TITLE OF THE RESEARCH PROJECT

1. TITLE OF THE RESEARCH PROJECT Effectiveness of multimodal preoperative preparation program on the psycho physiological parameters of children undergoing surgery and their parental anxietyin a selected hospital Mangalore. Candidate: Mrs. PriyaReshmaAranha, Reg No:082/2012 July Assistant Professor, Yenepoya Nursing College, Mangaluru Guide : Dr. PrakashSaldanha Prof. and HOD, Dept of Paediatrics, Yenepoya Medical College Hospital, Mangaluru Co-guide : Dr. Larissa Martha Sams Principal,Laxmi Memorial College of Nursing, Mangaluru

2. Suggestions given in the fourth report presentation

3. Introduction and Background • Hospitalization and surgery are stressful events • 75% of children undergoing surgery experience anxiety(Debora et al 2013) • Child may have fears of separation from the parents and home environment , loss of control, unfamiliar routines, surgical instruments and hospital procedures. • 67% of children may develop postoperative negative behavioural changes (Kain et al 1999)

4. Contd. • A study found that lack of control over upcoming medical procedures is one of the major sources of stress, which may cause considerable anxiety in children undergoing surgery. ( Li et al 2007) • A study was conducted to examine the child’s immediate behavioral response to separation from their parent with or without the implementation of alternative techniques when the children were taken for surgery. The study revealed that 80% of the subjects had a change in their behavioural response once separated from their parents. (Shannon 2007)

5. Literature survey

6. Related to psychological and physiological parameters • A study evaluated the physiological and behavioral measures of stress and anxiety in children during dental procedure. And confirmed that there is a direct correlation between the blood pressure and pulse rate during anxiety producing dental situations.(Raven et al 2006) • A cross-sectional cohort study was conducted to explore a potential association between preoperative anxiety and postoperative nausea and vomiting. The study showed that 33 children (65%) reported nausea and 21 children (41%) developed vomiting. In contrast children who were more anxious in preoperative period had less vomiting compared to those who were calm in preoperative period. The nausea and vomiting were similar in boys and girls(Kain et al 2000)

7. Literature related to preoperative preparation 0f children • A study was conducted to examine the effect of video distraction on the anxiety of children undergoing inhaled induction before ambulatory surgery. The study revealed a significant difference in the anxiety scores (Mifflin 2012) • A descriptive study on Meta analysis was conducted to compare the effectiveness of media based education about anesthesia. The results showed that anxiety level before anesthesia were less intense in subjects receiving the video and printed information about general processes and anesthesia for patient education before surgery(Anna 2003) • A study was conducted to evaluate the efficacy of a playroom next to the operating room to reduce preoperative anxiety in children. The study showed a significant reduction in preoperative anxiety (Hosseinpour 2010)

8. Literature related to preoperative preparation of children contd. • A study was conducted to determine the beneficial effects of viewing an animated cartoon and playing with a favorite toy on pre operative anxiety in children aged 3 to 7 years in the operating room before anesthesia induction. The study results showed that in the preanesthetic holding room, the children with toy , and parent exhibited significantly lower anxiety level than that of other two groups (mYPAS: P= 0.007; parent, VAS: P= 0.02). In the operating room, the children in cartoon group had the lowest mYPAS and parent recorded anxiety VAS scores among the 3 groups (mYPAS: P< 0.001; parent recorded anxiety VAS: P< 0.001). Thus the study concluded that Allowing the viewing of animated cartoons by pediatric surgical patients is a very effective method to alleviate preoperative anxiety. (Jeongwoo et al 2012)

9. Contd. • A single-blind, randomized clinical trial was performed to test the efficacy of a psychological preoperative preparation intervention (PPPI), in the form of a cartoon coloring book, designed to reduce anxiety/fear before surgery in hospitalized children. State anxiety at post-intervention was significantly less in the PPPI group than in the usual care group (Duangrat 2013) • A study conducted to examine effects of receiving therapeutic play consisting of operation room tour, demonstrating and return demonstration of procedures on a mannequin. The state anxiety score was significantly lower in children who received the intervention (Nazanin 2011) • A study was conducted to compare the effectiveness of an internet preparation programme and the standard preparation programme for the adolescent undergoing tonsillectomy with or without adenoidectomv. Adolescent and parent satisfaction was also statistically significant: 61% of the Internet group was "very satisfied” compared to 14% o f the standard group (Susan 2001)

