Randomized Control Trial to Assess the Efficacy of Dry Ginger Powder on Management of Nausea and Vomiting Among Antenatal Mothers Attending Selected Urban Health Centres of Belgaum, Karnataka –

One Group Pretest Post Test Pre Experimental Study

Devangamath BG¹ , Raddi SA²

¹Senior Tutor, K.L.E. University’s Institute of Nursing Sciences, Belgaum, Karnataka.

²Professor, K.L.E. University’s Institute of Nursing Sciences, Belgaum, Karnataka.

*Corresponding Author Email: bgdevangamath@gmail.com

ABSTRACT:

“A Randomized Control Trial to assess the efficacy of dry ginger powder on management of nausea and vomiting among antenatal mothers attending selected Urban Health Centres of Belgaum, Karnataka”.

The objectives of the study were to:

1. To assess the severity of nausea and vomiting among experimental and control group of antenatal mothers using modified Rhodes index of Nausea and Vomiting.

2. To assess the efficacy of dry ginger powder in reduction of episodes of nausea and vomiting among antenatal mothers in experimental group as compared to control group.

Methods: Ludwig Von Bertalanffy’s General System Theory was used as a conceptual framework for this study.

The hypothesis formulated for the study was:

H1: The mean post test scores of antenatal mothers in the experimental group will be significantly lower than the mean pre test scores of antenatal mothers in the control group at 0.05% level of significance.

The research approach used for the study was the evaluative approach. The study was conducted using pre treatment and post treatment, randomized control design. The independent variable of the study was application of dry ginger powder and the dependent variable was nausea and vomiting.

Sample size were 60 antenatal mothers of less than 16 weeks of gestation, having complaint of nausea and vomiting (30 in experimental and 30 in control group) and who attended selected Urban Health Centres, Belgaum. Simple random sampling (lottery) method was used. Data was collected by using a modified Rhodes index rating scale and was tabulated and analyzed in terms of objectives of the study, using descriptive and inferential statistics.

Result: The major findings of the study were as follows: The mean difference between the pre and post treatment scores of the experimental group was (11.2) with differential standard deviation of 0.17 and the calculated Paired ‘t’ test between pre treatment and post treatment nausea and vomiting scores 21.88 which is greater than the tabulated value, it showed that there was significant reduction in nausea and vomiting (p<0.00001). The mean difference between the pre and post treatment scores of the control group was 0.8 with differential standard deviation of 0.27 and the calculated Paired ‘t’ test between pre and post treatment scores 8.3 which was greater than the tabulated value, it showed that there was no much reduction in nausea and vomiting. Unpaired ‘t’ test between post treatment scores in experimental group and post test scores in control group showed that there is significant reduction of nausea and vomiting in experimental group compared to control group.(p<0.00001).

The result showed that dry ginger powder is an effective, cost effective and non pharmacological treatment used for reduction in number of episodes of nausea and vomiting among antenatal mothers.

KEYWORDS: Dry Ginger Powder, Nausea and Vomiting, Antenatal Mothers.

INTRODUCTION:

“A baby is something you carry inside you for nine months, in your arms for three years and in your heart till the day you die”.

Mary Maso

During pregnancy physiological changes take place in every system of the body and this physiological adaptation to pregnancy is always underestimated. There are various changes in the body depending on time but these are designed or framed to enable the mother to nurse the fetus and to prepare her body for labour and lactation. This is due to the increased demands of the growing fetus.^1,2.Early pregnancy is manifested by the symptoms of nausea and vomiting.³

Discomforts experienced by women following conception which are not of serious nature, but may become serious if they escalate, nausea and vomiting is one among that which affects 80% of pregnant women.⁴

Nausea and vomiting usually develops by 5-6 weeks of pregnancy. These symptoms are more common during two months of pregnancy and improve by 4-5 months of pregnancy. About 15-20% of all pregnant women experiences nausea and vomiting until the third trimester and 5% of women till the delivery.⁵

Since each pregnancy is unique and degree of these symptoms is different from each other, the effect may be varied due to the nausea and vomiting among pregnant mothers. The severity of nausea and vomiting among 20% of pregnant women increases which is intolerable, and may result in impaired fluid balance, electrolytes, acid based balance, weight loss and nutritional deficiencies during pregnancy. It begins between 8-12 weeks of pregnancy and these symptoms usually disappear by 20^th week. These symptoms affects the health and well being of mother and fetus. Mild cases are treated with simple changes in the life pattern such as nutrition adequate rest and sleep and use of antacids. Severe cases requires hospitalization so that woman can receive intravenous therapy for fluid and nutrition balance.⁶

Reasons of nausea and vomiting of pregnancy is rarely understood. These are due to the mechanical causes such as lower oesophageal pressure, decreased peristalsis movements, gastric emptying during pregnancy.

