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1 SYNOPSIS PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION Miss. SHAMNA. C.K FIRST YEAR M.SC (NURSING) MEDICAL SURGICAL NURSING YEAR 2012-2014 THE KARNATAKA COLLEGE OF NURSING KOGILU MAIN ROAD, YELAHANKA BANGALORE – 560 064 2 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1. 2. 3. 4. 5. Miss. SHAMNA.C.K NAME OF THE CANDIDATE 1ST YEAR M. Sc (NURSING) ADITYA COLLEGE OF AND ADDRESS NURSING, KOGILU MAIN ROAD, YELAHANKA, BANGALORE – 560 064 ADITYA COLLEGE OF NAME OF THE INSTITUTION NURSING, BANGALORE-560064 COURSE OF THE STUDY AND 1ST YEAR M. Sc (NURSING), MEDICAL SURGICAL SUBJECT NURSING DATE OF ADMISSION TO THE 30-06-2012 COURSE “A STUDY TO ASSESS THE EFFECTIVENESS OF FOOT TITLE OF THE STUDY MASSAGE ON REDUCTION OF THE PAIN IN PATIENTS WITH BONE CANCER IN SELECTED HOSPITALS AT BANGALORE.” 3 6. BRIEF RESUME OF THE INTENDED WORK “Time is generally the best doctor” - (Ovid) INTRODUCTION Cancer is a disorder in which differentiated body cells undergo changes at the molecular level resulting in loss of normal cell regulation, characteristics and functions. Development of cancer is an orderly process comprising stages like initiation, promotion and progression. Causes of cancer may be genetic, radiation, chemical or viral in nature.1 It is estimated that 8 million people from around the globe will die from cancer in 2009. While pain can occur at any point during the course of the disease, in general the more advanced the cancer, the more likely it is that the patient will experience significant pain. Although bone is not a vital organ, many common tumors (of the breast, prostate, thyroid, kidney, and lung) have a strong predilection to metastasize to multiple bones at the same time. Tumor growth in bone results in pain, hypercalcemia, anemia, increased susceptibility to infection, skeletal fractures, compression of the spinal cord, spinal instability, and decreased mobility, all of which compromise the patient’s functional status, quality of life, and survival. Once tumor cells have metastasized to the skeleton, the “ongoing” tumor-induced bone pain is usually described as dull in character, constant in presentation, and gradually increasing in intensity with time.2 Bone cancer is one of the most serious forms of pain. Because of its severity and uniqueness with respect to other forms of pain, it is extensively researched. According to studies of bone cancer in mouse femur models, it has been determined that bone pain related to cancer occurs as a result of destruction of bone tissue. Chemical changes that 4 occur within the spinal cord as a result of bone destruction give further insight into the mechanism of bone pain.3 There are many ways to relieve pain, from drugs to surgery to acupuncture. Treatments vary from individual to individual, depending on the type and severity of pain, risk factors involved with using a particular treatment, and personal preference. Opioids, a common treatment for pain, can lead to dependence, addiction and tolerance. Pain is often under treated. Some of the most common treatments are analgesic drug therapy ,non-opioid analgesics, opioid analgesics, adjuvant drugs, WHO three-step analgesic ladder, psychotherapy ,anesthetic and neurosurgical pain management , neuro stimulatory procedures, acupuncture ,diathermy and cryotherapy, therapeutic exercise and massage and behavioral methods of pain control(Oncology channel.com).4 Foot massage is a complimentary therapy that has great potential for use by nurse in a multidisciplinary pain management programme. Foot massage is the process of gentle but firm manipulation of feet to stimulate specific reflex points of the body. This is based on the principle that there are reflexes running along the body which terminate in the feet and the hands, and that the body’s organs and systems are reflected onto the surface of the skin (Norman and Cowman 1989). Massage acts like an analgesic and inhibits those pain signals from being transmitted to the brain. It is also thought that massage helps the body to release endorphins. Grealish recommended the use of foot massage as a complementary therapy and as a relatively simple nursing intervention for patients experiencing nausea or pain related to the cancer experience.3 5 6.1 NEED FOR THE STUDY Cancer is a leading cause of death globally, an estimated 7.6 million people died of cancer in 2005 and 84 million people will die in the next 10 years if action is