebo and controls,
respectively. Birth weight, loss of birth weight, time of regain of birth weight, amount of
breast milk assessed on the third day after delivery were determined. Maximum weight loss
was significantly lower in infants in group 1 compared to both the placebo and control groups
(p<0.05). Infants in group 1 regained their birth weight earlier than those in control and
placebo groups (p<0.05). The mean measured breast milk volume of the mothers who
received galactagogue tea was significantly higher than the placebo and control groups
(p<0.05). Maternal galactagogue herbal tea supplementation seems to be useful for enhancing
breast milk production and facilitating infant birth weight regain in early postnatal days.12
6.3
Statement of the problem
A study to assess the effect of garlic preparation intake in promotion of breastfeeding
among postnatal mothers in a selected rural community area, at Mangalore.
8
6.4
Objectives of the study

To assess the level of breastfeeding promotion among postnatal mothers using
structured interview schedule in experimental and control group.

To assess the effectiveness of garlic preparation intake in promotion of breastfeeding
among postnatal mothers.

To find out the association between pre-test scores of level of breastfeeding and
selected variables among postnatal mothers.
6.5
Operational definitions
1.
Effect: Extent to which the garlic preparation will enhance the breast milk and in
returns which promotes breastfeeding as evidenced by structured interview schedule.
2.
Garlic preparation: It is a homemade preparation of garlic in which 4-6 cloves of
garlic are mixed with salt as per taste and chilly are ground together and this mixture
is served with rice, for 2 times daily for 1 week.
3.
Postnatal mother: In this study it refers a woman who have delivered a live baby and
who is residing a selected community area.
4.
Promoting breastfeeding: In this study it refers to successive encouragement of
feeding the baby with milk directly and adequately from mother’s breast.
6.6
Assumptions
1.
Use of garlic preparation may promote the breastfeeding among postnatal mothers.
2.
Promotion of breastfeeding could be assessed by structured interview schedule.
6.7
Hypotheses
The hypothesis will be selected at 0.05 level of significance.
H1:
There will be significant difference in the pre-test and post test score of level of
breastfeeding production among postnatal mother who consume garlic preparation.
H2:
There will be significant difference between level of breastfeeding among
experimental and control group.
9
H3:
There will be significant association between pre-test level of breastfeeding among
postnatal mothers and selected baseline variable.
6.8
Variables
Independent variables: Use of garlic preparation.
Dependent variables: Breastfeeding among postnatal mothers.
6.9
Delimitations of the study
Present study is delimited to:

7.
This study is limited to breastfeeding postnatal mothers in a selected community area.
Material and methods
7.1
Source of data
The data will be collected from the postnatal mothers in selected community area at
Mangalore.
7.1.1 Research design
Research design adopted for the study is quasi experimental design.
Phase I
Phase II
Phase III
Phase IV
Pre-test (O1)
Treatment (R)
Post-test (O2)
Effectiveness (E)
Experimental
group
Assessment of
level of
breastfeeding
using structured
interview
schedule
Administration
of garlic
preparation.
Assessment by
using
structured
interview
schedule.
Control group
Assessment of
level of
breastfeeding by
using structured
interview
schedule
No treatment
Assessment by
using
structured
interview
schedule.
Sample
E=O2-O1
10
7.1.2 Setting
The study will be conducted in selected community area at Mangalore.
7.1.3 Population
Postnatal mothers who expresses insufficient milk production.
7.2
Method of data collection
7.2.1 Sampling procedure
The purposive sampling technique will be used to collect data from the available
group falling under inclusive criteria.
7.2.2 Sample size
In this study, the sample will comprise 30 postnatal mothers from the selected
maternity hospital, Mangalore. Of the 30 postnatal mothers, 15 each will be randomly
assigned to the experimental group and the control group.
7.2.3 Inclusion criteria for sampling
Women who are:

Lactating and have dissatisfaction with breastfeeding.

Willing to participate in the study.

Available at the time of data collection.
7.2.4 Exclusion criteria for sampling
Mother who are

On breast milk enhancement drugs

Not interested to participate in the study.
11

Contraindicated for breastfeeding (HIV, Stillborn).

Mother who are having breast problem (mastitis, breast cancer).
7.2.5 Instruments intended to be used
Two instruments are intended to be used in this study.