10. Literature related to parental anxiety • A study was conducted in Nigeria to assess the parental distress and psychiatric morbidity before elective surgery in children. One hundred parents of children scheduled for elective surgery were asked to complete the 12th version of the general hospital questionnaire and the hospital anxiety and depression scale. The study results showed that 47% of the participants scored higher than cut off with the general hospital questionnaire indicating that they suffered from psychological distress , while 51% had probable anxiety and 19% had depression.( Osuoji et al 2012) • A study was carried out in Michigan to reduce anxiety in parents and children before and during paediatric anaesthesia induction. 80 children requiring an inhalation anaesthetic induction were selected and randomized into two groups. The parents in the experimental group viewed a video demonstrating paediatric mask induction and pamphlet. Parents in the control group received only information pamphlet. Parental anxiety was measured perioperatively . The study results showed that the mean arterial blood pressure for children in the experimental group was significantly lower during preoperative holding and following induction (p<0.05). The level of post op anxiety was also lower in experimental group children and parents(p<0.05). (Zuwala et al 2012)

11. Social relevance and uniqueness of the work

12. Uniqueness of the intervention • Routine preoperative preparation of children includes only verbal instructions given by doctors and nurses • Multimodal preoperative preparation programme has been prepared based on the needs of school age children and their parents. • It includes audiovisual instructions along with real life situations provided to child and parent. • As it includes both child and family together, it increases their confidence and bondage

13. Aim The study aims to assess the effectiveness of multimodal preoperative preparation program on children undergoing surgery and their parents, in terms of its effect on the psycho physiological parameters ie, to reduce the fear and anxiety of children, stabilize their physiological parameters, decrease post operative pain, decrease the parental anxiety and help them to cope better.

14. Objectives 1.To determine the psycho physiological parameters of children undergoing surgery. 2.To determine the anxiety of parents of children undergoing surgery. 3.To test the effectiveness of multimodal preoperative preparation program on the psycho physiological parameters of children undergoing surgery in the intervention group who receive the multimodal preoperative preparation program. 4.To test the effectiveness of multimodal preoperative preparation program on the anxiety of parents of children undergoing surgery in the intervention group.

15. Objectives contd. 5.To find association of psycho physiological parameters with the selected demographic variables of children 6. To find association of parental anxiety with the selected demographic variables of parents. 7.To find the correlation between the psychological and physiological parameters of children undergoing surgery. 8.To measure the satisfaction of parents regarding the preparation of children for surgery

16. Hypotheses to be tested are H1: There will be a significant difference in the mean pre and post tests scores of psycho physiological parameters of children within the intervention and non intervention groups H2: There will be a significant difference in the mean change scores of psycho physiological parameters of children between the two groups H3: There will be a significant difference in the mean pre and post tests scores of parental anxiety within the intervention and non intervention groups H4: There will be a significant difference in the mean change scores of parental anxiety between the intervention and non intervention groups H5: There will be a significant association between psycho physiological parameters and demographic variables of children H6: There will be a significant association between parental anxiety and demographic variables of parents H7: There will be a significant correlation between psychological and physiological parameters of children undergoing surgery H8: There will be a significant difference in the mean score of parental satisfaction between the intervention and non intervention groups