not taken. The World Health Organization (WHO) has proposed a global goal of reducing chronic disease death rate by 2% per annum from 2006 to 2015.5 According to National cancer control programme (NCCP), Cancers in all forms are causing about 12 per cent of deaths throughout the world. In the developed countries cancer is the second leading cause of death accounting for 21% (2.5 million) of all mortality. In the developing countries cancer ranks third as a cause of death and accounts for 9.5% (3.8 million) of all deaths. Tobacco, alcohol, infections and hormones contribute towards occurrence of common cancers all over the world.6 According to NCCP Cancer has become one of the ten leading causes of death in India. It is estimated that there are nearly 1.5-2 million cancer cases at any given point of time. Over 7 lakh new cases of cancer and 3 lakh deaths occur annually due to cancer. Nearly 15 lakh patients require facilities for diagnosis, treatment and follow up at a given time. Data from population-based registries under National Cancer Registry Programme indicate that the leading sites of cancer are oral cavity, lungs, esophagus and stomach amongst men and cervix, breast and oral cavity amongst women. Cancers namely those of oral and lungs in males, and cervix and breast in females account for over 50% of all cancer deaths in India.7 Oncology channel says that 90% patients with advanced cancer experience severe pain. 30%-50% have pain at the time of diagnosis. 70% to 90% have severe pain when the disease is advanced. 40% die with severe pain. 60%-80%complains of inadequate 6 pain relief by their physician. 30% are not relieved by drug treatment alone, so require interventional pain management. More than 90% cancer pain can be adequately controlled.8 In the United States, cancer is the second most common cause of death and it is expected that about 562,340 Americans will have died of cancer in 2009. Bone cancer pain is common in patients with advanced breast, prostate, and lung cancer as these tumors have a remarkable affinity to metastasize to bone. Once tumors metastasize to bone, they are a major cause of morbidity and mortality as the tumor induces significant skeletal remodeling, fractures, pain, and anemia. Currently, the factors that drive cancer pain are poorly understood. However, several recently introduced models of bone cancer pain, which closely mirror the human condition, are providing insight into the mechanisms that drive bone cancer pain and guide the development of mechanism-based therapies to treat the cancer pain. Several of these mechanism-based therapies have now entered human clinical trials. If successful, these therapies have the potential to significantly enlarge the repertoire of modalities that can be used to treat bone cancer pain and improve the quality of life, functional status, and survival of patients with bone cancer.8 As tumor growth and tumor-induced bone remodeling progress, severe “incident pain” frequently occurs. This incident pain is also known as “breakthrough pain” as the pain “breaks through” the analgesic regime that is controlling the ongoing pain. Incident pain is defined as an intermittent episode of extreme pain that occurs spontaneously (where there is no obvious precipitating event) or more commonly is induced by normally non-noxious movement or mechanical loading of the tumor-bearing bone(s). 7 Major problems with incident pain in bone cancer are that it is usually more severe than ongoing pain, it appears suddenly (within seconds to minutes), it can occur multiple times each day, and it is frequently difficult to predict. With the therapies that are currently available, and with its rapidity of onset and severity, incident pain remains one of the most challenging of cancer pains to control and can be highly debilitating to the patient’s functional status and quality of life.9 Thus the problem of dealing with pain and accompanying emotional stress presents a conundrum for both nurses and cancer patients alike one which cannot be solved with a set medication schedule, but demands consideration of a holistic care approach and the individualization of treatment. This made the researcher to think about a therapy that emphasis on comfort, cure and symptom control when cure is no longer possible.10 At Alphonsa Pain and Palliative Centre, Bangalore, 555 cancer patients got admitted from the period of May 2008 to May 2009 .Among them 165 patients died at the hospital.90% of them