Age-speciﬁc and family-centered information modalities to prepare children at home for day-care surgery

Background: Surgery induced stress and anxiety in children and parents can be reduced by providing preoperative information adapted to their needs. Aim of this study was to evaluate the effects of three different information modalities (coloring page, mobile application and videos) to prepare children and their parents for day-care surgery on preoperative anxiety and postoperative pain experienced by the child, and preoperative anxiety and satisfaction of parents. Methods: Prospective observational study including children and their parents that were offered speciﬁcally developed information modalities to prepare for day-care surgery. Results were compared between children and their parents that used none (i.e., control group) versus one or more information modalities (i.e., intervention group). Primary outcomes were preoperative anxiety measured using PROMIS v2.0 Anxiety and postoperative pain in children. Secondary outcomes were preoperative parental anxiety (STAI questionnaire) and family satisfaction with information and communication (modiﬁed PedsQL Health- care Satisfaction questionnaire). Subgroup analyses were performed between preschoolers (0-5 years) and school-aged ( ≥ 5) children. Results: 93 patients (male 53%) were included in the intervention (n = 56) and control group (n = 37). Levels of children’s preoperative anxiety and postoperative pain, and parental anxiety did not differ between both groups. Families of prepared children were more satisﬁed with information and communication about preoperative surgical information (8 vs. 6.6, p = 0.004) and satisfaction with how parents (7 vs 8, p = 0.019) and children (8 vs 6, p = 0.018) were prepared for surgery. Conclusions: Preoperative anxiety did not differ between prepared and unprepared children. The use of speciﬁcally developed family-centered and age-appropriate information modalities to prepare children for day-care surgery at home results in superior family satisfaction. Level of Evidence: III )

and fear of the unknown. Preoperative anxiety in children may be related to negative postoperative outcomes and behavioral disturbances, e.g. eating disorders, separation anxiety, nightmares and bedwetting [1] . Formerly available information modalities mainly focused on procedural information for parents as parents' emotional state and anxiety and knowledge about the procedure also influence the child's perioperative anxiety and postoperative behavior [2] .
Children are more susceptible to stress and anxiety in contrast to adults due to limited cognitive development and life experience, lack of independency, self-control and understanding the current situation [3] . Children are most distressed on not knowing what to expect [4] , and the provision of developmentally ap-propriate information is shown to be one of the key components of effective preparation in pediatric patients [5] . Previous studies have already shown that preoperative digital information about the hospital (and its facilities), roles and responsibilities of healthcare professionals and medical information about the medical disease and treatment increases confidence, reduces anxiety and potentially prevents postoperative negative behavioral changes in children [4 , 6-8] . More specifically, family-centered preparation for surgery has been shown to reduce preoperative anxiety and improve perioperative outcomes (e.g. less requirement of analgesia in the recovery room) in children requiring surgery [9] .
To limit preoperative anxiety in children in the hospital, many (distraction) techniques are used (e.g. virtual reality, distraction videos, therapeutic plays) and have limited efficacy to prepare children at home since they take place once children have already been admitted. Providing preoperative information and materials including educational and procedural information adapted to the need of both children and their families increases their knowledge about the procedure and helps children to become familiar with what to expect at the day of surgery. This consequently ensures that children experience less preoperative stress and anxiety and potential postoperative psychological complaints. Furthermore, adequate knowledge about the procedure enables parents to support their child through this stressful situation [9][10][11][12] . This supports the need for a family-centered approach and highlights the need to timely prepare children for surgery [2 , 8 , 9 , 13] .
The provision of information that is adapted to the developmental and psychosocial needs of patients in every age group is shown to be one of the key components of effective preparation for pediatric patients undergoing surgery [5] . Concerning the type of information, a systematic review (n = 38 studies) of technologybased preoperative preparation interventions showed that tablet and handheld devices with interactive capacity had most consistent effects on preoperative anxiety in children, while for parents video preparation is a viable option to address preoperative anxiety. Though, passive viewing of preoperative information video appears less effective for children [14] . It is not known what kind of information modality to prepare for surgery will be most effective for children of different ages. This study aimed to evaluate the effects of three different information modalities to prepare children and their families for day-care surgery on preoperative anxiety and postoperative pain experienced by the child, and preoperative anxiety and satisfaction of parents, and investigates the hypothesis that the use of these information modalities decreases preoperative anxiety and postoperative pain experienced by the child, and potentially preoperative anxiety and satisfaction of parents.

