Anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety.1,2 Various factors like unfamiliar surroundings, separation from parents, or fear of needles and sharp instruments contribute to preoperative anxiety in children. Preoperative anxiety if not tackled appropriately can lead to adverse postoperative outcomes and negative behavioral changes.2,3
Pediatric anesthetists have tried various pharmacological and nonpharmacological means to combat preoperative anxiety. Despite the wide safety profile of the sedative and anxiolytic drugs, there have been reports of respiratory depression associated with them.4,5 Nonpharmacological modalities like video games, cartoons, etc, can provide a safer and an effective alternative to reduce preoperative anxiety in children.6–8
Children >4 years of age are more receptive to any behavioral intervention.9 Interventions focused on distracting the children or familiarizing them about the procedure effectively reduce preoperative anxiety. The majority of studies have used newer information technology devices like iPods, computers, video games, or tablets, which are easily available in health care setups in high-resource countries.8,10,11
However, constrained financial resources in health care facilities often limits their use in low-resource settings. There is gross paucity of literature on the use of nonpharmacological means for allaying anxiety in children from low-income settings. An updated version of the published Cochrane review on nonpharmacological interventions for allaying preoperative anxiety included 28 trials on 2681 children, all of which were conducted in high-income group countries.12 This highlights the need for a simple, cost-effective intervention that is feasible in low-income settings.
We devised a low-cost, incentive-based game using the facemask and the anesthesia circuit to reduce preoperative anxiety in children between 4 and 8 years of age. We hypothesized that active involvement in the game would help to distract the children and their parents, while the use of anesthesia tools would help in familiarization to the anesthesia induction procedure, thereby reducing preoperative anxiety. The aim of the study was to evaluate the efficacy of incentive-based game therapy in conjunction with parental involvement in reducing preoperative anxiety in children undergoing elective surgery under general anesthesia.
The present, prospective randomized study was conducted after getting approval from Institute Ethics Committee (Memo no. 10315/PG-2Trg/2015) and written informed consent from the parents or guardians of children enrolled in the trial. The trial was registered before patient enrollment at clinical trial registry of India (CTRI/2016/05/006900, Principal investigator: B.C., Date of registration: May 05, 2016). Eighty school-attending children 4–8 years of age of American Society of Anesthesiologists grade I and II physical status scheduled for surgery under general anesthesia with inhalation induction were enrolled, after obtaining written informed consent. Children who were mentally challenged, deaf, had cerebral palsy, and those who were premedicated or were uncooperative were excluded from the trial.
The children were randomly allotted into a control group (n = 40) and intervention group (n = 40) using computer-generated random number table. Children in both the groups were induced in the presence of parents, while children in the intervention group additionally participated in an incentive-based game in the preoperative room. Children were fasted overnight according to the standard nil per os guidelines (8 hours for any solid food, 4 hours for milk, and 2 hours for clear water). The children enrolled in the study did not receive oral, intravenous (IV) anxiolytic, or analgesic drug in the preoperative period. In the intervention group, the children and their parents were shown the anesthesia circuit and mask in the preoperative area. The children were taught how to blow through the mask to inflate the balloon. As per the game, a similar anesthesia circuit was handed over inside the operation theater, and the child who was able to blow through the mask for the longest period counting 1, 2, 3, 4… was declared the winner. The children were appraised that the air could be foul smelling but despite that they would have to blow into the mask and inflate the balloon. The parents accompanied their children to the operation theater, cheering them to win. The incentives (apple juice) were shown to the participants before the start of case and were informed that these would be given at the end of surgery to the winner of the game (although each child was considered a winner and handed over the juice at the end of surgery). They were instructed to have their juice after the break of nil per os orders in the presence of staff nurse posted in the postanesthesia care unit.
While in the control group, children were not told about any game and were accompanied with either of the parents inside the operation theater.
General anesthesia was induced with a gradual increase in the concentration of sevoflurane to 8% in 100% oxygen. IV access was obtained, and 2 μg/kg fentanyl was administered for intraoperative analgesia. Standard monitoring included oxygen saturation, noninvasive arterial blood pressure, electrocardiography, and capnography (Aestiva 5TM 7900; Datex-Ohmeda, Madison, WI). Appropriate size laryngeal mask or endotracheal tube was inserted. Atracurium 0.5 mg/kg was administered to achieve muscle relaxation in children requiring endotracheal intubation. Anesthesia was maintained with isoflurane 2% in air–oxygen mixture ensuring a cumulative minimum alveolar concentration between 1 and 1.3 and ventilated to maintain an Etco2 of 35–45. At the end of the surgery, the trachea of the patient was extubated after complete reversal of neuromuscular blockade.