were experiencing pain due to cancer.7 Cancer usually occurs in the later years of life and with increase in life expectancy to more than 60 years, an estimate shows that the total cancer burden in India for all sites will increase from 7 lakh new cases per year to 14 lakh by 2026. (NCCP).10 Reducing pain to a “tolerable” level is one of the goals of pain management. Pain management strategies include both pharmacologic and non-pharmacologic approaches. These approaches are selected on the basis of patient requirement and goals. The pharmacologic interventions include local anesthetic agents, NSAIDS and tricyclic antidepressant agents and anticonvulsants medications. The non-pharmacologic 8 interventions include cutaneous stimulation, massage, ice and heat therapies, transcutaneous electrical nerve stimulation, distractions, relaxation techniques, guided imaginary and hypnosis.11 The new emerging measure in pain management is alternative and complementary therapy. The therapies that come under this are therapeutic touch, music therapy, herbal therapy, reflexology, magnetic therapy, electrotherapy, acupressure, massage etc. Massage is the most widely used complementary therapy in nursing practice and foot massage is one among them.12 Foot massage is an important and much neglected aspect of nursing care. Foot massage has physical and psychological benefits for the whole person. Interested family members can perform foot massage on their loved ones, and nurses can support families by teaching them this simple skill. Foot massage is a very effective means of communication. It provides physical contact in a very acceptable way within the Indian culture. It can be particularly valuable for those who receive little human touch. To be touched in a gentle and unembarrassed way can be very comforting. It is also a good way of getting to know someone well by developing a relationship based on honesty and trust. 6.2 REVIEW OF LITERATURE The primary purpose of reviewing relevant literature is to gain a broad background or understanding of the information that is available related to a problem. The present study investigates the effect of foot message on pain among patients with cancer. The reviews of selected studies were presented in the following headings. 9 I. II. III. Study related to bone cancer in general Studies related to foot massage in general. Studies related to foot massage and pain in bone cancer patients. I. Study related to bone cancer in general A N Serafini, (2010) conducted a study to assess the evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebocontrolled study. Patients with painful bone metastases secondary to a variety of primary malignancies were randomized to receive 153Sm-EDTMP 0.5 or 1.0 mCi/kg, or placebo. This study concluded that A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded.13 Andrew G. Glass, (2010) conducted a study to assess the Epidemiology of Bone Cancer in Children. He examined 1,532 death certificates of all children in the United States dying from these neoplasms, 1960–66, and 396 hospital charts from 12 institutions. Bone tumors increased progressively with age through childhood and adolescence. Girls had slightly higher rates at the start of adolescence, but much lower rates after 15 years. There were no time-space variations to suggest environmental factors, such as infectious agents or radioactive materials resulting from the testing of nuclear weapons. Bone cancer seemed related to a variety of antecedent skeletal defects, but not to nonskeletal anomalies.14 Stefan Grond, (2011) conducted a study to assess the prevalence of different pain syndromes. In a prospective study of 2266 Bone cancer patients, we assessed 10 localisations, aetiologies and pathophysiological mechanisms of the pain syndromes. Thirty percent of the patients presented with 1, 39% with 2 and 31% with 3 or more distinct pain syndromes. The majority of patients had pain caused by cancer (85%) or antineoplastic treatment (17%); 9% had pain related to cancer disease and 9% due to aetiologies unrelated to cancer. Pain could be classified as originating from nociceptors in bone (35%), soft tissue (45%) or visceral structures (33%) or otherwise as of as neuropathic origin (34%). In most patients, pain syndromes were located in the lower back (36%), abdominal region (27%), thoracic region (23%), lower limbs (21%), head (17%) and pelvic region (15%).15 Nancy M. Luger, (2010) conducted a study to assess the effectiveness