RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA.

SYNOPSIS PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1) Name of the candidate and address: Mrs. OBULAKSHMI.S #29, ATTUR LAY OUT, SANTHOSH NAGAR, YELAHANKA 4TH PHASE, YELAHANKA NEW TOWN, BANGALORE - 560106 2) Name of the institution : MIRANDA COLLEGE OF NURSING, CA-29, 5TH PHASE, KHB COLONY YELAHANKA NEW TOWN, BANGALORE-560106.

3) Course of study and subject : M.Sc NURSING COMMUNITY HEALTH NURSING

4) Date of admission to the course : 9th October, 2009

5) Title of the study : A COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF DISTRACTION TECHNIQUES IN ALTERING BEHAVOUR RESPONSE TO PAIN AMONG TODDLER RECEIVING IMMUNIZATION AT SELECTED PRIMARY HEALTH CENTRES IN BANGALORE. 6) BACKGROUND OF THE STUDY: “A child is precious and beautiful, A source of joy and happiness, A focus of love and care, A subject of dreams for the future.” (Child care. 1996) Immunisation is an important part of health promotion and disease prevention strategy for all children1. One of the most dramatic advances in pediatrics has been the decline of infectious diseases during the twentieth century because of the widespread use of immunisation for preventable diseases2. Despite recent advances in the assessment and management of acute pediatric pain, outlined in the clinical practice guidelines of the Agency for Healthcare Policy and Research (AHCPR), children continue to be subjected to pain and distress during immunisation4. Reports from children, parents and nurses consistently indicate that many children do indeed fear the “shot.” This finding is also supported by research indicating that a minority of the adult population also suffer from fear involving needles3. A child’s anxiety and fear of a procedure and actual pain experience during the procedure often are manifested by the child’s distress behaviour such as crying, flailing and refusal to cooperate. The child’s distress is upsetting not only for the child but also for the adults involved, both parents and professionals, and it often makes it more difficult to complete the needed procedure7. Children are precious to their family. The term “terrible twos” has been often used to describe the toddler years; the period from 12 to 36 months of age is the time for intense exploration of the environment as children attempt to find out how things work power of temper tantrums, negativism and abstinence6. Parents want their child to be safe from diseases. For this reason, they selected immunisation as a preventive measure; routine immunisation is an almost universal experience for children. Although it is a relatively minor painful procedure, the fear of the “shot” is widespread, fear of injection is most frequent in children and persists in 140/1000 people at age 20. Immunisation is a proven tool for controlling and eliminating life-threatening infectious diseases and is estimated to avert 2 million deaths each year6. Cohen LL.et.al (2002) conducted a comparative study to isolate and compare childrens procedural anxiety and pain. Results suggested that anxiety and pain are highly correlated13. Cohen LL.et.al (2002) conducted study to examine the nurse directed distraction for reducing infant immunization distress. Results suggested that infants engaged in distraction and reduced behavioral distress13. Behavioural observation is the primary assessment approach for pre-verbal and non- verbal children, and is an adjunct to assessment for verbal children. Observations focus on vocalizations (e.g., crying, whining, or groaning) verbalisations, facial expressions, muscle tension and rigidity, ability to be consoled, guarding of body parts, temperament, activity and general appearance. Adequate reliability and validity documentation is lacking for behavioural observations, even though clinicians often attribute greater importance to non-verbal expression than to self-report7. To ensure adequate pain relief and to make the children a sense of control over the situation, non-pharmacological methods are widely accepted as additional strategies that may be used independently or in addition to medication. When used in association with medical procedure, use an intervention before, during, and after the procedure. This gives the child a chance to recover, feel mastery and remember coping. Cutaneous stimulation, electro-analgesia, imagery, relaxation technique, hypnosis and distraction are common non-pharmacological techniques9. Distraction is a non-pharmacological intervention that diverts attention from a noxious stimulus through passively redirecting the subject’s attention or by actively involving the subject in the performance of diversion task. Distraction involves capturing child’s attention and focusing away from the stressful situation and towards something more pleasant. It takes little training to learn, is easy to administer and requires few materials and something familiar to most individuals. It is particularly useful for younger children. Examples of distracters used with children are picture books, talking with the child, music, party blowers, kaleidoscope, prop up book, blowing bubbles, looking for hidden objects in the room, counting out loud, hand-held computer games, imagining fun and exciting things or quiet and relaxing scenes10. 7. BRIEF RESUME OF THE INTENDED WORK: 7.1. NEED FOR THE STUDY Routine immunisation bumps and bruises, and childhood illnesses mean that pain is a part of the everyday experiences of all infants and children. Younger children are particularly in need of interventions because they report more pain and display more behavioural distress during medical process11. Horn MI.et.al (2000) conducted a comparative study to compare the distress behaviours and perception of distress in 4-6 year old children who received their immunisation sequentially and the result revealed that there was no significant difference between the distress behaviour and perception of distress among the children23. Megal ME. Et.al. (2001), conducted an experimental study to investigate the effect of audio-taped lullabies on physiological and behavioural distress and perceived pain among children during routine immunisation. Half of the children received musical intervention during the immunisations, while the other half did not. Total distress scores were significantly lower for the experimental group. These results indicated that immunisation is a stressful experience for children24. The immunisation is a distressful experience for children. Because mostly it is given by the nurses working in primary care settings, it is necessary for them to reduce child distress during immunisation. Nurses who perform painful procedures and support infants and children during and after these procedures have long been concerned about how children respond to pain. However, although numerous studies have reported assessment and management of infant’s and children’s pain, the application of the findings to the practice setting has not been systematic. This has been a serious barrier to innovative care practice11. The investigator, during her clinical posting, observed that children who attended the immunisation clinics showed some painful behavioural responses like crying, facial expressions, muscle tension and rigidity, guarding of body parts and temperament to pain during immunisation. Many children receive immunisations with little or no formal attempt at reducing the fear and pain associated with the procedure. So, nurses are having difficult to carry out the immunization and to reduce the pain and anxiety level of the children in their busy schedule. So the investigator felt, distraction is necessary to change their behavior responses during immunization. This motivated the investigator to do a study on distraction technique among toddlers receiving immunization.

