Effects of Thermomechanical Stimulation during Vaccination on Anxiety, Pain, and Satisfaction in Pediatric Patients: A Randomized Controlled Trial

Purpose: Vaccination can be a significant source of pain for pediatric patients, which could result in fear of medical procedures and future reluctance to seek medical care. It is important for nurses to provide pain prevention during these procedures. This study sought to measure the impact of an intervention combining cold and vibration on pain scores during routine pediatric immunization.

Design and methods: A prospective, open-label, randomized controlled trial to examine the effectiveness of the Buzzy device (thermomechanical stimulation) compared to no intervention (control group) in reducing child-reported pain during routine immunization. The Wong Baker Faces scale was used to collect child, parent, and observer reported anxiety and pain. Parents reported satisfaction with the procedure and overall office visit.

Results: Fifty children between the ages of 3 and 18 were included in the present analysis. Mean child-reported pain scores were significantly lower in the group receiving thermomechanical stimulation compared to control (3.56 vs 5.92, p=0.015). Buzzy did not impact child-reported anxiety or how much pain the child expected. Parent-reported satisfaction did not vary significantly between groups, but was strongly associated with parent-reported pain scores.

Conclusions: Thermomechanical stimulation with the Buzzy device significantly reduced pain during pediatric immunization over a wide range of ages compared to control, but did not impact pre-procedure anxiety.

Practice implications: The Buzzy device is an easy to implement intervention to reduce pediatric pain during vaccination. It may have the greatest impact in younger children but could be offered during all immunizations.