RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGLORE, KARNATAKA

“A STUDY TO ASSESS THE EFFECTIVENESS OF SODIUM BICARBONATE ORAL WASH IN

REDUCING ORAL MUCOSITIS AMONG CANCER PATIENTS IN SELECTED

INSTITUTES OF ONCOLOGY AT MYSORE”

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

Mr. VIKRAM SINGH

I YEAR M.Sc NURSING

MEDICAL SURGICAL NURSING

GOPALA GOWDA SHANTHAVERI MEMORIAL COLLEGE OF NURSUNG

T.N. PURA ROAD, NAZARBAD

MYSORE-570010

KARNATAKA

Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka

PROFORMA SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the Candidate and Address Mr. VIKRAM SINGH,

M.Sc NURSING 1ST YEAR,

GOPALA GOWDA SHANTHAVERI

MEMORIAL COLLEGE OF NURSING,

T.N. PURA ROAD, NAZARBAD,

MYSORE- 570010.

2. Name of the Institution Gopala Gowda Shanthaveri Memorial

College of Nursing.

3. Course of study and subject 1st Year M.Sc Nursing,

Medical Surgical Nursing

4. Date of admission to course 28-06-2012

5. Title of the Topic:

“The Effectiveness Of Sodium Bicarbonate Oral Wash In Reducing Oral Mucositis

Among Cancer Patients.’’

6. Brief resume of the intended work:

6.1 Need for study

6.2 Review of literature

6.3 Objectives of study

6.4 Operational definitions

6.5 Hypotheses of study

6.6 Assumptions

6.7 Delimitations of study

6.8 Pilot study

6.9 Variables

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

Enclosed

7. Materials and methods:

7.1 Source of data: The data will be collected from cancer patients with oral mucositis,

receiving chemotherapy and radiation therapy in selected institutes of oncology at

Mysore.

7.2 Methods of data collection: The data collection procedure will be carried out for a

period of one month. This study will be conducted after obtaining permission from the

concerned authorities. Subject will be selected according to selection criteria of the study.

Consent from the client will be obtained. Oral cavity will be assessed with WHO oral

mucositis scale for both experimental and control group .Sodium bicarbonate oral wash

will be provided twice a day to the experimental group for one week. The effectiveness of

sodium bicarbonate oral wash in reducing oral mucositis will be assessed after one week

in experimental group and will be compared with control group.

7.3 Does the study require any interventions or investigation to the patients or other

human being or animals?

YES, Sodium bicarbonate oral wash to be administered to the cancer patients

with oral mucositis.

7.4 Has ethical clearance been obtained from your institution?

Yes, ethical committee’s report is here with enclosed.

8. List of references Enclosed

Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka

PROFORMA SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the Candidate and Address Mr.VIKRAM SINGH

M.Sc NURSING 1ST YEAR,

GOPALA GOWDA SHANTHAVERI

MEMORIAL COLLEGE OF NURSING,

T.N. PURA ROAD, NAZARBAD,

MYSORE- 570010.

2. Name of the Institution Gopala Gowda Shanthaveri Memorial College

Of Nursing,

3. Course of the study and subject 1st Year M.Sc Nursing,

Medical Surgical Nursing

4. Date of admission to course 28-06-2012

5. Title of the topic:

“The Effectiveness Of Sodium Bicarbonate Oral Wash In Reducing Oral Mucositis

Among Cancer Patients.’’

6. BRIEF RESUME OF THE INTENDED WORK.

INTRODUCTION

“The most important thing in illness is never to lose heart”

~Nikolai Lenin

The World Health Organization defines health as "a state of complete physical, mental, and social well-

being and not merely the absence of disease or infirmity.” The maintenance and promotion of health is achieved

through different combination of physical, mental, and social well-being, together sometimes referred to as the

“health triangle”. Systematic activities to prevent or cure health problems and promote good health in humans

are delivered by health care providers.1

Cancer is an antagonist or aberration of nature, its nearly universal occurrence as a biologic phenomenon

suggests that cancer is among the most common process of nature. Cancer in medical term is called malignant

neoplasm. The word neoplasm is derived from Greek word 'neon' means new and 'plasia' known as moulding

that is a class of diseases in which a group of cells display uncontrolled growth or division beyond the normal

limits invasion, intrusion and destruction of adjacent tissues. These three malignant properties of cancers

differentiate them from benign tumours, which are self-limited and do not invade or metastasize.2

Cancer is a leading cause of disease worldwide 7.6 million People worldwide died from cancer in 2008.