of Osteoprotegerin on reducing bone Cancer Pain. Administration of osteoprotegerin, a naturally secreted decoy receptor that inhibits osteoclast maturation and activity and induces osteoclast apoptosis, or vehicle was begun at 12 days, when significant bone destruction had already occurred, and administration was continued daily until day 21. Results indicated that osteoprotegerin treatment halted further bone destruction, reduced ongoing and movement-evoked pain, and reversed several aspects of the neurochemical reorganization of the spinal cord.16 Ilora G Finlay, (2010) conducted a study on Radioisotopes for the palliation of metastatic bone cancer. Radioisotopes are effective in providing pain relief with response rates of between 40% and 95%. Pain relief starts 1–4 weeks after the initiation of treatment, continues for up to 18 months, and is associated with a reduction in analgesic use in many patients. The effectiveness of radioisotopes can be greater when they are combined with chemotherapeutic agents such as cisplatin. Further studies are needed to 11 address the questions of which isotope to use, what dose and schedule to use, and which patients will respond.17 II. Studies related to foot massage in general. Wang M.Y. et al., (2008) reported a study to assess the efficiency of reflexology in any condition. Cohrane library, pubmed, medline, EBM review, proquest medical bundle and scopos data bases were searched using following subject heading reflexology, foot reflexology, reflexocolgical treatment & foot massage. The publication data limited from 1996 to 2007 43 abstracts selected which are written in English or Chinese using a controlled clinical trial design. Study quality was reviewed based on the evidence rating system of the United States. Results suggest that treatment effect for urinary systems was large.18 Xavier.R. (2007) undertook a quasi experimental study to determine the effectiveness of reflexology (foot massage) in reducing pain in specific urologic conditions in CMC-Vellore among 30 patients who undergone urological surgery using simple random sampling and each patient received 30-45 minutes of foot massage, pre and post assessment of pain was done by using visual analogue scale, using a ten point scale and the interview schedule using a likert scale with scoring 0-3. Comparison between pre and post assessment was done by Wilcoxon signed rank test. After foot massage the pain level of 19 (63.3%) patients were reduced from severe to moderate, in 2(6.6%) patients was reduced from moderate mild and for 9(30%) patients it remained in same level after foot massage (P<0.001).19 Abraham.P.S. (2006) reported an experimental study to assess the effectiveness of reflexology in reducing chemotherapy induced nausea and vomiting (CINN) at CMC 12 Vellore consisting of 128 subjects 64 (control) and 64 (experimental) who received moderate, high and very high emetogenic chemotherapy selected by purposive sampling technique. The instruments used were demographic data, clinical variables, nausea assessment by numerical rating scale and questionnaire. The study revealed that there was a reduction in the mean total score for nausea in experimental group (2.93) than in control group (3.46). Also the mean of total number of episodes of nausea less in experimental group (19.96%) than in control group (22.2), (P=.23 and .68 respectively).20 Lee.Y.M. (2006) reported a quasi experimental study of the pre and post test design in a non equivalent control group to determine the effects of foot reflexology in fatigue and insomnia in experimental group of twenty nine and the control group of thirty patients suffering from coal workers pneumoconiosis. Foot reflexology was performed for 60 minutes twice a week through five weeks the experimental group but none in the control group. Fatigue was evaluated by fatigue symptoms inventory and insomnia with the visual analogue scale (VAS). Data of this experimental was analyzed by Chi-square test, t-test, unpaired t-test and repeated measures ANOVA with the SAS program. The scores of fatigue and insomnia decreased in experimental group but not in the control group.21 Qualtrin.R.et.al., (2006) Conducted a study to examine the effectiveness of reflexology foot massage in hospitalized Cancer patients undergoing second or third chemotherapy cycles consisting of 30 patients , 15 experimental and 15 control being admitted to the oncology unit at a scientific research hospital in Italy. The