Various hormonal causes like high levels of human chorionic gonadotrophin (hCG) and estrogen levels. Social and psychological factors also contribute to nausea and vomiting.³

Since ancient period ginger has always been used for the treatment of nausea and vomiting. Ginger scientifically known as “Zingiber officinale” is used as a herbal supplement. Ginger consists of dozens of phytonutrients called gingerols. It has got anti nauseant properties. This helps to suppress gastric contraction and produces the gastrointestinal motility and helps in spontaneous peristalsis due to anticholinergic and antiserotonin action.⁷

Nausea and vomiting is self limiting condition that may be controlled by 4-5 months. If the woman experiences persistent vomiting, it leads to decrease in more fluid volume and causes dehydration⁸. Number of studies have shown that women may suffer not only physically but also psychologically due to nausea and vomiting during pregnancy. Women have made decision to terminate their pregnancy rather than suffering intolerable symptoms.⁹

Delayed emptying of the stomach leads to the increase level of cholecytokinin and cause nausea in pregnancy.¹⁰ Nausea and vomiting may not reduce totally it may require different types of treatment over a period of days and weeks and usually resolves by second trimester.¹¹

Traditionally treatment for nausea and vomiting involves change in the diet pattern a bland low fat diet, dry toast small quantity of food with frequent intervals.⁵ Nausea and vomiting reduces with reassurance, change in the diet pattern, small and frequent meals and avoidance of more amount of fluid intake in the early morning. Adapting the alternative therapies such as Aroma therapy, other interventions included that acupressure, acustimulation, acupuncture, ginger, peppermint vitamin B6, and antiemetic medications have shown to relive symptoms.

Nausea and vomiting are generally common in pregnancy that leads to distress, use of home remedies and herbal therapy is safer. Treatment for this condition is limited due to the fear of potential teratogenic effect.¹²

NEED FOR STUDY:

Every woman is different from each other like wise every pregnancy is unique. During pregnancy each woman experiences one or the other discomforts. During pregnancy there is physiological and emotional changes. These changes are being associated with hormonal and physical changes brought by an enlarging gravid uterus.¹³

In the year 2000-2005, the total fertility rate was 2.7 in the World and 3% in India. Total birth per women in India was reported to be 2.63 in 2010, according to a World Bank report published in 2012.¹⁴ The population rate of India in the year 2011 was 1.21 billion. The population rate of Karnataka in the year 2011 was 61,130,704. The current population rate of India is 1.27 billion. The current population rate of Karnataka is 64,055,400 and the fertility rate is 2.6.¹⁵

According to the center for disease control and prevention (CDC), every year around 4 million women give birth, among this 1/3 of the pregnancies end up with some complications. Sometimes pregnancy is associated with varying degree of nausea and vomiting, which cause distress to mother during pregnancy.¹⁶

Early pregnancy is characterized with the symptoms of nausea, vomiting, intense hunger and vertigo. Nausea is caused by delayed emptying of the stomach; it also occurs due to high levels of production of Cholecytokinin.¹⁰

Nausea and vomiting begins between 4-7 weeks of gestation after the last period of menstruation. These symptoms occur approximately to 80% of pregnant mothers and disappear by 20^th weeks of gestation. Nausea and vomiting are generally mild and self limiting condition that may be controlled by conservative treatment. These symptoms are worse in the morning but it can happen at any time of the day.¹⁷

Management for nausea and vomiting includes reassurance, change in the diet pattern, complementary alternative therapy such as psychotherapy, use of herbal remedies, acupressure and pharmacological therapy.³ In India, home remedial measures are used fortreating minorailments during pregnancy. Ginger is one of the indigenous system of health practice, this herbal remedy are used in the treatment of nausea and vomiting during pregnancy.¹⁶

