Study of the Robotic Seal PARO to Reduce Postoperative Agitation, Anxiety, Pain, and Delirium in Adults Undergoing Elective Visceral Surgery

What this Trial Is About

Postoperative agitation is a serious and common complication after visceral and transplant surgery, often leading to longer hospital stays and increased risk of self-harm. This research aims to observe the use of the robotic seal PARO in patients undergoing elective visceral surgery to see if it can reduce the occurrence and severity of postoperative agitation. The study is conducted as a prospective, randomized clinical trial led by Hannover Medical School. Participants are randomly assigned to either receive standard care alone or standard care plus interaction with the PARO robotic seal. PARO is a device designed to interact with patients through verbal communication, motor responses, facial expressions, and gestures, using audiovisual recognition, tactile sensors, and artificial intelligence. The study includes monitoring twice daily for three days after surgery to assess agitation using the Richmond Agitation-Sedation Scale and evaluate pain, anxiety, and delirium with standardized tools. During the study, researchers collect sensor data from PARO and video recordings of patients to analyze interactions, movements, and responses to stimuli. They also evaluate how nursing staff and other clinical groups use and accept PARO on wards. Additionally, a hygiene study examines how well hygiene protocols integrate into clinical routines when using PARO, especially in intensive care units. The total observation period for primary outcomes is the first three postoperative days, with ongoing assessments of neuropsychiatric symptoms and surgical complications.

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