The design adopted for the study was cluster randomized controlled trial. The schematic representation of the study design was developed according to Consolidated Standards of Reporting Clinical Trials (CONSORT) statement 2010 and is presented in Fig. 1. The study was conducted in a pediatric surgical unit of a tertiary care hospital in Karnataka, India. Every year approximately 200–300 pediatric surgeries are performed in this hospital. The children in the experimental group received a combination of distraction interventions and pharmacological treatment as interventions.

The participants included children aged 2–7 years and undergoing abdominal and urogenital surgeries; inpatient in the pediatric surgical unit for a minimum of 3 postoperative days (PODs); able to understand and speak Kannada or English and the child who is accompanied by mother for 3 PODs. The exclusion criteria were children undergoing cardiac, head and neck and orthopedic surgeries, mentally retarded and physically challenged and those children posted for emergency surgery.

The sample size for the present study was calculated based on previous studies. Considering postoperative pain as primary outcome, the sample size of 160 (80 experimental and 80 control) was recruited. The power of 80% at a level of 0.05 significance and drop-out rate of 10% were considered.

The participants in the study were randomly allocated to experimental and control group through week-wise randomization method. Since only one pediatric surgical unit was available, the entire pediatric surgery unit was considered as a cluster, and the weeks were randomized as experimental or control group for selecting the children in the study. The researcher was blinded on allocating the participants into the experimental and control group. Allocation of the children to the experimental and control group was done by the secondary investigator who was not directly involved in the recruitment of the children to the study. Researcher had taken an informed consent from parents and assent from the children. Due to the nature of trial the researcher was not blinded while data collection and follow-up.

The children in the experimental group received the intervention for 3 consecutive PODs (starting from POD 1 to day 3). Age-appropriate distraction interventions along with the usual care (pharmacological treatment i.e., Morphine, Acetaminophen, Paracetamol based on type of surgery) were provided to the children in the experimental group. The nurse researcher offered the child an age-appropriate distraction kit which included distraction activities developed separately for 2–4 years and 5–7-years-old children. The main aim of the researcher was to divert the child’s attention from the painful stimuli. The kit for the children aged 2–4 years consisted of soft toys with different colours, book with pictures of animals, push and pull toys, breathing activities by blowing colourful feathers and pin wheel, role play game cards, simple blocks for construction, matching cards with different colours and pictures and colouring books. The distraction kit for the children aged 5–7 years were role play toys (kitchen set, doctor set), puzzle cards, drawing books and a magic book app that consisted of following items: counting the number of items in the images, finding the missing item, match the following and identifying the names in the images. The intervention was provided along with the mother for 3 postoperative days starting from the 1st POD. On POD 1, the distraction was provided once (after 6 hours of surgery). On PODs 2 and 3 the distraction was provided twice a day (morning and evening). Along with pain management interventions the mother was present with the child, monitoring of the child was done by the doctors and nurses and children received pain analgesics. The children in the control group received only the usual care (pharmacological treatment i.e., Morphine, Acetaminophen, Paracetamol based on type of surgery) and the mother being present with the child for 3 PODs, monitoring of the child was done by doctors and nurses and children received pain analgesics as per schedule. To prevent the cross-infection from the toys used by the children the kit was cleaned daily with alcohol-based solution (dettol) in the pediatric ward and soiled toys were exchanged with a new one. On POD 3, control group received a toy as a gift for participation in the study.

The outcome measures of the study were pain, anxiety, and physiological parameters (heart rate, respiratory rate, and oxygen saturation)

EVENDOL pain scale is a standardized instrument to measure the postoperative pain among younger children. This tool assesses the behavior of the child during postoperative period. The tool is composed of 5 subscales: vocal or verbal expression, facial expression, movements, postures, and interaction with the environment. The scale contains score from 0 to 3 for each item: 0 indicates=sign absent, 1=sign weak or transient, 2=sign moderate or present about half the time, 3=sign strong or present almost all the time. After obtaining the permission to use the tool in the study, researcher had checked for the reliability of the tool. Inter-rater reliability showed kappa 0.7–0.9. In the study EVENDOL scale was used for 3 PODs among the children who had undergone surgery. The pain measurements were taken by the researcher on 3 PODs. On POD 1, the pain measurements were taken after 2 hours of surgery and then continued for every fourth hourly. On PODs 2 and 3, pain was measured every seventh hourly. If the analgesic was administered during pain assessment through oral route pain was reassessed after 45 minutes, 10 minutes later if administered through intravenous route as per the guidelines provided in the scale.