Approximately 70% of cancer deaths occur in low- and middle-income countries.30%of cancers could be prevented. In

India, around 555000 people died of cancer in 2010, according to estimates published in March 28 2012 It is estimated that

about 9 million new cancer cases are diagnosed every year and over 4.5 million people die from cancer each year in the

world. In India the estimated number of new cancers in India per year is about 7 lacks and over 3.5 lacks people die of

cancer each year. Out of these 7 lacks new cancers about 2.3 lacks (33%) cancers are tobacco related. In Karnataka there

would be about 1.5 lakes cancer cases at any given time and about 35,000 new cancer cases are added to this pool each

year.3

Cancer may affect people at all ages, even fetuses, but the risk for most varieties increases with age.

Usually the cancer has three treatment modalities chemotherapy, radiation and surgery. Radiation therapy is

known as a type of palliative therapy. Radiation therapy uses a high energy ionizing radiation; those rays will

destroy the cell's ability to reproduce. Surgery is mainly done for the diagnosis, staging, and treatment. Surgery

plays a good role in rehabilitation and palliation. In some of the cancer condition either one or two modes are

provided. The treatment is mainly to decrease the cell multiplication and further complication. Addition of

advance technologies in these modalities of medical science has its own role towards good prognosis. 4

Chemotherapy is the specific treatment of cancer, where the specific antineoplastic agents are used.

These agents interfere with the cellular function, including replication. It is used primarily to treat the systemic

disease. It may be combined with surgery, radiation therapy, or both. Repeated dose of chemotherapy are

necessary over a prolonged period.5

Cancer chemotherapy is used to destroy rapidly proliferating cells. However, normal cells with high

mitotic indexes are also affected by chemotherapy, particularly those in the oral and gastrointestinal mucosa and

the hemopoietic system. Ultimately, this may lead to certain oral complications of cancer chemotherapy such as

mucositis, infection, haemorrhage, xerostomia, and neurologic and nutritional disorders.6

Prevalence rate of oral mucositis in cancer patients have been estimated up to 40% in patients receiving

standard dose chemotherapy, 90% in head and neck cancer patients subjected to chemo– radiotherapy and 99%

in patients undergoing high dose myeloablative chemotherapy for hematopoietic stem cell transplant. Oral

mucositis is a complex process of biologic phenomena primarily related to the type and dosage of cancer

therapy. Clinically, oral mucositis is usually observed three to five days after initiation of chemotherapy.

Chemotherapy induced oral mucositis reaches peak intensity at 7 -14 days and slowly resolves unless

complicated by infection or repeated drug administration.7

Oral mucositis is defined as an injury of the oral mucosa in cancer patients, either induced by irradiation

of patients who have head and neck cancer, or due to chemotherapy. This has debilitating and painful side-effects

and adversely affects the nutritional status of the patient. Mucositis is associated with an increase in the number

of systemic infections, days in hospital, and overall costs and these aspects have a negative impact on health-

related quality of life (HRQOL). Mucositis was reported to be the most troubling side-effect of cancer therapy by

38% of patients treated with head and neck irradiation and 42% of the patients treated with high-dose

chemotherapy. 7

Mucositis is the main adverse effect of the chemotherapy drug. Mucositis is the painful inflammation

and ulceration of the mucous membranes lining the digestive tract. Oral mucositis refers to the particular

inflammation and ulceration that occurs in the mouth and throat. The discomfort can range from mild to severe.

Mild discomfort is a change in the way the mouth feels. It is easily treated and quickly healed. Moderate

discomfort is considered to be redness and open sores in the mouth. Severe mucositis involves many sores in the

mouth, bleeding, and severe pain. None of these discomfort levels are pleasant. Each can cause other problems

including difficulty in swallowing, talking, eating, and infection. 8

Historically, mucositis was thought to arise as a consequence of direct and indirect toxic effects on

epithelial cells. The colonization of the damaged mucosa by bacteria, fungi, and viruses can superimpose

secondary infections .Furthermore, it was thought that the development of mucositis was facilitated by trauma,

i.e., due to the effects of dentures on the oral mucosa or to oral hygiene habits.9

