The effect of combined external cold and vibration during immunization on pain and anxiety levels in children

Context: Pain associated with needle procedures is very common among children and causes discomfort among them. Aim: The purpose of this study is to evaluate the effectiveness of combined external cold and vibration during immunization on pain and anxiety levels in children. Setting and Design: This study was a randomized clinical trial in the Abdullahi Comprehensive Health Services Center in Qom, Iran, in 2019. Materials and Methods: One hundred and five eligible children were allocated into experimental (external cold and Buzzy), placebo (off Buzzy device without cold), and control groups (no intervention). Simultaneous external cold and vibration (with Buzzy device) and appalling off Buzzy device were used in the experimental and placebo groups, respectively. Children in the control group had received routine care during immunization. The pain and anxiety levels of the children were measured using the Wong–Baker FACES Scale and Children's Emotional Manifestation Scale. Statistical Analysis Used: Data were analyzed using Chi-square, one-way ANOVA, ANCOVA, and Scheffe post hoc analysis. Results: Pain during immunization in the experimental group (3.71 ± 1.61) was significantly lower than the placebo (5.25 ± 1.37) and control groups (4.45 ± 4.45). The difference between before and after anxiety level was not significant in the three study groups (P < 0.001). Conclusion: The simultaneous external cold and vibration (with Buzzy device) can be used as an effective intervention in pain reduction during intramuscular vaccine injection in children.