The primary objective of the study was to evaluate the effect of the incentive-based game therapy on the modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia. The secondary outcomes were to record the Induction Compliance Checklist (ICC) score and parental anxiety score.
The mYPAS13 was used to evaluate the anxiety level of children. The mYPAS is an observational measure of preoperative anxiety consisting of 27 items in 5 domains (activity, emotional expressivity, state of arousal, vocalization, and use of parents). The adjusted mYPAS total score ranges from 22.9 to 100, with higher scores indicating greater anxiety.
The baseline mYPAS of the children was recorded a day before the surgery in the pediatric ward. On the day of the operation, the mYPAS was recorded in the preoperative room before the intervention and again in the operation theater during anesthetic induction. We used a smartphone for recording the anxiety of children. The recordings were made without the children being aware of it. They were saved on a separate memory card in the smartphone camera that was kept with the investigator. The scoring was done after looking at the recordings by another blinded investigator who was unaware of the group allocation.
A Hindi version of State-Trait Anxiety Inventory (STAI) scale was used to evaluate parents anxiety on the day of surgery.14 STAI is a self-report anxiety assessment instrument containing 2 separate, 20-item rating scales for measuring trait and state anxiety.15 Total scores for state and trait anxiety range from 20 to 80 each; higher scores denote higher levels of anxiety. STAI trait was recorded preoperatively, while the STAI state was measured before and after the anesthesia induction.
ICC grading was done to assess cooperation of the child for mask holding. A scoring system on a 0–10 scale was given by Kain et al,16 where a perfect induction (in which the child does not exhibit negative behaviors, fear, or anxiety) is scored as “0” and the child with fear, negative behavior, and anxiety is scored 10. A validated simplified 3-point scoring system for ICC by Varughese et al9 (perfect [ICC = 0], moderate [ICC = 1–3], and poor [ICC ≥4]) was used in our trial during induction. Parental satisfaction was graded either as “satisfied” or “not satisfied” at the end of surgery.
The statistical analysis was performed using Statistical Package for Social Sciences (SPSS Inc, Chicago, IL; version 17.0 for Windows). Mean and median were calculated for all quantitative variables and measures of dispersion, and standard deviation or standard error was calculated. Normality of data was checked by measures of Kolmogorov–Smirnov tests of normality. For normally distributed data, the means of 2 groups were compared using t test. For skewed data, the Mann-Whitney test was applied. Qualitative or categorical variables were described as frequencies and proportions. Proportions were compared by using χ2 or Fisher exact test, as appropriate. For comparison of time-related variables, repeated-measure analysis of variance followed by 1-way analysis of variance was applied. All statistical tests were 2-sided and were performed at a significance level of α = .05.
The sample size was estimated based on the mean difference of modified mYPAS 15 ± 10.48 between 2 groups in a pilot study of 12 patients. Our sample size came out to be 32 subjects per group at a power of 90% and 5% significance level. For possible dropouts, it was decided to include 40 patients per group.
Out of the 80 enrolled children, none of them dropped out from the study (Figure 1). The demographic details of 80 children and the accompanying parents are given in Table 1.
The mean mYPAS score (95% confidence interval [CI]) in the 2 groups was not significant during preoperative checkup (P = .48) and in the holding area (P = .40).
The mean mYPAS (95% CI score) was 32.0 (30.4–34.5) in the intervention group compared to 52 (48.9–56.3) in the control group during induction of anesthesia. The mean difference (95% CI) of the mYPAS at induction in the 2 groups was 20 (95% CI, 16–24; P < .001; Table 2).
Thirty-three (82.5%) children in the intervention group showed a decrease in anxiety compared to 5 (12.5%) children in the control group (Figure 2). The change in the mYPAS score from the holding room to the operation theater was significantly lower in the intervention group (Figure 3). Fourteen (35%) children in study group and 2 (5%) children in the control group had no anxiety (mYPAS score <30) (difference of −30%; 95% CI, −11% to −49%; P < .001).