Latest information of USA reveals that Approximately 400,000 patients per year may develop acute or

chronic oral complications during chemotherapy. Some degree of oral mucositis occurs in approximately 40% of

patients who receive cancer chemotherapy. These high incidences highlight the necessity of treatment of the

mucositis.3

Today, mucositis is recognized as an epithelial and sub epithelial injury and is thought to develop in a

five-stage model: (1) initiation; (2) up-regulation with generation of messengers; (3) signaling and amplification;

(4) ulceration with inflammation; and (5) healing.7

Mucositis has been of interest to scientists for more than 20 years. Unfortunately, this has not resulted in

the development of standard procedures for its prevention and management. To cope with this side-effect and to

prevent opportunistic infections that may emerge during treatment, attempts are taken to provide preventative

and comfort measures. In this context, baking soda (oral rinse) has become a cheap and readily applicable

method in reducing the development or decreasing the severity of oral mucositis caused due cancer treatment. 9

Sodium bicarbonate is basically a chemical compound, which is also often known as baking soda, bread

soda, cooking soda and bicarbonate of soda also nicknamed sodium bicarbonate as sodium bicarb, bicarb soda.

Sometimes it is also simply known as bi-carb. The Latin name for sodium bicarbonate is Saleratus, which means,

'aerated salt'. Sodium bicarbonate is a natural buffer that maintains a healthy pH in mouth to promote a clean and

fresh oral environment.10

Toothpaste containing sodium bicarbonate has in several studies shown to have a better whitening and

plaque removal effect than toothpastes without it. Sodium bicarbonate is also used as an ingredient in some

mouthwashes. It works as a mechanical cleanser on the teeth and gums, neutralizes the production of acid in the

mouth and also acts as an antiseptic to help prevent infections.11

A mouthwash can be prepared by dissolving one teaspoon of sodium bicarbonate in a glass of water.  It is

recommended in patients suffering from mucositis or erosion, due to its ability to increase salivary pH and

suppress the growth of acid uric micro-organisms .Sodium bicarbonate can improve taste and it neutralizes acids

and thus prevents erosion. It is bland and will not irritate the oral mucosa in patients with mucositis .12

The effect of a sodium bicarbonate mouthwash solution is thought to aid in the formation of granulation

tissue and to promote healing. Sodium bicarbonate mouthwash solution is safe and economical and has been

used in cancer patients.  Sodium bicarbonate mouthwash solution gargles cleanses the wounds, reduces swelling,

and can decrease pain. Sodium bicarbonate has also been used as a cleansing agent because of its ability to

dissolve mucus and loosen debris. The combination of salt and sodium bicarbonate raises oral pH and prevents

overgrowth of aciburic bacteria. Sodium bicarbonate mouthwash solution is found to be as effective as other

mouthwash in management of mucositis.11

6.1 NEED FOR THE STUDY:

Cancer is already emerged as major non communicable health problem globally. Cancer is not a single

disease with a single cause; rather it is group of distinct diseases with different causes, manifestation, treatment

and prognosis. Irrespective of the site of the cancer, it is characterized by a number of associated symptoms that

impair the quality of life of patients.13

As per the WHO meeting at Geneva on 3 April 2003 and The World Cancer Report the most

comprehensive global examination of the disease to date stated that Cancer rates could increase by 50% and

15million new cases in the year 2020. However, the report also provides clear evidence that healthy lifestyles

and public health action by governments and health practitioners could stem this trend, and prevent as many as

one third of cancers worldwide. 2

Mucositis is inflammation of the mucosa in the mouth. It occurs as a common side effect of

chemotherapy and radiation treatment. Because cytotoxic therapy targets dividing cells, it is the immune system

and epithelial layers that are most vulnerable, explaining why GI tract disturbance, immunosuppressant and

alopecia are the most obvious and treatment limiting side-effects. In the mouth, killing epithelial progenitor cells

inhibits the ability of the mucosal layer to repair micro lesions, leading to ulceration exacerbated by infection.7

