Abstract
Purpose
In this study, we aimed to compare the effects of two distraction interventions—DistrACTION Cards and Buzzy—on pain relief in children undergoing intravenous infusions in the emergency department.
Methods
A quasi-randomized controlled trial was conducted in children aged 4–6 years receiving intravenous infusions in a single emergency department. Participants were assigned to the DistrACTION Cards group (n=31), Buzzy group (n=30), or control group (n=31). Pain was assessed using the pulse rate, Faces Pain Rating Scale, and Face, Legs, Activity, Cry, Consolability scale.
Results
Both distraction interventions significantly reduced observed pain (Face, Legs, Activity, Cry, Consolability scores) compared to that in the control group. The DistrACTION Cards group showed significantly lower pain scores than the control group during the procedure (p<.05) and demonstrated a consistent trend of pain reduction across all phases. Self-reported pain scores (Faces Pain Rating Scale) after the procedure were significantly lower in both intervention groups compared to those in the control group (p<.05); however, no significant differences were found in the extent of change between groups. No significant group differences were observed in pulse rate.
Conclusion
Both DistrACTION Cards and Buzzy effectively reduced intravenous infusion-related pain in preschool children. DistrACTION Cards showed greater consistency than Buzzy in pain reduction as measured by the Face, Legs, Activity, Cry, Consolability scale, suggesting they may be considered as a preferred option in clinical practice. Further research in diverse clinical settings is needed to confirm these findings.
Keywords: Attention, Hospital emergency services, Intravenous infusions, Pain, Preschool child
INTRODUCTION
Children visiting the emergency department frequently experience pain, distress, and anxiety owing to the various medical procedures administered [1]. Among these, intravenous procedures are common interventions performed for diagnostic and therapeutic purposes in pediatric patients and are considered a major cause of pain and distress in children [2]. In particular, the emergency department environment—where children experience heightened fear and anxiety—exacerbates their perception of pain [3].
Inadequately managed needle-related procedural pain can cause needle phobia in children, which may trigger physiological responses such as vasovagal reactions, increased heart rate, and elevated blood pressure during subsequent procedures, as well as increased distress and fear. Needle phobia may also result in avoidant behaviors toward medical procedures and parental refusal to adhere to vaccination schedules, ultimately affecting the child physiologically, emotionally, and psychologically. Therefore, effective pain management is essential during intravenous procedures in children [4-6].
The International Association for the Study of Pain recommends an integrated approach to reduce needle-related procedural pain in children, which includes non-pharmacological interventions such as distraction and relaxation techniques, the use of topical anesthetics, active parental involvement, and the use of age-appropriate language [7]. Among these, non-pharmacological interventions are non-invasive, free of side effects, and can be independently applied by nurses, making them effective for acute procedural pain management in children. Such interventions include distraction, massage, heat or cold therapy, guided imagery, information sharing, and relaxation techniques [8,9]. According to Distraction Theory, distraction is a cognitive-behavioral strategy that reduces pain, stress, and anxiety by redirecting the child's attention away from painful stimuli toward more engaging and pleasurable ones [10].
Despite the proven effectiveness of distraction techniques, their application in clinical practice remains limited [11]. The emergency department presents significant challenges for effective pediatric pain management owing to high patient turnover, time constraints, staffing shortages, and a lack of structural and institutional support for pain management strategies. Therefore, the introduction of cost-effective, rapid, and easy-to-use interventions is necessary to effectively manage procedural pain in children in this setting [12].
DistrACTION Cards and Buzzy are frequently used distraction interventions for effective intravenous pain management. DistrACTION Cards use various visual stimuli to divert the child's attention, thereby reducing pain and anxiety during procedures. They are simple, cost-effective, and can be easily applied by nurses or caregivers without specialized training [13]. Buzzy is a bee-shaped vibrating device with a built-in ice pack, reported to effectively reduce intravenous-related pain in children through the combined effects of vibration and cold stimulation. According to the Gate Control Theory, non-noxious stimuli such as touch, vibration, and cold can activate sensory pathways that close the “gate” in the dorsal horn of the spinal cord, thereby inhibiting the transmission of pain signals to the central nervous system [14]. The vibration and cold stimulation provided by Buzzy may activate this mechanism, thereby effectively minimizing pain. Buzzy is particularly suitable for emergency settings owing to its ease of use, affordability, minimal preparation time, and rapid effect in reducing procedural pain [15]. Previous studies comparing the pain-relieving effects of DistrACTION Cards and Buzzy during intravenous cannulation in children have reported inconsistent results. Some studies reported that Buzzy significantly reduced pain scores compared to DistrACTION Cards [16], whereas others found Buzzy to be more effective in reducing both pain and anxiety [13]. In contrast, another study demonstrated that both interventions markedly reduced pain without significant differences between them [17]. There have been inconsistent findings regarding the effects of DistrACTION Cards and Buzzy on venipuncture pain in children, and no domestic research has directly compared the effects of these interventions. Furthermore, previous studies have mainly focused on hospitalized school-aged children (6–12 years), and, to our knowledge, no study has been conducted on preschool children in the emergency department setting. Preschool children differ developmentally from school-aged children in how they perceive and express pain, and they experience greater fear and anxiety owing to their limited understanding of illness and medical procedures. In addition, because of magical thinking, they may interpret pain as a form of punishment, further amplifying procedure-related anxiety [18], and the unfamiliar emergency department environment can exacerbate these responses [19]. Therefore, in this study, we aimed to compare the effects of DistrACTION Cards and Buzzy on venipuncture pain in preschool children visiting the emergency department, thereby addressing the inconsistent findings of previous research, filling the gap in domestic studies, and examining the effectiveness of distraction interventions in a developmentally vulnerable age group within a highly stressful clinical setting. We hypothesize that there will be differences in pain levels among the DistrACTION Cards, Buzzy, and control groups. The specific research hypotheses (H1–H3) are as follows:
H1: Physiological pain scores measured before, during, and after intravenous procedures are expected to differ among the DistrACTION Cards, Buzzy, and control groups.
