PARO robotic seal to reduce agitation after visceral surgery
Postoperative Agitation, Anxiety and Pain With the Use of the Robotic Tool PARO - A Prospective Randomised Study
This trial tests whether interacting with PARO, a social robotic seal, reduces postoperative agitation in adults having elective visceral surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 1 site (Hanover, Lower Saxony) |
| Trial ID | NCT07568093 on ClinicalTrials.gov |
What this trial studies
This interventional study introduces the PARO robotic seal to adult patients undergoing elective visceral surgery and monitors patient-robot interactions in the postoperative period. PARO responds to touch, sound, facial expressions and gestures and uses audiovisual recognition, tactile sensors, and embedded AI to engage patients. The study compares the occurrence, duration, and severity of postoperative agitation in a cohort using PARO versus a cohort not using the device. The trial is conducted at the Medical School Hannover with in-person enrollment and follow-up.
Who should consider this trial
Good fit: Adults aged 18 or older who speak German, can give informed consent, and are scheduled for elective visceral surgery without known dementia, immunodeficiency, severe hearing loss, acute central nervous system damage, preoperative systemic infection, severe immunosuppression, or colonization with certain multidrug-resistant organisms are ideal candidates.
Not a fit: Patients with known dementia, immunodeficiency, anacusia, acute CNS damage, active systemic infection, severe immunosuppression or colonization with multidrug-resistant organisms, drug dependence, or a known chronic pain syndrome are excluded and unlikely to benefit in this study.
Why it matters
Potential benefit: If successful, PARO interaction could reduce how often and how long patients experience postoperative agitation, potentially shortening hospital stays and lowering the risk of self-harm.
How similar studies have performed: PARO has demonstrated reduced agitation and anxiety in people with dementia and some hospitalized populations, but its application specifically for postoperative agitation after visceral surgery is novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanover, Lower Saxony
- Medical School Hannover — Hanover, Lower Saxony, Germany (Recruiting)
Study contacts
- Study coordinator: Hans Worthmann, PD Dr.
- Email: worthmann.hans@mh-hannover.de
- Phone: +495115322393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.