When using cytotoxic chemotherapeutic drugs, it is extremely important to keep patients free from the

oral foci of infection and pain to minimize local infection and bacteremia and to enable them to maintain a

nutritious diet. The chemotherapeutic agents utilized to eradicate tumor production also adversely affect normal

cells, particularly those that have relatively high turnover rates, such as oral epithelial tissues. The depressant

effect of therapy on oral epithelial mitoses can result in thinning and ulceration of the tissues as well as salivary

glands and taste dysfunctions. The oral ulcerations may be due to direct cellular cytotoxicity from the

chemotherapeutic agents, increased susceptibility to micro organisms owing to neutropenia (bone marrow

suppression), trauma, or a combination of these factors. 8

For most cancer treatment, about 5-15% of patients get mucositis. However, with 5-fluorouracil (5-FU),

up to 40% get mucositis, Irinotecan is associated with severe GI mucositis in over 20% of patients. 75-85% of

bone marrow transplantation recipients experience mucositis, of which oral mucositis is the most common and

most debilitating, especially when melphalan is used. 9

Oral mucositis is a frequent adverse effect of cancer chemotherapy and radiotherapy. Fluorouracil,

radiotherapy and conditioning regimens for hematopoietic stem cell grafting often cause severe oral mucositis,

preventing patients from drinking and eating normally. Complication can be attenuated by timely oriental care

such as extraction of damaged teeth, treatment of tooth decay, and care of trauma due to dentures.13

Effective approaches for the prevention or treatment of oral mucositis have not been standardized, and

vary considerably among institutions. Prophylactic measures begin with an increased emphasis on improved oral

status. Oral cryotherapy, the therapeutic administration of cold, is a prophylactic measure for oral inflammation.8

Randomized controlled trials involving about 200 patients at high risk of severe oral mucositis sucking ice

during chemotherapy reduced the incidence of severe oral mucositis, from 14-74% to 4-21%. Other treatments

were no more effective and carry a risk of known or poorly documented adverse effects. Analgesics (especially

morphine) are used to treat intense pain. Local aesthetics have not been tested in patients with damaged oral

mucosa, but they can cause a burning sensation and carry a risk of swallowing disorders due to an aesthesia of

the oropharyngeal junction. In practice, prevention of oral mucositis due to cancer chemotherapy or radiotherapy

is based on orodental care and non pharmacological methods 14

Aggressive cancer therapy places patients at greater risk for oral complications and treatment-related

consequences. Unfortunately, prevention or treatment of such oral squealed has often become overlooked as

priorities of the treatment team.15

Nurses have a critical role in all aspects of managing mucositis, including assessing it, teaching oral care,

administering pharmacologic interventions, and helping patients cope with symptom distress. Mucositis can have

a negative impact on the overall treatment experience, especially when severe pain or infections occur. Many

interventions for managing mucositis exist; however, some are based in tradition or expert opinion and have not

been studied in large, randomized, controlled trials. In addition, a variety of assessment tools are available, which

create confusion and difficulties when comparing interventions across studies. Many reviews provided empirical

evidence related to interventions for oral mucositis. Oral care and rinses, pharmacologic interventions, and other

techniques are evaluated.15

A comparative study was done to test the effectiveness of 3 mouthwashes used to treat chemotherapy-

induced mucositis Three mouthwashes were saltandsoda, chlorhexidine and "magic" mouthwash lidocaine,

Benadryl, and Maalox A randomized, double-blind clinical trial was implemented in 23 outpatient and office

settings. Participants were monitored from the time they developed mucositis until cessation of the signs and

symptoms of mucositis, or until they finished their 12-day supply of mouthwash. All participants followed a

prescribed oral hygiene program and wash were randomly assigned a mouthwash. Nurses used the Oral

Assessment Guide for initial assessment and taught patients how to assess their own mouths, then phoned the

patients ever other day to gather reports, In 142 of 200 patients, there was a cessation of the signs and symptoms

of mucositis within 12 days. The most effective and less cost among the mouthwashes was salt and soda mouth.16

The researcher, during the clinical posting observed that the oral mucositis induced by cancer therapy can

be reduced by the use of sodium bicarbonate oral wash. Hence the researcher was intended to assess the extent of

effectiveness of sodium bicarbonate oral wash in reducing oral mucositis among cancer patient.

6.2 REVIEW OF LITERATURE:

The purpose of   Review of Literature is the identification, selection, critical analysis and reporting of

existing information on the problem chosen for the study. 17

Review of literature helps to know what is already known and helps in developing a broad conceptual

content in to which the research problem will fit in. Main goal is to develop a sound study that will contribute to

further knowledge in development of nursing theory, education, practice and research.17

