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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1 Name of the candidate and address ANUMOL K. V. (in block letters) ADYAR SAHYADRI COLLEGE OF NURSING MANGALORE-575007. 2 SAHYADRI COLLEGE OF NURSING Name of the institution ADYAR MANGALORE-575007 3 M. Sc. NURSING Course of the study and subject MEDICAL SURGICAL NURSING 4 Date of admission to the course 5 Title of the study A COMPARATIVE 01.06.2010 STUDY TO ASSESS THE EFFECTIVENESS OF HOT FOMENTATION VERSUS COLD COMPRESS IN REDUCING INTRAVENOUS INFILTRATION AND PAIN AMONG PATIENTS IN A SELECTED HOSPITAL AT MANGALORE, KARNATAKA. 1 6 Brief resume of the intended work 6.1 Need for the study Intravenous infusion has become an indispensable component in medical therapy. It is used to correct electrolyte imbalances, to deliver medications, for blood transfusion or as fluid replacement to correct dehydration. In spite of its therapeutic effects the most frequently encountered problems are infiltration and extravasation. Unfortunately, they are so common, that they are sometimes overlooked or not addressed as soon as they should be, or else they can produce debilitating effects1 A study conducted by infusion nursing society on incidence of intravenous catheter complications in the hand and forearm reported that 67 patient had developed intravenous catheter complication in a hospital over a three year period in which 56 minor complications and 11 major complications. In 68% of minor complications, the patients were aged 50 years or older and 68% were women in which minor complications comprised 26 intravenous infiltrations and 23 cases of thrombophlebitis. The most common complication of peripheral venous cannulation is infiltration which results in an inflammatory reaction, and is manifested as pain, swelling, and erythema that may prolongs the duration of hospital stay. Therefore, nurses are in a pivotal position to manage infiltration through effective nurseinitiated intervention that are economical in both nursing times and resources. In the past, drugs have been the conventional methods to alleviate pain and swelling, but in many instances, medications themselves do not provide optimal results. The modality of hot and cold compression have a very appropriate role in the treatment of almost all injuries involving soft tissues involves pain, possible bleeding and a leakage of fluid from damaged tissues into the area.2 A comparative study was conducted in Pune on effectiveness of hot fomentation versus cold compress for reducing intravenous infiltration. The sample size was sixty patients (30 for hot fomentation and 30 for cold compress) with mild to moderate degree of infiltration stayed in hospital for 8-14 days and data was analysed by using descriptive and inferential statistics. Findings prove that the pretreatment mean score of degree of infiltration was 7.1667 reduced to 0.7071 on the 2 third day of treatment with hot fomentation. In cold compress pre-treatment mean score 6.9333 reduced to 0.70571. The study concluded that both hot fomentation and cold compress are effective in treatment of intravenous therapy related infiltration3. In contrast, a study was conducted on effectiveness of warm versus cold applications of intravenous infiltrations at Health Science Centre, New York. Differences in pain intensity, surface area measurements of induration and erythema, and interstitial fluid volume when warm versus cold applications were randomly made to an intentional intravenous infiltrate of 5 ml of a designated solution were examined. Three solutions were used: 0.5 saline, normal saline, and 3% saline. Study was done with 18 samples .There was induration and erythema was no difference in remaining infiltrate when 0.5 saline or normal saline were used, but a significant (p<0.001) difference was found with 3% saline. Pain intensity did not differ by treatment but a significant (p<0.005) difference was found by solution, with 3% saline producing the greatest difference. Erythema was absent with all solutions. Surface induration was affected by solution and decreased overtime (p=0.001) .There was no effect of warmth or cold on surface area induration4. Some studies shows that hot and cold application is very effective in reducing intravenous infiltration at the same time others shows there is no effect. Since it is contradictory to nursing practice investigator felt that there is a need to be check the effectiveness of hot fomentation versus cold compress in reducing intravenous infiltration. 6.2 Review of literature A comparative study was conducted in Pune on effectiveness of hot fomentation versus cold compress for reducing intravenous infiltration. The sample size was sixty patients (30 for hot fomentation and 30 for cold compress) with mild to moderate degree of infiltration stayed in hospital for 8-14 days and data was analysed using descriptive and inferential statistics. Findings prove that the pretreatment mean score was 7.1667 reduced to 0.7071 on the third day of treatment with hot fomentation. In cold compress pre-treatment mean score 6.9333 reduced to 3 0.70571. The study concluded that both hot fomentation and cold compress are effective in treatment of intravenous therapy related infiltration3. An interventional study was conducted in Mangalore on effectiveness of nursing interventions (ichthammol glycerine, thrombophob, hot fomentation) on patients with phlebitis related to peripheral intravenous infusion. The sample consist of 45 subjects and three treatment was administered to 15 patients for three days two times a day. The collected data were analysed by using ANOVA and t test. The study concluded that treatment with warm ichthammol glycerine dressing was most effective ,pre treatment score 7.67 reduce to 1.47 on the third post treatment day