H2: Self-reported pain scores measured before and after intravenous procedures are expected to differ among the DistrACTION Cards, Buzzy, and control groups.
H3: Nurse-observed pain scores measured before, during, and after intravenous procedures are expected to differ among the DistrACTION Cards, Buzzy, and control groups.
METHODS
Ethical statements: This study obtained approval from the Institutional Review Board (IRB) of Busan St. Mary’s Hospital (IRB no., 24-14000-111). Informed consent was obtained from all participants.
1. Study Design
This study was a quasi-randomized controlled trial designed to assess the effects of distraction interventions (DistrACTION Cards and Buzzy) on pain during intravenous procedures in children visiting the emergency department. The study was conducted in accordance with the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) guidelines [20].
2. Study Setting and Sample
Children who visited the emergency department of a general hospital located in Busan, South Korea, were recruited through convenience sampling. The inclusion criteria were as follows: (1) preschool children aged 4–6 years receiving intravenous procedures, (2) children without cognitive issues who had not received sedatives, anticonvulsants, or antipyretic/analgesic medications within the previous 6 hours, (3) children experiencing fever with a body temperature of <39°C, dehydration, or mild gastroenteritis within the first 24 hours (excluding children with febrile seizures, bleeding, or trauma), and (4) children and their parents who understood the purpose of the study and consented to participate.
The exclusion criteria were as follows: (1) children undergoing both intravenous procedures and blood sampling simultaneously, (2) children whose intravenous procedure was unsuccessful on the first attempt, (3) children demonstrating poor cooperation or excessive resistance, (4) children with Raynaud's syndrome or sickle cell disease, and (5) children with skin damage, abrasions, nerve injury, or sensory impairments at the site where the intervention device would be applied.
The sample size was calculated using G*Power ver. 3.1.9.7 (Heinrich-Heine-Universität Düsseldorf) for repeated-measures analysis of variance (ANOVA) with a within–between interaction. Based on a previous study [13], the effect size (f) was set at .40, significance level at .05 (two-tailed), and statistical power at 98%, which resulted in a required sample size of 28 participants per group (total participants, 84). A higher power level (98%) was chosen to minimize the risk of type II error in this study involving preschool children undergoing invasive procedures in the emergency department. Because pain responses in this population are highly variable owing to developmental differences, heightened fear and anxiety, and the uncontrollable nature of the emergency department environment, we anticipated wide score dispersion. This conservative approach was therefore used to ensure that true intervention effects would not be missed despite the expected variability. Considering a potential dropout rate of 20%, a total of 105 children were recruited, with 35 participants in each group. Among them, four participants in the DistrACTION Cards group, five in the Buzzy group, and four in the control group were excluded owing to unsuccessful intravenous insertion on the first attempt or excessive resistance. Ultimately, 92 participants were included in the final analysis (Figure 1).
Figure 1.
Study flowchart. FLACC, Face, Legs, Activity, Cry, Consolability; FPRS, Faces Pain Rating Scale; IV, intravenous; PR, pulse rate.
3. Variables and Measurements
1) Pulse rate
Physiological pain was assessed using a pulse oximeter (Nellcor Bedside SpO2 Patient Monitoring System; Covidien). An elevated pulse rate indicates a greater degree of pain.
2) Faces Pain Rating Scale
Self-reported pain was measured using the Faces Pain Rating Scale (FPRS) developed by Wong and Baker [21]. This tool consists of six facial expressions, and children were asked to select the face that best represented their level of pain. The scale is scored as 0, 2, 4, 6, 8, and 10, with higher scores indicating greater pain intensity.
3) FLACC scale
Nurse-observed pain was assessed using the five items of the Face, Legs, Activity, Cry, Consolability (FLACC) scale developed by Merkel et al. [22]. Each item is scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates relaxed and comfortable, 1–3 indicates mild discomfort, 4–6 indicates moderate pain, and 7–10 indicates severe discomfort or pain.
4) DistrACTION Cards
Each DistrACTION Card (Pain Care Labs) measures approximately 5×8 cm. A set consists of five cards with various illustrations. Four different sets were used in total, with each card featuring a unique picture on the front and questions on the back that require careful observation to answer. These cards are used to divert the child’s attention during the procedure by questioning them about the illustrations.
5) Buzzy
The Buzzy device (Pain Care Labs) measures 8×5×2.5 cm and is a non-invasive, battery-operated, bee-shaped plastic device that produces vibration and includes detachable, wing-shaped ice packs. The ice pack is stored in the freezer and attached to the device before use. Buzzy is placed approximately 5 cm above the intravenous site. When activated, it delivers vibration and cold stimulation to the site for at least 30 seconds to relieve pain. The application time ranges from 30 to 120 seconds. After use, the ice pack is wiped with 83% alcohol and stored in the freezer for reuse.
4. Procedures
1) Data collection
Data collection was conducted first for the control group from July 15 to July 27, 2024, and then for the intervention group from July 28, 2024, to January 1, 2025. Children who visited the emergency department were enrolled sequentially after their caregivers were informed of the study’s purpose and procedures and provided written consent. Participants in the intervention groups were randomly assigned to the DistrACTION Cards or Buzzy groups. Randomization was performed by having the caregivers draw a number card from an opaque box (20×20×20 cm); odd numbers assigned the child to the DistrACTION Cards group, and even numbers assigned the child to the Buzzy group. The control group did not receive any distraction intervention and underwent standard intravenous procedures performed in the emergency department.