Ethical approval
The Medical Ethics Review Committee of the VU medical center Amsterdam reviewed this study (reference number 2018.448) and confirmed that the Medical Research involving Human Subjects Act (WMO) does not apply and an official approval of this study is not required. Written informed consent was obtained from parents of all participants.

Setting and participants
This is a prospective observational study including children and their parents who were scheduled for day-care surgery at the department of pediatric surgery in Amsterdam UMC, location VU medical center or at the ear nose throat (ENT) department in OLVG location West between October 2018 and June 2021, that were offered specifically developed information modalities to prepare for surgery. Inclusion criteria consisted of children aged between six months and 18 years old scheduled for inguinal hernia repair, (adeno)tonsillectomy, adenoidectomy or middle-ear drainage in day-care setting. Exclusion criteria were: parental age < 18 years old. After children were scheduled for inguinal hernia or ENT surgery, a researcher contacted the parents to ask informed consent to participate in this study. All patients and their parents received standard preoperative oral information at the outpatient department. Thereafter, the available preoperative information modalities and accompanying guide were sent to parents by e-mail at least one week before surgery. Parents and children were free to choose what method(s) they used. Patients were categorized into two groups based on their actual use of information modalities to prepare for surgery. Children and their parents that did not use any of the specifically developed information modalities were included in the control group. Patients and parents that used one or more of the specifically developed information modalities to prepare for surgery were included in the intervention group. Outcome parameters were assessed at the day of surgery. Patients with incomplete or missing data on more than one outcome parameter were excluded.

Preoperative information modalities to prepare for surgery
We developed three different information modalities that focus on preparing children in a family-centered way for surgery: coloring page, mobile application and videos. Every method includes educational and procedural information that allows children to become familiar with what to expect at the day of surgery. In addition to the modalities, we developed a guide for parents with additional information regarding the operation, including the preoperative nil per mouth instructions, the admission to the hospital, the preparations before entering the operating room, different types of anesthesia (infusion or breathing mask) and the postoperative period (recovery room, discharge from the hospital and recovery of the wound). Parents were instructed to use the accompanying guide to stimulate interaction and discussion with their child while using the information video, coloring page or application. All information modalities were developed and repeatedly evaluated and refined in close collaboration with pediatric and ENT surgeons, pediatricians, psychologists, childcare workers, children and their parents and representatives of the "Child & Hospital Foundation" (a patient organization devoted to child medical care; Dutch: "Stichting Kind & Ziekenhuis"). Before the start of the study we conducted a pilot study including five to ten consecutive children and their parents that were scheduled for each of the included treatments and asked them to use all different information modalities to prepare for surgery. Subsequently, we evaluated all modalities together with the patient and parent(s) in detail per person and refined the modalities before it was send to the next patient. We continued until no further refinements had to be made. The coloring page and mobile applications were available for both the pediatric surgery and ENT department, the information videos were only available for children with inguinal hernia. Hereafter, the modalities will be further explained.

Coloring page
The coloring page walks children through the surgery in nine simple steps: on the way and admission to the hospital, going to the operating room, induction of anesthesia, the surgery including the treatment itself, waking up after surgery, postoperative checkup and discharge from the hospital. Parents can use the guide to elaborate on these different steps.

Mobile application "Bye inguinal hernia" and "Bye tonsils"
Before the mobile application starts, parents are able to read the aforementioned guide that will help them talk their children through the different themes of the application. The app also includes text boxes that contain information about a certain subject. Children start the application by creating characters for the whole family after which they will slide through different themes and learn about what they can expect surrounding their surgery in an animated way. The first theme: "the surgery" is subdivided in the children's ward, the way to the operating room, the operating room and postoperative recovery. The second is "who you run into (i.e. employees of the hospital)" and the third theme is "following surgery" (i.e. information on postoperative recovery and wound healing).

