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Smartphone-based behavioural intervention alleviates children's anxiety during anaesthesia induction

A randomised controlled trial

Cumino, Débora O.; Vieira, Joaquim E.; Lima, Luciana C.; Stievano, Livia P.; Silva, Raquel A.P.; Mathias, Ligia A.S.T.

European Journal of Anaesthesiology (EJA): March 2017 - Volume 34 - Issue 3 - p 169–175
doi: 10.1097/EJA.0000000000000589
PAEDIATRIC ANAESTHESIA
Free

BACKGROUND Preoperative anxiety negatively influences children's anaesthetic and surgical experience, and results in postoperative complications, such as emergence delirium and behavioural changes. Nonpharmacological management using alternative therapies that alleviate psychological stress can be as important as pharmacological ones in reducing children's anxiety. Nevertheless, their validity as an effective anxiety-reducing strategy in children remains controversial.

OBJECTIVE(S) To verify whether nonpharmacological strategies, that is, leaflet and distraction with smartphone application presented to parents/guardians and children, respectively, were effective in preventing children's anxiety during anaesthesia induction.

DESIGN Randomised clinical trial.

SETTING A tertiary care teaching hospital.

PATIENTS In total, 84 children (aged 4 to 8 years; American Society of Anesthesiologists I and II) undergoing minor-to-moderate elective surgical procedures and their parents/guardians.

INTERVENTIONS Children were randomised into four groups: control group, in which the parent/guardian was verbally informed about the anaesthetic procedure; the informed group, in which the parent/guardian was also provided with an information leaflet about the anaesthetic procedure; the smartphone group, in which the parent/guardian was verbally informed and the child received a smartphone application to play with while in the holding area before entering the operating room and the smartphone and informed group, in which the parent/guardian also received an information leaflet and the child, a smartphone application to play with while in the holding area before entering the operating room.

MAIN OUTCOME MEASURES Children's anxiety at two time points: in the holding area of the surgical centre and in the operating room during induction of anaesthesia by facemask.

RESULTS Median (IQR) anxiety levels were greater at time point operating room for children in the control group (55.0; range: 30.0 to 68.4) than in the other groups: informed group, 28.4 (23.4 to 45.0); smartphone group, 23.4 (23.4 to 30.0); smartphone and informed group, 23.4 (23.4 to 25.9).

CONCLUSION The behavioural distraction strategies using smartphones were effective in preventing an increase in children's anxiety during anaesthesia induction.

TRIAL REGISTRATION clinicaltrials.gov identifier: NCT02246062.

From the Department of Anesthesiology and Pain, Irmandade da Santa Casa de Misericordia de São Paulo (DOC); Department of Anesthesiology, Faculdade de Medicina da Universidade de São Paulo (JEV); Faculdade Pernambucana de Saúde (LCL); and Santa Casa de São Paulo School of Medical Sciences (LPS, RAPS, LASTM)

Correspondence to Débora O. Cumino, Department of Anesthesiology and Pain, Irmandade da Santa Casa de Misericordia de São Paulo, Rua Nilo, 35 ap 113 (Aclimação) São Paulo, SP, CEP 01533-010, Brazil Tel: +55 11 98555 4440; e-mail: dcumino@gmail.com

Published online 18 January 2017

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Introduction

Studies suggest that up to 50% of children undergoing surgery experience fear and significant anxiety in the preoperative period.1–3 Reducing anxiety in children undergoing anaesthetic procedures is important both for compassionate reasons as well as to increase their cooperation during anaesthesia induction, and to reduce the risk of postoperative emergence delirium and behavioural changes.4

Preoperative anxiety affects not only the children but also their parents.5 Parental fear and anxiety, even if unintentional, will usually affect their children. The anaesthetist should recognise these interactions and take steps to prevent and address such manifestations.5