Pregnancy induced nausea and vomiting can be treated with ginger. Ginger is one of the non pharmacological treatment commonly used as herbal supplement which is reasonable and a safe alternative therapy. It has got anti-nauseant and anti-vomiting agent, and has no dangerous effects on outcome of pregnancy.⁷ Ginger has direct effect on gastrointestinal tract, as it has the properties of aromatic, spasmolytic, carminative and absorbent, no side effects of ginger are shown in the researches. Several clinical researcher have recorded that the dose of 250 mg of ginger consumed 4 times a day for 4 days are more effective to prevent nausea and vomiting.¹⁸

Nausea and vomiting are common in pregnancy, affecting up to 70% to 85% of pregnant women. Pernicious vomiting of pregnancy is a complication of pregnancy that affects various areas of the woman’s health, including homeostasis, electrolytes, kidney function and may have adverse fetal consequences.¹⁹

The condition is not treated in time leads to severe dehydration, muscle wasting, electrolyte imbalance, ketonuria and weight loss of more than 5% of body weight. Malnourished have experienced adverse pregnancy outcomes.²⁰ protection against and relief from nausea and vomiting is necessary. The student investigator selected this topic for research study to maintain well and healthy pregnancy.

STATEMENT OF THE PROBLEM:

A Randomized Control Trial to assess the efficacy of dry ginger powder on management of nausea and vomiting among antenatal mothers attending selected Urban Health Centres of Belgaum, Karnataka.

OBJECTIVES OF THE STUDY:

The objectives are as follows:

1. To assess the severity of nausea and vomiting among experimental and control group of antenatal mothers using modified Rhodes index of Nausea and Vomiting.

2. To assess the efficacy of dry ginger powder in reduction of episodes of nausea and vomiting among antenatal mothers in experimental group as compared to control group.

Assumptions

Dry ginger powder may be effective in reducing nausea and vomiting in antenatal mothers.

Hypothesis

H₁: The mean post test scores of antenatal mothers in the experimental group will be significantly lower than the mean pre test scores of antenatal mothers in the control group at 0.05% level of significance.

Operational Definitions

1. Efficacy: It refers to the ability of an intake of ginger as prescribed to reduce the incidence of nausea and vomiting in pregnant mothers.

2. Morning sickness: It refers to the nausea and vomiting which occurs during first three months of pregnancy.

3. Dry Ginger powder: It refers to dried ginger powder consumed four times a day before food and at bed time by boiling 250mg of dry ginger powder in 250ml of water for 5 minutes each time for four consecutive days.

4. Nausea: It refers to an unpleasant sensation vaguely referred to the epigastrium and abdomen, with a tendency to vomit.

5. Vomiting: It refers to the act or an instance of eject part or all of the stomach contents through the mouth, usually in a series of involuntary spasmic movements.

6. Antenatal mother:

It refers to women who are pregnant and are in the first trimester of pregnancy suffering with nausea and vomiting irrespective of parity

Delimitations:

· Antenatal mothers who are in the first trimester of pregnancy suffering with nausea and vomiting irrespective of parity.

· Antenatal mothers attending the ANC selected Urban Health Centres of Belgaum, Karnataka.

Conceptual frame work

Ludwig Von Bertalanffy’s General System Theory was used as a conceptual framework for this study.

RESEARCH METHODOLOGY:

Research Approach: Evaluative approach approach was adopted in this study.

Research Design: A randomized controlled trial (one group pre test and post test control group design) was adopted to carry out the present study.

Research Setting: The research setting selected for this study was Ramanagar and Ashoknagar Urban Health Centres, Belgaum, Karnataka.

Research Variable: Independent variable- Dry ginger powder, Dependent variable- Nausea and Vomiting.

Population: In the study, antenatal mothers were the population. The accessible population for the present study are those who fulfilled the selection criteria and those who were available in the Ashoknagar and Ramnagar Urban Health Centres.

Sample and Sample Size: The sample for present study were Antenatal Mothers attending selected Urban Health Centres, Belgaum, Karnataka.

and the sample size is comprised for the study was 60 antenatal mothers attending selected Urban Health Centres.