Information videos
Two different information videos of 1:35 and 3:40 minutes were created. The first information video includes mostly procedural information as it shows a child who is having inguinal hernia surgery (in the same hospital as children included in this study) from the moment he arrives in the morning before surgery until he is discharged. The second video includes mostly information about the etiology of inguinal hernia and its treatment.

Primary outcome measures 2.4.1. Preoperative anxiety
Preoperative anxiety was only assessed in school-aged children ( ≥ 5 years). Primary outcome could not be assessed in infants, toddlers and pre-school children due to lack of reliable (short) questionnaires. Preoperative children's anxiety was measured at the day of surgery before surgical treatment using PROMIS v2.0 Anxiety. In children aged between 5-17 years anxiety was assessed using the proxy report item bank (13 items). Children aged ≥ 8 years also reported anxiety using a self-report short form 8a (8 items). All items used a seven-day recall period and were scored on a five-point Likert scale (1 = never; 2 = almost never, 3 = sometimes, 4 = often, 5 = almost always). Raw scores were translated into standardized T -scores with corresponding standard errors (SE's). Tscores were calculated by the formula: (the level of severity x standard deviation) + population mean, i.e. ( θ x 10) + 50. The Cronbach's alpha values in the present study showed good internal consistency for parent proxy reported (13 items; α= .86) and self-reported (8 items; α= .88) anxiety. Higher scores representing higher levels of anxiety. The mean T-scores of the PROMIS v2.0 Anxiety self-report form of prepared and unprepared children included in this study were compared with norm scores of a representative sample of the Dutch general population of children aged between 8 and 12 years [15] .

Postoperative pain in children
Assessment of postoperative pain in children was measured by nurses using the COMFORT behavior (COMFORT-B) scale (up to 6 years, proxy report), the FLACC scale (4-7 years old, proxy report) or using a self-report Visual Analog Scale (VAS)/Numerical Rating Scale (NRS) [16][17][18][19] . The comfort scale rates different intensities (from one to five) of behavior on six different categories (alertness, calmness/agitation, crying (for spontaneously breathing children), body movements, facial tension and muscle tone). The FLACC (Face, legs, activity, crying, and consolability) scale is based on observations on five areas and is used to assess the level of pain (from zero to two) in children who are too young to cooperate verbally. The VAS and NRS uses numbers to rate pain ranging from 0 (no pain) to 10 (worst possible pain). Pain assessments/observations in the direct postoperative period (i.e. within one hour after surgery) were included for data analyses. The ENT department only used VAS scores for the assessment of postoperative pain in children.
Higher scores indicate more pain.

Secondary outcomes 2.5.1. Preoperative parental anxiety
Preoperative stress, anxiety and fear of parents was measured at the day of surgery prior to surgical treatment by administering the short form of the validated State-Trait Anxiety Inventory/Self-Assessment Questionnaire (STAI/ZBV) [20] in both fathers and mothers. Current/temporary (i.e. state) anxiety level was measured using six, and general (i.e. trait) anxiety level using ten items that scored whether parents experienced a certain feeling using a fourpoint Likert scale (1 = almost never; 2 = sometimes; 3 = often; 4 = almost always). Total scores of state and trait anxiety were calculated per parent (and ranged from 6-24 and 10-40 respectively). These scores were converted to scores (range 20-80) that were comparable to original 20-item STAI State and Trait scores (ranging from 20-80). Higher scores represent higher levels of anxiety. The Cronbach's alpha values in the present study showed good internal consistency for state (6 items; α= .87) and trait (10 items; α= .84) anxiety.

