Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 5:47 PM
Study NCT ID:
NCT07299006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children.
Sponsor:
Fondation Lenval
Organization:
Study Overview
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.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARO
Brief Summary:
Peripheral intravenous catheterization is one of the most frequently performed procedures in children in emergency rooms and pediatric units. It often causes anxiety for both the child and their parents, which increases the pain associated with the procedure itself, as fear and pain are closely linked. Managing the child's pain and anxiety is essential to optimize the child's well-being in the short, medium, and long term.
The quality of pediatric analgesia largely depends on the multimodal approach to interventions offered to children in pain. Recently, several non-pharmacological therapies for pain management and anxiety reduction have been developed. Among these techniques, new technologies have emerged, such as therapeutic assistance robots equipped with artificial intelligence, but their therapeutic benefits still need to be evaluated.
The investigators therefore aim to conduct a study on PARO, a therapeutic assistance robot shaped like a baby seal, to evaluate its role in pain management during peripheral venous catheterization in children. The investigators intend to compare the therapeutic effects of PARO combined with standard techniques versus standard techniques alone during painful procedures. The objective is to determine whether the use of this therapeutic assistance robot can improve and optimize the overall management of children undergoing needle-induced skin punctures. Thus, the investigators plan a multicenter, randomized, open-label, superiority study conducted in five pediatric centers. The investigators aim to recruit 120 infants and children aged 12 months to 7 years who will undergo peripheral venous catheterization. Pain will be assessed using the FLACC (Face-Legs-Activity-Cry-Consolability) hetero-assessment scale in this age group.
Secondary objectives include assessing and comparing distress in the two groups using the PRIC (Procedural Restraint Intensity for Children) tool, which measures restraint intensity, as well as monitoring heart rate variability, the number of attempts required to complete the procedure, parental anxiety via the STAI (State-Trait Anxiety Inventory) questionnaire, and finally, the satisfaction of both parents and paramedical staff.
The quality of pediatric analgesia largely depends on the multimodal approach to interventions offered to children in pain. Recently, several non-pharmacological therapies for pain management and anxiety reduction have been developed. Among these techniques, new technologies have emerged, such as therapeutic assistance robots equipped with artificial intelligence, but their therapeutic benefits still need to be evaluated.
The investigators therefore aim to conduct a study on PARO, a therapeutic assistance robot shaped like a baby seal, to evaluate its role in pain management during peripheral venous catheterization in children. The investigators intend to compare the therapeutic effects of PARO combined with standard techniques versus standard techniques alone during painful procedures. The objective is to determine whether the use of this therapeutic assistance robot can improve and optimize the overall management of children undergoing needle-induced skin punctures. Thus, the investigators plan a multicenter, randomized, open-label, superiority study conducted in five pediatric centers. The investigators aim to recruit 120 infants and children aged 12 months to 7 years who will undergo peripheral venous catheterization. Pain will be assessed using the FLACC (Face-Legs-Activity-Cry-Consolability) hetero-assessment scale in this age group.
Secondary objectives include assessing and comparing distress in the two groups using the PRIC (Procedural Restraint Intensity for Children) tool, which measures restraint intensity, as well as monitoring heart rate variability, the number of attempts required to complete the procedure, parental anxiety via the STAI (State-Trait Anxiety Inventory) questionnaire, and finally, the satisfaction of both parents and paramedical staff.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-A00617-42 | OTHER | ANSM | View |