A comparative study was done to assess the effect of three alcohol-free mouthwashes on radiation-induced

oral mucositis in patients with head and neck malignancies. 80 patients with head and neck malignancies,

scheduled to undergo curative radiotherapy, were randomly assigned to receive one of the three alcohol-free test

mouthwashes (0.12% chlorhexidine, 1% povidone-iodine, or salt/soda) or a control. The patients were instructed

to rinse with 10 ml of the mouthwash, twice a day, for a period of 6 weeks. Mucositis was assessed at baseline

and at weekly intervals during radiation therapy, using the World Health Organization criteria for grading of

mucositis. A post test for repeated measures was used to find the difference of mean mucositis scores between

the groups at various intervals Among the 76 patients who completed the study, patients in the povidone-iodine

or salt/soda group had significantly lower mucositis scores when compared to the control group from the first

week of radiotherapy. Their scores were also significantly lower when compared to the chlorhexidine groups

from the fourth and fifth week respectively, after radiotherapy. This study demonstrates that use of alcohol-free

povidone-iodine or salt/soda mouthwash can reduce the severity and delay the onset of oral mucositis due to

antineoplastic radiotherapy.18

A Randomized clinical trial was done with micronized sucralfate verses salt and soda mouth washes on

oral mucositis, The purpose of this pilot study was to compare the efficacy of micronized sucralfate (Carafate R)

mouthwash and salt & soda mouthwash in terms of the severity of the mucositis, the severity of mucositis-related

pain, and the time required to heal Radiation Therapy -induced mucositis in patients with HNC. All patients in

this randomized clinical trial carried out a systematic oral hygiene protocol called the PRO-SELF: Mouth Aware

(PSMA) Program. Patients who developed Radiation Therapy-induced mucositis anytime during their course of

Radiation Therapy were randomized to one of the two mouthwashes and followed to the completion of Radiation

Therapy and at one month following Radiation Therapy. Thirty patients successfully completed the study.. At the

one-month follow-up assessment no significant differences were found between the mouthwashes in MacDibbs

scores or pain ratings (upon swallowing). The analysis of the efficacy of the two mouthwashes revealed no

significant differences in the time to heal (in days) from the Radiation Therapy -induced mucositis. The findings

from this trial provide important clinical information regarding cost analysis of Radiation Therapy

mucositis management. Given that there is no significant difference in efficacy between micronized sucralfate

and salt & soda, but use of the less costly salt & soda is prudent and cost-effective.19

A study was conducted to investigate whether medicated mouthwashes are effective in the prevention of

oral mucositis among patients undergoing chemotherapy. Randomized controlled trials (RCTs) on the use of

mouthwashes for the treatment oral mucositis in adult participants undergoing chemotherapy were eligible for

inclusion. The severity of mucositis was scored using a World Health Organization (WHO) instrument (or an

adaptation of this scale), The instructions for use ranged from a 20 second rinse twice daily to a one minute rinse

four times daily. The intervention mouthwashes were salt solution with sodium bicarbonate mouthwash without

the active ingredient (chlorhexidine or chamomile), amine-stannous fluoride or water. Two authors

independently performed the study selection. Disagreements were resolved through discussion with a third

reviewer. Chlorhexidine mouthwash was not found to be more effective than control, the results do not support

the use of chlorhexidine mouthwash in the prevention of oral mucositis, and hence the author concluded that the

use of salt solution with sodium bicarbonate rather than chlorhexidine mouthwash for the prevention of oral

mucositis associated with chemotherapy is effective.20

A study was conducted on client to see the effect of baking soda oral rinse in reducing chemotherapy and

radiation therapy induced stomatitis and mucositis The patient presented with a change in his voice, weight loss,

and pain in his throat for two months. Following biopsy, he was diagnosed with infiltrating moderately

differentiated carcinoma of the right tonsil; he was started with treatment, which consisted of chemotherapy and

radiation therapy (40 sessions). He developed mucositis and stomatitis. Identified his pain as a 10+ on the visual

analog scale, and he had extremely thick saliva and xerostomia. Nurse planed (a) rinsing his mouth with baking

soda intrepid water several times a day, (b) using abioadherent oral gel mixed with water every eight hours, and