The children in the intervention group were more compliant with mask induction and had significantly less ICC score compared to the control group (P < .001; Table 3).
There was no difference in the anxiety of parents before the intervention in the holding area (P = .189).
Thirty (75%) parents in the intervention group were satisfied at the end of surgery compared to 6 (15%) in the control group (difference of −60%; 95% CI, −39% to −73%; P < .001).
The use of incentive-based game therapy reduced the anxiety scores and improved the compliance to facemask during anesthesia induction in children.
The Cochrane review highlighted the potentially promising role of nonpharmacological methods parental acupuncture, clowns/clown doctors, and audiovisual interventions using videos of the child’s choice or handheld video games for allaying preoperative anxiety in children.12 Although clowns have been successfully shown to decrease the anxiety of children from the holding area to the operation theater, the benefit of this intervention during the period of mask induction has been debatable. Golan et al17 observed a contrary increase in the mYPAS score at the time of anesthesia induction in children accompanied by clowns. Majority of the audiovisual interventions have used newer technology-based gadgets. Patel et al6 demonstrated reduction of preoperative anxiety using active distraction by playing video games during anesthesia induction. In another study, the authors showed significant reduction of preoperative anxiety in children using an application on a tablet depicting a tour of the operating room and clown physicians a day before surgery.18 However, limited affordability of these gadgets may limit its applicability in low-income settings.
In contrast to these sophisticated gadgets, we used a simple, low-cost incentive-based game that incorporated various components of behavioral techniques like play therapy,19 active distraction,20 familiarization,21 incentives,22 and parental presence.23 Anesthesia mask and circuit were used as play objects, which could have helped in familiarization to the induction techniques. The use of rewards or incentives can act as a booster to motivate the child, especially when there is no intrinsic motivation to perform the task like blowing a balloon to undergo surgery, as was seen in the present trial.24
Although parents were present during anesthesia induction in both the groups, their passive presence in the control group did not affect the anxiety among children. This is in accordance with the Cochrane review, in which the pooled data of 5 trials failed to demonstrate any benefit of mere parental presence in reducing preoperative anxiety in children.12 However, in our study, in the intervention group, parents were not only present but were also actively involved in cheering their child to win. This could have resulted in decreased parental anxiety by distracting the attention of the parents from the fear of surgery to encouraging their child to win and see them perform. High parental anxiety has been implicated as an important factor in increasing child’s anxiety.25 Decreased parental anxiety might have contributed to decreasing anxiety of children in the incentive-based game group, though the study was not specifically powered to examine differences in parental anxiety.
The results of our study should be interpreted in the light of some limitations. Preoperative anxiety leads to negative postoperative behavior2,3; however, the postoperative effects of our intervention were not studied. We had excluded uncooperative children and those with any developmental delay or autism to create a homogeneous study population. However, this could certainly have resulted in study bias. This study was done in children undergoing inhalational anesthesia induction; therefore, the results cannot be extrapolated for children undergoing IV induction technique. The possibility of observer bias cannot be ruled out. It is difficult to measure the sole effect of our intervention as parental presence, which is considered one of the strategies to decrease the anxiety, was there in both the groups. However, this should not have affected the results, as parents were made to be present in both the groups.
In conclusion, incentive-based game therapy reduces preoperative anxiety and improves the compliance with inhalational anesthesia induction in children between 4 and 8 years of age undergoing surgery. It can form a simple, viable, and cost-effective modality to reduce preoperative anxiety in children.
The authors would like to thank Dr Ramesh Goel for his assistance with the statistical analysis. The authors would like to thank Dr Nayanika Singh, former assistant professor, Department of Psychology, Rayat Bahra University, Mohali, for her assistance.
Name: Bijay Chaurasia, MD.
Contribution: This author helped collect the data and analyze the statistical data.
Name: Divya Jain, MD.
Contribution: This author helped generate the concept, plan the methodology, and prepare the manuscript.
Name: Swati Mehta, MD.
Contribution: This author helped collect the data and edit the final manuscript.
Name: Komal Gandhi, MD.
Contribution: This author helped analyze the statistical data and edit the final manuscript.
Name: Preethy J. Mathew, MD.