Sampling Technique: The sampling technique used for the study was simple random sampling technique ( by lottery method) 30 in experimental group 30 in control group (15 sample in experimental and 15 sample in control group from each area)

Development and description of tool:

The tool was divided in two parts.

Part I- Comprised of Obstetrical variables

Part II- Modified Rhodes Index

Description of the tool:

As per the expert’s suggestions the final tool consists of

Section I- Obstetrical variables which include:- Age, Gravida, Gestational age in weeks, Religion, Education, Occupation, Parity, Type of family.

Section II- Detail modified Rhodes index to assess nausea and vomiting

Scoring key:

Section I –Obstetrical variables

Section II- 5 points scale with options such as

O	1	2	3	4
Never	Almost Never	Sometimes	Fairly Often	Very Often

To interpret, the scores were categorized as follows:

Score	Severity of Nausea and Vomiting
0 - 12	Normal
13 - 24	Mild
25 -36	Moderate
37 - 48	Severe

Method used for data collection:

The data was collected with formal information and permission of Medical Officer from January 2014- February 2014 at Ashoknagar and Ramnagar, Urban Health Centres.

The steps followed for data collection were as follows:

Step 1: The investigator obtained permission from respective authority to conduct the study.

Step 2: Investigator introduced self to the mothers and explained the and purpose of study to mothers.

Step 3: The written consent was obtained by the Participants.

Step 4: Selection of subjects. (Antenatal Mothers having nausea and vomiting with less than 16 weeks of gestational period).

Step 5: The pre- treatment assessment with modified Rhodes Index scale to assess the severity of nausea and vomiting in antenatal mothers was done.

Step 6: Dry ginger powder was administered to the experimental group at the end of the pre test.

· Consumption of dried ginger powder 4 times a day, before breakfast, lunch, dinner and at bed time by boiling 250mg of dry ginger powder in 250ml of water for 5 minute each time for 4 consecutive days.

Step 7: The post- treatment of the study was carried out after 7 days, using the same tool as that used for pre- treatment with modified Rhodes index scale and effectiveness of severity of nausea and vomiting was assessed in antenatal mothers.

Fig 1

RESULTS:

The major findings of the study were as follows:

Section I: Distribution of sample characteristics according to obstetric variables of respondents

Table 1: Frequency and percentage distribution of subjects according to obstetric variable in experimental and control group. n= 60

Table 3.a: Mean and Standard deviation score of antenatal mothers in experimental group. n=30

Area of analysis	Mean	SD
Pre test	28.1	3.1
Post test	16.9	2.93
Difference	11.2	0.17

Table 3.a: reveal that there is positive outcome in reduction of nausea and vomiting among antenatal mothers of mean, mean percentage, standard deviation scores after administering dry ginger powder in experimental group.

Table 3.b: Mean, and standard deviation, scores of antenatal mothers in control group. n=30

Area of analysis	Mean	SD
Pre test	23.2	4.96
Post test	22.4	4.69
Difference	0.8	0.27

Table 3.b : reveal that there is no much difference in pre test and post test scores of t nausea and vomiting in control group as compared to experimental group. This shows that there is no difference or much difference without administering dry ginger powder in control group.

Testing of hypothesis:

H₁- The mean post test scores of antenatal mothers in the experimental group will be significantly lower than the mean pre test scores of antenatal mothers in the control group at 0.05% level of significance.

Table 4.a: Mean differences, standard error and Paired‘t’ test of severity of nausea and vomiting scores in experimental group.

Mean difference	Standard error	Paired t- test
		Calculated	Tabulated
11.2	2.8	21.88	2.04

(p< 0.05)

Table 4.a: reveal that the calculated paired ‘t’ test (t= 21.88) is greater that tabulated ‘t’ value (t= 2.04). Hence post test nausea and vomiting score was lesser than pre test nausea and vomiting score. Therefore it can be inferred that application of dry ginger powder was effective to improve nausea and vomiting among antenatal mothers.

Hence H₁is accepted.