Anxiety was assessed using mYPAS (modified Yale Preoperative Anxiety Scale).It is a standardized tool developed by faculty of Yale University School of Medicine. The scale consists of 22 items divided into 5 subscales: activity, vocalizations, emotional expressivity, state of apparent arousal and use of parents. Each of the 5 categories has an individual score, ranging from the least anxious, to the most anxious behaviors. The higher the number the more the anxious behavior of the child. Reliability of the original tool ranged from 0.68 to 0.86. Researcher had assessed the reliability of the tool by using interobserver method. The reliability coefficient value was r=0.92 which shows that the tool was reliable. The anxiety measurements were taken on the day of admission of the child in a pediatric surgical unit and on POD 3 by the researcher. The behavior of the child in a pediatric surgical unit was observed and recorded.

The physiological parameters (heart rate, respiratory rate, and oxygen saturation) were measured by Philips cardiac monitor (Intellivue MP5). Calibration of the monitor was done in the pediatric surgical unit. Researcher had assessed the reliability of the monitor by using interobserver method and agreement was 1 which shows that it is reliable. The physiological parameters were taken by connecting the probe to the child’s finger and the researcher recorded the measurements after the pain assessment. Child’s physiological parameters were also monitored for 3 PODs.

The trial was approved by the Institutional research committee. Researcher approached the participants, and a detailed Participant Information Sheet was given to the mothers before enrolling mother and child in the study. The sheet included details on the study procedure, intervention, benefits, and risk (none). The mothers were explained about the study by the researcher and informed consent from the mothers and assent from the children were taken. The protocol of this study was registered at the Clinical Trials Registry-India.

The data collection for the study was done from May 2019 to February 2021. After obtaining the permission from Institutional Ethical committee, cluster randomization was performed to allocate children to the experiment or control group. With randomization, every child had an equal chance of being assigned to the experiment or control group. Children who fulfilled the inclusion criteria were included in the study. Informed consent from the parents and assent from the child were taken. Further allocation of participants to experiment or control group was done by a person who is not directly involved in the study. The children in both the groups were followed from admission to POD 3.

Descriptive statistics such as mean, standard deviation, frequency, and the percentage were used. The chi-square test, Fisher exact, and ‘t’ test were conducted to test the homogeneity of all baseline comparisons for the groups. Fisher exact value was considered if the frequency cells were lesser than 5. Repeated measures of analysis of variance (ANOVA) were performed to test the effectiveness of the intervention.

One hundred sixty children fulfilling inclusion criteria were randomly allocated to the experimental and control group (80 in each group). A CONSORT flow diagram of this trial is presented in Fig. 1. Most of the children (58.8% in the experiment and 56.3% in the control group) in the study were in the age of 2–4 years. During the data collection phase male children were operated more in number in both the groups. This is because most of the surgeries were conducted among males in the pediatric surgical unit. It was observed that 3.8% children in the experimental and 15% in the control group had previous history of surgery. It was found that 83.9% of the children in the experiment and 84.1% in the control group had undergone urogenital surgeries. Among them 27.5% of the children in the experimental and 26.3% in the control had undergone urethroplasty (Table 1).

Mean pain score of children on POD 1 in the experimental group was 4.52±2.17 and control group 5.19±2.21 respectively. On POD 2, pain score in the experimental group was 3.0±2.04 and control group was 3.98±2.31 respectively. On POD 3, pain score in the experimental group was 2.0±1.77 and control group was 3.51±2.13 respectively. The children in the experimental group showed a considerable decrease in the pain compared to control group. The pain was reduced from PODs 1 to 3 in both the groups, but it is more evident in the experimental group on PODs 1 and 2 (Table 2).

The analysis of repeated measures of ANOVA on effectiveness of nurse assisted distraction strategies on pain scores, which showed a greater statistically significant difference between the groups, F_(1,158)=6,110.29, P<0.05, partial η²p=0.956. Within the experimental group analysis of repeated-measures ANOVA within the groups did not show a statistical significance F_(1,158)=510.68, P=0.905, partial η²p=0.132 (Table 3, Fig. 2). The between group effect size of 0.956 represents a greater statistical significance in the experimental group and within group effect size of 0.132 shows moderate statistical significance. The findings prove that study findings decreased pain levels among children undergoing surgery. The data on mean difference and confidence interval of anxiety is described in Table 4.

The decrease in anxiety mean scores from admission to POD 3 in the experimental group was greater with the mean difference of 20.3 whereas in control group the mean difference was 16.8. The decrease in anxiety scores in the experimental group was much higher in the posttest measures as compared to the control group. There was reduction in anxiety scores in the control group also, but it was minimal when compared to the children in the experimental group (Table 2).