subjects self reports of anxiety measured by spiel burger state anxiety inventory were recorded before, after and 24 hours after the intervention. There was average decrease of 7.9 points on the 13 state anxiety scale in the treatment group and of 0.8 points in the control group (P<0.0001).22 Sang.R.H., Kim.D.H., (2006) Conducted non-equivalent control group pre-test and post test quasi experimental study to examine the effects of foot reflexion massage on sleep disturbance, depression disorder and physiological index of the elderly in nursing homes consisting of 25 elderly people in control group and 25 in experimental group. The foot reflex ion on massage was provided for 12 sessions, 30 minutes per sessions. The selected dependent variables were sleep disturbance, depression disorder and physiological indices. Data analysis included chi 2 test, t-test, paired t-test and ANCOVA using the SPSS program package. The result showed improved sleep quality, less depression disorder and high serotonin levels in experimental group than control group.23 Williamson.J., et.al., (2002) reported a randomized controlled trial of reflexology for menopausal symptoms consisting of sixty six women, aged between 45 and 60 years reporting menopausal symptoms. The women were randomized to receive nine sessions of either reflexology or non specific foot massage by four qualified reflexologists given over a period of 19 weeks. The tools used are woman’s health questionnaire (WHQ), primary measures being the sub scores for anxiety and depression (VAS) and frequency of flushes and night sweats. Mean (SD) scores for anxiety fell from 0.43 (0.29) to 0.22 (0.25) in the reflexology group and from 0.37(0.27) to .27 (0.29) in the control group over the course of treatment. Mean (SD) scores of depression fell from 0.37 (0.25) to 0.20 (0.24) in the reflexology group and from 0.36 (0.23) to 0.20(0.21) control (foot massage) group over the same period. For both scores there was strong evidence of a time effect (P<0.001).24 14 III. Studies related to foot massage and pain in cancer patients. Currin.J, Meister EA (2008) undertook a nonrandomized single-group pre- and post design study to assess the impact of a Swedish massage intervention on oncology patients' perceived level of distress. A total of 251 oncology patients participated in this study for over a 3-year period at a university hospital setting in southeastern Georgia. Each patient's distress level was measured using 4 distinct dimensions: pain, physical discomfort, emotional discomfort, and fatigue. The analysis found a statistically significant reduction in patient reported distress for all 4 measures: pain (f = 638.208, p = .001), physical discomfort (f = 742.575, p = .001), emotional discomfort (f = 512.0, p = .001), and fatigue (f = 597.976, p = .001). This reduction in patient distress was observed regardless of gender, age, ethnicity, or cancer type.25 Molly (2007) observed the therapeutic effect of foot-massage to reduce pain as a measure in palliative care using interrupted time series design. The study was conducted in institute of pain and palliative medicine, Calicut consisting of 30 samples. The tools selected for the study were a standardized visual analogue scale and an observation record for recording pain intensity, pulse and respiratory rate. Majority of patients (60%) had duration of pain more than 12 months, about 26% of the patients had pain the range of 6-12 months and the remaining had pain for less than 6 months. Posttest on 3rd day shows that only 6% patients had severe pain and majority of them (70%) had moderate pain.26 Shiow-Luan.et.al., (2005) investigated the efficacy of foot reflex therapy as adjuvant therapy in relieving pain and anxiety in postoperative patients with gastric cancer and hepatocellular cancer using randomized control trail in Taipei, Taiwan .Sixty- 15 one patients who had received surgery were randomly allocated to an intervention (n = 30) or control (n = 31) group. Patients in the intervention group received the usual pain management plus 20 minutes of foot reflex therapy during postoperative days 2, 3, and 4. Patients in the control group received usual pain management. Data collected thorough the short-form McGill Pain Questionnaire, visual analog scale for pain, summary of the pain medications consumed, and the Hospital Anxiety and Depression Scale. Results demonstrated that studied patients reported moderately high levels of pain and anxiety postoperatively