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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.

RecruitingNAAges 1 Year - 7 YearsAllFondation Lenval
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age between 12 months and 7 years. 2. Requirement for peripheral intravenous catheterization (PIC). 3. Written informed consent obtained from at least one parent or legal guardian. 4. Affiliation with the national health insurance system (social security). Exclusion Criteria: 1. Requirement for contact isolation, including colonization or infection with multidrug-resistant organisms (MDROs). 2. Visual or hearing impairment. 3. Known psychiatric disorder. 4. Inability to understand French. 5. Life-threatening emergency requiring immediate intervention. 6. Need for strong analgesic medication (e.g., morphine, ketamine, or intranasal analgesics).
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What it tests

  • Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot.
  • Non-pharmacological and standard pharmacological interventions.
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Where

5 sites
Chu Morvan
Brest, France
Centre hospitaliers de Grasse
Grasse, France
Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
Nice, France
CHU de NICE
Nice, France
Centre Hospitalier Universitaire Toulouse
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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