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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE ANNEXURE-11 PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION Mrs. NAVYA .GOPINADH UNITY COLLEGE OF NURSING 1 Name of the candidate and address (in block letters) SHEDIGURI, DAMBEL ROAD ASHOKNAGAR POST MANGALORE-575006 UNITY ACADEMY OF EDUCATION, COLLEGE OF NURSING, 2 Name of the institution SHEDIGURI, DAMBEL ROAD ASHOKNAGAR POST MANGALORE-575006 3 Course of study and subject 4 Date of Admission to the course MSc. NURSING PEDIATRIC NURSING 1.7.2010 5 Title of the study ‘A COMPARITIVE TEPID Vs WARM STUDY TO ASSESS THE EFFECIVENESS OF WATER SPONGING IN LOWERING BODY TEMPERATURE AMONG CHILDREN WITH PYREXIA IN SELECTED HOSPITALS OF MANGALORE’ . 6 BRIEF RESUME OF THE INTENDED WORK 6.1 INTRODUCTION Pyrexia has been recognized as a cardinal sign of disease since the beginning of recorded history. It is among the most common and most incontrovertible manifestations of disease and is one of the most frequent presenting symptoms in pediatric clinics and emergency rooms .The under –five mortality in India during the year 2005 is 74/1000 children .The common symptoms found in children were cough, cold, dysentery, fever and jaundice. More than 75% of the children admitted to the government hospital were with complaints of fever, body ache, joint pain and loss of appetite .Inspite of the attempts to support child health, the increasing incidence of fever is still a question and challenge posed on healthcare delivery system .8 Fever remains the most common reason why parents bring their children into the emergency room .Fever is a complex phenomenon, involving the highly coordinated interplay of autonomic, neuroendocrine, and behavioral responses to a variety of infectious and noninfectious inflammatory challenges. The febrile reaction is quite stereotyped and independent of precise causation. Various exogenous pyrogens (eg, toxins, infectious agents, antigen–antibody complexes) produce fever in humans by inducing the production of proteins, collectively termed endogenous pyrogens, by phagocytic leukocytes. These enter the circulation and interact with specialized receptor neurons in the preoptic, anterior hypothalamus. Signaling there leads to the production of prostaglandins, particularly PGE2, which is believed to be the critical mediator of the febrile response, and impacts on hypothalamic neurons that reset the thermostatic set point and result in several responses.11 The major effect of fever is on the vasomotor center which results peripheral vasoconstriction of cutaneous beds with redirection of blood flow to deeper tissues, thus minimizing skin heat loss. Additionally, sweating is decreased; vasopressin secretion falls, resulting in lowered extracellular fluid volume that requires heating; and behavioral modifications such as shivering and seeking a warmer environment are stimulated. These effects combine to elevate body temperature. Very rarely, fever is the result of central nervous system dysfunction (eg, hypothalamic tumor, infarction) that alters the thermostatic set point directly, rather than via pyrogen induction.11 A fever is the body's natural way of fighting off infection. It happens when the body's immune system releases chemicals that raise the body's temperature. Causes of a fever can include viral and bacterial infections as well as heat illnesses such as heat stroke, possible side effects to medications and immunization shots, and teething. There are several different categories of fever: low grade, common and high grade. A low-grade fever is considered to be a temperature between 99 and 1000 F. A common fever is considered to be a temperature of 101 and 103.6 0 F. A high-grade fever is considered to be a temperature of 103.60 F and above, which can be extremely dangerous for children. 5 Fever is having mild as well as fatal complications. Unusual complications include meningitis encephalitis, myocarditis and haemolytic anemia. A wide variety of techniques are used to reduce the patient’s body temperature during pyrexia .They are nursing the child in a cool environment, providing cold drinks ,improving the ventilation by fan or air conditions ,unwrapping or light clothing ,tepid sponging or cold bath . The febrile child can be treated with antipyretic drugs as well as non pharmacologic adjunctive measures .Antipyretic drugs lower the central set point, which minimize heat generation, still, external cooling has been considered as an effective measure to reduce body temperature .It has been used since antiquity to treat high temperature. Alexander the great received external cooling in the form of repeated cool baths as his principal