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Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children.

NCT07299006 · Fondation Lenval · Updated 20 Aug 2026

What is being tested
Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot.; Non-pharmacological and standard pharmacological interventions.
For
Pain Management
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 1 year to 7 years. About 120 people. The full rules are on the registry page.
Where
France (5 sites)
When
Starts or started 3 March 2026, ends 30 March 2027. Registered 23 Dec 2025.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT07299006

Sites

  • Chu MorvanBrest, France
  • Centre hospitaliers de GrasseGrasse, France
  • Fondation Lenval Hôpitaux pédiatrique Nice CHU LenvalNice, France
  • CHU de NICENice, France
  • Centre Hospitalier Universitaire ToulouseToulouse, France