Table 4.b: Mean differences, standard error and Paired ‘t’ test of severity of nausea and vomiting scores in control group. n=30

Mean difference	Standard error	Paired t- test
		Calculated	Tabulated
0.8	0.5	8.3	2.3

(p< 0.05)

Table 4 b: reveal that the calculated paired ‘t’ test value ( t=8.3) is greater than tabulated ‘t’ value (t=2.3). Hence there was no much difference between pre test and post test scores of nausea and vomiting in pregnancy.

Table 4.c: Standard error and unpaired ‘t’ test value of severity of nausea and vomiting scores between post test scores in experimental and control group. n=60

Standard error	Unpaired ‘t’t test
	Calculated	P value
1.03	5.337 <0.00001

(p<0.05) t (n₁₊n₂) =58

Table 4.c: reveal that p value is less than 0.05 suggesting of significant difference of post test scores between experimental and control group. Hence application of dry ginger powder helped in reduction in severity of nausea and vomiting among antenatal mothers.

Table 5: reveal that mean pre test severity of nausea and vomiting scores in control group was less than the experimental group mean post test score of experimental group was significantly less than the control group. Reduced number of episodes of nausea and vomiting in experimental group, which is significantly less than the control group. which proves that second objectives of research study was achieved.

DISCUSSION:

1. Findings related to sample characteristics in experimental and control group.

2. Findings of pre treatment and post treatment severity of nausea and vomiting scores of antenatal mothers in experimental and control group.

3. Compare the severity of nausea and vomiting scores between post treatment scores in experimental and control group.

1. Findings related to sample characteristics

The study showed that in experimental group, 19 (63.33%) belonged to the age group of 21-25 years, 9 (30 %) belonged to the age group of 26-30 years, 2 (6.7%)belonged to the age group below 20 year. In control group 20 (66.67%) belonged to age group of 21-25 years, 6 (20%) belonged to 26-30 years, 3 (10%) belonged to age group below 20 years, remaining 1 (3.33%) belonged to above 30 years.

The study result on gravida showed that, in experimental group 17 (56.66%) were multigravida and 13(43.33%) were primigravida. In control group 16(53.33%) were multigravida and 14 (46.67%) were primigravida.

In present study, gestational age in weeks findings showed that, in experimental group 16(53.33%) belonged to the 10-12 weeks of gestational period, 10 (33.33%) belonged to the 13-16 weeks of gestational period, 4 (13.33%) belonged to 7-9 weeks of gestation period. In control group 18(60%) belonged to the 10-12 weeks of gestation, 8 (26.7%) belonged to the 13-16 weeks of gestation period and 4 (13.33%) belonged to 7-9 weeks of gestation period.

Present study results on educational status showed that in experimental group 23 (76.67%) belonged to secondary educational status 6 (20%) belonged to higher secondary 1(3.33%) belonged to no formal education. In control group 24 (80%) belonged to secondary education, 5 (16.7%) belonged to higher secondary education and 1 (3.33%) belonged to graduation.

The study result on occupation in experimental group 27(90%) were house-wives, 2(6.67%) were self employee. 1 (3.33%) was government employee. In control group 29 (96.7%) were house-wives, 1(3.33%) was a government employee.

In this study findings in the experimental group, showed that 27 (90%) belonged to joint family, 3 (10%) belonged to nuclear family. In control group 25 (83.33%) belonged to joint family, 4(13.33%) belonged to nuclear family and 1(3.33%) belonged to extended family.

2. Findings of pre treatment and post treatment severity of nausea and vomiting scores of antenatal mothers in experimental and control group

In experimental group the study findings showed that pre treatment scores were 3 (10%) had mild degree of nausea and vomiting, 27 (90%) had moderate degree of nausea and vomiting. After intervention of dry ginger powder post treatment scores were 29 ( 96.67% ) had mild degree of nausea and vomiting, 1(3.33%) had normal degree of nausea and vomiting . In control group pre test scores were 20 (66.67%) were in mild degree, 10 (33.33%) were in moderate degree. In post test scores 23 (76.67%) had mild degree, 7 (23.33%) had moderate degree of nausea and vomiting.