17. H1 is splitted and written as H1a: There will be a significant difference in the mean pre and post tests scores of fear of children within the intervention and non intervention groups H1b: There will be a significant difference in the mean pre and post tests scores of anxiety of children within the intervention and non intervention groups H1c: There will be a significant difference in the mean pre and post tests scores of pulse of children within the intervention and non intervention groups H1d: There will be a significant difference in the mean pre and post tests scores of respiration of children within the intervention and non intervention groups H1e: There will be a significant difference in the mean pre and post tests scores of systolic BP of children within the intervention and non intervention groups H1f: There will be a significant difference in the mean pre and post tests scores of diastolic BP of children within the intervention and non intervention groups H1g: There will be a significant difference in the mean pre and post tests scores of oxygen saturation of children within the intervention and non intervention groups H1h: There will be a significant difference in the mean pre and post tests scores of pain of children within the intervention and non intervention groups

18. H2 is splitted and written as H2a: There will be a significant difference in the mean change scores of fear of children between the intervention and non intervention groups H2b: There will be a significant difference in the mean change scores of anxiety of children between the intervention and non intervention groups H2c: There will be a significant difference in the mean change scores of pulse of children between the intervention and non intervention groups H2d: There will be a significant difference in the mean change scores of respiration of children between the intervention and non intervention groups H2e: There will be a significant difference in the mean change scores of systolic BP of children between the intervention and non intervention groups H2f: There will be a significant difference in the mean change scores of diastolic BP of children between the intervention and non intervention groups H2g: There will be a significant difference in the mean change scores of oxygen saturation of children between the intervention and non intervention groups H2h: There will be a significant difference in the mean change scores of pain of children between the intervention and non intervention groups

19. Sampling Technique Data collection tool Sample Analysis Intervention Variables Non intervention group 55 children and their parents Independent Variable Multimodal preoperative preparation programme Dependent variable *Fear, anxiety, pulse, respiration, BP, oxygen saturation, pain of children *Parental anxiety *Parental satisfaction Demographic Variables Children : Age, gender, type and name of surgery, Duration of admission prior to surgery, Previous hospital admission Parents Age , gender, education, type of family, occupation, Place of residence, Exposed to surgical procedure in the family, Relationship with the person underwent surgery, Previous experience of surgery, Prepared the child for surgery and source of information *Descriptive Statistics *Inferential statistics *Baseline Proforma *Numerical anxiety scale *Faces fear scale *State Trait anxiety Inventory *Pulse oxymeter, digital BP monitor, *Faces pain scale *Parental satisfaction scale Purposive Sampling Routine care Intervention group 55 children and their parents Multimodal preoperative preparation programme Interpretation of Findings METHODOLOGY ResearchApproach and design Experimental approach & Quasi experimental design Setting Selected hospital of Mangalore Population: Children admitted for surgery and their parents Fig: Schematic representation of methodology

20. Inclusion criteria: Children who areat the age of 8 to 12 years • Undergoing elective surgery • Anticipated to have hospital stay of at least 48 hours after surgery • Having normal cognitive ability as determined by age appropriate grade • Having a parent during admission and throughout the hospitalization • Speaks Kannada/English/Malayalam language Exclusion criteria: Children who areat the age of 8 to 12 years • Have physical or psychological conditions that are not appropriate to participate in multimodal pre preoperative preparation program such as blindness, deafness, mental retardation, or psychiatric conditions, • Has history of previous surgery

21. Inclusion criteria: Parents • Who will accompany the child throughout the hospitalization • Speaks Kannada/English/Malayalam language • Willing to participate in the study Exclusion criteria: Parents • Have physical or psychological conditions that are not appropriate to participate in multimodal pre operative preparation program such as blindness, deafness or psychiatric conditions,

22. Research DesignQuasi experimental, non randomized control group design

23. Procedure followed • Ethical clearance obtained from the institutional ethics committee • Formal permission obtained from the concerned authority • Assessed the children who were admitted for the surgery and their parents and who met the inclusion criteria were selected as study sample • Using purposive sampling technique, the first come children and their parents were assigned to non intervention group and the later into intervention group • Prior to data collection, informed consent was obtained from the parents • Intervention group – Multimodal preoperative preparation programme • Non intervention group – Routine care • Data collected

