RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA. SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION.

1 .

NAME CANDIDATE

OF

THE Ms.ARYA MOHAN D/O MR.K.K.MOHANANATHAPILLAI ATHIRA(H) AZHOOR P.O, PATHANAMTHITTA. KERALA STATE

AND ADDRESS

2 .

NAME

OF

THE M.S.RAMAIAH NURSING RESEARCH.

INSTITUTE

OF AND

INSTITUITION

EDUCATION

M.S.R.I.T. POST,BANGALORE- 54 3 . COURSE OF STUDY AND M.Sc NURSING SUBJECT MEDICAL SURGICAL NURSING DISSERTATION PROTOCOL 4 . 5 . TITLE OF THE ON STUDY: EFFECTIVENESS OF FOOT DATE OF ADMISSION 11/07/2011

REFLEXOLOGY

NAUSEA,VOMITING

AMONG

CANCER

PATIENTS RECEIVING CHEMOTHERAPY

6. BRIEF RESUME OF THE INTENTED WORK

INTRODUCTION: Health is the level of functional and (or) metabolic efficiency of a living being. In humans, it is the general condition of a person in the mind, body and spirit, usually meaning to be free from illness, injury or pain .The World Health Organization (WHO) defined health in its broader sense in 1946 as "a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity1. Illness (sometimes referred to as ill-health or ailment) is a state of poor health. Illness is sometimes considered another word for disease. An impairment of the normal state of a human being that interrupts or modifies its vital functions is known as disease. It includes communicable and non communicable disease1 In India, the life expectancy at birth has steadily risen from 45 years in 1971 to 62 years in 1991, indicating a shift in the demographic profile.1 It is estimated that life expectancy of the Indian population will increase to 70 years by 202125.2 This has caused a paradigm shift in the disease pattern from communicable diseases to non-communicable diseases like cancer, diabetes and hypertension.

Noncommunicable disease, is a medical condition or disease which is non-infectious and are diseases of long duration and include disease ,stroke , cancer , asthma, diabetes, chronic kidney disease. The World Health Organization (WHO) reports NCDs to be by far the leading cause of mortality in the world. Among these, cancer is one of the most common disease.2 According to WHO cancer is the leading cause of death worldwide and total number of case globally is increasing .The impact of cancer is far greater than mere

numbers. Its diagnosis causes immense emotional trauma and its treatment, a major economical burden, especially in a developing country like India. The initial

diagnosis of cancer is perceived by many patients as a grave event, with more than one-third of them suffering from anxiety and depression. Cancer is equally distressing for the family as well. It could greatly affect both the familys daily functioning and economic situation.3 There are four standard methods of treatment for cancer: surgery, chemotherapy, radiation therapy, immunotherapy and biologic therapy.

Chemotherapy is one of the standard methods of treating cancer with an antineoplastic drug. The effects of chemotherapy are good in terms of killing cancer cells and stopping the spreading of the cancer causing cells but there are a few negative effects for chemotherapy treatment. The common side effects of chemotherapy are hair loss, constipation, mouth sores, diarrhea, fatigue, bleeding, vomiting, taste difference, liver damage, loss of appetite.4 Nausea and vomiting remains as one of the most distressing and debilitating adverse effects of chemotherapy despite recent advances in pharmacologic therapy.Chemotherapy-induced emesis continues to negatively affect quality of life and can deter patients from continuing treatment Nausea and vomiting associated with chemotherapy can be acute, delayed, or anticipatory. Chemotherapy-associated emesis is divided into acute (within 24 h of treatment), delayed (occurring more than 24 h after treatment for up to 1 week), and anticipatory emesis which occurs before chemotherapy in patients with poorly controlled emesis from a previous course of chemotherapy. Many cancer patients now opt to complement conventional treatments with alternative therapies that may not only temper the adverse side effects of conventional cancer therapy, but also improve its effectiveness via independent anti3

cancer effects. These include the use of herbal, vitamin, and nutritional supplements, as well as physical and psychological interventions such as exercise, relaxation, massage, prayer, hypnotherapy.5 Massage has been shown to relieve pain and nausea and relax hospitalized patients with cancer. Foot reflexology massage is found to be effective in reducing nausea and relieving nausea, vomiting in cancer patients. Foot reflexology is also extremely safe, simple and effective method. Reflexology is sometimes referred to as zone therapy. The principle of reflexology is founded on the understanding of how the nerves work and what they mean to human body. Feet contain reflex buttons which are connected to all organ and glands. When these reflex centers are stimulated, they instantly send a surge of new vigor to the part of the body they are connected to and with no side effects. Benefits of the reflexology treatment include increased circulation, relaxation and release of tension, nausea, relieve of pain, stiffness, headache, stress, asthma, constipation, sinusitis and migraine.6