with warm ichthammol glycerine5. A study was conducted in West Bengal on effectiveness of four modalities (hot fomentation, glycerine magnesium sulphate application, ichthamol magnesium sulphate and ichthamol belladonna) of nursing interventions evaluated. Tool included the demographic data to know the sample characteristics, phlebitis measurement chart, observation check list and visual analogue scale. The pre test mean pain score related to peripheral IV infiltration were 61.23 and post test mean pain scores were 13.27 in treatment with ichthamol belladonna dressing with hot fomentation which was found to be most effective out of all the 4 interventions. Thus the study concluded that ichthamol belladonna dressing with fomentation was effective6. An interventional study was conducted in Mangalore on effectiveness of ice packs versus thrombophob gel for reducing iv infiltration in patients admitted in paediatric wards. The study was conducted on 40 samples (20 for thrombophob gel group and 20 for ice cube group) selected using purposive sampling technique. The infiltration was assessed by using modified infiltration scale. The results showed that before the treatment, majority (65%) of patients had grade two infiltration after the treatment with thrombophob and 100% of patient’s infiltration had reduced to grade one infiltration. In group two majority (80%) had grade two infiltration after the treatment with ice cube 100% had grade one infiltration. The study concluded that both thrombophob gel and ice pack are effective in reducing intravenous infiltration among paediatric patients7. 4 A comparative study was conducted in Portland on the effect of warm and cold application on resolution of phlebitis. The sample was composed of 18 healthy adult volunteers. The findings reveals that application of warm to sites of iv phlebitis produced faster resolution of extravasation than did cold application at a significance difference (F=14.38,p<0.001)8. A comparative study was conducted at monarch university on effect of elevation, warmth and cold on phlebitis .Nursing interventions used to treat intravenous phlebitis generally included application of warmth and cold, elevation. The study concluded that effect of warmth versus cold on phlebitis shown that warmth is better than cold in decreasing the symptoms or speeding re-absorption of the infiltrate9. 6.3 Problem statement A comparative study to asses the effectiveness of hot fomentation versus cold compress in reducing intravenous infiltration and pain among patients admitted in a selected hospital at Mangalore, Karnataka. 6.4 Objectives of the study The objective of the study are: To assess the degree of infiltration before and after intervention in both groups as assessed by standardised infiltration scale. To assess the pain before and after intervention in both groups as assessed by numerical pain scale. To determine the effectiveness of hot fomentation on intravenous infiltration and pain. To determine the effectiveness of cold compress on intravenous infiltration and pain. 5 To compare the effectiveness of hot fomentation versus cold compress on intravenous infiltration and pain. To find association between pre-test score of infiltration and pain with selected demographic variables. 6.5 Operational definitions Effectiveness: Effectiveness means capability of producing some effect (Wikipedia). In this study, effectiveness refers to the extent to which the hot fomentation and cold compress in reducing intravenous infiltration and pain as measured by infiltration measurement scale and numerical pain scale respectively. Hot fomentation: A preparation of hot moist material applied to any parts of the body to increase local circulation, alleviate pain or soften the skin (Oxford Dictionary). In this study, hot fomentation refers to application of gauze pad soaked in hot water (40-450C) to area of infiltration for the duration of 15 minutes twice a day in the morning and evening for three days. Cold compress: Cold compress is a local moist cold application made out of folded layers of gauze, lint piece or old soft linen, wring out of cold or ice water or in some evaporating lotion applied to the required area (Sister Nancy). In this study cold compress refers to the application of ice cube covered by gauze to the area of infiltration for the duration of 15 min twice a day in the morning and evening for three days. 6 Intravenous infiltration: Infiltration refers to escape of escape of fluid in to the subcutaneous tissues due to the dislodgement or malfunctioning of the cannula characterized by swelling, pain or itching, burning, skin that is cool to the touch or discoloration (Whaley and Wong, 2006) . In this study, infiltration refers to the infusion site with features of swelling, pain or, skin is cool to touch or discoloration. Pain: Pain is a feeling of distress, suffering or agony, caused by stimulation of specialized nerve endings (Bailliere’s Nurse’s Dictionary). In this study, pain refers to subjective feeling of discomfort measured by scores of numerical pain scale. Patient: Patient refers to a person receiving or registered to receive medical treatment (Wikipidea). In this study, patient refers to a male or female admitted with age group of 25-40 years receiving peripheral intravenous infusion with the signs of infiltration. 6.6 Assumptions The study assumes that: Patients on intravenous therapy are at risk for developing infiltration. Hot and cold applications inducing vasodilation and vasoconstriction respectively there by reducing intravenous infiltration. 6.7 Delimitations The study is delimited to a period of one month. The study is delimited to adults of age group 25-40 years. Only limited to selected hospital in Mangalore. 