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PERFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the candidate and address : Ms. Archana .B 1st Yr M.sc Nursing (2008-2009) JSS college of Nursing, I st Main, Saraswathipuram Mysore. 2. Name of the institution : JSS College of Nursing , I st Main Saraswathipuram Mysore 3. Course of study & subject : M.sc Nursing in Medical- Surgical Nursing 4. Date of admission to the course : 5. Title of the topic : A study to assess the effectiveness of Reflex Zone Therapy on selected distressing side effects related to chemotherapy among cancer patients at selected hospital of Karnataka. 1 6.0. BRIEF RESUME OF THE INTENDED WORK INTRODUCTION: Cancer is the 2nd leading cause of the death in US and the scenario of cancer shows the different treatment modalities like chemotherapy, radiation therapy and many more adjuvant therapies. Palliative care is an important aspect as the cancer patient’s suffering is common, in which there are new emerging therapies which provides a great sense of feeling and self control and on among these one is the Reflex Zone Therapy. 6.1 NEED FOR THE STUDY : “The Nursing Research is concerned with whole of the Nursing” Cancer is a group of more than 200 diseases characterized by uncontrolled and unregulated growth of cells. It can occur in person of all ages and all ethnicities and is a major health problem. Chemotherapy is used in the treatment of many solid tumors and is the primary therapy for leukemia and lymphomas. Chemotherapy as a treatment option has evolved as a palliative care “last – ditch efforts” treatment modalities to one that can offer cure for certain cancer, control other cancer for long periods of time and offer palliative relief of symptoms when cure or control no longer is possible1. Being Nurses one should be able to understand the condition of cancer patients who are undergoing the chemotherapy. This treatment has an effect on both the psychological and physiological aspects of human life viz. pain, sleep disturbances, nausea, vomiting, stress, anxiety ,Gastrointestinal disturbances 2 etc., these side effects could be so intense in nature which pose a challenge to health personals to keep these side effects at their minimal levels. There are 3 main approaches to cancer prevention 1. Education 2. Regulation 3. Host modification. A client health beliefs can be vital determinants of learning readiness when information is made available. Host modification aims to alter the body’s internal environment to decrease the risk of cancer or to reverse a carcinogens process which includes the chemoprevention and complementary and alternative approaches along with the nursing care. The use of Complementary and Alternative Therapies (CAT) by public is growing, Estimates suggest that up to 82% of clients have used the CAT sometimes in their lives. Complementary approaches often combine one or more elements such as : 1. Spiritual, Psychological, Nutritional, Physical, Pharmacological, Herbal electromagnetic or psychic approaches. 2. Traditional medicines 3. Unconventional uses of conventional therapies 4. Unconventional instruments. 5. Human approaches 6. Massage therapy 3 It is also found that the use of CAT increase clients sense of control and well – being2. Reflex zone therapy comes under one of the CAT where in Reflexology is a zonal therapy and a science in the skillful manipulation is applied to the individual identified on the body points to stimulate the individual functional system or parts of the body. This stimulation area is mainly the feet and hands. It can help alleviate many of problems in a natural way. The reflexes are generated through the manipulation of response focal points in the body for each system, the resulting reactions. This reaction node can be used effectively in the liberation of large numbers of complaint taking no chance with the unwanted side effects, otherwise inevitable in the chemotherapy. It has proves to be beneficial reducing stress pain, anxiety and nausea. It acts by quick and claming feeling. Besides this these are validated by the great relief of patients with positive results in the treatment of cancer with no chance of any kind of adverse effect. As reflexology eliminates toxins in the body it is reported that patient get the ability to deal with chemotherapy and the related side effects.3 The impact of these studies can be utilized in the Nursing practice for rendering effective care in counteracting the side effects of chemotherapy. Palliative care is an important aspect to be delt with the cancer patient. Hence, any therapy which helps to reduce there distressing side effect will be a boon to the patient and so as to the effectiveness of nursing care in enhancing comfort to the patient. 4 As the reflex zone therapy is an emerging field in the health care delivery system the researcher found dearth in the applicapability of Reflex Zone Therapy in Indian setting/Contest when compare to abroad setting. Hence in order to explore the effect reflex zone therapy can produce in reducing in the distressing side effects related to chemotherapy among the cancer patients, the researcher has planned to do this study. 