The distraction interventions and assessments were performed by eight research assistants, all of whom were general nurses working in the emergency department with ≥1 year of clinical experience and excluded head nurses. This criterion was applied because we considered it essential for research assistants to have a minimum level of practical experience with the emergency department environment and pediatric procedures to ensure reliable assessment. For each case, one research assistant was randomly assigned to measure the child’s physiological pain (pulse rate), self-reported pain (FPRS), and nurse-observed pain (FLACC). In the DistrACTION Cards group, a different research assistant applied the intervention to clearly separate the roles of intervention and assessment.
Prior to data collection, the researcher provided standardized training to all research assistants. The training was directly conducted by the researcher, who utilized three video clips showing preschool children undergoing needle-related procedures. One video was used for instructional purposes to familiarize the research assistants with the evaluation procedures of the FLACC tool. The remaining two videos were used for practice. The research assistants viewed the two practice videos and independently rated the children’s pain using the FLACC tool. Scores for each video were calculated, and the mean value was used to verify inter-rater agreement. Each training session lasted approximately 30 minutes and was repeated until a Fleiss’s Kappa coefficient of ≥0.8 was achieved. Consequently, three training sessions were conducted. This process ensured consistency in the application of the FLACC tool across research assistants and enhanced the reliability of observational pain assessment during the study.
2) Intervention
This study was conducted in a private space with an area of 59.7 m2. To reduce children’s anxiety, the walls of the space were decorated in yellow and adorned with illustrations of cartoon characters to create a familiar and comforting atmosphere. The room temperature was maintained between 22°C and 24°C to provide a comfortable environment for the children. The study was conducted privately, with only one child and their caregiver present at a time, to ensure that participating children were not exposed to or influenced by the intravenous procedures performed on other children. To minimize confounding variables that could affect pain levels, all intravenous procedures were performed consistently by a researcher with >5 years of experience in the emergency department.
(1) General protocol
The child and their caregiver were guided to the laboratory, and the procedure was explained. A research assistant attached a patient monitor sensor connected to a pulse oximeter (Nellcor Bedside SpO₂ Patient Monitoring System; Covidien) to the hand on the side opposite to the injection site to measure physiological pain. Nurse-observed pain and self-reported pain were assessed using the FLACC scale and FPRS, respectively. A tourniquet was applied approximately 12–15 cm above a suitable vein to facilitate catheter insertion, and the optimal vein for intravenous insertion was selected. Hand hygiene was performed using 4% chlorhexidine gluconate or 70% alcohol. The injection site was disinfected using an 83% alcohol swab in a circular motion from the center outward over a 5–8 cm area. A 24G Jelco catheter was inserted into the vein. Once proper insertion was confirmed, the tourniquet was released and the needle stylet was removed. The research assistant measured pre-procedure physiological pain and nurse-observed pain using the pulse oximeter and FLACC scale. The intravenous line was connected to pre-prepared fluids and secured with Tegaderm. The child was allowed to rest for 5 minutes, and subsequently the physiological pain, nurse-observed pain, and self-reported pain were assessed again using the pulse oximeter, FLACC scale, and FPRS. The participant was informed that the experiment was completed and was given a coffee coupon as a compensation. Participants who were excluded from the study also received the same compensation.
(2) DistrACTION Cards group
In the DistrACTION Cards group, the research assistant continuously applied the intervention from the time the pre-procedure pain assessment was completed. The research assistant showed the cards to the child and repeatedly provided verbal prompts in the form of questions, such as, “How many ladybugs are in the picture?,” “How many spots does the ladybug have?,” and “Where are the elephant and monkey?.” The intervention was maintained throughout the procedure and discontinued after intravenous fluid connection and securement were completed.
(3) Buzzy group
In the Buzzy group, immediately after the pre-procedure pain assessment, the researcher retrieved the ice pack from the freezer, attached it to the Buzzy device, and allowed the child to touch the device to stimulate initial interest. Once the intravenous site was determined, Buzzy was placed approximately 5 cm above the insertion site, and an additional tourniquet was used to secure the device to prevent movement. The vibration and cold stimulation were applied for at least 30 seconds and up to 120 seconds to ensure sufficient sensory stimulation. The intervention was maintained throughout the procedure and was discontinued after the intravenous fluid connection and securement were completed.
(4) Control group
In the control group, no distraction intervention was applied. From the completion of the pre-procedure pain assessment, the researcher provided general verbal support to the child using everyday expressions, such as, “It will be over soon, you are doing well,” or “Mom is right here.” These expressions were maintained at a level similar to that of typical clinical environments. The verbal support was maintained throughout the procedure till the intravenous fluid connection and securement were completed.
5. Data Analysis
The collected data were analyzed using the IBM SPSS/WIN ver. 29.0 program (IBM Corp.). The general characteristics of the participants were analyzed using frequencies and percentages. Homogeneity among the three groups was assessed using the chi-square test. To examine the homogeneity of dependent variables before the intervention, a one-way ANOVA or Kruskal-Wallis test was performed. The normality of pre-intervention dependent variables was assessed using the Shapiro-Wilk normality test. Repeated-measures ANOVA was used to analyze normally distributed variables. For the repeated-measures ANOVA, Mauchly’s test of sphericity was conducted to verify the assumption of sphericity (W=5.951, p=.051). As the assumption was not violated, the results based on the sphericity assumption were reported. For variables that did not meet the assumption of normality, the Wilcoxon test, Friedman test, and Kruskal-Wallis test were applied.
RESULTS
1. Homogeneity Test for General Characteristics
A total of 92 children participated in this study, with 31 assigned to the DistrACTION Cards group, 30 to the Buzzy group, and 31 to the control group. The results of the homogeneity test for general characteristics and dependent variables among the three groups are presented in Table 1.
Table 1.