24. STATISTICAL TESTS USED FOR ANALYSIS

25. RESULT

26. The study results are presented under the following sections: Section I: Description of demographic characteristics of children and parents Section II : Assessment and comparison of psychological (fear and anxiety) and physiological parameters (Pulse, respiration, BP, oxygen saturation and pain) of children Section III : Assessment and comparison of parental anxiety Section IV: Association between the physiological & psychological parameters of children and the selected demographic variables and Association between the parental anxiety and the selected demographic variables Section V: Correlation between the physiological and psychological parameters of children Section VI : Determination of parental satisfaction regarding the preoperative preparation of their children

27. Section I Description of demographic characteristics of children and parents

28. Distribution of children according to demographic characteristics n=55+55 **Statistically significant (p < 0.01)

29. Distribution of parents according to demographic characteristics n=55+55 *Statistically significant (p < 0.05)

30. Distribution of parents according to demographic characteristics *Statistically significant (p < 0.05)

31. Section II Assessment and comparison of psychological (fear and anxiety) and physiological parameters (Pulse, respiration, BP, oxygen saturation and pain) of children

32. 1.Parameter: Fear a)Description of fear of children in intervention and non intervention groups Line diagram showing the comparison of fear score of children between the groups

33. b)Comparison of fear of children over different period of time within the intervention and non intervention groupn=55+55 ***Statistically significant (p < 0.001)

34. c)Pair wise comparison of fear score is by Wilcoxon signed rank test to see the changes of fear score at different time point within the groups ***Statistically significant (p < 0.001)

35. d) Pair wise comparison of fear score between the groups by Mann Whitney test ***Statistically Significant (p<0.001)

36. 2.Parameter:Anxiety a. Description of anxiety scores of children in the intervention and non intervention group Line diagram showing the comparison of anxiety score of children between the groups

37. b. Comparison of anxiety of children over different period of time within the intervention and non intervention group n=55+55 *** Statistically significant p<0.001 , **Statistically significant p<0.01

38. c)Pair wise comparison of anxiety score is by Wilcoxon signed rank test to see the changes of anxiety score at different time point within the groups *** Statistically Significant, p< 0.001

39. d)Pair wise comparison of anxiety of children between the groups by Mann Whitney Z test ***Statistically Significant, p< 0.001

40. 3. Parameter: Pulse a) Description of pulse of children in intervention and non intervention groups Line diagram showing the comparison of pulse score of children between the groups

41. b) Comparison of pulse of children over different period of time within the intervention and non intervention groupn=55+55 *** Statistically Significant, p< 0.001

42. c)Post hoc analysis is done by Bonferroni test to compare the effect between different times of observation of pulse ***Statistically Significant , p< 0.001 **Statistically Significant p<0.01

43. d)Comparison of post test scores of pulse between the intervention and non intervention groups ***Statistically Significant p<0.001, **Statistically Significant p<0.01, *Statistically Significant p<0.05

44. 4.Parameter: Respiration a) Description of respiration of children in intervention and non intervention groups Line diagram showing the comparison of respiration score of children between the groups

45. b) Comparison of respiration of children over different period of time within the intervention and non intervention group *** Statistically Significant p< 0.001

46. c)Post hoc analysis is done by Bonferroni test to compare the effect between different times of observation of respiration ***Statistically Significant, p< 0.001, **Statistically Significant p< 0.01, *Statistically Significant, p< 0.05

47. d) Comparison of post test scores of respiration between the intervention and non intervention groups ***Statistically Significant, p<0.001, **Statistically Significant p<0.01, *Statistically Significant p<0.05

48. 5.Parameter: Systolic Blood Pressure a) Description of systolic blood pressure of children in intervention and non intervention groups Line diagram showing the comparison of fear score of children between the groups

49. b) Comparison of systolic blood pressure of children over different period of time within the intervention and non intervention groupn=55+55 ***Statistically Significant, p<0.001

50. c)Post hoc analysis is done by Bonferroni test to compare the effect between different times of observation of Systolic blood pressure ***Statistically Significant, p<0.001, **Statistically Significant p<0.01, *Statistically Significant p< 0.05