(c) applying the patient already had been prescribed nystatin to rinse with and expectorate. As the treatment

sessions continued, performance status remained at 90 and his stomatitis scale wavered from 2.0–3.0 (on a scale

from0 = no stomatitis to 4 = tissue necrosis, significant bleeding, and life-threatening consequences).Through the

use of multiple interventions during his therapy, the client was able to reduce his pain, maintain a good

performance status, and maintain his lifestyle without severe changes. .The study concluded that oral rinse with

baking soda are aimed at preventing or minimizing oral mucositis.21

A comparative study was conducted to determine the efficacy of a mouthwash in relieving mucositis-

induced discomfort in patients receiving chemotherapy, (lidocaine, diphenhydramine and sodium bicarbonate in

normal saline mouthwash) when they developed mucositis of any severity. The complications were assessed on

the CALGB (Cancer and Leukaemia Group B) scale. The response to the mouthwash was reported on a self-

assessment scale. Patients' response data were analyzed with reference to: (1) relief throughout the duration of

mucositis and (2) relief during the worst stage (for each episode) of mucositis. The average duration of mucositis

was 7.9 days (range 3–23 days), and the mean duration of the worst stage of mucositis was 4.81 days (range 2–

13 days). The mean mucositis severity score was 1.9 (range 1–4), and the average self-assessment (response)

score was 0.81 (range 0–2). The mean mucositis score during the worst stage of mucositis was 2.25 (range 1–4),

and the average self-assessment (response) score during the worst stage of mucositis was 0.91 (range 0–2.7).

These results suggest that this three-drug mouthwash provides effective symptomatic relief in patients with

chemotherapy-induced oral mucositis.22

A comparative Study was conducted to see the effectiveness of sodium bicarbonate solution with

chlorhexidine mouthwash in oral care of acute leukemia patients under induction chemotherapy. Forty-eight

patients were randomly selected and assigned to a sodium bicarbonate solution group or chlorhexidine based

product group according to acute myelogenous leukemia or acute lymphoblastic leukemia. Patients were asked to

rinse their mouth four times a day from the day before chemotherapy started until discharge. The World Health

Organization mucositis grade, patient-reported Oral Mucositis Daily Questionnaire, and clinical signs associated

with infection were assessed on a daily basis. The onset of oral mucositis was later in the sodium bicarbonate

group than the chlorhexidine group. The oral bacterial colonization in the sodium bicarbonate group was

significantly higher than that in the chlorhexidine group, but clinical signs associated with infection did not differ

in both groups. As a result of this study, it was found that oral care by sodium bicarbonate solution for acute

leukemia patients undergoing chemotherapy was an effective intervention to improve oral health.23

A Study was conducted to see the effect of three test mouthwashes and a control were studied. 0.12%

chlorhexidine, 1% povidone-iodine, Salt/sodium bicarbonate, Plain water (control) Coloring agents, sweeteners,

and flavoring agents were added to the mouthwashes so that all had identical color and taste. All were alcohol

free, 76 completed Compliance was assessed weekly by WHO oral assessment scale .Significant difference in

mean mucositis scores were observed among all four groups. Post hoc analysis for repeated measure showed a

statistically significant difference between the povidone group and control group (p = 0.013) at the end of week

1.At the end of week 2, povidone, chlorhexidine and salt/soda groups differed significantly from the control

group at end of week 4, significant difference also were observed between the povidone and salt/soda groups (p

=0.16). Thus the study concluded that all the 3 mouthwashes were effective in reduction of mucositis.24

6.3 OBJECTIVES OF THE STUDY:

1. To assess the pretest level of oral mucositis among cancer patient in experimental group and control

group.

2. To administer sodium bicarbonate oral wash to the cancer patient in experimental group.

3. To assess the effectiveness of sodium bicarbonate oral wash in reducing oral mucositis in experimental

group.

4. To compare the reduction of oral mucositis between the experimental group and control group.

5. To find out the association between pretest level of oral mucositis and selected demographic variables

like age, gender, food pattern, maintenance of oral hygiene, duration of chemotherapy and duration of

radiation therapy.

6.4 OPERATIONAL DEFINITIONS

1. Assess: It refers to the process of measuring presence of oral mucositis among the cancer patient by

using WHO oral assessment scale.

2. Effectiveness: It refers to the significant reduction in the level of oral mucositis after administration of

sodium bicarbonate as measured by WHO oral assessment scale.

3. Sodium bicarbonate oral wash: It refers to washing oral cavity of the cancer patients with sodium

bicarbonate solution (one tea spoon of sodium bicarbonate in 250 ml of water) twice a day for one week.

4. Oral mucositis: It refers to the presence of redness, swelling, pain and ulceration related to inflammation

of oral Mucosa in the oral cavity.

5. Cancer patients: It refers to the individual diagnosed to have any form of malignancy, receiving

chemotherapy and radiation therapy.