Homogeneity test of general characteristics and dependent variables of participants (N=92)
| Characteristic | DC group | Buzzy group | Control group | χ2, F, H | p |
|---|---|---|---|---|---|
| Gender | 5.303 | .077 | |||
| Male | 20 (64.5) | 19 (63.3) | 12 (38.7) | ||
| Female | 11 (35.5) | 11 (36.7) | 19 (61.3) | ||
| Age (yr) | 6.978 | .140 | |||
| 4 | 5 (16.1) | 11 (36.7) | 9 (29.0) | ||
| 5 | 12 (38.7) | 11 (36.7) | 16 (51.6) | ||
| 6 | 14 (45.2) | 8 (26.7) | 6 (19.4) | ||
| Parent | 0.826 | .971a) | |||
| Mother | 23 (74.2) | 21 (70.0) | 21 (67.7) | ||
| Father | 7 (22.6) | 8 (26.7) | 9 (29.0) | ||
| Etc. | 1 (3.2) | 1 (3.3) | 1 (3.2) | ||
| Previous IV injection experience | 2.190 | .988 | |||
| 0 | 1 (3.2) | 0 (0.0) | 1 (3.2) | ||
| 1 | 2 (6.5) | 1 (3.3) | 2 (6.5) | ||
| 2 | 4 (12.9) | 3 (10.0) | 3 (9.7) | ||
| ≥3 | 24 (77.4) | 26 (86.7) | 25 (80.6) | ||
| Chief complain | 3.414 | .489 | |||
| Fever | 17 (54.8) | 13 (43.3) | 20 (64.5) | ||
| Acute gastroenteritis | 11 (35.5) | 15 (50.0) | 9 (29.0) | ||
| Etc. | 3 (9.7) | 2 (6.7) | 2 (6.5) | ||
| Position | 7.780 | .074a) | |||
| Sitting | 1 (3.2) | 1 (3.3) | 3 (9.7) | ||
| Supine | 28 (90.3) | 22 (73.3) | 19 (61.3) | ||
| Parent’s embrace | 2 (6.5) | 7 (23.3) | 9 (29.0) | ||
| Pre-procedural pulse rate | 124.58±17.68 | 127.10±23.69 | 132.00±22.13 | 0.973 | .382 |
| Pre-procedural FPRS | 7.10±3.34 | 7.13±3.22 | 7.42±3.06 | 0.100 | .951b) |
| Pre-procedural FLACC scale | 1.65±2.69 | 2.80±2.73 | 2.52±2.28 | 4.965 | .084b) |
Values are presented as number (%) or mean±standard deviation.
DC, DistrACTION Cards; FLACC, Face, Legs, Activity, Cry, Consolability; FPRS, Faces Pain Rating Scale; IV, intravenous.
a)By Fisher’s exact test: when expected frequency is less than 25%. b)By Kruskal-Wallis test.
The mean pre-intervention pulse rate was 124.58 beats per minute (bpm) in the DistrACTION Cards group, 127.10 bpm in the Buzzy group, and 132.00 bpm in the control group, with no statistically significant differences among the groups. The mean pre-intervention FPRS score was 7.10 in the DistrACTION Cards group, 7.13 in the Buzzy group, and 7.42 in the control group, with no significant differences among the groups. The mean pre-intervention FLACC score was 1.65 in the DistrACTION Cards group, 2.80 in the Buzzy group, and 2.52 in the control group, with no significant differences among the groups.
The results confirmed that there were no statistically significant differences in the general characteristics or dependent variables (pulse rate, FPRS, FLACC) among the three groups, indicating homogeneity.
2. Hypothesis Testing
1) Hypothesis 1
Physiological pain scores (pulse rate) measured before, during, and after intravenous procedures may differ among the DistrACTION Cards, Buzzy, and control groups.
There were significant differences in pulse rate over time within each group (F=78.815, p<.001). In the DistrACTION Cards group, the pulse rate was highest during the procedure (M=132.81) and lowest after the procedure (M=116.84). In the Buzzy group, the pulse rate was highest during the procedure (M=133.27) and lowest after the procedure (M=116.37). In the control group, the pulse rate was highest during the procedure (M=142.94) and lowest after the procedure (M=121.48). Thus, in all groups, pulse rate increased during the procedure and decreased after the procedure.
However, no statistically significant differences were observed in pulse rate among the groups at each time point (F=1.464, p=.237) and no significant interaction effect between time and group (F=.916, p=.456). Therefore, Hypothesis 1 was rejected (Table 2).
Table 2.
Repeated measures ANOVA of pulse rate (N=92)
| Group | Pre IV insertion1 | During IV insertion2 | Post IV insertion3 | F (p) | Post-hoc | Sources | F (p) |
|---|---|---|---|---|---|---|---|
| DC group | 124.58±17.68 | 132.81±16.15 | 116.84±15.73 | 23.805 (<.001) | 2>1>3 | Group | 1.464 (.237) |
| Buzzy group | 127.10±23.69 | 133.27±23.51 | 116.37±18.73 | 22.910 (<.001) | 2>1>3 | Time | 78.815 (<.001) |
| Control group | 132.00±22.13 | 142.94±23.00 | 121.48±19.87 | 32.851 (<.001) | 2>1>3 | G×T | 0.916 (.456) |
| F (p) | 2.262 (.110) | .744 (.478) |
Values are presented as mean±standard deviation unless otherwise stated.
ANOVA, analysis of variance; DC, DistrACTION Cards; IV, intravenous.
2) Hypothesis 2
Self-reported pain scores (FPRS) measured before and after intravenous procedures may differ among the DistrACTION Cards, Buzzy, and control groups.
Significant within-group differences were observed in FPRS scores before and after the procedure. In the DistrACTION Cards group, the FPRS score significantly decreased from 7.10 to 4.06 (p<.001). In the Buzzy group, the FPRS score significantly decreased from 7.13 to 4.47 (p<.001). In the control group, the FPRS score significantly decreased from 7.42 to 6.19 (p=.013).