6.2 REVIEW OF LITERATURE : A study was conducted to determine the therapeutic effect of foot massage on pain, pulse rate and respiratory rate among 50 patients suffering from cancer pain. The tool used for data collection was the interview technique, VAS, Observation record and the result revealed that 66.7% had moderate pain and remaining had mild pain, Pulse rate was noticed to be more than 100 and respiratory rate was above the normal respiration among 97 % .4 A study was conducted on the effect of foot massage combine with foot bath on 28 clients with nausea induced by chemotherapy. The intervention was introduced on 3rd day of chemotherapy to the 5th day. The duration of each foot massage was for 10min after foot bath for 7min. An ECG was taken to find out the variability in heart rate, VAS score was used measure the nauseating perception. A comparisons was made immediately, before care and 30 minutes after care and results revealed that 86% of subjects experiencing achieving reduction in perception of nausea and suggested that foot massage combined with a foot bath leads to the relaxation response and improves the perception of delay of nausea induced chemotherapy5. 5 A study was conducted to examine the effectives of foot reflexology among the hospitalized cancer patients undergoing 2nd and 3rd cycles of chemotherapy. The study was conducted on 30 patients admitted to the oncology unit at scientific research hospital in Italy Among 30, the 15 patients received the therapeutic massage and the data collection techniques was self report of anxiety which as recorded before, after and 24hr after the intervention. The results revealed that there was an average decrease of 7.9 point on anxiety scale in the treatment group and 0.8 point in the control group6. An empirical study was conducted on the use of foot massage as a nursing intervention among hospitalized patients with cancer, in view to provide relief from pain nausea and anxiety. 87 patients participated in the study and each received a 10min foot reflexology (5min per foot) and the result revealed that it had a significant and immediate effect on the patient’s perception of pain, anxiety and nausea7. A study was conducted by Korean nursing school on the menopausal women between the age of 40 – 64yrs, to find the effectiveness of self foot reflexology on depression, stress and immune function of women; The subjects were assessed for initial 4 weeks (control period) without any intervention. Followed by this, they were trained for 2 weeks and then they continued with self treatment for a period of 6 weeks. Pretest to post test comparison revealed that the women not only achieved significant decrease in depression and perceived stress, even their immune system got boosted as there was increases in levels of natural killer cells and immunoglobulin.8 6 A study was conducted about the effect of foot reflexology on nausea and vomiting related to chemotherapy. The participants were 34 patients with breast cancer undergoing chemotherapy. The group was divided into 18 experimental and 16 control group. A Pretest-posttest control group design was used and the result revealed that there was a significant decrease in the level of nausea, vomiting and fatigue in the experimental group who received foot reflxology9. A study was conducted on 23 patients with breast cancer and lung cancer about the effect of foot reflexology in relieving the pain and anxiety, A within group design was used and the results obtained before and after intervention revealed that their was a significant decrease in pain and anxiety among the patients who received foot reflexology.10 A study was conducted on the effect of foot reflexology and placebo foot treatment, for patients in palliative cancer care. 12 participants were randomly assigned to either reflexology or placebo foot treatment with the same therapist administering the two interventions and the outcome was measured through a linear self assessment scale of quality of life. Both groups indicated improvement but the group with reflexology showed significantly positive results in the quality of life.11 A study was conducted to investigate the benefits of reflexology on sleep problems among 50 elderly nursing home residents. The study design was experimental, pre-post design .The subjects were divided into interventional and control groups. The sleep disturbances, depression and physiological indices of serotonin and cortisol levels were assessed before and after intervention the. 7 Results revealed that comparison of control group with the experimental group. Showed improved quality of sleep, decreased depression and increase serotonin levels in experimental group .12 STATEMENT OF THE PROBLEM A study to assess the of effectiveness of Reflex Zone Therapy on selected distressing side effects related to chemotherapy among cancer patient at selected hospitals of Karnataka. 