therapy for the febrile illness to which he succumbed in 323 BC.2 6.2 NEED FOR THE STUDY Treating the fever in children is essential because it significantly increases comfort, activity, feeding and fluid intake is an issue of comfort for the child. Seizures due to fever occur in an age range of 4 months to 6 years ,which is associated with an abrupt rise in temperature.12 Certainly the higher the fever goes, the worse the child feels. Some of the mild side effects of fever include being lethargic, warm to the touch, fussy, having a loss of appetite, body aches, headaches, rapid breathing and trouble sleeping. Untreated fever may lead the child to fatal complications like brain damage.5 The drug therapy and hazardous substance committee of the Canadian pediatric society accepted that paracetamol as safer drug than other antipyretics. The most serious side effect is hepatotoxicity .There are reported cases of serious hepatotoxicity in children given paracetamol in dosages as low as 147-152 mg/kg/day when taken for 1 -4 days . Other literature identified 6 out of total 47 cases of hepatotoxicity where the child had received 100 mg/kg/day or less of acetaminophen .The therapeutic dose of paracetamol is close to toxic dose and is found in many preparations-both over the counter and prescription .This means that despite being one of the recommended doses there is a large potential for overdose and toxicity .1 Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. The elimination half-life varies from about 1 to 3 hours. The drug will be administered 6th hourly or 4th hourly. There is a chance of abrupt increase of temperature during the interval between dose of antipyretics after its peak action of 2 hours. While waiting for the medication to take effect, the temperature can also be brought down by lukewarm water baths; cold water or ice water is not recommended as they can cause the blood vessels in the skin to constrict, and decrease the body's ability to get rid of extra heat. Also, cold or chilly water will cause the child to shiver, which will increase the body's internal heat. Alcohol baths should not be used, since there is a small risk of alcohol poisoning.5 The evidence shows that physical therapy offers a simple and cost effective way of lowering the body temperature. Physical therapy (tepid sponging), in addition to administered antipyretic medication (paracetamol), is more effective than antipyretic medication alone in reducing fever in children. The primary purpose of any intervention is to increase the child's comfort (or decrease their discomfort). The decision to treat fever therefore needs to be: individualized, based on knowledge of effectiveness, balanced against any risk of harm that might result from intervening. Interventions that assist the body's physiological responses to infection (eg. encouraging fluids and removing excess clothing or wrappings) are particularly recommended. Studies exploring parental knowledge of fever have exposed unfound fears and misconceptions leading in many cases to unnecessary or inappropriate treatments and or visit to hospital or medical practitioners. Parental concern in some cases amounts to what has been labeled as fever phobia. Parental knowledge about normal body temperature and the temperature that indicates fever is poor. Mild fever is misclassified by many as high, and they actively reduce mild fever with incorrect doses of antipyretics. Although some parents acknowledge the benefits of mild fever, concerns about brain damage, febrile convulsions and death from mild to moderate fever persist irrespective of parental education or socio-economic status. Many base their fever management practices on inaccurate temperature readings. Increased use of antipyretics to reduce fever and waking sleeping febrile children for antipyretics or sponging reflects heightened concern about harmful effects of fever. There is a need for interventions based on behaviour change theories to target the precursors of behaviour, namely knowledge, attitudes, normative influences and parents' perceptions of control.10 Tepid sponging is a time honoured and well known method of reducing the elevated temperature. There is no hard evidence to suggest that reduction of temperature by tepid sponging adversely affects the disease process. But tepid sponging is sometimes perceived as a discomfort, especially by children and it may not be ideal for patients under intensive care, as it may induce vasoconstriction and shivering. As against tepid sponging, cold sponging can cause constriction of the cutaneous vessels and may even increase the core temperature. Therefore, tepid sponging (and not cold sponging) can be used as a method