Analysis of post-procedure FPRS scores among the groups revealed statistically significant differences (H=7.159, p=.028). The control group had the highest FPRS score (M=6.19) than the DistrACTION Cards (M=4.06) and Buzzy (M=4.47) groups. However, no significant differences were observed between the DistrACTION Cards and the Buzzy groups.
Furthermore, no statistically significant differences were found among the groups in the extent of change in FPRS scores ∆(pre-post), leading to the rejection of Hypothesis 2 (Table 3).
Table 3.
Wilcoxon signed-rank and Kruskal-Wallis test results for self-reported pain (FPRS) analysis (N=92)
| Group | Pre IV insertion | Post IV insertion | Z (p) | ∆(Pre–Post) | H (p) |
|---|---|---|---|---|---|
| DC group1 | 7.10±3.34 | 4.06±3.29 | –4.061 (<.001) | 3.03±3.18 | 4.159 (.125) |
| Buzzy group2 | 7.13±3.22 | 4.47±3.43 | –3.875 (<.001) | 2.67±2.99 | |
| Control group3 | 7.42±3.06 | 6.19±3.07 | –2.472 (.013) | 1.23±2.86 | |
| H (p)a) | 7.159 (.028) | ||||
| Post-hoc | 3>1,2 |
Values are presented as mean±standard deviation unless otherwise stated.
DC, DistrACTION Cards; FPRS, Faces Pain Rating Scale; IV, intravenous.
a)By Kruskal-Wallis test.
3) Hypothesis 3
Nurse-observed pain scores (FLACC) measured before, during, and after intravenous procedures will differ among the DistrACTION Cards, Buzzy, and control groups.
Significant within-group differences were observed in FLACC scores across time points. In the DistrACTION Cards group, no significant difference was observed between the pre-procedure (M=1.65) and during-procedure (M=2.61) FLACC scores; moreover, the lowest score was observed after the procedure (M=0.39). In the Buzzy group, no significant difference was observed between the pre-procedure (M=2.80) and during-procedure (M=3.30) FLACC scores; and the lowest score was observed after the procedure (M=0.13). In the control group, the FLACC score was highest during the procedure (M=4.84) and lowest after the procedure (M=0.94).
Analysis of FLACC scores during the procedure showed significant differences among the groups (p=.022). The control group had significantly higher FLACC scores (M=4.84) than the DistrACTION Cards group (M=2.61); however, no significant differences were noted between the Buzzy and control groups or between the DistrACTION Cards and Buzzy groups. Post-procedure FLACC scores also showed significant differences among the groups (p=.034). The control group had higher FLACC scores (M=0.94) than both the DistrACTION Cards (M=0.39) and Buzzy (M=0.13) groups.
Analysis of the change in FLACC scores ∆1 (from pre- to during-procedure) revealed statistically significant differences among the groups (p=.003). The control group showed an increase of 2.32 points, whereas the DistrACTION Cards and Buzzy groups showed smaller increases of 0.97 and 0.50 points, respectively. These results indicate that both intervention groups experienced a smaller increase in FLACC scores during the procedure compared to the control group. Therefore, Hypothesis 3 was supported (Table 4).
Table 4.
Friedman test results for observed pain (FLACC) across time points (N=92)
| Group | Pre IV insertion1 | During IV insertion2 | Post IV insertion3 | χ2 (p) | Post-hoc | ∆1 (Pre–During) | ∆2 (Pre–Post) | ∆3 (During–Post) |
|---|---|---|---|---|---|---|---|---|
| DC group4 | 1.65±2.69 | 2.61±2.87 | 0.39±1.23 | 27.387 (<.001) | 1,2>3 | –0.97±1.76 | 1.26±2.07 | 2.23±2.40 |
| Buzzy group5 | 2.80±2.73 | 3.30±2.65 | 0.13±0.57 | 34.523 (<.001) | 1,2>3 | –0.50±1.57 | 2.67±2.56 | 3.17±2.56 |
| Control group6 | 2.52±2.28 | 4.84±3.48 | 0.94±1.97 | 41.040 (<.001) | 2>1>3 | –2.32±2.51 | 1.58±2.31 | 3.90±3.43 |
| H (p)a) | 7.659 (.022) | 6.765 (.034) | 11.360 (.003) | 4.859 (.088) | 4.448 (.108) | |||
| Post-hoc | 6>4 | 6>4,5 | 6>4,5 |
Values are presented as mean±standard deviation unless otherwise stated. Friedman test followed by the Wilcoxon signed-rank test with Bonferroni correction.
DC, DistrACTION Cards; FLACC, Face, Legs, Activity, Cry, Consolability; IV, intravenous.
a)By Kruskal-Wallis test.
DISCUSSION
This study examined the effects of distraction interventions on pain during intravenous procedures in preschool children visiting the emergency department.
To test Hypothesis 1, changes in pulse rate were analyzed. After the intravenous procedure, the pulse rate decreased by 15.97 bpm in the DistrACTION Cards group, 16.9 bpm in the Buzzy group, and 21.46 bpm in the control group compared to the pulse rate during the procedure. However, no statistically significant differences were observed between the groups and no significant interaction effects were noted between time and group. All groups showed an increase in pulse rate during the intravenous procedure, followed by stabilization over time. These findings are consistent with those of Kim and Park [23], who examined pain changes after applying topical anesthetic cream (EMLA 5% cream) during intravenous procedures in hospitalized children aged 6–10 years. In their study, heart rate increased during venipuncture and decreased after the procedure; however, there were no statistically significant differences between the experimental and control groups. Similarly, the results support those of Yıldırım and Gerçeker [24], who investigated the application of virtual reality and Buzzy during intravenous procedures in children aged 4–10 years in a pediatric emergency department. Their study found no significant differences in pulse rate among the groups before, during, or after the procedure. Pulse rate changes can be influenced by various factors beyond pain, including anxiety, fever, and fatigue [25]. As this study was conducted in the unique setting of an emergency department, accurately assessing physiological responses to pain was challenging. Children received treatment without prior preparation in an unfamiliar environment; hence, environmental and psychological factors could increase fear and perceived pain, making pain management more challenging [19]. Although the study environment was designed to reduce children’s anxiety, the inherent urgency and unpredictability of the emergency setting may have influenced physiological responses. Moreover, children’s perception and expression of pain vary depending on their developmental stage, and the same stimulus can elicit different reactions at different times. Therefore, relying on a single indicator may be insufficient to objectively assess pediatric pain [26]. Future research should aim to control external factors such as children’s psychological states more rigorously and adopt a multifaceted approach that considers various variables influencing pain responses.