An evidence-based review concluded that parental presence during induction of anaesthesia (PPIA) does not alleviate the anxiety of children, and in the those cases where PPIA appeared to decrease anxiety, it was associated more with preanaesthetic medication and other nonpharmacological interventions, such as toys and video games, than with parental presence per se.6 Electronic games, smartphones and tablets have become part of children's and adolescents’ culture, and these are being extensively adopted in healthcare settings for the purpose of distraction and as behaviour modification therapy.7,8 When children play with portable media devices, they remain focused and oblivious to their surroundings, disregarding verbal and tactile stimuli.7,8

In preparation for anaesthetic procedures, this study proposes a programme comprising both an information leaflet and the use of a smartphone application. The programme is aimed at providing information to the parents/guardians about the anaesthetic procedure and introduces the children to distraction techniques with the aim of reducing their anxiety levels in the preoperative period.

The goal of this study was to determine whether distraction with a smartphone could be used to help reduce anxiety in paediatric patients. As a few previous studies have used smartphones as a distraction in the perioperative setting and found it useful, we expected that playing with a smartphone during the preoperative period and facemask anaesthesia induction would be effective in reducing children's anxiety.

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Methods

Ethical approval for this study (Ethical Committee N° 288.712, Plataforma Brasil CAAE registration number 16609613.9.1001.5479) was provided by the Ethical Committee in Human Research of Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil (Chairperson Professor Nelson Keiske Ono) on 29 May 2013. The study started in November 2013 and ended in September 2015. All parents or legal guardians provided written consent on the day before surgery, and the children's verbal agreement was obtained when the child was six or older and had the ability to understand the study.

Thereafter, a prospective, open, randomised clinical trial was conducted to examine the effects of two behavioural interventions on preoperative anxiety in children undergoing general anaesthesia. The study aims were to compare the prevalence and levels of anxiety in children, according to the quality of information provided to the parent/guardian and also on the use of smartphones by the children in the immediate preoperative period.

The inclusion criteria were as follows: unpremedicated, healthy children aged 4 to 8 years old inclusive, with American Society of Anesthesiologists (ASA) physical status I and II scheduled to undergo minor-to-moderate elective surgical procedures with general anaesthesia. The exclusion criteria were as follows: children with a history of developmental disabilities, neurological diseases or psychoactive medication use; children with hearing and/or visual impairment; children with a history of previous surgery.

At the preoperative visit on the day before surgery the participants were randomly allocated into four groups. Group allocation was based on a computer-generated random number sequence. At the preoperative visit, the control group family received only verbal information about the anaesthetic procedure. In the informed group (IG), as well as the verbal information, the family also received a leaflet containing information about the anaesthetic procedure. In the smartphone group, the family received verbal information only at the preoperative visit and the child received a smartphone in the presurgical holding area on the day of surgery. Finally, in the smartphone and informed group (SIG), the family received the verbal information and a leaflet containing information about the anaesthetic procedure, and the child received a smartphone in the presurgical holding area on the day of surgery.

The children's anxiety levels were measured using the modified Yale Preoperative Anxiety Scale (m-YPAS),9 translated into Portuguese and validated.10 This is a tool by which the behaviour of the child is observed and scored, and it can be completed in less than1 min. The m-YPAS was calculated as originally proposed by Kain et al.9. ‘Cut-off points’ were set to classify patients: a score of 23.4 to 30 for no anxiety, and any score greater than 30 for anxiety.9 The researchers who assessed children's anxiety using the m-YPAS were trained in a pilot study so as to obtain good reliability. An independent research assistant double-coded 25% of the data to assess interrater reliability. In accordance with Kain et al.9, this instrument has excellent reliability.

The information leaflet11 contained questions and answers that are commonly asked by the parents, and consists of 17 brief items related to anaesthesia in children, and included information on the risks of anaesthesia, possible interruption of routine medication, laboratory tests, the need for fasting to avoid a ‘full stomach’ and its complications, the induction process and parental presence, the recovery room, restarting oral intake and how they could contribute to a successful anaesthesia experience for their children.