of reducing temperature, but it can cause some discomfort to the patients, specially children.13 The use of luke warm water must be encouraged in febrile patients. To reduce the level of discomfort, they can be advised to have their bath whenever the temperature has settled down from its peak. Bathing with luke warm water will certainly help in dilating the sweat glands and reducing the stink of sweat and will give some freshness. Bathing at the height of fever, particularly with cold water, is probably not advisable. Also patients who are sick, bed ridden and elderly may be given a warm sponge bath and a regular bath or cold sponging is not advisable in these patients.12 The inconsistent nursing management of fever due to lack of evidence to support the routine use of physical methods, especially sponging .The purpose of intervening the pyrexic child must be clearly identified .It must be to increase child’s comfort by decreasing the temperature or to reduce parental anxiety .These considerations should be balanced against any harm that might result from intervening, for example placing the child at risk for liver damage. Sponging is considered as one of the most effective measures in physical treatment for reduction of fever which can be easily taught to the parents and therefore need not divert nursing staff from other duties. Tepid water and cold water are commonly used for sponging which can cause discomfort like shivering goose pimples and crying and these are the same symptoms which sponging aim to reduce .Still many hospitals are using this method as an adjunctive therapy to antipyretics . This can be avoided by the use of warm water for sponging the pyrexic child .Pyrexia is treated with water from the recorded history but the optimum temperature for sponging considering comfort of the child with fever, is not studied .So the researcher felt a need to compare the effects of two physical methods of ie tepid and warm water sponging in lowering body temperature and to compare the behavioral responses exhibited by the children. 6.3 REVIEW OF LITERATURE Literature review is a compilation of resources that provides the ground work for further studies .When the researcher is able to find the right number of quality resource articles to guide the study a doorway is opened. The literature reviewed has been organized under the following headings. 1.Perception on pyrexia 2.Causes and management of fever 3 .Effectiveness of warm water sponging in reduction of fever. 4. Effectiveness of tepid sponging in reduction of fever. 1.Perception on pyrexia The understanding of fever ,its treatment and beliefs about its consequences was surveyed in parents and health care providers .Self administered surveys were distributed to 3 parent groups and four health care provider groups .Parent group included the parents of children with fever ( n =209 )with injury (n=160),and healthy school children ( n= 141).The health care provider groups included pediatric physicians ( n=16) ,pediatric nurses( n=39),general pediatricians( n =26) .Parent group considered a temperature of 37.90 Celsius , to be fever 39.10 Celsius to be high fever ,and 39.90 Celsius to be dangerous fever .They were almost concerned about the discomfort seizures and dehydration .1 2.Causes and management of fever A study was conducted to describe the epidemiology, management and outcomes of children with fever in pediatric primary care practice in a cohort of 20,585 children, 3 -36 months of age cared for in 11 peadiatric officer. Among 3819 initial visits of an illness episode, 41 % of children had diagnosed bacterial or specific viral source. Of these 13%with a temperature of 38 0 and 30 % with a temperature of greater than or equal to 390 Celsius received laboratory testing .The majority of febrile children in ambulatory settings were diagnosed with a bacterial infection and treated with an antibiotic .2 3 .Effectiveness of warm water sponging in reduction of fever. The effect of warm sponging alone and warm sponging with medication including a single oral dose of aspirin 15 mg /kg or paracetamol 15 mg/kg or ibuprofen 8 mg/kg was compared in 224 children between 6 months and 5 years with rectal temperature greater than 30 0 C .Rectal temperature was recorded every 30 minutes for 3 hours .Sponging was found to be more effective in the first 30 minutes than 3 medications (P ≤ 0.001) but after 60 minutes the effect of each medication became superior to sponging with tepid water in reducing body temperature .Further comparing the effect of 3 different medication showed that the antipyretic efficacy of aspirin and ibuprofen with warm sponging showed high antipyretic efficiency .3 The efficacy of 3 interventions