while patients were managed with patient controlled analgesia and less pain (P < .05) and anxiety (P < .05) over time were reported by the intervention group than the control group. In addition, patients in the intervention group received significantly less opioid analgesics than the control group (P < .05).27 Stephenson.N.L, Weinrich.S.P., and Tavakoli.A.S., (2001) conducted a quasi experimental study to assess the effects of foot reflexology on anxiety and pain in patients with breast and lung cancer at the School of Nursing, East Carolina University . The samples consisted of 23 in patients who were receiving regularly scheduled opioids and adjuvant medications on the control and intervention day. The tool included pain and anxiety scales. Researchers noted a significant decrease in anxiety for patients diagnosed with breast or lung cancer and a significant decrease in pain for patients with breast cancer.28 Grealish.L, Lamasery.A., and Whiteman.B., (2000) assessed the therapeutic effect of foot massage on pain, nausea and relaxation in University of Canberra, Australia.. 87 participants were included in the study ranging age from 18-88 years. The massage sessions were of 10 minutes duration for three consecutive evenings between 16 7am and 8pm. The pain, nausea and relaxation measured using 0-100mm visual analogue scale .For the control session, the pretest mean pain score was 21.3 + 20.2 mm and post test mean pain score was 20.4 + 19.8mm representing a mean difference of .874 mm (t=.867, P =0.1943). The pretreatment mean pain score for massage session I was 25.1 + 21.7mm, which decreased to 15.3 + 19.0mm (t=5.979; p=0.001)) immediately after massage, resulting in a mean difference of 9.8 mm. similarly the mean pain score for massage session II decreased 9.4 mm from 27.9 +25.5mm to 18.5 + 19.1mm (+-5.751; P= 0001).29 6.3(A) STATEMENT OF THE PROBLEM “A study to assess the effectiveness of foot massage on reduction of the pain in patients with bone cancer in selected hospitals at Bangalore.” 6.3(B) OBJECTIVES OF THE STUDY To assess the pain among patient with bone cancer in control group. To assess the pain among patient with bone cancer in experimental group To re-assess the pain, after 4 hours, among patients with bone cancer who had undergone foot massage intervention in experimental group. To re-assess the pain, after 4 hours, among patient with bone cancer in control group. To compare the mean difference in level of pain among bone cancer patients between the experimental and control group. To test the association between the mean difference in level of pain and selected demographic variables among patients with bone cancer in experimental group. 17 6.3(C) OPERATIONAL DEFINITION Assess It refers to evaluation of desired or intended outcome of the study. Effectiveness It refers to the extent to which the foot massage has achieved the desired outcome. Pain It refers to an unpleasant sensory and emotional experience associated with activity or potential tissue damage. Pain is measured in terms of pain scores by numerical pain rating scale. Foot massage The foot massage should be done by slow firm or gentle strokes (toward the heart), from the base of the toes up the foot and lower leg to the knee. (Reflexology) Bone cancer A bone cancer is a cancerous neoplasm that found in the bone marrow. A bone tumor may be cancerous (malignant) or noncancerous (benign). Patient A patient is, one who receives medical attention, care, or treatment Reduction Reduction is defined as the action or fact of making a specified thing smaller or lesser in amount, degree or size 18 6.3(D) RESEARCH HYPOTHESIS There will be a significant difference in level pain before and after foot massage among patients with cancer between experimental and control group. There will be a significant difference in the mean difference of level of pain among cancer patients between the experimental and control group. There will be a significant association between mean difference in pain and selected factors among patients with cancer in experimental group 6.3(E) LIMITATION This study is limited to patients with bone cancer in selected hospitals at Bangalore. This study is limited to 4 weeks. 6.3 (F) ASSUMPTIONS 1. The patient would co-operate and be willing to participate in the study. 2. The items included in the tool will be adequate and represent the measure of pain of cancer patient. 3. The response to numerical pain rating scale would be the true measure of the pain experienced by the bone cancer patients. 