Background & Aims

Needle procedures are one the most common medical procedures in children and are often associated with pain, anxiety and/or distress. Little NIRVANA is a holistic and multisensory pain and distress management solution that incorporates multiple techniques, such as active distraction and breathing, to support children before, during, and after medical procedures. Little NIRVANA consists of a series of digital tools to be used during the entire care cycle; First, a waiting room app introduces the child and the parent to the Little NIRVANA world and the digital buddy Milo. The procedural experience consists of a multisensory 2D/3D set-up that encourages comfort, calm breathing, active distraction, and engagement. Finally, a home app is provided to stimulate positive completion of the procedural experience. The aim of this clinical study is to compare Little NIRVANA with Standard of Care (SoC) during needle procedures and evaluate the effect on pain, anxiety, and distress of the child.

Methods

The study took place at UZ Leuven, Belgium. All children between 2 and 10 years old who were referred to the outpatient service and required a needle procedure (i.c. blood sampling, vaccination or puncturing a catheter) were eligible for participation after parental consent. Randomization took place by randomly selecting time windows for Little NIRVANA and SoC. During these time slots all eligible children were asked to participate in the assigned intervention for that time slot (Little NIRVANA or SoC). The primary outcome was the score on the FLACC rated by a neutral observer during puncture. Additionally, the child, parent, health care professional (HCP) performing the procedure and the observer completed a questionnaire after the procedure to evaluate the level of experienced or perceived distress, anxiety, and pain. Independent t-sample tests were used to compare the two groups.

Results

100 children were recruited. The mean age was 5.65 years (SD 2.2) for the little NIRVANA group (n=50) and 5.90 years (SD 2.5) for the SoC group (n=50). The Little NIRVANA solution was used successfully in 48 of the 50 children. In the SoC group 84% of the children received support by local anesthesia and/or distraction (e.g. VR, watching tv). The FLACC score rated during the puncture was significantly higher in the SoC group (mean 4.5, SD 3.9 vs mean 1.54, SD 2.33; t(96)=-4.5, p<.001). The level of distress during the puncture rated by the child (t(72)=-3.9, p<.001), parent (t(96)=-2.16, p=0.033), HCP (t(96)=-2.54, p=0.013) and observer (t(96)=-3.68, p<.001) was higher in the SoC group. The level of anxiety rated by the parent (t(96)=-2.2, p<0.030) and observer (t(96)=-2.02, p=0.045) were higher in the SoC group. No significant differences were found for pain level. Total procedure time was not significantly different between both groups (t(96)=1.58, p=0.12).

Conclusions

The results of this randomized clinical trial demonstrate that Little NIRVANA helps to reduce FLACC scores. The FLACC is considered a standard measure for evaluating procedural pain and/or procedural distress. Our results suggest that Little NIRVANA mainly has a positive effect on procedural distress and not so much on pain. Since the majority of the SoC (72%) and all children of the Little NIRVANA group received local anesthesia, the latter is an expected result.
Little NIRVANA seems feasible to incorporate into clinical practice without significantly increasing procedure time. Children and parents were extremely positive about Little NIRVANA (likeability and satisfaction scores above 9 on a 10-point scale), but also HCPs (scores above 8).
These findings show that Little NIRVANA is a highly promising tool to support children during needle related procedures to manage procedural distress.

References

Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.

Presenting Author

Lemiere Jurgen

Poster Authors

Jurgen Lemiere

PhD

UZ Leuven

Lead Author

Barbara Weyn

PhD

KU Leuven

Lead Author

Jessica Nijs

MSc

UZ Leuven

Lead Author

Marie Sjolinder

PhD

RISE

Lead Author

Olov Stahl

PhD

RISE

Lead Author

Chloe Barraclough

MSc

AARDMAN

Lead Author

Gunnar Buyse

PhD

KU Leuven / UZ Leuven

Lead Author

Topics

  • Pain in Special Populations: Infants/Children