in lowering body temperature was tested in a randomized control trial in 73 children with rectal temperature higher than 38.90 Celsius. They were categorized as antipyretic alone (n = 28) and sponging alone (n = 19). Antipyretic group received acetaminophen 10 – 15 mg/ kg antipyretic and sponging group received acetaminophen 10-15 mg/kg followed by warm water sponging and sponging only group received sponging for 20 minutes . There was no difference between groups after 30 minutes and 60 minute temperature reduction was greater in acetaminophen alone group than sponging only group p =( 0.03).The reduction of temperature was greater in acetaminophen with sponging than acetaminophen alone group( p = 0.003) where the former reduced the temperature by 9 0C while the latter only 40 C .4 A randomized open, parallel group study was conducted using factorial design to compare the effect of unwrapping; only warm sponging with unwrapping, and paracetamol with unwrapping on fever reduction among 52 children. The axillary temperature was assessed and continuous data logging was done. The study heightened a little effect with unwrapping alone whereby paracetamol decresed the temperature below 37.2o C in 4 hours compared to unwrapping .However warm sponging caused rapid reduction in temperature15. 4. Effectiveness of tepid sponging in reduction of fever. Fever reduction interventions like acetaminophen alone and acetaminophen accompanied with 15 min tepid sponging was carried out in randomly assigned children between 5-68 months of age .The temperature was monitored by infrared tympanic thermometer initially and at 30 minutes intervals during the 2 hour study period .The tepid sponge lasting 15 minutes was administered 30 minutes after acetaminophen dose .They were also monitored for signs of discomfort like crying , shivering and goose bumps at 15 minute intervals through out the study period and a minute interval during bath .Sponged group temperature dropped more quickly in the first hour but no significant difference between groups over 2 hours was observed .However sponged group exhibited higher discomfort ( P = 0.009) during sponging .5The effectiveness of tepid sponging, in addition to antipyretic medication, in the reduction of temperature in febrile children living in a tropical environment, was assessed in a prospective, randomized, open trial. Seventy-five children aged between 6 and 53 months who attended the casualty department of the Children's Hospital, Bangkok, Thailand, with fever (rectal temperature > or = 38.5 degrees C) of presumed viral origin were randomized to received either tepid sponging and oral paracetamol (sponged group) or paracetamol alone (control group). Rectal temperature and the occurrence of crying, irritability, and shivering were recorded over the following 2 hours. A greater and more rapid fall in mean rectal temperature occurred in the sponged group than in the control group. Temperature fell below 38.60 C sooner in children in the sponged group than in control children (P < 0.001). At 60 minutes, 38 (95.0%) of the controls still had a temperature of 38.6 0 C or greater, compared with only 15 children (42.9%) in the sponged group (P < 1 x 10(-5). Crying was associated with sponging, but shivering and irritability occurred in only one child who was being sponged. It is concluded that tepid sponging, in addition to antipyretic medication, is clearly more effective than antipyretic medication alone in reducing temperature in febrile children living in a tropical climate.14 A block randomized clinical trial was conducted to compare the efficacy of tepid sponging with the use of paracetamol in 80 febrile children with an age between 0-54 months .Axillary temperature and assessment of discomfort were recorded every 30 minutes for two hours .A significantly greater and more rapid reduction of fever was demonstrated with paracetamol than tepid sponging .Tepid sponging without antipyretics was often used to reduce fever but only for first 30 minutes.9 6.4 PROBLEM STATEMENT A COMPARITIVE STUDY TO ASSESS THE EFFECIVENESS OF TEPID Vs WARM WATER SPONGING IN LOWERING BODY TEMPERATURE AMONG CHILDREN WITH PYREXIA IN SELECTED HOSPITALS OF MANGALORE. 6.5 OBJECTIVES The objectives of the study are to: evaluate the effectiveness of tepid water sponging in lowering body temperature among children with pyrexia. evaluate the effectiveness of warm water sponging in lowering body temperature among children with pyrexia. compare the behavioral response among children with pyrexia during tepid and warm water sponging. find the association between effect of tepid and warm water sponging with selected demographic variables of children with pyrexia. 