To test Hypothesis 2, FPRS scores before and after the intravenous procedure were compared. The FPRS score decreased by 3.04 points in the DistrACTION Cards group, 2.67 points in the Buzzy group, and 1.23 points in the control group after the procedure compared to that before the procedure. Analysis of post-procedure FPRS scores showed that both the DistrACTION Cards group and the Buzzy group had significantly lower pain scores than the control group. However, when comparing the extent of change in FPRS scores before and after the procedure among the groups, no statistically significant differences were found. This result suggests that all three groups showed a similar pattern of change in self-reported pain scores, implying that the interventions may have been more effective in reducing the actual pain experienced immediately after the intravenous procedure rather than influencing the degree of change itself. These findings are consistent with those of Sivri et al. [17], who applied Buzzy, ShotBlocker, and DistrACTION Cards during venous blood sampling in hospitalized children aged 9–12 years. In their study, post-procedure FPRS scores were significantly lower in all intervention groups than in the control group, but no significant differences were observed among the intervention groups. In contrast, Cho et al. [27] reported contradictory results in a study applying Buzzy during intravenous procedures in hospitalized children aged 3–7 years in Taiwan. In their study, the FPRS scores of the control group increased after the intravenous procedure, differing from the results of the present study. Although both the study by Cho et al. [27] and the present study defined pre-procedure scores as anticipated pain and post-procedure scores as experienced pain, these discrepancies may be attributed to the environmental and cultural differences between Taiwanese and Korean children. Cheng et al. [28] investigated pain perception and beliefs among the Han, Amis, and Atayal ethnic groups in Taiwan and found distinct emotional and cognitive approaches to pain perception among different ethnic groups. The Han, who comprise approximately 90% of Taiwan’s population, have a cultural background strongly influenced by Confucian values, which emphasize rational rather than emotional expression of pain and a typically negative attitude toward the use of analgesics. These cultural tendencies are likely reflected to a certain extent in children and may have influenced their pain expression and response to interventions. Although Korean children also belong to a Confucian cultural context, Korean parents place greater emphasis on emotional expression in their parenting beliefs, which is often reflected in supportive behaviors that encourage children’s emotional expression [29]. These parenting styles may foster a tendency in children to express pain through self-reports, potentially affecting actual pain assessment scores. Therefore, future research should carefully consider cultural factors that may influence children’s perception and expression of pain. Cross-cultural comparative studies involving children from diverse cultural backgrounds are required to examine the universality and validity of pain assessment tools.
To test Hypothesis 3, FLACC scores were analyzed. The change in FLACC scores ∆1 (from before to during the procedure) was significantly smaller in the DistrACTION Cards and Buzzy groups compared to that in the control group, suggesting that distraction interventions were effective in regulating children’s pain responses. This finding is meaningful in that the interventions helped mitigate the sharp increase in pain scores typically observed at the time when actual pain occurs compared to observations in the pre-procedure phase. When comparing pain scores during the procedure, the DistrACTION Cards group showed significantly lower FLACC scores than the control group, confirming that this intervention effectively reduced pain responses during the actual intravenous procedure. Although the Buzzy group did not show a statistically significant difference compared to the control group, the smaller increase in FLACC scores from pre- to during the procedure indicates that Buzzy provided a certain degree of pain relief. These findings are partially consistent with those of Cho et al. [27], who applied the Buzzy intervention to hospitalized children aged 3–7 years in Taiwan. Their study measured only FLACC scores during the intravenous procedure and reported significantly lower scores in the Buzzy group than the control group. In contrast, our study measured FLACC scores before, during, and after the procedure, and the most consistent pain control effect was observed for the DistrACTION Cards group. Although there was no significant difference between the Buzzy and control groups during the procedure, the Buzzy group exhibited the greatest reduction in pre- to post-procedure scores among the three groups. These findings suggest that DistrACTION Cards are most effective in modulating immediate pain responses, whereas Buzzy may have potential benefits in facilitating pain recovery after the procedure. These differences may be attributed to the distinct cognitive engagement mechanisms of the two interventions. In situations such as intravenous procedures, where pain occurs suddenly and unpredictably, a strategy that redirects attention to external tasks may be more effective in suppressing emotional pain responses than merely responding to sensory stimulation [30]. This observation is further supported by the finding that pain scores increased sharply during the procedure in the control group, whereas pain scores remained relatively stable in the DistrACTION Cards group. Additionally, post-procedure pain scores were lower in both the DistrACTION Cards and Buzzy groups than the control group, suggesting that distraction interventions may have a sustained effect on pain control even after the procedure. These results are consistent with those of Ballard et al. [31], who applied a distraction kit to children aged 3 months to 5 years visiting the emergency department and measured FLACC scores before, during, and after procedures. Their study similarly found the highest pain scores during the procedure and similar pain scores before and after the procedure across groups. The researchers interpreted these findings as evidence that distraction interventions promote faster pain recovery after the procedure. Therefore, this study showed that distraction interventions can contribute to pain control before, during, and after procedures in children, suggesting that strategies involving cognitive engagement may positively influence both immediate pain responses and post-procedural pain recovery.
