Postoperative Agitation, Anxiety and Pain With the Use of the Robotic Tool PARO - A Prospective Randomised Study
Trial ID: NCT07568093
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-12-15
Completion date: 2027-05
Sponsor: Hannover Medical School
Conditions: Agitation; POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE; Anxiety After Surgery; Postoperative Pain
Interventions: PARO
Locations: Medical School Hannover
Countries: Germany
Enrollment: 300
Age range: 18 Years - None
Sex: ALL

Summary:
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 team. The occurrence of other neuropsychiatric symptoms and postoperative surgical complications will also be assessed.

Additionally, the interaction between PARO and the patients is analyzed regarding movements, reactions to haptic and auditory stimuli, and the frequency of interaction. Our approach involves quantitatively monitoring these metrics to collect sensor data from the robot and video recordings of the patients to identify facial expression and posture patterns. The use and acceptance of the robot on clinical wards by various professional groups are evaluated. The focus is particularly on nursing staff, who have the most interactions with patients. The project is complemented by a hygiene study examining how successfully the hygiene protocol is integrated into clinical routines and what challenges the use of PARO poses in an intensive care unit. The aim is also to examine the workflow and time-related aspects of its usage. The study will be submitted as a clinical trial of the medical device within its intended use, without any additional invasive or burdensome procedures, in accordance with the provisions of Section 15 of the Medical Practitioners Act (MBO).

Eligibility criteria:
Patient inclusion criteria:

* ≥18 years of age
* Elective visceral surgery
* german-speaking
* Patient is capable of giving informed consent

Patient exclusion criteria:

* Known dementia
* Known immunodeficiency
* Anacusia
* Acute damage to the central nervous system
* A preoperative systemic infection
* Pre-existing severe immunosuppression or colonization with multidrug-resistant organisms (methicillin resistant Staphylococcus aureus (MRSA), quadruple multidrug-resistant Gram-negative pathogens (MRGN), Candida auris, vancomycin-resistant enterococci (VRE), and linezolid-resistant enterococci (LRE))
* Postoperative systemic infection
* Drug dependence
* Known chronic pain syndrome

Outcomes:
Agitation