PARO robot to ease pain and anxiety during IV placement in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares standard multimodal pediatric pain management with and without the addition of the PARO therapeutic robot during peripheral intravenous catheterization. Children aged 12 months to 7 years who require an IV line are enrolled and receive usual pharmacological and non‑pharmacological measures, with the experimental group also interacting with PARO during the procedure. Pain and anxiety outcomes around the procedure are recorded to determine whether PARO provides additional analgesic or anxiolytic benefit. The protocol excludes children with sensory impairments, certain psychiatric disorders, requirements for contact isolation, urgent life‑threatening conditions, or those needing strong systemic analgesics.

Why it matters

Who can join: the full rules

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).

Where it's running

• Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
  Nice, France Recruiting
• CHU de NICE
  Nice, France Recruiting
• Chu Morvan
  Brest, France Not yet recruiting
• Centre hospitaliers de Grasse
  Grasse, France Not yet recruiting
• Centre Hospitalier Universitaire Toulouse
  Toulouse, France Not yet recruiting

Study contacts

• Principal investigator: Barbara LE GALLO, MD — Hôpitaux pédiatrique Nice CHU Lenval
• Study coordinator: Aline Joulie, Phd
• Email: joulie.a@chu-nice.fr
• Phone: +33492030520

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.