4. Every client is unique and responds in a unique manner to pain. 7. MATERIALS AND METHODS This chapter gives a description of the research approach, research design, variables, the setting of the study, population, sampling, research tool, and methods of data collection and plan for data analysis. 19 7.1 Sources of data Data will be collected from patients with bone cancer in selected schools at Bangalore. 7.2 Methods of data collection I. Research design True experimental research design. Research approach Two group pre-test post-test approach II. Research variables a. Dependent variables Level of pain among patient with bone cancer.. b. Independent variables Foot massage for reducing the pain among patient with bone cancer. c. Demographic variables The demographic variables are characteristics of patients such as Age, sex, educational status, socioeconomic status of the family and family history of cancer. III. Setting Study is planned to conduct in the selected cancer hospitals at Bangalore. IV. Population The population is the patients with bone cancer in selected hospitals at Bangalore. 20 V. Sample Samples should be selected from, the patients with bone cancer in selected hospitals at Bangalore. For pilot study sample size will be 6. For main study the sample size will be 60. VI. criteria for sample selection a) Inclusion criteria Those who diagnosed with bone cancer Those who with both sexes Those who were above 18 years Those who had pain >4 as monitored in pain intensity scale on the first day of study. Those who were willing to participate in the study. Those who were present at the time of data collection. Those who were able to understand Kannada. a) Exclusion criteria Those who are not willing to participate in the study Those who are not admitted in selected hospitals at Bangalore. Patients with other than bone cancer. VII. Sampling Technique In this study the investigator will be using non probability convenience sampling technique. 21 VIII. Tool for data collection The investigator will be used Numerical pain rating scale to assess the pain for assessing the level of pain among patient with bone cancer. Section I: This section consisted of background factors like age, sex, marital status, educational status, occupation, religion, family monthly income. Section II: This section consisted of disease related factors such as diagnosis, duration of illness, treatment, analgesics and alternative pain relievers. Section III: It consisted of a scale ranging 0-10 to assess the pain among cancer patients. The response ranged from no-pain at all - 0 to severe pain-10. IX. Methods of data collection After obtaining permission from concerned authority an informed consent will be collected from each sample. Phase 1 Pretest will be conducted to assess level of pain among patient with bone cancer by using numerical Pain Rating Scale. Phase 2 The investigator will be administering the foot massage to each sample in experimental group. Phase 3 After foot massage post test will be administered to assess the level of pain among patient in experimental and control group with bone cancer. The duration of the study will be 4 weeks. 22 X. Plan for data analysis The data will be analyzed by means of descriptive and inferential statistics. a) Descriptive statistics Mean, median, mode, standard deviation, percentage distribution, will be used to assess the level of pain among patient with bone cancer. b) Inferential statistics Chi-square test will be used to associate level of pain among patient with bone cancer with their selected demographic variables. ‘T’ test will be used to assess the effectiveness of foot massage among patient with bone cancer. XI. Projected outcomes After the study, the investigator will able to know how much the foot massage will be effective for reducing the level of pain among patient with bone cancer. 7.3 Does the study require any investigation or intervention to the patient or other human being or animal? No 7.4 Has ethical clearance been obtained from the concerned authority to conduct the study? Yes a) The investigator should get the approval from the research committee of the institution. b) Permission will be obtained from the Director of selected hospitals at Bangalore. 23 c) Informed consent will be obtained from the patients who are admitted in selected hospitals at Bangalore to participate in the study with their own knowledge. 