Study on Using the PARO Therapeutic Robot to Manage Pain During Peripheral Intravenous Line Placement in Children Aged 1 to 7 Years

What this Trial Is About

Peripheral intravenous catheterization is a common procedure in pediatric emergency departments and hospitals, often causing significant anxiety and pain in children and their parents. Since fear and pain are closely linked, managing both effectively is important for the childs well-being. This trial evaluates a therapeutic assistance robot named PARO, designed as a baby seal, to see if it helps reduce pain during peripheral intravenous catheterization in children aged 1 to 7 years. The study compares two groups one receiving standard multimodal pain management including pharmacological and non-pharmacological methods such as topical anesthesia, inhaled analgesia, music therapy, or cartoons and the other group receiving the same standard care supplemented by the PARO robot. The PARO device is introduced about 15 minutes before the procedure to help the child become familiar with it. The procedure starts when the needle first penetrates the skin and ends once the needle is withdrawn and a dressing is applied. Participants will be assessed during and after the procedure using pain scales like FLACC and PRIC, heart rate variability, and the number of attempts needed for catheter placement. Parental anxiety and satisfaction, as well as healthcare staff satisfaction, will be measured shortly after the procedure. The study aims to enroll 120 children from multiple centers, with evaluations focusing on pain management effectiveness during the catheterization process.

Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children.