The analysis of repeated measures of ANOVA between experimental and control group showed a statistical significance, F_(1,158)=347.6, P<0.006, partial η²p=0.957. Within the experimental group analysis of repeated-measures ANOVA showed a higher statistical significance F_(1,158)=306.6, P=0.101, partial η²p=0.660. The between group effect size of 0.957 represents high statistical significance between the 2 groups and within group effect size of 0.660 represents moderate statistical significance. The findings prove that intervention decreased anxiety of children undergoing surgery (Table 3, Fig. 3). The data on mean difference and confidence interval of anxiety is described in Table 4.

The mean heart rate observed from 1st, 2nd, and 3rd POD in the experimental group was (93.5±4.19, 93.0±4.18, 92.7±3.46) and in control group (92.7±3.46, 92.9±3.48, and 92.8±3.47) respectively. The mean respiratory rate in the experimental group was (23.2±1.30, 23.8±1.34, and 22.5±0.75) and control group was 24.7±2.12, 23.4±1.32, and 23.0±1.28. The mean oxygen saturation in the experimental group was (96.7±0.85, 97.5±0.93, and 98.7±1.15) whereas in the control group was (96.4±0.82, 96.4±0.82, and 97.8±0.95) (Table 2).

The repeated-measures ANOVA on physiological parameters (heart rate) between the groups showed a higher statistical significance, F_(1,158)=10.45, P<0.005, partial η²p=0.998. Further, within the experimental group analysis of repeated-measures ANOVA had shown moderate statistical and clinical significance with F_(1,158)=15.44, P<0.115, partial η²p=0.089. The repeated-measures ANOVA on physiological parameters (respiratory rate) between the experimental and control group showed a higher statistical significance, F_(1,158)=19.52, P<0.005, partial η²p=0.992. Further, within the experimental group analysis of repeated-measures ANOVA had shown moderate statistical and clinical significance with F_(1,158)=19.0, P<0.005, partial η²p=0.107. The repeated-measures ANOVA on physiological parameters (oxygen saturation) between the experimental and control group showed a higher statistical significance, F_(1,158)=24.4, P<0.005,partial η²p=0.201. Further, within the experimental group analysis of repeated-measures ANOVA had shown moderate statistical and clinical significance with F_(1,158)= 31.0, P<0.005, partial η²p=0.154. The children in the experimental group had shown a significant improvement in the heart rate, respiratory and oxygen saturation during all measurements as compared to the control group (Table 3, Figs. 4–6).

On POD 1, 77.5% children in the experimental group and 77.6% in the control group received 2 doses of analgesics. However, there are 3.7% children in the control group who received 3 doses of analgesics. On POD 2, 40% children in the experimental group received 1 dose of analgesic. Whereas 57.6% children in the control group received 2 doses of analgesics. On POD 3, 33.7% children in the experimental group received one dose of analgesic and 61.2% children did not receive any analgesics. Whereas, in the control group 41.2% children had received 2 doses of analgesics. The findings show that on 3 PODs children those received distraction intervention received less doses of analgesics as to those who did not receive the intervention.

Distraction is an effective method for children to cope with pain and anxiety. Nurses should be better informed on different sorts of distractions and how to use them in different situations. Nurses should be cautious when employing distraction or any other nonpharmacological strategy to treat anxiety and moderate-to-severe pain. To effectively manage pain and anxiety, both pharmacological and nonpharmacological treatments must be employed. Pain management courses should be included in the nursing undergraduate curriculum in low income and developed countries. This can be used as a starting point for incorporating distraction and other nonpharmaceutical treatments into nursing care. Nurses must also be educated on the latest research results on distraction and other pain management strategies through educational programmes. These programmes should also emphasize the development of skills related to distraction and the encouragement of nurses to constantly document their nursing interventions provided for the children to reduce pain and anxiety.

Based on the findings of this study, it appears that distraction intervention is effective to reduce pain and anxiety among children undergoing surgery. Furthermore, future study should examine the efficiency of various distractions such as active versus passive distractors as well as the child’s preference of distraction. Additionally, the impact of distraction on major surgeries should be assessed. Furthermore, research studies to evaluate parent satisfaction with pain management, both pharmacological and nonpharmacological, are required. Nurses should also investigate the use of distraction interventions that children can utilize without the presence of a nurse. Also, further studies can explore the effect of music, phone games, and deep breathing exercises as a distraction technique among children in the pediatric surgical unit.

In conclusion, distraction interventions provided by nurse helps to reduce anxiety and pain among pediatric surgical children. The findings of this study add to the growing body of knowledge about nonpharmacological therapies for children who have undergone surgery. These measures can be implemented based on these encouraging findings to lessen children's pain and anxiety and promote positive postoperative recovery.

Nurses in the pediatric surgical unit can practice the distraction interventions among children to alleviate pain and anxiety. The children in the pediatric surgical unit can receive a combined pain management treatment (pharmacological and distraction interventions). A pain management nurse can be appointed who can extensively focus on pain assessment and management of the children in the postoperative period.