This study had several limitations. First, the site of intravenous insertion was not considered as a variable, although pain intensity may vary depending on the insertion site, which could have influenced the results. Second, the study was conducted at a single institution with a relatively small sample, limiting the generalizability of the findings. Third, FLACC scores were evaluated by research assistants through observation, and thus some degree of subjectivity may have been involved. Nevertheless, this was the first study in Korea to comparatively evaluate the effectiveness of DistrACTION Cards and Buzzy in relieving intravenous injection pain in children, and the findings carry educational, clinical, and research significance. Educationally, they provide a case of a non-pharmacological intervention suitable for preschool children, contributing to nursing education. Clinically, they demonstrated the effectiveness of distraction interventions easily applicable in emergency settings, thereby helping reduce children’s pain and improve satisfaction with nursing care. From a research perspective, this study enhances methodological validity by evaluating distraction interventions in the Korean clinical context and highlights the need for replication and multicenter studies to further expand the evidence base.
CONCLUSION
This study aimed to examine the effects of distraction interventions (DistrACTION Cards and Buzzy) on pain relief during intravenous procedures in preschool-aged children visiting the emergency department. The results showed that both interventions were effective in reducing nurse-observed pain (FLACC), with DistrACTION Cards demonstrating a more consistent trend of pain reduction, suggesting it may be prioritized in clinical settings. However, no significant differences were found in physiological indicators or self-reported pain scores, highlighting the need for a multidimensional approach to pain assessment. Future studies should incorporate designs that better control for external factors and include a broader population to enhance generalizability.
Footnotes
Authors’ contribution
Conceptualization: all authors. Data collection: ML. Formal analysis: ML. Writing–original draft: ML. Writing–review and editing: all authors. Final approval of the published version: all authors.
Conflict of interest
No existing or potential conflict of interest relevant to this article was reported.
Funding
None.
Data availability
Please contact the corresponding author for data availability.
Acknowledgements
The authors would like to thank the children and their families for their participation in this study, as well as the nurses who supported the research process.
REFERENCES
- 1.Pancekauskaitė G, Jankauskaitė L. Paediatric pain medicine: pain differences, recognition and coping acute procedural pain in paediatric emergency room. Medicina (Kaunas) 2018;54(6):94. doi: 10.3390/medicina54060094. https://doi.org/10.3390/medicina54060094 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Wong CL, Choi KC. Effects of an immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a randomized clinical trial. JAMA Netw Open. 2023;6(2):e230001. doi: 10.1001/jamanetworkopen.2023.0001. https://doi.org/10.1001/jamanetworkopen.2023.0001 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Ferraz-Torres M, Soto-Ruiz N, Escalada-Hernández P, García-Vivar C, San Martín-Rodríguez L. Can virtual reality reduce pain and anxiety in pediatric emergency care and promote positive response of parents of children?: a quasi-experimental study. Int Emerg Nurs. 2023;68:101268. doi: 10.1016/j.ienj.2023.101268. https://doi.org/10.1016/j.ienj.2023.101268 . [DOI] [Google Scholar]
- 4.Orenius T, Säilä H, Mikola K, Ristolainen L. Fear of injections and needle phobia among children and adolescents: an overview of psychological, behavioral, and contextual factors. SAGE Open Nurs. 2018;4:2377960818759442. doi: 10.1177/2377960818759442. https://doi.org/10.1177/2377960818759442 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.McMurtry CM, Pillai Riddell R, Taddio A, Racine N, Asmundson GJ, Noel M, et al. Far from “just a poke”: common painful needle procedures and the development of needle fear. Clin J Pain. 2015;31(10 Suppl):S3–S11. doi: 10.1097/AJP.0000000000000272. https://doi.org/10.1097/AJP.0000000000000272 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Taddio A, McMurtry CM, Logeman C, Gudzak V, de Boer A, Constantin K, et al. Prevalence of pain and fear as barriers to vaccination in children: systematic review and meta-analysis. Vaccine. 2022;40(52):7526–7537. doi: 10.1016/j.vaccine.2022.10.026. https://doi.org/10.1016/j.vaccine.2022.10.026 . [DOI] [PubMed] [Google Scholar]
- 7. International Association for the Study of Pain. Pain in children: management [Internet]. International Association for the Study of Pain; 2021 [cited 2025 Aug 20]. Available from: https://www.iasp-pain.org/resources/fact-sheets/pain-in-children-management/
- 8.Checa-Peñalver A, Lírio-Romero C, Luiz Ferreira EA, Hernandes-Iglesias S, García-Valdivieso I, Pérez-Pozuelo JM, et al. Effectiveness of non-pharmacological interventions in the management of pediatric chronic pain: a systematic review. Children (Basel) 2024;11(12):1420. doi: 10.3390/children11121420. https://doi.org/10.3390/children11121420 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Sufyanti Y, Hidayah N, Utami R. Behavioral intervention on nonpharmacological pain management for child: a systematic review. Bali Med J. 2022;11(3):1141–1145. doi: 10.15562/bmj.v11i3.3531. https://doi.org/10.15562/bmj.v11i3.3531 . [DOI] [Google Scholar]
