Background and Aims Procedural pain due to immunization is often untreated due to the limited effectiveness of available methods. The aim of this study is to value the effectiveness of a psychosomatic technique called Cala-Dol for the reduction of pain caused by immunization in children.

Materials and methods: Randomized controlled trial. 500 children aged 3 to 13 undergoing intramuscular vaccination against meningitis in the deltoid muscle were enrolled and randomized into two groups. Group A received standard care (no intervention), group B received the Cala-Dol technique. Cala-Dol consists in a combination of local cutaneous stimulation with two small rubber balls -one smooth and one with soft protrusions- and distraction. The cost of the devices is 2 Euros. Two Pain was measured with a 0–10 faces Wong scale (up to 7 years) or a 0–10 Visual analog scale (VAS).

Results Mean pain score in Group B (2.2, sd 1.89) was significantly lower than pain score in Group A (3.38, sd 1.84, p=0.0001). Children were stratified according to age. With regards to age, pain score means were significantly lower in Group B at all ages from 3 to 8, in particular in children from 3 to 6 (Group B: 1.91, sd 1.88, Group A: 3.94, sd 1.54, p=0.00001), but not from age 9 to 13.

Conclusion Our study shows that the Cala-Dol technique is an effective, simple and inexpensive way to reduce pain caused by intramuscular immunization in the deltoid muscle in in children aged 3 to 9.