6.3 OBJECTIVES: 1. To assess the distressing side effects ( pain , nausea ,anxiety and sleep disturbance )related to chemotherapy before and after Reflex Zone Therapy among the cancer patients. 2. To find out the effectiveness of Reflex Zone Therapy in terms of reduction in distressing side effects related to chemotherapy among cancer patients 3. To find the relationship between cancer patient’s; Pain and anxiety Pain and Nausea Pain and Sleep disturbance(insomnia) Anxiety and Nausea Nausea and Sleep disturbance(insomnia) Anxiety and sleep disturbance(insomnia) 8 4. To find out the association of the distressing effects related chemotherapy among cancer patients with their selected personal variables viz age, gender, chronicity (duration) of the condition stage of cancer, type of Cancer, type of Chemotherapy, and number of Chemotherapy cycles received. CONCEPTUAL THEORITICAL FRAMEWORK : Roger’s Health Belief Model OPERATIONAL DEFINITION : 1. Reflex Zone Therapy(RZT) – Also known as foot reflexology: Is a therapeutic method of reliving pain by stimulating the predefined pressure points on the feet. In this study it refers to relieving the distressing side effects of chemotherapy by providing a 15min daily foot massage and foot acupressure for each extremity for a duration of 1week for the cancer patients undergoing chemotherapy. 2. Selected Distressing side effects related to chemotherapy 2a) Distress: Feeling of discomfort or an extra, unwanted, unusual effect or unexpected result of situation or course of action that happens along with the results you are aiming for. 2b) Selected side effects : it refers to the side effects Occurring due to chemotherapy viz.. 9 Pain - Bodily suffering caused by illness, pressure, injury, as measured through Standardised Visual Analogue Scale. Anxiety – Troubled state of mind or worries as measured by Standardised Anxiety Scale Nausea – Inclination to vomit as measured by standardized Visual Analogue Scale Sleep disturbance (Insomnia) – Sleeplessness as measured through observation checklist. The selected distressing side effects refers to the side effects ( pain , nausea, anxiety and sleep disturbance )causing discomfort or suffering to cancer patients. * please note : the term reflex zone therapy will be refered to as RZT throughout the study 3. Chemotherapy – Refers to one of the treatment modalities of cancer using chemical substances. 4. Cancer Patients – Refers to patients who are suffering from one or other type of cancer and are undergoing chemotherapy. 5. Effectiveness – Means quality of being able to bring about an effect/Intended Outcome. 10 In this study it refers to the effectiveness of reflex zone therapy in bringing about reduction in the distressing side effects related to chemotherapy as perceived by the cancer patients and is measured through standardized scaled (above details are given along with the distressing side effects ). HYPOTHESIS : H1: The mean post test scores of distressing side effects related to chemotherapy among cancer patients receiving RZT will be significantly higher than the mean post test scores of cancer patients who did not received the RZT. H2: The mean post test scores of distressing side effects related to chemotherapy among cancer patients receiving RZT will be significantly higher than their mean pretest scores. H3: There will be significant relationship between the cancer patients level of ; Pain and anxiety Pain and Nausea Pain and Sleep disturbance(insomnia) Anxiety and Nausea Nausea and Sleep disturbance(insomnia) Anxiety and sleep disturbance(insomnia) 11 H4: The mean pre test scores of distressing side effects related to chemotherapy among cancer patients will be significantly associated with their selected personal variables viz. age, gender, chronicity (duration) of the condition stage of cancer, type of Cancer, type of Chemotherapy, and number of Chemotherapy cycles received. ASSUMPTIONS : Chemotherapy leads to certain side effect which causes suffering to the patients receiving it. The reflex zone therapy has the ability to increase the blood circulation and relax the whole body and induce sleep It can also remove the toxins from the body and reduce pain. Relaxation of body and mind will reduce the Pain, Anxiety, Nausea and induce sleep. Cancer patients will have positive attitude to undergo reflex zone therapy. DELIMITATION: Study is delimited to cancer patient undergoing chemotherapy who are admitted in the selected hospital. 12 7.0 MATERIALS AND METHODS : RESEARCH APPROCH/DESIGN : Quasi Experimental Study, Non equivalent experimental control group before and after design with repeated post test . Experimental group : O 1 X O2 O 3 O 4 Control group : O1 - O2 O3 O4 VARIABLES OF THE STUDY: Independent variable : Reflex zone therapy Dependent Variable : Distressing side effects of chemotherapy pain, nausea, anxiety and sleep disturbance (insomnia) Other Variables : Age, gender, chronicity (duration) of the condition stage of cancer, type of Cancer, type of Chemotherapy, number of Chemotherapy cycles receiving. 