7.2. REVIEW OF LITERATURE Kleiber. C. et.al (2002), conducted an evaluative study to find out effect of distraction on children’s pain and distress during medical procedures and found that there is positive correlation between the distraction technique and children’s pain and distress14. Willis WHM. et.al (2003), conducted a descriptive observational study to test the validity of the face, legs, activity, cry and consolability (FLACC) behavioral pain assessment scale for use with children and found that there was significant and positive correlation between the FLACC scores for the entire sample children (r(30)=0.5, p=0. 001)12. French MG.et.al. (2003), conducted an evaluative study to find the effect of an active distraction technique on pain in preschool children receiving diphtheria; pertussis and tetanus immunization clinics aged 4-7 years and found that there was an experimental group pain behaviour (5.24±0.56) was lesser than the control group (5.26±0.64)16. Reis S.et.al ( 2004), conducted a comparative study to compare the efficiencies of two pain management methods in reducing immediate immunisation injection pain and distress in school aged children (4-6 years) scheduled to receive diphtheria and tetanus toxoid and acellular pertussis vaccine (DTaP) during health supervision visits and was concluded that when combined with distraction, vapocoolant spray significantly reduces immediate injection pain compared with distraction and is equally effective as well as less expensive and faster acting than EMLA cream17. Reis EC.et.al (2004), conducted an experimental study to assess the effectiveness, feasibility, and parental acceptance of a simple combination pain reduction intervention for 116 infants receiving multiple immunisation injections and was concluded that combining sucrose, oral tactile stimulation and parental holding was associated with significantly reduced crying in infants receiving multiple immunisation injections15. Preetha S. (2004), conducted a study to evaluate the effectiveness of kaleidoscope as a distraction technique among hospitalized children during their acute pain experience and the result revealed that there was the significant difference in the behavior response and intensity of pain between group I and group II18. Daniel. D (2005), a descriptive study was conducted to determine the characteristic responses to pain among hospitalised postoperative children in the age group of 3-6 years and found that there was no association between level of pain and age of the child previous exposure to hospital areas of surgery, at 0.05 level of significance20. Cohen LL.et.al (2005), conducted a study to assess the effecticveness of nurses coaching and cartoon distraction to reduce child, parent and nurse distress during immunisations” and the results revealed that in the two interventions conditions, children coped more and were less distressed, nurses and parents exhibited more coping and promoting behaviour and were less distressed than in the control condition19. Cohen LL.et.al (2006), conducted a randomised controlled trial to investigate the effectiveness of movie distraction in reducing infants’ immunisation distress. Results indicated that parents in the distraction group engaged in higher rates of distraction than those in the typical case group. In addition, infants in the distraction group displayed fewer distress behaviour than in the typical case group, both prior to and during recovery from the injection. Findings suggested that a simple and practical distraction intervention can provide some distress relief to infants during routine injections13. Flowler KS.et.al ( 2007) conducted an experimental study to assess the value of two cognitive strategies (suggestion and music distraction) in reducing pain in children. Determinant of the success of distraction. The result supported the use of music distraction in the reduction of injection pain in children21. Mukesh CS. (2007) conducted a study to compare the effectiveness of two distraction techniques in altering behavior responses to pain among children (1-3 yrs) receiving immunization at selected immunization clinics and found that the study supported the effectiveness of toy as a distractor compared to music22.

