Clinical trial · Interventional
Animal Assisted Interactions With Animal Robot in the Intensive Care Unit (ICU)
Animal Assisted Interactions With an Animal Robot During Physical and Occupational Therapy Sessions in the Pediatric ICU: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Animal Assisted Therapy | — | UNRESOLVED | — |
| Critical Illness | — | UNRESOLVED | — |
| Occupational Therapy | — | UNRESOLVED | — |
| Physical Therapy Modalities | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PARO therapy seal | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- The Physical Therapy/Occupational Therapy (PT/OT) provider will assess whether the patient meets eligibility criteria. If the patient is eligible to participate, they will then introduce the study to the patient and their parent or guardian. If the patient is interested in participating, the PI or PI's research assistant (RA) will seek written informed consent. After informed consent is obtained, the PI or RA will begin pretest data collection. Then, the PT/OT provider will begin the therapy session with Paro. The PI or RA will remain in the room during therapy session to record field notes. When the therapy session is complete, the PI or RA will begin posttest data collection. The patient will remain in the study for up to 7 PT/OT sessions or until they are discharged from the PICU. The PT/OT providers will coordinate all subsequent therapy sessions with the PI/RA while the patient remains on the study protocol.
- interventionNames
- Device: PARO therapy seal
Primary outcomes (15)
- measure
- Pain: Wrong-Baker FACES Pain Rating Scale
- timeFrame
- Baseline measures data recorded within ten minutes prior to the therapy session, outcome measure data recorded within ten minutes after each therapy session and an average of the after-therapy session scores was record.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available