13 7.1 SOURCE OF DATA SETTING : Selected Oncology hospitals of Karnataka POPULATION : Cancer patients undergoing chemotherapy. 7.2 METHOD OF COLLECTION DATA SAMPLE & SAMPLING CRITERIA: SAMPLE : Cancer patients undergoing chemotherapy SAMPLING CRITERIA : (A) Inclusion criteria : Cancer patients undergoing chemotherapy who are; willing to participate ; above 18yrs of age. Who can comprehend and speak Kannada and English (B)Exclusion criteria : Cancer Patients undergoing chemotherapy who are ; Not willing participate In debilitating condition. Patients on combine treatment. 14 : Non probability, purposive sampling SAMPLE SIZE : 30 each in experimental and control group. DATA COLLECTION : Interview, Observation technique : * Standardised VAS, for (Pain and Nausea) SAMPLING TECHNIQUE TECHNIQUE METHOD OF DATA COLLECTION * StandardisedAnxiety scale * Observational check list for insomnia DATA COLLECTION PROCEDURE: Group Experimental Group Control group Pretest Day1 Assessment of Pain Intervention Day 1 to 7 Receives Reflex Zone Therapy Post test Day 8 & Day15 Assessment of Pain Nausea Nausea Anxiety Anxiety Receives Sleep Disturbance Routine Care Sleep Disturbance PLAN OF DATA ANALYSIS: Data will be analyzed using descriptive and multivariate statistics Descriptive and inferential statistical analysis is used to describe the characteristics of sample of frequency and percentage. 15 Chi square test for association among the variables Karl Pearson’s Coefficient of correlation used for finding the relationship ‘t’ test to find the effectiveness 7.3 Does the study require any investigation or intervention to be conducted on patients or other human or animals? If so, Please describe briefly. Yes, Patients are exposed to Reflex zone therapy as mentioned in the methodology. 7.4 Has ethical clearance been obtained from your institution in case of 7.3. Yes ,the ethical clearance has been obtained from concerned oncology institute and the college. 16 8.0 BIBILIOGRAPHY 1. Lewis Sharon, Heitkemper, Dirksen .Medical Surgical Nursing: Assessment and management of clinical problems. 6th ed. Washington :Mosby ;2004 .p 290,311 2. Black Joyce M, Jacob Esther Matassarin. Medical Surgical Nursing :clinical management and positive outcomes ; 7th ed. Elsevier publications .2004 .p 311 3. Dudi . All you should know about the reflexology and chemotherapy,. [serial online]. 2008 [cited 2008 july 2nd ];1 (1) :[5 screen] available from http:/www. Artilebase.com/ cancer articles 4. Ratna prakash ; Elsa santhobi; Moly . Easing cancer pain and anxiety. Journal of Nursing Times .2008.september ( ) 36-39. 5. Nitta Norie ; Aso Yoky; Hayama Yuka ; Nakhira mieko ,Numanami setsuko .”the effect of relaxation on foot massage combined with foot bah for delayed nausea induced by chemotherapy” . Japanese Journal of nursing research .2004 vol.37 (6) 517-528 6. Quattrin,R .Zanini ,A.Buchini,S. “use of reflexology foot massage to reduce anxiety in hospitalized cancer patients in chemotherapy treatment methodology and outcomes”. Journal of nursing management.2006 march vol 14 (2) 96-105. 17 7. Grelish, L ,Lomasney,A, Whiteman,B “Foot massage; A nursing intervention to modify the distressing symptom of pain and nausea in patients hospitalized with cancer” . Cancer nurse . 200, June vol 23 (2) ; 237 -243. 8. Y.M.Lee, “Effect of Self-Foot Reflexology Massage on Depression, Stress Reponses and Immune Functions of Middle Aged Women,” Taehan Kanho Hakhoe Chi 36, no.1 (2006): 179-88. 9. J.H.Yang , “the effects of foot reflexoloty on nausea, vomiting and fatigue of breast cancer patients undergoing chemotherapy “, Taehan Kango Hakhoe chi 35,no 1 (2005) : 177-85. 10. N.L..Stephenson, S.P.Weinrich and, A.S. Tavakoli, “the effect of foot reflexology on the pain and anxiety in patients with breast and lung cancer” , oncology nursing forum 27 no 1 (2000):67-72. 11. H.Hodgson , “Does reflexology impact on cancer patients quality of life ?” nursing standard 14, no .31 (2000): 33-38. 12. R.H. Song and H. Kim do, “The effects of foot reflexion massage on sleep disturbances ,depression disorders and the the physiological index of the elderly” ,Taehan Kanho Hakhoe chi 36 no.7 (2006):15-24. 18 9.0 SIGNATURE OF THE CANDIDATE : 10.0 REMARKS OF THE GUIDE : 11.0 NAME AND DESIGNATION OF (in block letters ) 11.1 GUIDE Dr. BHARTI .M. Professor & principal, JSS College Of Nursing Ist Main, Saraswathipuram, Mysore . 11.2 SIGNATURE : 11.3 CO- GUIDE (if any ): 11.4 SIGNATURE : 11.5 HEAD OF THE MEDICAL SURGICAL NURSING Nil DEPARTMENT : Dr. BHARTI.M . Professor & Principal, JSS College Of Nursing Ist Main, Saraswathipuram, Mysore. 11.6 SIGNATURE : 19 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL: Recommended and forward Dr. BHARTI.M . Professor & Principal, JSS College Of Nursing Ist Main, Saraswathipuram, Mysore 12.2 SIGNATURE : 20 SYNOPSIS PROTOCOL/OUTLINE SUBMITTED BY : ARCHANA .B 1 Year MSc Nursing J.S.S College of Nursing Mysore ST SUBMITTED ON 28/11/08 21