STATEMENT OF THE PROBLEM A COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF DISTRACTION TECHNIQUES IN ALTERING BEHAVIOUR RESPONSE TO PAIN AMONG TODDLER RECEIVING IMMUNIZATION AT SELECTED PRIMARY HEALTH CENTRE IN BANGALORE. 7.3. OBJECTIVES OF THE STUDY

1. To assess the behavioural responses to pain among toddler receiving immunization. 2. To compare the behavioural responses to pain among the experimental and control group. 3. To associate the behavioral responses to pain with selected demographic variables.

7.4. OPERATIONAL DEFINITIONS

EFFECTIVENESS: Effectiveness refers to the extent of alteration in behavioural distress due to immunisation pain with the use of distractions. DISTRACTION: Distraction involves introducing a sound producing toy to the children aged between 1 and 3 years to help the focus their attention on something other than pain and anxiety associated with the procedure (immunization). BEHAVIORAL RESPONSES: Behavioral responses are the responses shown by the child due to immunization pain as observed by behavioral observation scale in which the parameters observed are look, cooperation cry, face, eye, nose, extremity, movement respiration and posture. IMMUNIZATION: A process of protecting an individual from a disease through introduction of a live, killed or partial component of the invading organism into the individuals system.

7.6. ASSUMPTIONS 1. Pain is multifactorial. 2. Behavioral responses to pain are most common during the shot of injection while immunization. 3. Children exhibit a wide range of behavioral responses to painful stimuli. 4. Children’s behavioral responses can be minimized using nonpharmacological measures. 7.5. HYPOTHESES: RH1: There will be significant different in the severity of behavioral responses in score of experimental and control group. RH2: There will be a significant association between the behavioral responses to pain among children at selected demographic variables.

8. MATERIAL AND METHODS: 8.1. SOURCE OF DATA: Data will be collected from children who are all coming for immunization in primary health centers, Bangalore. 8.2. METHODS OF DATA COLLECTION: a. DEFINITIONS OF THE STUDY SUBJECT: The children with age group of 1-3 years, who come for immunization at selected primary health centers. b. CRITERIA FOR SELECTION OF SAMPLE: Inclusion criteria: 1. Children visiting the immunisation clinic. 2. Children undergoing invasive immunisation. 3. Mothers who were willing to give consent. Exclusion criteria 1. Children who were ill. 2. Visually handicapped children. 3. Children age more than three years of age. c. RESEARCH DESIGN: The research design selected for this study is post test only design which is a basic experimental design.

E X O1 C O2 E - Experimental group C - Control group X - Distraction technique O1 and O2 - Observation d. SETTING OF THE STUDY: The study is conducted in primary health centers, Bangalore. e. SAMPLING TECHNIQUE: Simple random sampling technique will be used for this study. f. SAMPLE SIZE: A sample of 40 children. g. DURATION OF THE STUDY: 30 days. h. TOOLS OF RESEARCH: The tools used for the data collection in this study were: Tool 1: Baseline proforma. Tool 2: Behavioural observation scale.

Tool 1: Baseline proforma The baseline proforma consisted 7 items like age, sex, religion, name of the immunisation the child is going for, child’s response to previous immunisation, child’s reaction towards health personnel in general, and relationship of the child with the caregiver present during immunisation. Tool 2: Behaviour observation scale This tool was used by the investigator to observe the children’s behavioural response during immunisation. It included 10 parameters, namely, look, cooperation, cry, face, eyes, nose, arms and fingers, legs, respiration and posture. i. COLLECTION OF DATA: To collect the data regarding behavior response to pain by using behavior observational scale among children (1-3 yrs) of selected primary health centre.

j. METHOD OF DATA ANALYSIS AND PRESENTATION: - Frequencies and percentage for the analysis of background data. - Mean, mode and median and standard deviation of the post test scores. - Paired T test will be used to assess the effectiveness of distraction techniques in altering the behavior responses to pain among children (1-3 yrs) receiving immunization. - Chi- square test will be used to find out association between post test score and the selected variables. 8.3. Does the study require any investigation to be conducted on patients or other human or animals? Yes, the study will be conducted for children (1-3 years) who are receiving immunization. 8.4. Has ethical clearance has been obtained from your institution in case of 8.3. Ethical clearance will be obtained from concern authority and written consent from participate for study. Anonymity and confidentiality of the subject will be maintained. 9. LIST OF REFERENCES: 1) Potts NL.Et.Al (2002), Pediatric Nursing Care for Children and their Families, 2nd

edition,Delmar Publishers. 1121-1124.

2) Wong DL.Et.Al (2003 ), Nursing Care of Infants and Children, 7th edition, Mosby

Publishers. 604-608.

3) Rockville C.Et.Al. (1992), Agency for Healthcare Policy and Research, Acute Pain

Management in Infants, Children and Adolescents, Operative and Medical Procedures,

AHCPR Publication.

