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413 Effectivenes of the Cala-Dol, a New Non Pharmacological Method to Reduce Pain in Children Undergoing Intramuscular Immunization: Randomized Controlled Trial
  1. M Calamini1,
  2. C Neri2,
  3. F Festini1
  1. 1University of Florence
  2. 2Meyer Children Hospital, Florence, Italy

Abstract

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.

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