Baseline profoma

Structured interview schedule.
7.2.6 Data collection method
Step 1: Prior to the data collection, permission will be obtained from the concerned authority
for conducting the study.
Step 2: Subjects will be selected according to the selected criteria and confidentiality will be
assured.
Step 3: Written consent will be obtained from the subjects.
Step 4: The investigator will collect the baseline proforma and assess the level of
breastfeeding.
Step 5: Experimental group will be encouraged to consume garlic preparation from Day 1
twice a day for one week.
Step 6: The investigator will check the post-test level of breastfeeding among postnatal
mothers in the experimental group and control after the intervention of garlic preparation.
Step 7: Reassess the level of breastfeeding.
Step 8: Prepare the data for analysis.
7.2.7 Plan for data analysis
Data will be analyzed using descriptive and inferential statistical and findings will be
presented in the form of tables and figures.
12
7.3
Does the study require any investigations or interventions to be conducted on
patients, or other animals? If so please describe briefly.
Yes, because the researcher is assessing the effect of garlic preparation in postnatal
mothers by promotion of breastfeeding.
7.4.
Has ethical consideration been obtained from the institution in case of the above?
Permission will be obtained from the institutional ethical research committee of Dr. M. V.
Shetty College of nursing, Mangalore.
Permission will be obtained from authorities of selected community area at, Mangalore.
Informed consent will be obtained from women, who are willing to participate in the study.
13
8.
References
1.
Datta DC. Textbook of obstetrics. 5th ed,New central book agency publishers.
2004,P:149-50.
2.
Lauwers J, Swisher A. Counselling the nursing mother. 4th ed..Jones and bartlett
publishers 2005.P:279.
3.
Gupta A. Breastfeeding and complementary feeding.2nd ed. Delhi: BPNI
Publications; 2001.page no: 207-216
4.
UNICEF. Nursing Times.[online] 2007 Aug [cited 2013 oct 24]Available from: URL:
http://www.unicef.org/jamaica/media_15153.htm
5.
Chan SM, Nelson EA, Leung BS. Breastfeeding in a longitudinal post partum
maternal nutrition study. Journal of Hong Kong Paediatrics 2000 Oct;36(5):466-71.
6.
Otsuka K, Dennis CL, Tatsuoka H, Jimba M. The relationship between breastfeeding
self-efficacy and perceived insufficient milk among Japanese mothers [online] 2008
Sep- Oct [Citied 2013 Oct 20];
AvailableFrom:URL:http://www.ncbi.nlm.nih.gov/pubmed/18811774
7.
Nice FJ, Luo AC. Medications and breastfeeding, current concepts. Am Pharm Assoc
[online]2012 [Cited 2013 oct 20];52(1):86-94:available from:URL: http://www.
medscape.com/viewarticle/757147
8.
Mennella JA, Beauchamp GK. The effects of repeated exposure to garlic flavoured
milk on the nursling's behaviour. Monell Chemical Senses Center,
Philadelphia.[online] 1993.[cited 2013 oct 5]: Available from:
URL:www.ncbi.nlm.nih.gov/pubmed/8108198.
9.
Sholapurkar ML. 'Lactare' for improving lactation. Indian Pract.[online] 1986;[cited
2013 0ct 20]39:1023-6.Available from:URLhttp://www. drugs.com/ breastfeeding/
wild-asparagus.html.
10.
Robbers JE, Tyler VE. Tyler’s Herbs of choice. The therapeutic use of
phytomedicinals. Bighamton, NY: Haworth Press; [online]2000[cited 2013 oct 24]. P.
14
1327.Available
from:
http://www.amazon.com/Tylers-Herbs-Choice-Therapeutic-
Phytomedicinals/dp/0789028093
11.
Sim TF, Sherriff J, Hattingh HL, Parsons R, Tee LB. The use of herbal medicines
during breastfeeding: a population-based survey in Western Australia. BMC
Complement Altern Med [online]2013 Nov 13;[cited oct 23]13(1):317Available from:
URL:http://www.ncbi.nlm.nih.gov/pubmed/
12.
Turkyılmaz C, Onal E, Hirfanoglu IM, Turan O, Koç E, Ergenekon E, Atalay Y. The
effect of galactagogue herbal tea on breast milk production and short-term catch-up of
birth weight in the first week of life. J Altern Complement Med [online]2011
Feb;[cited 2013 oct23]17(2):139-42.Available from
URL:http://WWW.gaiaskinnaturals.com/skin1/docs/the_natural_alternative_aug_11.p
df.
15
9.
Signature of the candidate
10.
Remarks of the guide
11.
Name and designation of (in block letters)
11.1 Guide
The study is feasible and it will be helpful in
establishing healthy motherhood and infancy.
MRS. REKHA S. GHODAGERI
HOD, OBSTETRICS AND
GYNAECOLOGICAL NURSING,
DR. M. V. SHETTY COLLEGE OF NURSING,
KAVOOR.VIDYANAGAR
MANGALORE -575 013.
11.2 Signature
11.3 Co-guide (if any)
11.4 Signature
12
12.1 Head of the department
MRS. REKHA S. GHODAGERI
HOD, OBSTETRICS AND
GYNAECOLOGICAL NURSING,
DR. M. V. SHETTY COLLEGE OF NURSING,
KAVOOR.VIDYANAGAR
MANGALORE -575 013.
12.2 Signature
13.
13.1
Remarks of the Chairman and Principal
13.2
Signature
16
17
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