6.1. NEED FOR THE STUDY:

Cancer is a generic term for a large group of diseases that can affect any part of the body .According to WHO , Cancer is a leading cause of death worldwide, accounting for 7.6 million deaths (around 13% of all deaths) in 2008 and Lung, stomach, liver, colon and breast cancer cause the most cancer deaths each year. The most frequent types of cancer differ between men and women. It is estimated that about 9 million cancer cases are diagnosed every year and over 4.5 million people die from cancer each year in the world2

. The estimated number of new cancers in India per year is about 7 lakhs. New cases of cancer in the same period are estimated to jump from 11.3 million in 2007 to 15.5 million in 2030. More than half of all cancer cases occur in developing countries. 7 Historically approximately 70-80% of all cancer patient receiving

chemotherapy experiences emesis, there have been dramatic improvements since the introduction of effective antiemetic therapy In last 20 years , several studies

attempted to quantify the burden of chemotherapy side effects on cancer patients , nausea and vomiting trouble are mentioned as major physical side effects and most in pharmacology in

.although there have been recent advancement

prevention of chemotherapy induced nausea and vomiting .Foot reflexology is one of the alternative therapy which is effective on nausea, vomiting in cancer patients receiving chemotherapy.8 A Meta-Analysis study was conducted to assess the effectiveness on FootReflexo-Massage for Cancer Patients. The purpose of the study was to analyze the characteristics and effects of intervention studies on foot-reflexo-massage applied to cancer patients. In the study a total of 159 studies were retrieved from search engines such as RISS, nanet, KISS, richis and Korea Med. 16 studies published from 1990 to 2010 were selected based on the inclusion criteria. The data were analyzed with the RevMan 5.0 program of Cochrane library. The result revealed that the mean score of 1 implement time on foot-reflexo-massage was 25.62 minutes, the average number of days was 4.12 days, and the total number of average intervention frequency was 4.25 times. The effect sizes of the intervention studies showed that higher effect size were in order, anxiety (d=-1.76), fatigue (d=-1.43), depression (d=-1.03), nausea and

vomiting (d=-0.83), pain (d=-0.77), pulse rate (d=-0.61), blood pressure (d=-0.55), and sleep satisfaction (d=0.43). This study suggests that foot-reflexo-massage can increase sleep satisfaction, whereas decreasing blood pressure, pulse rate, anxiety, fatigue, depression, nausea, vomiting and pain.9 6.2. REVIEW OF LITERATURE: Review of literature is the basis of most of the research projects in various sciences and humanities. It forms the foundation upon which all future work will be built. A descriptive study was conducted to assess the expectations of cancer patients regarding treatment related side effects in Bhopal. The sample consisted of 160 newly diagnosed cancer patients who were planning to undergo either chemotherapy or radiotherapy. The samples were selected randomly from the list of OPD patients who had not initiated the therapy. The information obtained through questionnaire. Side effects queried were the most common side effects usually experienced by cancer patients ,i.e. hair loss, vomiting, weight loss, pain, fatigue, sleep problems, depression, burning micturition and mouth ulcer. Each patient was interviewed prior to initiation of the therapy to assess the current symptoms due to cancer itself and expected symptoms regarding treatment related side effects.The result shows that that out of 160 patients, 47.5% were females and 52.5% were males. The study result shown that females expected significantly higher number of side effects than males. Hair loss was the most common side effects (77.5%), pain (59%), sleep problems (59%). The results shows that high number of side effects expected by patients before initiation of therapy, though there was a slight difference in the number of side effects expected by patients based on the different characteristics of
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the patients. The study concluded that most of the cancer patients expect high number of side effects related to cancer treatment.10 An experimental study conducted to assess the effect of foot massage combined with footbath for delayed nausea induced by chemotherapy in Japan. The sample consisted of twenty-eight patients with lung cancer. The perception of nausea was measured on a visual analog scale. The intervention, foot massage was given to samples after a footbath of 7 min from the 3rd day of chemotherapy to the 5th day. An ECG was continuously monitored to find out the variability in heart rate, VAS score was used to measure the nauseating perception. The comparisons were made of immediately before and 30min after the intervention. The result shows that the values of VAS after the intervention was significantly lower than the values of VAS immediately before intervention (day 3: p=.000, day 4: p=.013, day 5: p=.028). The result revealed that 86% of subjects experiencing nausea achieved a reduction in the perception of nausea. All subjects expressed feeling good on the subjective evaluation. The results suggest that foot massage combined with a footbath leads to the relaxation response and improves in the perception of delayed nausea induced by chemotherapy.11