- 10.McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984;95(3):516–533. doi: 10.1037//0033-2909.95.3.516. [DOI] [PubMed] [Google Scholar]
- 11.Atefeh S. Barriers and facilitators of pain management in children: a scoping review. BMC Anesthesiol. 2025;25(1):148. doi: 10.1186/s12871-025-02941-2. https://doi.org/10.1186/s12871-025-02941-2 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Bice AA. Inadequate pediatric procedural pain management in the emergency room: a policy analysis. Sch J Emerg Med Crit Care. 2017;1(1):25–30. doi: 10.36959/592/374. https://doi.org/10.36959/592/374 . [DOI] [Google Scholar]
- 13.Erdogan B, Aytekin Ozdemir A. The effect of three different methods on venipuncture pain and anxiety in children: Distraction Cards, virtual reality, and Buzzy(R) (randomized controlled trial) J Pediatr Nurs. 2021;58:e54–e62. doi: 10.1016/j.pedn.2021.01.001. https://doi.org/10.1016/j.pedn.2021.01.001 . [DOI] [PubMed] [Google Scholar]
- 14.Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965;150(3699):971–979. doi: 10.1126/science.150.3699.971. https://doi.org/10.1126/science.150.3699.971 . [DOI] [PubMed] [Google Scholar]
- 15.Jin F, Wang X, Qi M, Zhang W, Zhang Y. Effectiveness and safety of Buzzy device in needle-related procedures for children under twelve years of age: a systematic review and meta-analysis. Medicine (Baltimore) 2024;103(15):e37522. doi: 10.1097/MD.0000000000037522. https://doi.org/10.1097/MD.0000000000037522 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.Inal S, Kelleci M. The effect of external thermomechanical stimulation and distraction on reducing pain experienced by children during blood drawing. Pediatr Emerg Care. 2020;36(2):66–69. doi: 10.1097/PEC.0000000000001264. https://doi.org/10.1097/PEC.0000000000001264 . [DOI] [PubMed] [Google Scholar]
- 17.Sivri BB, Balci S, Dolgun G. The effect of 3 methods (Buzzy, ShotBlocker, and DistrACTION Cards) used while taking blood samples from children with pain and anxiety: a randomized controlled trial. Pediatr Emerg Care. 2023;39(8):600–607. doi: 10.1097/PEC.0000000000002866. https://doi.org/10.1097/PEC.0000000000002866 . [DOI] [PubMed] [Google Scholar]
- 18.Kyle T, Carman S. Essentials of pediatric nursing. Yoon HY, Gu YJ, Kim GE, Kim EY, Park EA, Bae SH, et al., translators. Seoul: Hyunmoonsa; 2022. [Google Scholar]
- 19.Gripko M, Joseph A, MohammadiGorji S. Effects of the physical environment on children and families in hospital-based emergency departments: a systematic literature review. J Environ Psychol. 2023;86:101970. doi: 10.1016/j.jenvp.2023.101970. https://doi.org/10.1016/j.jenvp.2023.101970 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Des Jarlais DC, Lyles C, Crepaz N. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004;94(3):361–366. doi: 10.2105/ajph.94.3.361. https://doi.org/10.2105/ajph.94.3.361 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988;14(1):9–17. [PubMed] [Google Scholar]
- 22.Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997;23(3):293–297. [PubMed] [Google Scholar]
- 23.Kim Y, Park HR. Effects of topical anesthetic cream on pain at venipuncture in children. Child Health Nurs Res. 2014;20(3):142–148. doi: 10.4094/chnr.2014.20.3.142. https://doi.org/10.4094/chnr.2014.20.3.142 . [DOI] [Google Scholar]
- 24.Yıldırım BG, Gerçeker GÖ. The effect of virtual reality and Buzzy on First insertion success, procedure-related fear, anxiety, and pain in children during intravenous insertion in the pediatric emergency unit: a randomized controlled trial. J Emerg Nurs. 2023;49(1):62–74. doi: 10.1016/j.jen.2022.09.018. https://doi.org/10.1016/j.jen.2022.09.018 . [DOI] [PubMed] [Google Scholar]
- 25.Sammito S, Thielmann B, Böckelmann I. Update: factors influencing heart rate variability: a narrative review. Front Physiol. 2024;15:1430458. doi: 10.3389/fphys.2024.1430458. https://doi.org/10.3389/fphys.2024.1430458 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.Wong D. Pain assessment in children. Anaesth Intens Care Med. 2025;26(3):139–142. doi: 10.1016/j.mpaic.2024.12.008. https://doi.org/10.1016/j.mpaic.2024.12.008 . [DOI] [Google Scholar]
- 27.Cho YH, Chiang YC, Chu TL, Chang CW, Chang CC, Tsai HM. The effectiveness of the Buzzy device for pain relief in children during intravenous injection: quasirandomized study. JMIR Pediatr Parent. 2022;5(2):e15757. doi: 10.2196/15757. https://doi.org/10.2196/15757 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28.Cheng Y, Lin M, Wang H. The cultural meanings of pain experiences among three ethnic groups in Eastern Taiwan. Formosa J Ment Health. 2009;22(2):181–202. doi: 10.30074/FJMH.200906_22(2).0004. https://doi.org/10.30074/FJMH.200906_22(2).0004 . [DOI] [Google Scholar]
- 29.Jeong Y, Park H. Korean parent’s belief about children’s emotion and emotion related parenting. Korean J Dev Psychol. 2012;25(2):107–128. [Google Scholar]
- 30.Birnie KA, Noel M, Parker JA, Chambers CT, Uman LS, Kisely SR, et al. Systematic review and meta-analysis of distraction and hypnosis for needle-related pain and distress in children and adolescents. J Pediatr Psychol. 2014;39(8):783–808. doi: 10.1093/jpepsy/jsu029. https://doi.org/10.1093/jpepsy/jsu029 . [DOI] [PMC free article] [PubMed] [Google Scholar]
- 31.Ballard A, Le May S, Khadra C, Lachance Fiola J, Charette S, Charest MC, et al. Distraction kits for pain management of children undergoing painful procedures in the emergency department: a pilot study. Pain Manag Nurs. 2017;18(6):418–426. doi: 10.1016/j.pmn.2017.08.001. https://doi.org/10.1016/j.pmn.2017.08.001 . [DOI] [PubMed] [Google Scholar]