N/A
N=19
Animal Assisted Interactions With Animal Robot in the Intensive Care Unit (ICU)
Acute Lymphoblastic Leukemia (ALL) · Critical Illness · Physical Therapy Modalities · Occupational Therapy · Animal Assisted Therapy
Bottom Line
View on ClinicalTrials.gov: NCT05075395 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Pain: Wrong-Baker FACES Pain Rating Scale — 3.94 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PARO therapy seal (Device)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain: Wrong-Baker FACES Pain Rating Scale |
3.94 | — |
| PRIMARY Anxiety: Children's Anxiety Meter-State (CAM-S) |
2.24 | — |
| PRIMARY Hospital Acquired Infections- Central Lines |
14; 1; 4 | — |
| PRIMARY Hospital Acquired Infections- CAUTI |
15; 4 | — |
| PRIMARY Hospital Acquired Infections- Enteroviruses |
15; 4 | — |
| PRIMARY Hospital Acquired Infections- Influenza |
15; 4 | — |
| PRIMARY Hospital Acquired Infections - Multi-drug-resistant Organisms (MDR) Organisms |
1 | — |
| PRIMARY Hospital Acquired Infections- Surgical Site |
1 | — |
| PRIMARY Hospital Acquired Infections- VAP |
1 | — |
| PRIMARY Microbial Contamination Screening |
7 | — |
| PRIMARY Activity Performance Form |
35.8 | — |
| PRIMARY Physiologic Variables- Heart Rate |
99 | — |
| PRIMARY Physiologic Variables- Blood Pressure |
119; 71 | — |
| PRIMARY Physiologic Variables- Respiratory Rate |
25 | — |
| PRIMARY Physiologic Variables- Oxygen |
97 | — |
Summary
The purpose of this study is to:
1. Establish the feasibility and acceptability of a therapeutic robot, Paro, for critically ill patients admitted to the Pediatric Intensive Care Unit
2. Explore safety considerations related to infection control [participant hospital-acquired infection (HAI) rates, screening for the presence of microbial contamination with real-time adenosine triphosphate (ATP) testing
3. Examine the therapeutic effect of Paro on patient psychological variables, physiological variables, and sedative and analgesic medication requirements.
Eligibility Criteria
Inclusion Criteria
- age 5-18
- admitted to the PICU
- have an available parent or guardian
- an active consult request for physical therapy or occupational therapy
- awake, alert, and able to follow commands
- able to understand English
- free from significant vision or hearing deficits
- able to verbalize
Exclusion Criteria
- have a pacemaker
- have droplet, enteric, or enhanced contact precautions
- have open wounds without a covering dressing or a dressing that is visibly soiled
- have known adverse psychological reactions to animals
- show signs of acute agitation (yelling, screaming, moaning, or is otherwise inconsolable)
- have excessive bodily secretions per primary bedside nurse
- report feeling nauseated
Data sourced from ClinicalTrials.gov (NCT05075395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.