6.6 OPERATIONAL DEFINITIONS Effectiveness : Effectiveness refers to the extend to which a febrile child will regain normal body temperature and remain comfortable following tepid as well as warm water sponging for a duration of 15 minutes as measured orally by using digital thermometer , after 30th and 45th minute of sponging and the level of discomfort will be measured during sponging using behavioral response observational check list. Tepid water sponging: Tepid sponging in this study refers to wiping the child’s whole body with wet sponge cloth for 15 minutes using tepid water having room temperature of 30-400C as an intervention to reduce the elevated body temperature to near normal limits, irrespective of antipyretic administration . warm water sponging : warm water sponging in this study refers to wiping the child’s whole body with wet sponge cloth for 15 minutes using warm water with temperature between 65-700 C as measured using a lotion thermometer as an intervention to reduce elevated body temperature to near normal limits, irrespective of antipyretic administration . Hospitalized children : children with fever aged between 3 -8 years who are admitted in pediatric ward for medical care, irrespective of their sex, disease condition and duration of hospital stay. Pyrexia: pyrexia in this study refers to a hyperthermic state ranging from 1010 F to 1040 F as measured orally using a digital thermometer. 6.7 ASSUMPTIONS The study assumes that, 1. sponging with tepid water or warm water will reduce fever among children . 2. in combination with sponging the effect of antipyretic can be enhanced . 3. ineffectively managed fever will leave children with fatal side effects like febrile seizures , permanent brain damage and in very severe cases ,even death. 4. children who are given sponging with tepid water will exhibit more discomfort than those who receive warm water sponging . 6.8 DELIMITATIONS The study is delimited to, 1. children with hyperthermic state ranging between 101-104 0 F. 2. children within the age group 3 – 8 years . 3. children those who are admitted in the pediatric wards of selected hospitals during the data collection period . 4. children will be observed only in the 30th and 45th minute after giving intervention. 6.9 HYPOTHESES All hypotheses will be tested at 0.05 level of significance H1: There will be significant difference in the effect of tepid water sponging and warm water sponging in lowering body temperature among children with pyrexia. H2 : : There will be significant difference in the behavioral response of pyrexic children sponged with tepid water as compared with children sponged with warm water . H 3: There will be significant association between the effect of tepid and warm water sponging with selected demographic variables of children. 7 MATERIALS AND METHOD 7.1. SOURCE OF DATA In this study ,data will be collected from all children with hyperthermic stage ranging from 101-1040F who are admitted in pediatric ward for medical care , irrespective of their sex and duration of hospital stay in selected hospitals of Mangalore . .7.1.1. Research Design A Quasi- Experimental non -equivalent untreated control group and two experimental groups with post test measures more than one time interval design will be adopted. Pretest Warm water Treatment Post test 30th 45th min min O 1.2 O 1.3 O 1.4 O1.1 _X1 O2.1 X2 O 2.2 O 2.3 O 2.4 O3.1 ---- ----- O 3.2 O 3.3 Sponging Tepid water Sponging Control O1.1,O1.3 ,O1.4 :assessment of temperature before the intervention and after the intervention at 30th .and 45th minute in group 1 in which 20 children will be receiving warm water sponging. . O2.1, O2.3, O2.4 : assessment of temperature before the intervention and after the intervention at 30th .and 45th minute in group 2 in which 20 children will be receiving tepid sponging. O3.1, O3.2, O3.3 : assessment of temperature before and during the 30th .and 45th minute after the antipyretic administration in group 3 which will be a control group receiving neither tepid nor warm water sponging. X1 O : sponging with warm water : assessing the behavioral response during sponging using an observational checklist 1.2 in group 1. X2 O2.2 : sponging with tepid water : assessing the behavioral response during sponging using an observational checklist in group 2. 7.1.2 Setting The study will be conducted in pediatric wards of selected hospitals at Mangalore. 7.1.3 Population In this study, population consists of children aged 3-8 years admitted in the pediatric ward with the hyperthermic state ranging from 101 -104 0 F in selected hospitals of Mangalore. 7.2 METHOD OF DATA COLLECTION 7.2.1 Sampling procedure The samples will be selected by using non-probability Purposive sampling with random assignment. 