3. Compare the severity of nausea and vomiting scores between post test scores in experimental and control group

Effectiveness of dry ginger powder was assessed by comparing the post test scores of experimental group and control group by using unpaired ‘t’ test the findings showed that the difference between the experimental and control group on severity of nausea and vomiting scores of antenatal mothers was found to be significant at t₅₈= 5.337 at (p<0.05). It showed that there is reduced severity of nausea and vomiting among antenatal mothers in experimental group compared to control group. Hence H₁ was accepted.

CONCLUSION:

Based on the analysis of the findings of the study, the following inferences were drawn. There was a significant reduction in severity of nausea and vomiting among antenatal mothers after distribution of dry ginger powder. Thus it proved to be an effective treatment for nausea and vomiting. Therefore, this intervention should be promoted and implemented as a routine care for all antenatal mothers having nausea and vomiting.

NURSING IMPLICATIONS:

The findings of the study have implication for nursing practice, nursing education, nursing administration, nursing research.

1. Nursing Practice

a. The findings would help the nurse practitioner to develop insight into the importance of health education in their clinical practice in maintaining the health of society.

b. Nurses are in a position to adopt non pharmacological method for safe pregnancy.

c. The modified Rhodes scale can be used as a scale to assess the level of nausea and vomiting among antenatal mothers.

d. It also gives the insight for the nurses to plan and to organise effective treatment for nausea and vomiting among antenatal mothers.

2. Nursing education

a. The study suggests that health teaching should be given prime importance in nursing practice.

b. This study will help to teach the OBG nursing students who are posted in clinical setting on using of modified Rhodes Index Scale.

c. The study will help the nurse educator to know the degree of nausea and vomiting and which will guide her to impart the knowledge. It is assessment and the treatment to the nursing students.

d. It is one of the effective intervention for nausea and vomiting the nurse educator can motivate the student nurses to educate the mothers for early treatment.

e. The tool and findings of the study will provide as a guideline to develop further studies on various non- pharmacological methods to be used in pregnancy period.

3. Nursing administration

a. There is a need for clinical research for improving the nursing services.

b. The finding showed that there is need for continued health education programmes for pregnant mothers.

c. Policies and protocols should be made by the nurse administrators regarding the management of nausea and vomiting with the help of dry ginger powder.

d. The nurse administrator should take initiative to introduce the non – pharmacological methods to antenatal mothers who are less than 16 weeks of gestational period as a routine care by making this an institutional policy.

e. Nurse can provide better management for Antenatal mothers, it will recover fast from the symptoms of nausea and vomiting.

4. Nursing research

a. The findings of the study will provide guidelines for a new nurse researcher to take up similar studies in different settings.

b. Based on research findings future researchers or student nurse can conduct further study.

c. The result of the study can be published in nursing journals.

d. The outcome can be used as evidence based data for revising nursing curriculum, to develop effective non – pharmacological practice. Hence, Dry Ginger Powder for reducing early symptoms can be researched and tested by conducting several clinical trials to establish their effectiveness.

LIMITATION:

1. Generalization of the study could not made due to small size of the sample and limited area of setting.

2. Study is limited to the antenatal mothers who were available at the time of data collection.

3. The study was limited to antenatal mothers who are less than 16 weeks of gestation.

RECOMMENDATIONS:

The following recommendations are offered for further studies.

a. The study can be replicated on a greater sample to validate the findings of the present study.

b. Structured teaching programme can be carried out to evaluate the effectiveness of dry ginger powder on management of nausea and vomiting among antenatal mothers.

c. A comparative study can be done between the effectiveness of Dry Ginger Powder and Lemon.

d. A similar study can be undertaken in different settings.

e. A comparative study can be conducted among antenatal mothers residing at rural and urban area.

f. Similar study can be conducted in other tertiary care centres or states to validate and generalize the findings.

g. A correlational study can be done to identify the socio economic variables related to the problem.

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Received on 09.06.2015 Modified on 26.06.2015

Asian J. Nur. Edu. and Research 6(1): Jan.- Mar.2016; Page 17-26

DOI: 10.5958/2349-2996.2016.00005.7

Group	Pre test	Post test	Decrease	Paired t- test	df	P value
scores
Experimental Group	28.1+_3.10	16.9+_2.93	11.2+_0.17	21.88	29	<0.00001
Control group	23.2+_4.96	22.4+_4.69	0.8+_0.27	8.3	29	<0.00001