Collection of data began on the day before the surgical procedure. After a preanaesthetic evaluation and the provision of verbal information about anaesthesia, the parent/guardian was informed in detail about the purpose of the study and, if agreeable to their child being included, they were asked to sign an informed consent form. After enrolment in the study, in addition to the verbal information, the parents/guardians of the children in the informed group and SIG received an information leaflet about the anaesthetic procedure.

Before surgery, in the holding area of the surgical centre, a smartphone was handed to the children in the smartphone group and SIG. Six smartphone apps, selected by the researchers to suit the ages of the children, were offered in the same folder. The children were allowed to choose, or change, the apps as they wished. The chosen apps were Galinha Pintadinha (© Bromélia Produções LTDA, São Paulo-SP, Brasil), IGo To Farm (© Lisbon Labs, Lisbon, Portugal), Talking Tom (© Outfit 7 Limited, London, UK), Cut the Rope (© 2015 ZeptoLab UK Limited, London, UK) Where's My Water (© 2011 Disney, Florida, USA) and Angry Birds (© 2016 Rovio Entertainment Ltd, Espoo, Finland). After 30 min of playing with the smartphone, one of the researchers used m-YPAS to evaluate the child's anxiety (holding area time point). The smartphones were wiped with an alcohol-based solution before handing them out to the children.

The parents/guardians stayed with their child in the holding area, and in the operating room until the end of anaesthesia induction.

In the operating room, all children were monitored according to established standards and were evaluated using the m-YPAS score when applying the facemask for inhalation anaesthesia induction (operating room time point). The children in the smartphone group and SIG continued playing with the apps on the smartphone during anaesthesia induction. When the child lost consciousness the parent/guardian was asked to leave. The parents/guardians answered three questions as part of a satisfaction survey related to the information provided by the anaesthetist during the preoperative interview: ‘Were you satisfied with the information provided?’; ‘Did you feel calm after being informed?’ and ‘Has the information increased your knowledge about anaesthesia?’. Each question had three possible answers: No, partially and yes. Only the parents/guardians of children in the informed group and SIG were questioned about reading the leaflet.

For calculating the sample size, we estimated that the prevalence of anxiety in children inside the operating room would be 75%11,12 and that the proposed intervention would reduce this to 40%. Thus, using a 5% α risk and a 20% β risk with a confidence interval of 95%, we determined that 21 individuals were required in each group. In total, 86 participants were assessed for eligibility and were randomly selected by using a software randomiser (www.random.org; Fig. 1).

Fig. 1

Fig. 1

The Shapiro–Wilk and Anderson–Darling tests were used to test the assumption of normal distribution (P > 0.1). Normally distributed interval data are reported as mean (± SD), nonnormally distributed interval and ordinal data are reported as median (25 to 75% interquartile range), and categorical data are presented as counts (n).

The Kruskal–Wallis test was used to compare age variance, and the likelihood ratio test was used to compare sex, ASA physical status and the relationship to the parent/guardian. For all statistical analyses, a significant difference was determined by a P value of less than 0.05. For the anxiety scores, the Kruskal–Wallis Analysis of variance on ranks test and the Mann–Whitney U test were adjusted by a post hoc Bonferroni correction (P < 0.0085) for multiple comparisons across the groups. The Fisher's exact test was used to compare the prevalence of anxiety between the two time points.

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Results

Eighty-six children were assessed for eligibility and invited to participate in the study. Two were excluded because the parents/guardians refused consent. The remaining 84 patients, aged 4 to 8 years inclusive, were included in the study (Fig. 1).

No significant differences existed among the groups with respect to the sociodemographic data of the children and their parents/guardians, children's physical status (ASA classification) and relationship to the parents/guardians (Table 1). The children underwent various surgical procedures, and they were grouped according to the surgical specialty: paediatric general surgery or otorhinolaryngology (Table 1).