24 8. LIST OF REFERENCES 1. Brunner and Suddarth’s. Medical and Surgical Nursing, J.B. Lippincott, 1992, 7. p.497-498. 2. Lewis, Heit Kemper, Dirksen O’ Brien Bucher, Medical and surgical nursing, 2007, p.629-631. 3. Beare Gauntlett Patricia, Myers L. Judith (1998), “ADULT HEALTH NURSING”, 3 rd edition, Mosby publishers : Philadelphia ;Pg no. 1406 – 1446. 4. Black M. Joyce, Hawks Hokanson Jane (2005), “MEDICAL SURGICAL NURSING”, 7 th edition, Saunder’s publishers: Missouri; Pg no.1243-1288. 5. Dewit C. Susan (1998) ESSENTIALS OF MEDICAL SURGICAL NURSING”, 4 th edition, W.B. Saunder’s company: Philadelphia; Pg no. 793-819. 6. Dirksen Ruff Shannon, Lewis Manlik etal (1996), “ CLINICAL COMPANION TO MEDICAL NURSING” 1 st edition, Mosby Publications: Missouri; Pp no. 174-184. 7. Hargrove A. Ray, Huttel (2001), “MEDICAL SURGICAL NURSING”, 3 rd edition, Lippincott publishers: Philadelphia; Pg no. 242-245. 8. Healy F. Phyllis, Mourd A. Leona (1998), “ MEDICAL SURGICAL NURSING CERTIFICATION”, 2 nd edition, Springhouse corporation publishers: Pennsylvania; Pg no.190-194. 9. Hood Harkness Gail, Dincher R. Judith (1992), “TOTAL PATIENT CARE”, 8th edition, Mosby Publishers: Philadelphia; Pg no. 595 -611. 25 10. Sarah Wild, 2010, Global Prevalence of Diabetes Estimates for the year 2010 and projections for 2020, Journal of Diabetes Care, Volume: 12, Issue: 1, Page No: 256-262. 11. Alberto Barcelo, 2011, Incidence and prevalence of diabetes mellitus in the Americas, Journal of Public Health, Volume: 45, Issue: 3, Page No: 784-788. 12. Shankar PR, 2011, A Survey Among Individuals Attending A Diabetes-Screening Programme In Pokhara City, Western Nepal, Pharmacology online, Journal of Indian Medicine, Volume: 1, Issue: 1, Page No: 148-161 13. A N Serafini, (2010), Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial, Journal of Clinical Oncology, Volme: 34, Issue: 3, Pages: 346-349. 14. Andrew G. Glass, (2010), “Epidemiology of Bone Cancer in Children,” Journal of The National Cancer Institute, Volume:23, Issue: 1, Pages:1115. 15. Stefan Grond, (2011), Journal of Pain Management, Volume: 12, Issue: 3, Pages: 117-119. 16. Nancy M. Luger, (2010), The Journal Of Cancer Research, Volume: 32, Issue: 1, Pages: 67-69. 17. Ilora G Finlay, (2010), “Radioisotopes for the palliation of metastatic bone cancer,” The American Journal of Medicine, Volume: 6, Issue: 6, Pages: 228-229. 18. Wang M.Y et al., (2008), “The efficiency of reflexology: Systematic review” Journal of advanced nursing 2(5): 512-520. 19. Xavier Regina, Premkumar Beulah (2008), “A quasi experimental study to determine the effectiveness of reflexology in reducing pain in specific urology 26 conditions of patients admitted In U-ward, CMC, Vellore”, Nightingale Nursing Times, 11: 24-27. 20. Abraham P.S, "Effectiveness of reflexology in reducing chemotherapy induced nausea and vomiting in CMC, Vellore", March 2006. 21. Lee YM, Sohng KY (2005), “The effects of foot reflexology on fatigue and insomnia in patients suffering from coal workers pneumoconiosis”,Taehan kanho hakhoe chi 35 (7), 1221- 8. 22. Quattrin, et.al., (2006) “Use of reflexology foot massage to reduce anxiety in hospitalized cancer patients in chemotherapy treatment: methodology and outcomes”, Journal of nursing management,14(2)96-105. 23. Sang, (1999), “Immediate effects of five minute foot massage on patients in critical care”, Intensive critical care nursing,15(2):77-82. 24. Williamson.J., et.al., “Randomised controlled trial of reflexology for menopausal symptoms”, An international journal of obstetrics and Gynacology 109(9), 105055. 25. Currin J; Meister EA (2008), “A hospital-based intervention using massage to reduce distress among oncology patients”, Cancer Nursing. 31(3):214-21. 26. Moly et al., (2008), “Easing Cancer pain and anxiety”, Nightingale Nursing times, 10:36-42. 27. Shiow-Luan, et.al., “Effects of Reflexotherapy on Acute Postoperative Pain and Anxiety Among Patients With Digestive Cancer”, Cancer Nursing 31(2),109115. 27 28. Stephenson NL, Wainrich S, Tavakoli A, (2001) “The effects of foot reflexology on anxiety and pain in patients with cancer and lung cancer”, Oncology nursing forum, 27: 67-72. 29. Gerlish L. Lamasney A, et.al., massage : “A Nursing Intervention to modify the distressing symptoms of pain and nausea in patients hospitalised with cancer”, Cancer Nursing 23 (3):237-242. 28 9. Signature of the candidate : 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 : 12. Remarks of the Principal : 12.1 Signature :