Condition: Pain Management · Sponsor: Fondation Lenval
Peripheral intravenous catheterization is one of the most frequently performed procedures in pediatric emergency departments and hospital units. It is often associated with significant anxiety in both children and their parents, which may exacerbate the pain experienced during the procedure, as fear and pain are closely interrelated. Effective management of pain and anxiety is therefore essential to optimize the child's well-being in the short, medium, and long term. The quality of pediatric analgesia relies on a multimodal approach combining pharmacological and non-pharmacological interventions. In recent years, several non-pharmacological strategies have been developed to reduce pain and anxiety. Among these, innovative technologies such as therapeutic assistance robots incorporating artificial intelligence have emerged; however, their clinical benefits remain to be established. The present study aims to evaluate the effectiveness of PARO, a therapeutic assistance robot designed in the form of a baby seal, in the management of pain during peripheral intravenous catheterization in children. The investigators will compare the effects of PARO in combination with standard care versus standard care alone during needle-related procedures. The primary objective is to determine whether the use of this device improves pain management in children undergoing skin puncture. This study is designed as a multicenter, randomized, open-label, superiority trial conducted across five pedia…
This description comes directly from the study's public registry record.
ALINE JOULIE, PHD · +33492030520 · joulie.a@chu-nice.fr
Jennifer BATTISTA, MD · + 33 6 36 80 27 42 · battista.j@chu-nice.fr
Always discuss trial participation with your own doctor first.
| Chu Morvan | Brest, France | Not Yet Recruiting |
| Centre hospitaliers de Grasse | Grasse, France | Not Yet Recruiting |
| Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval | Nice, France | Recruiting |
| CHU de NICE | Nice, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07299006