PARO robot to ease pain and anxiety during IV placement in young children
Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children, a Multicenter Randomized Prospective Study.
This trial will test whether adding the PARO therapeutic robot to usual pain care helps children aged 12 months to 7 years feel less pain and anxiety during peripheral IV placement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Sponsor | Fondation Lenval Academic / other |
| Locations | 4 sites (Brest and 3 other locations) |
| Trial ID | NCT07299006 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 12 months to 7 years who need a peripheral IV, whose parent or guardian can give written consent, and who are treated at participating French centers and covered by the national health insurance are eligible.
Not a fit: Children with visual or hearing impairments, known psychiatric disorders, inability to understand French, contact isolation requirements, life‑threatening emergencies, or who need strong analgesics are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, using PARO could reduce pain and distress during IV placement and make the procedure less traumatic for young children.
How similar studies have performed: PARO has shown promise in reducing anxiety and improving mood in dementia and some pediatric settings, but evidence for reducing procedural pain in children is limited and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brest and 3 other locations
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.