Family satisfaction
Overall family satisfaction with information and communication and satisfaction with each of the information modalities individually was measured at the day of surgery using a modified and shortened version of the Dutch Pediatric Quality of Life (PedsQL) TM Healthcare Satisfaction Hematology/Oncology Specific Module questionnaire in one parent [21 , 22] . This modified questionnaire was developed by an expert panel consisting of pediatric surgeons, researchers and pediatric psychologists, and focused on satisfaction with information and communication in general, and satisfaction with information and communication via respectively use of coloring page, mobile app or video(s). The Cronbach's alpha values in the present study were good for all subscales: "general satisfaction with overall information and communication" (4 items; α= 0.72), "information and communication via video 1 and 2 " (video 1: 4 items; α= .72 and video 2: 4 items; α= 0.77), "information and communication via coloring page" (4 items; α= 0.85) and "information and communication via application" (4 items; α= 0.70). The degree of satisfaction was rated using a Visual Analog Scale ranging from 0 (not at all satisfied) to 10 (very satisfied). Higher scores indicate higher levels of satisfaction.

Statistical analysis
Data were prospectively assembled using Castor electronic data capture (EDC). Statistical analyses were performed using SPSS software, version 25.0.0.1 (IBM SPSS Statistics). Patient demographics and treatment characteristics are reported as mean values with standard deviation (SD) for continuous and as percentages for categorical variables. Results were compared between children and their parents that used none (i.e. control group) versus one or more (i.e. intervention group) of the specifically developed information modalities to prepare for surgery. Subsequently, patients were subclassified into different age groups following the developmental stages according to developmental psychologist and psychoanalyst Erikson; Group A: 0-5 years old (infants, toddlers and preschool children; further referred to as preschoolers) and group B: 5-18 years old (elementary school children and adolescents, further referred to as school-aged children) [23] . Pearson chi-squared or Fisher's exact test and independent samples t -test and Mann-Whitney U tests were used to compare groups. Scale score from the general satisfaction with overall information and communication subscale was computed as the sum of items divided by the number of items answered. Cronbach's alpha was used to measure the internal validity of the PROMIS, STAI and family satisfaction questionnaire, and α> 0.70 was considered high internal consistency. P value of < 0.05 was considered significant.

Study population
One-hundred and twenty-one patients were assessed for eligibility ( Fig. 1 ). Fifteen patients were excluded: two for not meeting the in-and exclusion criteria, nine parents declined participation, in two parents a language barrier was present and in two patients surgery was postponed. Parents of three eligible patients could not be reached and three patients were missed for screening. Hundred patients were finally included in this study. Since data on more than one outcome parameter were not available in seven of the included patients, 93 patients were finally included for data-analysis (n = 56 in the intervention and n = 37 in the control group); 53% was male, mean (SD) age at time of surgery was 4.4 (2.9) year. Inguinal hernia or hydrocele repair was performed in 60% of the patients (mean age 4 years), 40% underwent either (adeno)tonsillectomy (n = 16), adenoidectomy (n = 4), middleear drainage (n = 14) or middle-ear drainage combined with tonsillectomy (n = 2) or adenoidectomy (n = 1) in the ENT department (mean age 4.5 years). Baseline characteristics did not differ between the intervention and control group ( Table 1 ).

Use of information modalities
Children and their parents were able to choose for themselves what methods they wanted to use to prepare for day-care surgery. School-aged children (group B) or their parents more often used one or more of the available information modalities compared to preschoolers (68% versus 55%): they more frequently watched information videos or preoperatively used the application ( Table 2 ).

Preoperative anxiety
Anxiety was measured in a total of 35 children aged between 5-18 years. No differences were found between mean (SD) par- ent reported preoperative anxiety of prepared (n = 24) vs. nonprepared (n = 11) children aged ≥ five years (51.6 ± 7.3 vs 51.6 ± 5.7, p = 0.999). The mean T-scores of children aged ≥ eight years was measured in ten children and did also not differ between the intervention and control group (48.7 ± 8.2 vs 44.2 ± 9.4, p = 0.288).

Postoperative pain in children
Postoperative pain did not differ between the intervention and control group ( Table 3 ). Following stratification for age, postoperative pain did also not differ between the groups.

Preoperative parental anxiety
STAI questionnaires were completed by 118 parents of 93 children (22% male and 57% female; in 21% gender was not reported). Parental anxiety did not differ between the intervention and control group; Mean state anxiety was 33.3 ± 9.7 vs. 34.6 ± 11, p = 0.515 and trait anxiety 31 ± 8.1 vs. 31.2 ± 9.2, p = 0.895. Parental anxiety in younger (0-5 years) prepared vs non-prepared children and old ( ≥ 5 years) prepared vs non-prepared children did also not differ ( Table 4 ).