4) Schecter NL. (1989), The Under Treatment of Pain. An Overview. Pediatric Clinic,

Mosby Publishers. 781-794.

5) Abbot K.Et.Al. (1995), The Use of a Topical Refrigerant Anesthetic to Reduce

Injection Pain in Children. Journal of Pain and Symptom Management. 584-590.

6) Agars S.Et.Al. (1969), Volume 10, the Epidemiology of Common Fears and Phobias.

Comprehensive Psychiatry.1511-1156.

7) Www.Pubmed.Com

8) Www.Babytoday.Com

9) Ball JW.Et.Al. (1998), Pediatric Nursing, 2nd Edition, Mosby Publication. 231-237.

10) Mccarthy MA.Et.Al. (2006), Volume 21(3), A Conceptual Model of Factors

Influencing Children’s Response to a Painful Procedure When Parents are Coaches.

Journal of Pediatric Nursing.

11) Www.Whotopics.Com

12) Willis WHM.Et.Al. (2003), May Volume 29(3), FLACC Behavioral Pain Assessment

Scale: A Comparison with Childs Self Report. Pediatric Nursing. 140-146. 13) Cohen LL.Et.Al. (2006), November125 (1-2), A Randomized Clinical Trial of

Distraction for Infant Immunization Pain. 165-171.

14) Kleiber C.Et.Al. (2002), Feb.48, Effects of Distraction on Children’s Pain and

Distress during Medical Procedures: A Meta-Analysis. Nursing Research Journal. 401-

481.

15) Reis EC.Et.Al. (2004), July 158(7), Effective Pain Reduction for Multiple

Immunization Injections in Young Infants. Arch Pediatric Adolescent Med. 708.

16) French MG.Et.Al. (2003), June 6, Blowing Away Shot Pain: A Technique for Pain

Management during Immunization. Pediatrics. 210-217.

17) Reis EC.Et.Al. (2003), December 100(6), Vapocoolant Spray is Equally Effective as

EMLA Cream in Reducing Immunization Pain in School Aged Children. Pediatrics.

324-345

18) Preetha S. Effectiveness of Kaleidoscope as a Distraction Technique among

Hospitalised Children during their Acute Pain Experience. Unpublished M. Sc. Nursing

Dissertation Submitted To RGUHS, Bangalore. 2004.

19) Cohen LL.Et.Al. (2005), June 22(3), Nurse Coaching and Cartoon Distraction: An

Effective and Practical Intervention to Reduce Child, Parent and Nurse Distress During

Imunizaations. 355-370.

20) Daniel D. A Study to Determine The Characteristic Responses to Pain Among

Hospitalized Postoperative Children in the age Group of 3-6 Years at Mangalore.

Unpublished M. Sc. Nursing Thesis Submitted to RGUHS, Bangalore. 2005.

21) Flowler KS.Et.Al. (2007), Augest 30(2), Management of Injection Pain in Children.

169-175. 22) Mukesh CS. (2007), A Study to Assess The Effectiveness of Distraction Techniques in

Altering Behavior Responses to Pain Among Children (1-3 Years) Receiving

Immunization at Selected Immunization Clinics, Unpublished M.Sc Nursing Thesis

Submitted to RGUHS, Bangalore.

23) Horn MI.Et.Al. (2000), July 154(7), Children Response to Sequential Versus

Simultaneous Immunization Injections. Arch Pediatric Adolescence Med. 719-724.

24) Megal ME.Et.Al. (2001), Augest 23(4), Children Responses to Immunization:

Lullabies as a Distraction. Journal of Pediatric Pshychology. 249-253.

25) Basavanthappa BT.(2003), Nursing research, Jaypee Brothers Medical Publishers Pvt.

Ltd.75-147.

th 26) Polit DF.et.al. (1999), Nursing research principles and methods. 6 edition.

Lippincott publication.356-376. 10. SIGNATURE OF THE CANDIDATE :

11. REMARKS OF THE GUIDE :

As there is an increasing need to expand professional horizons to suit the challenges of immunization and changes in health care delivery, this study is highly recommended to be registered as the study addresses the same.

12.1. NAME AND DESIGNATION OF THE GUIDE : Prof. Selvarani. P Head of the Department,

Department of Community Health Nusing,

Miranda College of Nursing,

Bangalore.

12.2. SIGNATURE :

12.3. CO-GUIDE (IF ANY) : -

12.4. SIGNATURE : -

12.5. HEAD OF THE DEPARTMENT : Prof. Selvarani. P

Head of the Department,

Department of Community Health Nusing,

Miranda College of Nursing,

Bangalore.

12.6. SIGNATURE :

13. REMARKS OF THE CHAIRMAN AND PRINCIPAL: The study is highly recommended to be registered.

14. SIGNATURE OF THE PRINCIPAL :

Prof. Bosco Sunder Raj. J

Principal.