7 6.8 Hypotheses (All hypotheses will be tested at 0.05 level of significance) H1: There will be a significant reduction in infiltration and pain among patients after application of hot fomentation H2: There will be a significant reduction in infiltration among patients after the application of cold compress. H3: There will be a significant difference in infiltration and pain among those who receive hot fomentation and those who receive cold compress. H4: There will be significant association between pre-test scores of infiltration and pain with selected demographic variables. 7. Materials and methods 7.1 Source of data collection The data will be collected from patients with IV infiltration in selected hospital at Mangalore. 7.1.1 Research design Quasi-experimental Time series design Group I: R O1 X1 O2 X1 O3 X1 O4 Group II: R O1 X2 O2 X2 O3 X2 O4 O1: Observation made before the intervention O2: Observation on the first day of intervention O3: Observation on the second day of intervention O4: Observation on the third day of intervention 8 X1: Hot fomentation X2: Cold compress Group I: Patients receiving hot fomentation Group II: Patients receiving cold compress R: Randomisation 7.1.2 Setting The study will be conducted in medical surgical wards on selected hospital at Mangalore. 7.1.3 Population Population includes patients with signs and symptoms of intravenous infiltration admitted in selected hospital at Mangalore. 7.2 Method of data collection 7.2.1 Sampling procedure The samples for the study will be selected by purposive sampling technique. 7.2.2 Sample size The sample for the study would comprise of 60 patients (30 hot fomentation groups and 30 cold compress groups) who are having intravenous infiltration and pain as assessed by standardized infiltration measurement scale and numerical pain scale. 7.2.3 Inclusion criteria for sampling Patients who are: In the age group of 20-40 years, both male and female, receiving peripheral 9 intravenous infusion with signs of infiltration. Patients who are willing to participate in the study. Patients who are on IV fluid therapy irrespective of whether medicated or non-medicated. Patients who are conscious and well oriented. 7.2.4 Exclusion criteria for sampling Clients with moderate and severe dehydration. Clients with central venous infusion. Clients on chemotherapy. Clients who developed phlebitis. 7.2.5 Instruments used Demographic proforma. Standardized infiltration measurement scale. Numerical pain scale. 7.2.6 Data collection method The investigator will obtain formal permission from the selected institution. The purpose of the study will be explained to the patients and informed written consent will be obtained from them. Infiltration and pain measurement is done using standardized infiltration measurement scale and numerical pain scale respectively. Samples for Hot fomentation and cold compress will be assigned randomly 10 by lottery method. Hot fomentation will be applied to 30 subjects for 15 minutes twice a day for three days. Cold compress will be applied to another 30 samples for 15 min twice a day for three days. After each intervention post-test will be conducted using the infiltration measurement scale and numerical pain scale. 7.2.7 Data analysis plan Demographic data and observational record will be analysed using descriptive statistics. Effectiveness of intervention will be analyzed by using paired ‘t’ test and independent ‘t’ test. Chi-square will be used to find out association between pre-test infiltration and pain with selected demographic variables. 7.3 Does the study require any investigation to be conducted on patients or other humans or animals (if so, please describe briefly) Yes. In this study researcher has to apply hot fomentation or cold compress on patients with infiltration. 7.4 Has ethical clearance been obtained from your institution in case of 7.3? Yes, permission will be obtained from concerned authorities of selected institutions. Informal written consent will be obtained from participants. 11 8. LIST OF REFERENCES 1. Intravenous therapy. [online]. 2010 [cited 2010 Sep 25]; Available from: URL:http://www.answers.com/topic/content. 2. Fabian B. Intravenous complication: infiltration. Journal of Intravenous Nursing 2000 Jul;23(4):229-31. 3. Anjum S. Hot fomentation versus cold compress for reducing intravenous infiltration. Nursing Journal Of India 2007 Nov;xcviii(11):253-4. 4. Tompkins L, Roboson L, Szevrenj N. Effect of warm and cold applications on the resolution of IV infiltrations. Journal of Infusion Nursing 1993;(3):10. 5. Joseph J. Effectiveness of nursing interventions on patients with phlebitis related to peripheral intravenous infusion. Honours (thesis) submitted to Rajiv Gandhi University of Health Sciences, Bangalore; 2009. 6. Biswas D. A study to compare the effect of selected nursing interventions on patients with phlebitis related to peripheral intravenous infusion in selected hospital of Kolkata, West Bengal. Health Action 2005. 7. Vishwambaran N. Effectiveness of thrombophob versus ice application in reducing iv infiltration. Honours (thesis) submitted to Rajiv Gandhi University of Health Sciences, Bangalore; 2009. 8. Hastings MT, Tompkins J .Effect of warm and cold applications on resolution of IV phlebitis. Journal of Clinical Epidemiology 1993 Jun;16(3):171-2. 9. Yucha CB. Effectiveness of elevation, warmth and cold on phlebitis. [online]. 1998. Available from: URL:http:/www.springerlink.com/content. 12 8. Signature of the candidate 9. Remarks of the guide 10. Name and designation of (in block letters) 11 12. PROF. RAJA A. HOD MEDICAL SURGICAL NURSING SAHYADRI COLLEGE OF NURSING MANGALORE 10.1 Guide 10.2 Signature 10.3 Co-guide (if any) 10.4 Signature 11.1 Head of the department 11.2 Signature 12.1 Remarks of the Chairman and Principal 12.2 Signature PROF. RAJA A. HOD MEDICAL SURGICAL NURSING SAHYADRI COLLEGE OF NURSING MANGALORE 13 14 15