ARTICLE IN PRESS
with the preoperatively available information about the surgery and possible complications and satisfaction with how ii) parents and iii) children were prepared for surgery using information that was available in the preoperative period. Regarding the schoolaged children, parents were also more satisfied on these three items compared to parents of non-prepared school-aged children. Regarding the preschool children, no differences were found in general satisfaction ( Table 5A ).
Median (IQR) overall family satisfaction with information and communication via coloring page, mobile application and video 1 and 2 did not differ between pre-school and school-aged children. According to parents, both information videos may better be suited to the school-aged instead of the preschool children. The coloring page and mobile applications may be suited to both groups, al- though school-aged children did get a little more stress or nerves from using these modalities compared to the younger ( Table 5B ).

Discussion
Levels of preoperative anxiety and postoperative pain (primary outcome measures) in children did not differ between control group (no information is used) and intervention group (at least one modality is used). Parental anxiety did also not differ between groups. Subgroup analysis of the different age groups demonstrated similar results concerning child and parental preoperative anxiety and child's postoperative pain between the intervention and control group. Families of prepared children (intervention group) were more satisfied with overall information and communication compared to the control group.
The present study could not demonstrate a significant difference in preoperative anxiety using the PROMIS v2.0 Anxiety questionnaire(s) between the intervention and control group in both children and their parents. Postoperative pain in children was also not significantly reduced by using one or more of the specifically  developed information modalities. Patients who underwent previous surgical treatment were not excluded from our study population. However, the number of patients with previous surgical experience was equally dispersed among the intervention (14%) and control group (13%) and therefore we do not expect this would have an influence on the outcome effect. Previously, Thissen et al. assessed the minimally important differences (MID) for pediatric self-report measures and showed that the estimated MID using the PROMIS T-score scale was about 2-3 points [24] . In the present study, the difference in preoperative anxiety reported by children aged ≥ eight years in the intervention versus control group was 4 points (44.7 vs 48.7). Despite this is a non-significant difference, according to the study of Thissen et al. this decrease in preoperative anxiety in children aged ≥ eight years after use of one or more specifically developed information modalities should be considered a clinically relevant difference [24] . The pre-operative selfreport anxiety scores (mean T -scores) of children in the intervention (44.7 ± 7.7 vs 44.2 ± 9.4, p = 0.900) as well as control group (48.7 ± 8.2 vs 44.2 ± 9.4, p = 0.288) did however not differ from anxiety scores of peers from a representative sample of the Dutch general population of children aged between 8 and 12 years [15] . [15] . Moreover, the mean (SD) T -score of children in the control group was 48.7 ± 8.2 and thus considered to be relatively 'low', as T -scores < 50.77 indicated minimal symptoms [15] . This potentially indicates that they were not experiencing high(er) levels of anxiety. Interestingly, parental state anxiety -which is believed to influence child's perioperative anxiety -in our control group was remarkably lower compared to previously reported parental state anxiety measurements of comparable control patients using the STAI [9 , 10 , 25 , 26] . These studies included patients undergoing similar elective outpatient surgeries, e.g. circumcisions, inguinal hernia repair, tonsillectomy or adenoidectomy. A potential explanation could be that both the surgical and ENT department that participate in the present study already deliver family-centered standard of care and age-appropriate information; potentially reflecting the relatively low level of child and parental preoperative anxiety. Nevertheless, we believe continuous optimization of information modalities to prepare for surgery is of great importance. The recent COVID-19 pandemic highlights the necessity of at-home preparation since outpatient clinic visits are often (temporarily) replaced by a digital consult with only limited time and resources available to properly prepare children and their parents for surgery. Moreover, low-ambulatory procedures in children are increasingly performed as day-care or outpatient surgery, which further limits the possibility to prepare children for surgery during their short hospital stay. Consequently, evaluation and, if necessary, optimization of family satisfaction is crucial. A previous study explored parents' thoughts and perspectives concerning the design and content of virtual information for children to prepare for their hospital stay and most importantly showed that there was a strong need for information prior to the hospital admission [4] . Furthermore, parents acknowledged the need for digestible and easily conveyable medical information including information on what to expect, the hospital and healthcare staff, and how to prepare their child in an age-appropriate manner [4] . The present study showed higher family satisfaction with information and communication about the surgery and its potential complications and with the manner of preparing both parents and children for surgery, in patients who used one or more information modalities compared to patients who used none (control group). This potentially reflects that the specifically designed interventions meet the above-mentioned needs and desires of the parents and their children. Particularly families of school-aged children were found to be more satisfied following use of information modalities, potentially displaying that the need to prepare children for surgery increases with inclining age. Furthermore, these results show the importance of informing parents of patients before surgery. School-aged children more often prepared for surgery using one or more information modalities than younger children, preferring the use of an information video or mobile application. Median overall satisfaction between pre-school and school-aged children with information and communication via coloring page, mobile application or video 1 and 2 did not differ. According to their parents, information videos potentially better suited school-aged versus preschool children. Though according to a previous systematic review, passive viewing of a preoperative information video appears less effective for children [14] . School-aged children gotaccording to their parents -somewhat more stress or nerves from using the coloring page or application compared to the preschoolers. The information videos caused more stress to the preschoolers compared to using the coloring page or mobile application. Subsequently, in our study population information videos might be more convenient in school-aged children, whereas the coloring page and application potentially better fit the preschoolers. Future combination of multiple preoperative information modalities might further reduce preoperative anxiety, as children's and parental preoperative state anxiety levels were shown to be significantly lower if children received a combination of information modalities versus one of the materials alone [27] .