Contribution: This author helped plan the methodology and edit the final manuscript.
This manuscript was handled by: James A. DiNardo, MD, FAAP.
1. Chorney JM, Kain ZN. Behavioral analysis of children’s response to induction of anesthesia. Anesth Analg. 2009;109:1434–1440.
2. Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999;88:1042–1047.
3. Kotiniemi LH, Ryhänen PT, Moilanen IK. Behavioural changes in children following day-case surgery: a 4-week follow-up of 551 children. Anaesthesia. 1997;52:970–976.
4. Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and intervention strategies to alleviate preoperative anxiety in children: a critical review. Behav Modif. 2007;31:52–79.
5. Viitanen H, Annila P, Viitanen M, Tarkkila P. Premedication with midazolam delays recovery after ambulatory sevoflurane anesthesia in children. Anesth Analg. 1999;89:75–79.
6. Patel A, Schieble T, Davidson M, et al. Distraction with a hand-held video game reduces pediatric preoperative anxiety. Paediatr Anaesth. 2006;16:1019–1027.
7. Lee J, Lim H, Son JS, et al. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012;115:1168–1173.
8. Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012;115:1162–1167.
9. Varughese AM, Nick TG, Gunter J, Wang Y, Kurth CD. Factors predictive of poor behavioral compliance during inhaled induction in children. Anesth Analg. 2008;107:413–421.
10. Lacquiere DA, Courtman S. Use of the iPad in paediatric anaesthesia. Anaesthesia. 2011;66:629–630.
11. Low DK, Pittaway AP. A novel use for the Apple iPhone. Paediatr Anaesth. 2008;18:573–574.
12. Manyande A, Cyna AM, Yip P, et al. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015;14:CD006447.
13. Kain ZN, Mayes LC, Cicchetti DV, et al. Measurement tool for preoperative anxiety in young children: the Yale Preoperative Anxiety Scale. Child Neuropsychol. 1995;1:203–210.
14. Spielberger D, Sharma S, Singh M. Development of the Hindi edition of the State-Trait Anxiety Inventory. Indian J Psychology. 1973;48:11–20.
15. Spielberger CD, Gorsuch RL, Lushene PR, Vagg PR, Jacobs AG. Manual for the State-Trait Anxiety Inventory (Form Y). 1983.Palo Alto, CA: Consulting Psychologists Press, Inc
16. Kain ZN, Mayes LC, Wang SM, Caramico LA, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology. 1998;89:1147–1156.
17. Golan G, Tighe P, Dobija N, Perel A, Keidan I. Clowns for the prevention of preoperative anxiety in children: a randomized controlled trial. Paediatr Anaesth. 2009;19:262–266.
18. Liguori S, Stacchini M, Ciofi D, Olivini N, Bisogni S, Festini F. Effectiveness of an app for reducing preoperative anxiety in children: a randomized clinical trial. JAMA Pediatr. 2016;170:e160533.
19. Koukourikos K, Tzeha L, Pantelidou P, Tsaloglidou A. The importance of play during hospitalization of children. Mater Sociomed. 2015;27:438–441.
20. Chow CHT, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic review: audiovisual interventions for reducing preoperative anxiety in children undergoing elective surgery. J Pediatr Psychol. 2016;41:182–203.
21. Kain ZN, Caldwell-Andrews AA. Preoperative psychological preparation of the child for surgery: an update. Anesthesiol Clin North America. 2005;23:597–614, vii.
22. Xia YH, Song YR. Usage of a reward system for dealing with pediatric dental fear. Chin Med J (Engl). 2016;129:1935–1938.
23. Kain ZN, Caldwell-Andrews AA, Mayes LC, Wang SM, Krivutza DM, LoDolce ME. Parental presence during induction of anesthesia: physiological effects on parents. Anesthesiology. 2003;98:58–64.
24. Pierce DW, Cameron J. A summary of the effects of reward contingencies on interest and performance. Behav Anal Today. 2002;2:221–228.
Copyright © 2018 International Anesthesia Research Society
25. Kain ZN, Mayes LC, Wang SM, Caramico LA, Krivutza DM, Hofstadter MB. Parental presence and a sedative premedicant for children undergoing surgery: a hierarchical study. Anesthesiology. 2000;92:939–946.