An experimental study conducted to assess the impact of reflexology on cancer patients quality of life. The objective of this study was to determine whether reflexology has an impact on the quality of life of patients in the palliative stage of cancer. The sample consisted of twelve patients in the palliative stage of cancer with various tumor types. The samples were randomized into two groups. Samples were randomly assigned to receive either reflexology or placebo reflexology. Then the quality of life of all patients assessed using a linear analogue self-assessment scale. The experimental group received three sessions of reflexology
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and other group received three sessions of placebo reflexology. Then all participants completed a second linear analogue self-assessment scale relating to quality of life. The result shows that only 33%of the placebo group benefited from an improvement in quality of life compared to 100% of the reflexology group. There was a significant difference (p = 0.004) between the reflexology group and the placebo group. The result revealed that all participants felt that their quality of life had improved, even those who had received the placebo treatment. The reflexology group, however, reported more benefit than the placebo group. The study concluded that reflexology does have an impact on the quality of life of patients in the palliative stage of cancer.12 A quasi-experimental study to assess the effects of foot reflexology on nausea, vomiting and fatigue of breast cancer patients undergoing chemotherapy. : The research design used was quasi-experimental using a nonequivalent pre-post design . The sample consisted of 34 patients with 18 in the experimental group and 16 in control group. , In the study foot reflexology, which was consisted of 4phases for 40 minutes, was given by a researcher and 4 research assistants. for the experimental group . A pretest and 2 posttests were conducted to measure nausea, vomiting and fatigue. The data collected were analyzed by repeated measures ANOVA using the SPSS WIN 10.0program.The result revealed that there was a statistically significant decrease in nausea, and vomiting in the experimental group compared to the control group over two different times. The study concluded that foot reflexology was effective on nausea, vomiting and fatigue in breast cancer patients receiving chemotherapy in this study and therefore it can be usefully utilized as a nursing intervention in the field of cancer nursing for cancer patients receiving chemotherapy.13

A quasi-experimental study conducted to assess the effect of foot massage as a nursing intervention to modify distressing symptoms of pain and nausea in patients hospitalized with cancer in Australia. The sample consisted of 87 patients. The participants were assigned randomly to one of three factor control groups. The subjective symptoms were assessed using visual analog scale. The massage session were given for a duration of 10 minutes (5 minutes per foot).The subjective symptoms were assessed using the same scale. The result shows that

massage treatment reduces feelings of nausea. No significant difference was found between the control session pretest mean score of 18.4+22.5mm and the

corresponding post test mean score of 17.4+20.5mm(t=0.942;p=0.1745) In contrast the mean nausea score for massage session 1 decreased from 17.5 + 24.4 mm to 11.1 + 19.1 mm (t = 3.117; p = 0.0012), a mean difference of 6.4 mm The results revealed that the treatments produced a significant and immediate effect on the patients' perceptions of pain, nausea and relaxation .The study recommended that use of reflexology foot massage as a complementary method is relatively simpler nursing intervention for patients experiencing nausea or pain related to the cancer experience. The results were so positive that the researchers recommend that further research using larger numbers of patients in controlled clinical trials into its effectiveness of reflexology in alleviating pain, nausea and anxiety in the management of these symptoms by the family at home is warranted.14

STATEMENT OF THE PROBLEM

A STUDY TO ASSESS THE EFFECTIVENESS OF FOOT REFLEXIOLOGY ON NAUSEA, VOMITING AMONG CANCER PATIENTS RECEIVING

CHEMOTHERAPY IN SELECTED HOSPITALS OF BANGALORE. 6.3. OBJECTIVES 1. To assess the pretest severity of nausea, vomiting among cancer patients receiving chemotherapy in experimental group and control group. 2. To asses effectiveness of foot reflexology on severity of nausea, vomiting among cancer patients receiving chemotherapy by comparing pretest and post test in experimental group and control group. 3. To compare the effectiveness of foot reflexology on nausea, vomiting among cancer patients receiving chemotherapy by comparing post test scores of experimental group and control group. 4. To find out association between pretest severity of nausea, vomiting and selected socio-demographic variables in experimental group and control group. 6.4. HYPOTHESES H01 - there is no statistically significant difference between pre-test and post test severity of nausea, vomiting in experimental group and control group. H02-there is no statistically significant difference between post test severity of nausea, vomiting in experimental group and control group.

