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ClinicalTrials.gov ID

NCT07299006

Lead Sponsor

Fondation LenvalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

120Estimated

Last Update Posted

Aug 20, 2026Actual

Start Date

Mar 3, 2026Actual

Primary Completion Date

Mar 30, 2027Estimated

Completion Date

Mar 30, 2027Estimated

Official Title

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.

Brief Summary

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 pediatric centers. A total of 120 infants and children aged 12 months to 7 years undergoing peripheral intravenous catheterization will be enrolled. Pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale, which is validated for this age group.

Secondary objectives include the assessment and comparison of procedural distress between groups using the PRIC (Procedural Restraint Intensity in Children) score, evaluation of heart rate variability, number of catheterization attempts, parental anxiety measured by the STAI (State-Trait Anxiety Inventory), and satisfaction levels among both parents and healthcare staff.

• Pain Management

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

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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).

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Fondation LenvalOTHER

battista.j@chu-nice.fr+33492030039