7.2.2 Sample size Sample size will be 60 Among 60, 20 children will be assigned in each of 3 groups. 7.2.3 Inclusion criteria for sampling 1 .Hospitalized children with fever ranging from 101 -1040 F. 2. Children in the age group 3 – 8 years. 3. Children receiving only antipyretics and no other physical or external measures for lowering body temperature. 4. Children those who are co-operative during the intervention. 5. Children of mothers giving consent for the intervention. 7.2.4 Exclusion Criteria for Sampling Children who develop rigor before or during the intervention. Children those who are contraindicated for sponging like burns, headinjury, septicemia, open wounds etc. Unconscious or seriously sick children. Children receiving any other external cooling measure. 7.2.5 Instruments Tool 1:- baseline pro-forma. Tool 2 :- Part A :temperature recording data sheet Part B: behavioral response observation checklist for children during sponging . 7.2.6 Data collection method After obtaining permission from the concerned authorities and consent from the parents , data will be collected from the children in age group between 3- 8 years having fever ranging from 101 -1040 F. The sample size will be 60 and the samples will be selected by nonprobability purposive sampling. A 20 children will be randomly allotted to each of 3 groups .After pretest temperature recording using digital thermometer , children among group 1 will be receiving warm water sponging and children among group 2 will be receiving tepid water sponging and children among group 3 will be receiving neither warm or tepid water sponging. The behavioural response will be observed during sponging using a behavioural response observational checklist.A post test measurement of temperature recording at 30th and 45th minute will be completed. 7.2.7 Data analysis plan The data will be analyzed using descriptive and inferential statistics. 7.3 Does the study require any investigations or interventions to be conducted on patients, or other animals? If so please describe briefly. Yes. Tepid or warm water sponging will be given to children with fever ranging 1011040F lowering body temperature to near normal limits. 7.4 Has ethical clearance been obtained from your institution in case of 7.3? Yes .Ethical clearance will be obtained from the concerned authorities. 8 LIST OF REFERENCES 1. Karwowska A .Jordan C N, Johnson D ,Davies HD .Parental and healthcare provides understanding childhood fever : Can J Emerg Med 2002 ;4(6) :394-402 2 .Finkelstein J A , Christiansen CL, Platt R . Fever in paediatric primary care ,occurrence management and outcomes .Paediatr 2000; 105 (1):200 -65 3 .Aksoylar S , Aksit S ,Caglayan S,Yaprak T . Evaluation of sponging and antipyretic medication to reduce body temperature in febrile ,Acta Paediatr 1997 ;39:215-7 4 . Newman J. Evaluation of sponging to reduce body temperature in febrile children .Can Med Assoc J. 1985 ;132 :642-2 5. Sharber .J .The efficacy of tepid sponge bathing to reduce fever in young children ,Am J Emerg Med . 1997 ;15:188-92 6.Kothari CR .Rresearch Methodology .Methods and techniques .2nd ed New Delhi :2003 7.Atkins E .Fever :The old and the new .J Infect Dis 1984 ;149:339-49 8.Steel RW ,Tanaka PT ,Lara RP, Bass JW .Evaluation of sponging and of oral antipyretic therapy to reduce fever .J Pediatr 1979 ;7:194 -9 . 9 .Agbolosu NB ,Cuevas LE ,Milligan P ,Broadhead R L .Efficacy of tepid sponging versus Paracetamol in reducing temperature in febrile children . Trop Paediatr1997 ;17:283 – 288 . 10 . Walsh A, Edwards H . Management of childhood fever by parents . J Adv Nurs. 2006; Apr;54(2):217-27. 11. Gildea JH.When fever becomes an enemy. Pediatr Nurs 1992; 18: 165-167. 12 . Shackell S. Cooling hyperthermic and hyperpyrexic patients in intensive care. Nurs Crit Care 1996 Nov-Dec;1(6):278-82 13.Mahar AF, Allen SJ, Milligan P, Suthumnirund S, Chotpitayasunondh T, Sabchareon A,Coulter JB. Tepid sponging to reduce temperature in febrile children in a tropical climate:Clin Pediatr (Phila). 1994 ;33(4):227-31. 14.Meremikwu MM, Oyo –Ita A.Physical methods versus drug placebo or no treatment for managing fever in children .Cochrane Database Syst .Rev ,2003;( 2):cd004264 15 .Kinnmouth AL .Management of fever .Brit Med J .1992 Nov 7 ; 305 (6862):1134-6 9 SIGNATURE OF CANDIDATE 10 REMARKS OF THE GUIDE 11 NAME & DESIGNATION OF ( IN BLOCK LETTERS) 11.1 GUIDE Mrs .G .CHITHRA PROFESSOR UNITY COLLEGE OF NURSING MANGALORE. 11.2 SIGNATURE 11.3 CO-GUIDE ( IF ANY) 11.4 SIGNATURE 11.5 HEAD OF THE DEPARTMENT Mrs .G.CHITHRA PROFESSOR UNITY COLLEGE OF NURSING MANGALORE. 11.6 SIGNATURE 12 12.1 REMARKS OF THE CHAIRMAN & PRINCIPAL 12.2 SIGNATURE