6.5 HYPOTHESES OF THE STUDY:

H1: There is a significant difference between mean pre test level of oral mucositis and mean post test

level of oral mucositis among experimental group.

H2: There is a significant difference between mean post test level of oral mucositis between experimental

and control group.

H3: There is a significant association between pre test level of oral mucositis and selected demographic

variables among experimental and control group.

6.6 ASSUMPTIONS:

Chemotherapy and radiation therapy may cause oral mucositis in cancer patient.

Sodium bicarbonate oral wash may reduce oral mucositis in cancer patient.

6.7 DELIMITATION:

The study is limited to cancer patients with oral mucositis and receiving Chemotherapy and radiation

therapy.

6.8 PILOT STUDY:

The pilot study will be conducted with 20 samples to find out the feasibility for conducting the main

study and plan for statistical analysis.

6.9 VARIABLES:

1. Independent variable: sodium bicarbonate oral wash 2. Dependent variable: reduction of oral mucositis

3. Demographic variables: age, gender, food pattern, maintenance of oral hygiene, duration of

chemotherapy and duration of radiation therapy.

7. MATERIALS AND METHODS:

7.1 SOURCES OF DATA:

The data will be collected from cancer patients with oral mucositis.

7.1.1 RESEARCH DESIGN:

Quasi experimental design

7.1.2 REASEARCH APPROACH:

Evaluative Research Approach

7.1.3 SETTING OF THE STUDY:

The study will be conducted in selected institutes of oncology at Mysore.

7.1.4 POPULATION:

The population of the study consisted of the cancer patients with oral mucositis in selected institutes of

oncology at Mysore.

7.2 METHOD OF DATA COLLECTION:

The data collection procedure will be carried out for a period of one month. This study will be conducted

after obtaining permission from the concerned authorities. Subject will be selected according to selection criteria

of the study. Consent of the client will be obtained. Oral cavity will be assessed with WHO oral mucositis scale

for both experimental and control group. Sodium bicarbonate oral wash will be provided twice a day to the

experimental group for one week. The effectiveness of sodium bicarbonate oral wash in reducing oral mucositis

is assessed after 1 week in experimental group and will be compared with the control group.

Data collection instrument consist of following sections:

Section A: Demographic data.

Section B: WHO oral Mucositis Assessment scale.

7.2.1 SAMPLING TECHNIQE:

Non probability convenient sampling technique

7.2.2 SAMPLE SIZE:

In this study the sample size will be 60 cancer patients with oral mucositis in selected institutes of

oncology at Mysore (30 patients in control group and 30 patients in experimental group).

7.2.3 INCLUSIVE CRITERIA:

Cancer patients who are having oral mucositis and receiving chemotherapy and radiation therapy

Clients who are willing to participate in the study and are available during the time of data collection

7.2.4 EXCLUSIVE CRITERIA:

Clients who had not developed oral mucositis.

Clients who are having oral cancer.

7.2.5 TOOL FOR DATA COLLECTION:

WHO oral mucositis scale,

7.2.6 DATA ANALYSIS METHOD:

Data would be analyzed using descriptive statistics and inferential statistics.

o Descriptive statistics: Frequency, percentage, distribution, mean and standard deviation.

o Inferential statistics: independent ‘t’ test, paired ‘t’ test and chi-square test

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE

CONDUCTED ON PATIENTS OR OTHER HUMAN BEINGS OR ANIMALS?

Yes, sodium bicarbonate oral wash to be administered to the cancer patients.

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN

CASE OF THE ABOVE:

Yes. Formal permission will be obtained from the institutional ethical committee.

8. LIST OF REFERENCE: [VANCOUVER STYLE FOLLOWED]:

1. Health. [Serial online] 2012 [cited 2012 Oct 15]; Available from:

URL: http://en.wikipedia.org/wiki/Health.

2. Lewis, Heitkemper, Dirksen, O Brien, Bucher .Textbook of Medical surgical nursing. 7th ed. South Asia:

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3. WHO. World Cancer Report the major findings .[online] 2003 Apr 3 [cited 2012 Dec 20]; Available

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table-of-evidence.p

9. Signature of the Candidate Mr. Vikram Singh

10. Remarks of the Guide.

11 Name and Designation of

11.1 Guide

11.2 Signature

11.3 Co-Guide

11.4 Signature

11.5 Head of the department

11.6 Signature

Mrs. Latha.S

Mrs. Latha.S

12 12.1.Remarks of the Principal

12.2. Signature.