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PARO-agitation-study

NCT07568093 · Hannover Medical School · Updated 5 May 2026

What is being tested
PARO
For
Agitation; POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE; Anxiety After Surgery; Postoperative Pain
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 300 people. The full rules are on the registry page.
Where
Germany
When
Starts or started 15 Dec 2025, ends May 2027. Registered 5 May 2026.
Results
None posted yet.

In the researchers' words

Postoperative agitation is a common and serious complication in visceral and transplant surgery, associated with prolonged hospital stays and an increased risk of self-harm. Therefore, it is important to find an approach to improve the management of postoperative agitation and to reduce its duration and severity. The medical device "PARO" is a robotic seal that enables patient-robot-interaction. Patients respond to the device through verbal communication and motor responses, as well as facial expressions and gestures. The seal detects human interaction through audiovisual recognition, tactile sensors, and the integration of artificial intelligence. The aim of the study is to observe the use of "PARO" in patients undergoing elective visceral surgery and to analyze the occurence of agitation. A decrease in the incidence of postoperative agitation is to be expected in a cohort of patients undergoing visceral surgery who use PARO compared to a group of patients undergoing visceral surgery who do not use PARO. To monitor the occurrence of postoperative agitation, a standardized screening will be conducted twice daily for three days using the Richmond Agitation-Sedation Scale (RASS). To assess postoperative pain, anxiety and delirium, the Numerical Pain Scale (NRS), the State-Trait-Anxiety-Inventory (STAI) and a delirium screening tool (3D-CAM/CAM-ICU) are used by a trained study…
ClinicalTrials.gov, NCT07568093

Sites

  • Medical School HannoverHanover, Lower Saxony, Germany