A Mobile Application Can Be Used as an Alternative to the Traditional Preparation Method for Parents in Pediatric Day Surgery: A Randomized Controlled Trial

In day surgery, parents should be informed about the procedure to improve cooperation between the child and healthcare staff. Research indicates that parental anxiety and stress can be transmitted to children, leading to feelings of pain and fear [7‐9, 12, 13]. Parents often feel anxious during their child’s surgery due to a lack of control in a new environment [14]. This can result in feelings of guilt, lack of awareness, separation anxiety, and loss of control. Preparing children for day surgery can be a challenging task for parents who need to address their concerns and prevent negative experiences such as anxiety and stress [14]. Parents should support their child experiencing fear and anxiety, as these dynamics can negatively impact day surgery procedure and recovery [5, 6, 15, 16]. The situation can be challenging for children due to their active imaginations, which are stronger at younger ages and prevent them from employing abstract logical thinking [17].

Insufficient time for preparation has been associated with increased levels of anxiety and stress among parents [11]. While there is considerable knowledge on preparing parents for day surgery [5, 7, 18], there is lack on knowledge about the effectiveness of digital a interventions in surgical preparation [19]. According to Liu et al. [19] the mobile application was effective in preparing parents for their child’s hernia surgery. According to the findings, the application resulted in higher parental awareness and decreased the number of surgery cancellations [19].

Smartphones and their applications are integral to daily life. The WHO [20] has reported that digitalization supports human health, improves access to quality health services and enhances the efficiency of health systems. Integrating multiple methods before, during, and after day surgery may increase effectiveness. To optimize solutions that benefit both parents and children, it’s crucial to identify the key factors that lead to the best outcomes [21]. This study was conducted to determine if a mobile application intervention, which included audio-visual content, instructions, images, and timelines, was effective to decrease parental anxiety and stress. Mobile application interventions for pediatric day surgery preparation in parents have not been widely studied. Previous research has mainly concentrated on studying different age groups and children with long-term illnesses [22]. Research on digital interventions to support families and children is still lacking [23].

This study aimed to assess the effectiveness of a mobile application intervention in preparing parents for pediatric day surgery. Our hypothesis was as follows: parents in the intervention group have lower levels of anxiety (primary outcome) and stress during the day surgery process, as well as be more satisfied with the preparation they received (secondary outcomes), than parents in the control group. The study also aimed to describe the correlations between anxiety, stress and satisfaction experienced by parents.

The study was designed as a randomized controlled trial (RCT) with two groups.

The study was carried out between 2018 and 2019 at the pediatric day surgical department of one university hospital in Finland. The study included parents of children ages 2–6 who had elective day surgery under general anesthesia. (Table 1). The mobile application allowed parents to prepare their children up to 3–4 weeks prior to the operation. The sample size calculation was based on the study of Kain et al. [24]. They found that 46% of parents experience anxiety before their child’s surgery, according to the State-Trait Anxiety Inventory (STAI) as the primary outcome. For this study, we used an independent-sample t-test with an alpha value of 0.05 and 80% power. Based on this, we estimated that we would need 50 participants in total, with 25 participants in the intervention group and 25 participants in the control group. Sample size adjusted for 30% dropout rate, resulting in 70 parents: 51% (36 parents) in the intervention group and 49% (34 parents) in the control group.

The researcher contacted each parent to inquire about participation. Before that a pediatric surgeon had evaluated the need for surgery and secretaries had been trained by the researcher identified participants based on inclusion criteria. The intervention group received instructions for a mobile application to help prepare for surgery, while the control group received conventional instructions.

Parents brought a consent form and first measurements including demographic data and self-reported stress and anxiety, to the hospital (T1). Before taking measurements, the nurses were not informed whether the families belonged to the intervention or control group, and the researcher did not participate in data collection. The data on parents’ stress levels before (T2) and after (T3) their child’s surgery in the hospital was collected by the nurse. Afterwards (T4), the parents assessed their anxiety, stress, and satisfaction with their childsʼ preparation (Fig. 1).

The study conducted followed the Helsinki declaration and was approved by the Northern Ostrobothnia Regional Ethics Committee Board (EETTMK: 53/2017). At all stages of the research, ethical considerations were considered, including privacy, data protection, and participants’ right to information, respect, and honesty. Parents were informed about the study on preparing their child for day surgery and written consent was obtained.

All statistical analyses were conducted using the IBM SPSS statistical software for Windows (version 27; SPSS Inc., Chicago, IL). The t-test was used to assess the significance of between-group differences in the measured variables, while the Chi-square test was employed to compare the changes within and between pre-operative (T1, T2) and post-operative (T3, T4) measurements. Repeated Measures Analysis of Variance revealed differences between the intervention group and the control group in the STAI pre-surgery (T1) and post-surgery measurements (T4). The significance level for statistics was set at p < 0.05. Parental anxiety was assessed before and after the day surgery, and the scores of all parents in each group were summed up to calculate the average anxiety. Additionally, Spearman’s rho coefficient (T1, T4) was used to examine the correlations between anxiety, satisfaction, and stress.

