Therapeutic Robots for Alleviating ICU Stress in Children

The purpose of this study is: (a) to examine the changes in anxiety, depression symptoms, and positive/negative emotions before and after the intervention, as well as before discharge from the intensive care unit (ICU) in the experimental group (using the therapeutic robot PARO), the control group (using a stuffed seal), and the comparison group (receiving standard care). (b) To compare the effectiveness in relieving anxiety, depression symptoms, and positive/negative emotions among the experimental group, control group, and comparison group for ICU pediatric and adolescent patients in the school-age period. The research questions addressed in this study are: 1. What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the experimental group? 2. What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the control group? 3. What are the changes in anxiety, depression symptoms, and negative emotions before and after the intervention in the comparison group? 4. What is the effectiveness in reducing anxiety after the intervention among the experimental group, control group, and comparison group? 5. What is the effectiveness in alleviating depression symptoms after the intervention among the experimental group, control group, and comparison group? 6. What is the effectiveness in reducing negative emotions and increasing positive emotions after the intervention among the experimental group, control group, and comparison group?

NCT Number	NCT06854562
Lead Sponsor	National Yang Ming Chiao Tung University
Conditions	Pediatric Intensive Care Units
Enrollment	105 participants
Start Date	2025-08-14
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-22