Table 1

Table 1

A comparison of the level of anxiety in children at time points holding area and operating room in all the groups showed statistical differences at time point holding area (P = 0.0027) and at operating room (P < 0.0001; Table 2). Following this result, the Mann–Whitney U test was applied and adjusted by the Bonferroni correction. At time point holding area, despite the overall higher levels of anxiety in children in the control group referred to above, applying the Bonferroni correction and comparing each of the groups did not reveal any statistically significant differences (Table 3). At time point operating room, a visual comparison of the median and 25 to 75% interquartile range (Table 2) suggested the level of anxiety in children in the control group was higher than that of children in the other groups but only the differences between groups control vs. smartphone group and control group vs. SIG were found to be statistically significant when the Bonferroni correction was applied (P < 0.001; Table 3). A comparison between the time points holding area and operating room using the Mann–Whitney U test showed that at operating room, the level of anxiety was higher in the control group (median holding area 23.4 vs. median operating room 55.0, P = 0.0003) and in the informed group (median holding area 23.4 vs. median operating room 28.4, P = 0.048; Table 2).

Table 2

Table 2

Table 3

Table 3

No differences in the prevalence of anxiety in children in the various groups were observed at time point holding area (control group 23.8%, informed group 9.5%, smartphone group 4.8%, SIG 9.5%). In contrast, at time point operating room, the prevalence of anxiety observed in the control group was higher (76.2%, P = 0.001) than in the other groups: informed group (38.1%), smartphone group (23.3%), and SIG (19.0%; Fig. 2). A comparison between the time points using the Fisher's exact test showed that at operating room, the prevalence of anxiety was higher in the control group (P = 0.0017, Fig. 2).

Fig. 2

Fig. 2

The results of the likelihood ratio test revealed lower satisfaction levels with the information given (question 1) in the smartphone group than in the other groups (P = 0.005). No significant difference was observed among the groups regarding whether the parent/guardian felt calm as a result of the information received (question 2). Finally, an increase in knowledge after receiving information (question 3) through the leaflet (informed group and SIG) was confirmed in 100% of the cases, compared with the corresponding groups that did not receive the leaflet (control group, 90% and smartphone group, 75%; P = 0.043). In addition, 85.7% of the parents/guardians read the information leaflet completely upon receiving it.

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Discussion

The main finding of this study is that children who play with a smartphone in the holding area before surgery have significantly lower anxiety scores than other children. We observed a lower prevalence of anxiety in the intervention groups than in the control group. Within the same group, when comparing different time points (holding area and operating room), we observed a lower prevalence of anxiety at the operating room time point in the groups using the smartphone.

Several alternatives to nonpharmacological strategies for minimising preoperative anxiety have been studied, such as PPIA, music therapy, toys and education, both through posters and videos.13–16 However, all these strategies, when applied in isolation, have limitations, making it difficult to infer evidence-based conclusions.

Behavioural intervention programmes arise from the use of nonpharmacological strategies that are combined and family centred.17 Fortier et al.18 analysed the Advance programme proposed by Kain et al.17 and demonstrated that practising the use of an anaesthesia mask at home and distracting the children in the holding area of the surgical centre had the greatest impact on anxiety. The level of anxiety was significantly lower and remained stable during the preoperative period, suggesting that behavioural preparation programmes should include these strategies.

In the current scientific literature, we observed an increase in behavioural intervention strategies that use video games, cartoons, virtual video glasses and smartphone applications to distract children in the preoperative period. These strategies seemed to have good efficacy in alleviating anxiety.7,17,19–21

Although no differences were observed among the current groups in relation to sociodemographic data, the predominance of female parents/guardians in both groups is worth mentioning. This is a common occurrence in paediatric patients, and it did not result in a biased analysis of children's anxiety. As some authors suggest, mothers tended to be more anxious and had a greater influence on the anxiety of their children during anaesthesia induction.22 In contrast, the presence of a nonparental family member could be an additional factor contributing to a child's anxiety.22 Although we observed more male parents/guardians in the SIG, this did not attain statistical significance. This nonsignificant difference can only be because of chance and had no observable clinical implications.