The nurses who took part in data collection were given training by a researcher (HK). Buddy Healthcare employees trained the hospital staff on how to use the mobile application intervention. The study results were reported in accordance with the CONSORT Statement [30] and registered at ClinicalTrials.gov (NCT03774303). The data was collected by parents using validated measurements.

In this study, 70 parents were involved, with 36 in the intervention group and 34 in the control group. Before randomization, six families refused to participate in the study, citing reasons such as lack of time (n = 3), fear of surgery (n = 1), language barriers (n = 1), and recent participation in another study (n = 1). The loss rate for the intervention group was 22%, while the control group had a 24% loss rate. Apart from gender distribution, no significant differences were found in the demographic data (Table 2).

The study found no significant difference in anxiety levels between the intervention and control groups before and after surgery. Pre-operative anxiety score was 36.7 (SD 9.9; 78%) in the intervention group and 36.9 (SD 12.3; 76%) in the control group (p = 0.95). Post-operative anxiety score was 28.1 (SD 6.9; 67%) in the intervention group and 30.2 (SD 7.06; 50%) in the control group (p = 0.34).

Most of the parents in both groups experienced mild anxiety before (in the intervention group 68% and in the control group 69%; p = 0.77) and after the surgery (in the intervention group 88% and in the control group 94%; p = 0.63).

The results indicated a significant decrease in anxiety levels for both the intervention and control groups after surgery (IG: p = 0.003; CG: p = 0.002). There was no significant difference in anxiety levels between the two groups (p = 0.13). Parental anxiety decreased overall from pre-surgery (mean 36.3, SD 10.3) to post-surgery assessment (mean 29.4, SD 6.9).

The stress levels experienced by parents in both groups at home were similar before surgery. The majority of parents in both groups did not experience any stress or only experienced mild stress. Specifically, 61% of parents in the intervention group and 50% in the control group reported no or mild stress, with no significant difference between the groups (p = 0.61). However, before surgery at the hospital, most parents in the intervention group felt mild stress (77%) or moderate to intense stress (23%), while in the control group, 23% of parents felt no stress. There was a statistically significant difference between the groups, with a p-value of 0.02. After surgery at the hospital, most parents in both groups experienced no stress, with 47% in the intervention group and 50% in the control group reporting no stress (p > .99). After surgery at home, none of the parents in the intervention group, but 18% of parents in the control group experienced moderate to intense stress. The groups showed a statistically significant difference (p = 0.05). The stress levels decreased significantly after surgery in both groups, with a significant decrease observed for both the intervention group (p = 0.003) and the control group (p = 0.004) from T1 to T4.

The mean VAS score for parents in both groups was high: 8.8 for the intervention group (SD 1.9) and 8.6 for the control group (SD 0.9). These mean scores did not significantly differ (p = 0.794). Of the parents who participated in the research, 10 (24%) gave the maximum score of 10 when asked about preparation, 11 (27%) scored the preparation as 9–9.9, and 11 (27%) scored their satisfaction with the preparation as 8–8.9. The results revealed that 20% of parents were not completely satisfied.

Before the surgery (T1) there was a significant correlation between the anxiety experienced by parents and the perceived satisfaction in the intervention group (-0.624; p = 0.002) but not in the control group (−0.449; p = 0.071). After the surgery (T4) there was a significant correlation between the anxiety experienced by parents and the perceived satisfaction in both groups (IG; -0.565; p = 0.05) and (CG; -0.640; p = 0.006) (Fig. 2).

Before the surgery (T1) there was a significant correlation between the stress experienced by parents and the perceived anxiety in both groups (IG; 0.527; p = 0.004 and CG; 0.823; p = 0.000). After the surgery (T4) there was a significant correlation between the stress experienced by parents and the perceived anxiety in the CG (0.725; p = 0.001), but not in the IG (0.159; p = 0.457) (Fig. 3).

Before the surgery (T1) there was not a significant correlation between the stress experienced by parents and the perceived satisfaction in both groups (IG; 0.028; p = 0.903 and (CG; −0.229; p = 0.260). After the surgery (T4) there was also not a significant correlation between the stress experienced by parents and the perceived satisfaction in both groups (IG; 0.204; p = 0.351 and CG; −0.476; p = 0.053) (Fig. 4).

The study has certain limitations despite its aim to maximize validity and reliability. The sample size was inadequate to detect significant differences between groups due to missing responses from some parents. The statistical difference between the groups regarding the gender of the parents may affect the reliability of the results. Also, blinding was difficult, and some parents decided not to participate. The study results have been reported transparently, including statistically insignificant results. All participants were recruited from a single university hospital, which may limit generalizability of the results. Future studies should assess the effectiveness of mobile interventions over a longer period of time.

The mobile application intervention did not decrease anxiety, but it did help to reduce stress levels in parents. It seemed that mobile application interventions can be used to prepare preschool children’s parents for day surgery as an alternative to the traditional preparation method. Although mobile applications cannot fully replace face-to-face interaction, they could be a cost-effective option in the future. Future developments should consider the individual characteristics and needs of families in pediatric care to offer new effective solutions.