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H03 - there is no statistically significant association between pre-test severity of nausea, vomiting and selected socio demographic variables of both experimental and control group. 6.5. OPERATIONAL DEFINITIONS Effectiveness: refers to the extent to which the foot reflexology reduces the

severity of nausea, vomiting experienced by cancer patients receiving chemotherapy as manifested by reduction in the post-test scores assessed using modified Rhodes index of nausea and vomiting scale. Foot reflexology-. refers to a form of the alternative therapy, that involves

applying focused pressure to reflex points located in the foot, which corresponds to vomiting centre in brain, for a period of 20 minutes(10 minutes for each foot) twice a day for first 3 days of chemotherapy. Nausea, Vomiting-refers to degree of unpleasant feeling in throat or

epigastric region and or forceful expulsion of gastric content through mouth within 24 hours after chemotherapy which is assessed by modified Rhodes index of nausea and vomiting scale. Cancer Patients receiving chemotherapy-refers to person diagnosed to have

a cancer and admitted to the hospital and receiving any cycle of chemotherapy. 6.6. ASSUMPTIONS Cancer patients receiving chemotherapy may experience side effects like

nausea, vomiting

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Foot reflexology may be effective in reducing severity of nausea, vomiting

among the cancer patients receiving chemotherapy. Reduced severity of nausea, vomiting may help the patient to participate in

activities of daily living and improve their quality of life. 6.7. DELIMITATIONS Study is delimited to: Patients receiving chemotherapy admitted in selected hospitals of Bangalore. Four weeks of data collection.

7. MATERIALS AND METHODS:

7.1. SOURCE OF DATA: Cancer patients receiving chemotherapy admitted in selected hospitals of

Bangalore. 7.2. METHODS OF DATA COLLECTION: 7.2.1. Type of study/Research approach: Evaluative approach. 7.2.2. Research design:

Quasi

Experimental

Study,

Non

equivalent pre test post test control group design

7.2.3. Variables: Independent variables: Foot reflexology. Dependent variables: Nausea, Vomiting

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Attribute variables: Socio demographic variables which include age, gender, place of residence, occupation, dietary pattern,(vegetarian or non-vegetarian) educational status, cycle of chemotherapy , type of Cancer, type of Chemotherapy drugs, combination of chemotherapeutic drugs. 7.2.4. Sampling technique: Non probability, purposive sampling technique. 7.2.5. Sample and Sample size: Total 30 patients with cancer undergoing

chemotherapy who fulfil the selection criteria (15 patients in control group and 15 patients in experimental group) 7.2.6. Selection criteria: Inclusion criteria: Patients with cancer undergoing chemotherapy who are available during the period of data collection. are willing to participate in the study. can read, understand and respond either kannada or English.

Exclusion criteria: Patients who are In debilitating condition. with foot ulcer. with fracture leg, joint pain with skin disorders
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7.2.7. Follow up: Post test will be conducted on the 3rd day of chemotherapy after the intervention for both experimental group and control group .

7.2.8. Comparison parameter: pre test and post test severity of nausea, vomiting will be compared with in the group and between the groups. 7.2.9. Duration of the study: One month of data collection. 7.2.10. Tools/Instruments: Section A: Socio demographic variables which include age, gender, place of residence, occupation, dietary pattern,(vegetarian or non-vegetarian) educational status, cycle of chemotherapy , type of Cancer, type of Chemotherapy drugs, combination of chemotherapeutic drugs Section B: Severity of nausea and vomiting assess using modified Rhodes index of nausea and vomiting scale 7.2.11. Data collection procedure: A prior formal permission will be obtained from authority. Informed consent will be obtained from the subject after explaining the

purpose of the study. The pre interventional assessment will be done by using modified Rhodes

index of nausea and vomiting on the first day among cancer patients.
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Foot reflexology will be given to the experimental group for a period of 20

minutes twice a day for first 3 days of chemotherapy. Post interventional assessment will be conducted on the 3 rd day of chemotherapy after the intervention for both groups by using same scale 7.2.12. Plan for statistical analysis: The data obtained will be analysed in terms of the objective of the study using descriptive and inferential statistics. The plan of data analysis is as follows. Descriptive statistics: Frequency and percentage distribution will be used to describe the socio

demographic variables and severity of fatigue. Mean, mean percentage and standard deviation will be used to describe pre-

test and post-test severity of nausea and vomiting. Inferential statistics: Paired t test will be used to describe the pre-test and post test severity of

nausea, vomiting in each group. Studentt test will be used to compare pre-test and post test severity of

nausea, vomiting of experimental group with the control group. Chi-square test will be used to determine association between pre test severity

of nausea, vomiting and selected socio demographic variables. 7.3. Does the study require any investigation or interventions to be conducted on patients or others humans? If so, please descried
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Yes, the Modified Rhodes index of nausea, vomiting scale is used to assess the severity of nausea, vomiting among cancer patients receiving chemotherapy and foot reflexology is provided for the experimental group

7.4. Has ethical clearance been obtained from your institution in case of 7.3? Yes, Ethical clearance will be obtained from the concerned ethical committee and written consent will be taken from the patients. Confidentiality and anonymity of the subjects will be maintained.

