P: Effective management of pain, anxiety, and distress during medical procedures on children is
critical because of strong negative health-related risks and socio-economic costs associated with
those that did not receive proper support. Appropriate pain management should be multimodal,
including pharmacological and psychological tools, however, efficient tools, especially for young
children, are scarce.
I: KU Leuven has developed a PoC of a novel, multisensory, interactive pain management solution for
children (www.littleNirvana.eu) that we aim to further develop and validate for dental and needlerelated
medical procedures. Hereto, we will optimise the current prototype in order to be able to use
little NIRVANA in more varied (clinical) settings on a larger pediatric population and validate the
optimised solution via a large clinical trial.
C: A randomised clinical trial with +1000 children between 2-10 years old will be conducted to a)
evaluate the effect of little NIRVANA on distress and pain, B) to make a predictive model in order to
find the factors influencing the efficiency of little NIRVANA on the different patient profiles and C) to
analyse the impact of little NIRVANA on the clinical flows (duration, number of HCPs, …) in order to
assess the costs/benefits for the health care provider.
O: The results of these studies will be used to assess the clinical and socio-economical potential of
little NIRVANA with the ultimate aim to further valorise the little NIRVANA platform via a non-profit
organisation. In addition, the envisaged studies will allow for the definition of the optimal pediatric
patient profiling and procedural variables for pain management in standard of care-settings. This
information will be of great value for pediatric care teams worldwide