ARTICLE IN PRESS
This study has several limitations that could influence the interpretation of our results. First, this is a non-randomized observational study with a limited number of participants that could lead to selection bias. The small number of patients did not allow us to perform subgroup analyses between different interventions and procedures. Moreover, the selection of the control group potentially introduces bias. However, we believe that the enrollment of patients in this prospective observational study is an adequate reflection of our daily clinical practice, as not all parents and patients are in need and willing to use preoperative preparation materials. The timing of surveying family satisfaction was only carried out at the day of surgery, as we were particularly interested in whether patients and parents received adequate information before the start of the surgical treatment about what to expect at the day of surgery. To better evaluate family satisfaction about the postoperative period in future studies, we suggest to evaluate family satisfaction at two time points. Another limitation of this study is that uniform instruments to adequately assess preoperative anxiety and postoperative pain in children are lacking. These instruments vary largely depending on the age of the child. Thereby, state of the art questionnaires to assess preoperative anxiety in children are currently only available for school-aged children. Moreover, the perception of postoperative pain following e.g. (adeno)tonsillectomy is expected to be different from e.g. middleear drainage or inguinal hernia repair. In the present study, blood pressure tests and heart rate measurements -that could potentially provide additional information regarding anxiety and painwere deliberately omitted in order to interfere as little as possible since they can also create additional stress in this already stressful situation. Not only the postoperative perception of pain, but also the need and amount of preparing children for surgery might depend on the child's diagnosis, as well as the child's age. A few parents in both the intervention and control group did also prepare their children a little with help of e.g. a picture book, information from the internet or YouTube, or via a simple conversation or storytelling. This could lead to an underestimation of the anxiety levels and postoperative pain. Last, as the effects of preoperative preparation not only seem to vary with child's age but also the timing of the intervention [28] , this could also have an influence on the outcome effect.
In conclusion, preoperative anxiety and post-operative pain in children and preoperative anxiety in parents did not differ between prepared and unprepared children. There was however a clinically relevant decrease in preoperative anxiety in children more than eight years after use of one or more specifically developed information modalities. The use of family-centered and age-appropriate information modalities to prepare children for surgery at home results in superior family satisfaction with information and communication about their child's surgery and potential complications.

Funding
This research was supported by Innovatiefonds Zorgverzekeraars (Health Insurers Innovation Fund), project number 3.555, and by the Netherlands Organization for Health Research and Development (ZonMw), project Number 852001903.

Declaration of Competing Interest
None.