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8. LIST OF REFERENCE: 1. Park K. Parks text book of preventive and social medicine. 8 thed .Jabalpur: Banarsidas bhanot; 2005.p.12-30. 2. WHO. Are the numbers of cancer cases increasing or decreasing in the world. [Online].2008[cited 2011 Nov 11]; Available from:URL:http://www.who.int/features
3. Kataki AC. Emerging cancer scenario in the North-east. [Online]. 2010 May 21

[cited 2011 Nov 7 ]; Available from: URL:http://blog.deepsikha.org/?p=30 4. Rewari BB, Gupta S, Agarwal A K . Supportive Care in Oncology.[Online] 2004 sep[cited2011 Nov 11] ];Available from:URL: http://medind.nic.in/jac/t04/i1/jact04i1p38.pdf 5. Chemotherapy -induced nausea and vomiting.[Online].2011Mar 2[cited 2011 Nov 15] Available from: URL:http://www.standardofcare.com/mwiki/index 6. Wilson L. Foot and hand reflexology or channel therapy for healing.[Online] 2010 Sep[cited2011Nov11];Availablefrom:URL:http://www.drlwilson.com/articles/reflexo logy.htm 7. Ramachandra Reddy K. Kidwai memorial institute of oncology :Hospital based cancer registry.[Online].[cited 2011Nov17] Available from: URL:http://kidwai.kar.in/statistics.html 8. Promoting reflexology as a wellness alternative.[Online]. 2009 Aug13 [cited2011 Nov11]; Available from: URl:http://www.reflexology.com/overview.html 9. Kim MY, Oh PJ. Meta-Analysis of the Effectiveness on Foot-Reflexo-Massage for Cancer Patients. J Korean Oncol Nurs[serial online] 2011 Aug [cited 2011 Dec 6];

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11(2): 127-35. Available from:URL:http://www.koreamed.org/search.php RID=0139JKON/2011.11.2.127

10. Tiwari SC,Nandeshwar S, Agarwal V,Dusad A, Gupta M. A study of expectations of cancer patients regarding treatment related side effects in Bhopal. Indian J Community Med [Serial online] 2007 [cited 2011 Dec 6]; 32:6970. Available from: URL:http://www.ijcm.org.in/text.asp2007/32/69/53410 11. Norie N, Yoko A,Yuka H, Mieko N, Setsuko N. The Effect of Relaxation on Foot Massage Combined with Footbath for Delayed Nausea Induced by Chemotherapy. Japanese Journal of Nursing Research.[serial online] 2004 [cited 2011 Nov17] ; 37(6):517-28. Available from :URL: http://sciencelinks.jp/jeast/article/200501.php 12. Hodgson H.Does reflexology impact on cancer patients quality of life. Nurs Stand[Serialonline]2000Apr[cited2011Nov15];14(31):338.Availablfrom: URL:http://www.ncbi.nlm.nih.gov/pubmed/11973949 13. Yang JH. The effects of foot reflexology on nausea, vomiting and fatigue of breast cancer patients undergoing chemotherapy Korean Acad Nurs [serial online] 2005Feb[cited2011Dec7];35(1):Availablefrom: URL:http://www.komi.org/GSResult.php RID=1006JKAN/2005.35.1.177 14. Grealish L, Lomansey A, Whiteman B. Foot massage: A nursing intervention to modify the distressing symptoms of pain and nausea in patients hospitalized with cancer. Cancer Nurs [Serial online] 2000 Jun [cited 2011 Nov 6]; 23(3):237-43. Available from:URL:http://www.ncbi.nlm.nih.gov/pubmed/10851775

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9. 10.

SIGNATURE OF THE CANDIDATE: REMARKS OF THE GUIDE: .

11. 11.1

NAME AND DESIGNATION GUIDE: Mrs. SALOME LECTURER, MEDICAL SURGICAL NURSING

11.2 11.3 11.4 11.5

SIGNATURE: Co-GUIDE(if any): SIGNATURE: HEAD OF THE DEPARTMENT: Mrs. SALOME LECTURER, MEDICAL SURGICAL NURSING

11.6

SIGNATURE:

12.1

REMARKS OF THE PRINCIPAL:

12.2

SIGNATURE:

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