A low prevalence and low levels of anxiety were noted in the holding area for all groups. This may reflect the benefits of our hospital practice, for example, parental presence during hospital admission, television, toys and also other children in similar circumstances. These may all have a positive effect in alleviating anxiety. This finding is comparable with that reported by Kain et al.9 in their original study to validate the m-YPAS scale, as well as to the finding of a previous study conducted in this institution, in which an information leaflet handed to a family member resulted in a low prevalence and low levels of anxiety in the holding area.11

During anaesthesia induction, a higher prevalence of anxious children was observed in the control group than in the other groups. This high prevalence of anxiety at the operating room time point in the control group corroborates the existing literature which demonstrates a high prevalence of anxiety in children during anaesthesia induction in the operating room despite parental presence.2,3,12 In contrast, in our study, we found that providing a combination of strategies (information leaflets and smartphone apps), resulted in a lower prevalence of anxiety at the operating room time point than either the use of the smartphone and no parental leaflet or for the parental information leaflet alone. This finding is in accordance with that of previous studies demonstrating lower levels of anxiety both in children subjected to a combination of nonpharmacological strategies, including distraction techniques during anaesthesia induction,17–19 as well as in children given electronic devices during anaesthesia induction.20,21,23

At the operating room time point, we identified an increase in the prevalence of anxiety in the control group, which was consistent with the findings of other studies demonstrating that the entry into the operating room brings about a negative emotional impact and an increase in the anxiety of children.5,6,24 However, children who received smartphones (smartphone group and SIG) showed no increase in anxiety levels. Thus, it appears that playing with a smartphone has a significant impact on preventing a rise in the prevalence of anxiety during anaesthesia induction.

According to a study by Lee et al.20, the use of smartphone applications for preoperative distraction purposes can be offered to most children. This is a low-cost strategy that can be easily implemented, and the devices can be easily cleaned and transported. The smartphone, by providing distraction through both a pleasurable activity and cognitive and motor absorption, keeps the children oblivious to their surroundings and to factors likely to aggravate anxiety in the preoperative period.20

The increase in knowledge about the anaesthetic procedure provided by means of the information leaflet, as compared with verbal instruction alone, is in accordance with the findings of Spencer et al.25 and of other authors who demonstrated that written information enhances both parental knowledge and satisfaction.26

Recent evidence suggests that school-age children and their families value and desire comprehensive information about medical care.27 Thus, effective communication which provides information, respects individual needs and involves parents/guardians in clinical decisions plays an important role in improving the doctor–patient relationship.28

The main limitation of this study is that it did not compare the smartphone strategy with pharmacological sedation strategies. The second limitation of this study is that it did not include patients with behavioural problems or previous experience in an operating room, therefore, the observed results cannot be applied to these patient populations. Third, m-YPAS in the holding area was not evaluated before the child had received the smartphone and thus changes in anxiety during this period may have been missed. Fourth, the postanesthetic period was not studied, but this was because the inclusion of different surgical procedures could be a significant confounding factor. Finally, the researchers were not blinded to the smartphone intervention groups, because at the times of evaluation of the m-YPAS scores, both in the holding area and in the operating room, the children continued playing with the smartphone.

In conclusion, the results of this study clearly indicate that the use of smartphones to distract paediatric patients is indeed an effective strategy to alleviate anxiety in the preoperative period.

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Acknowledgements relating to this article

Assistance with the study: we would like to thank LCL, JEV, LASTM, Pedro Paulo Tanaka for critically reviewing the manuscript and Tales Maciel de Camargo, Rafael Gonçalves Ribeiro, Rodrigo Andrade Tonim, João Pedro Simões, LPS, RAPS for data collection.

Financial support and sponsorship: none.

Conflicts of interest: none.

Presentations: preliminary data for this study were presented as a poster presentation at the 62°Congresso Brasileiro de Anestesiologia, 2015, Florianópolis-SC/Brasil and VII Fórum Cientifico da Faculdade de Ciências Médicas da Santa Casa de São Paulo – SP/Brasil.

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