Animal Assisted Interactions With an Animal Robot During Physical and Occupational Therapy Sessions in the Pediatric ICU: A Feasibility Study
Phase: NA
Conditions: Acute Lymphoblastic Leukemia (ALL), Critical Illness, Physical Therapy Modalities, Occupational Therapy, Animal Assisted Therapy
Sponsor: University of Nebraska

Animal assisted interactions with an animal robot during physical and occupational therapy 
sessions in the Pediatric ICU: A feasibility study (PCRG) 
NCT05075395 
25 Jan 2022 

Study Protocol 
Purpose 
 
The purpose of this study is to evaluate the feasibility, acceptability, safety, and preliminary therapeutic 
treatment eﬀects of PAROTM, a therapeutic animal robot, during physical therapy and occupational 
therapy sessions with critically ill patients in the Pediatric ICU (PICU). 
 
 
Background & Rationale 
Symptom Experience in the PICU: Admission to the PICU can be an extremely upsetting experience for 
children of all ages. In addition to physical symptoms such as pain, thirst and fatigue, patients in the 
PICU also experience a multitude of psychological symptoms. Symptoms like anxiety, spells of terror, 
social isolation, disturbed sleeping patterns, restlessness, fear, confusion and loss of control are 
exacerbated in the PICU because patients often have limited mobility, decreased capacity to 
communicate, and rely on healthcare providers for survival. 
Symptom Management in the PICU: Large doses of sedative and analgesic medications are administered 
by nursing staﬀ to help alleviate distressing symptoms. Overuse of sedative medications can cause a 
sequelae of adverse eﬀects and, therefore, recent recommendations call for reducing sedative use as 
much as possible. To minimize the overwhelming symptom burden of acute critical illness and promote 
lasting psychological well-being during recovery, it is imperative to identify eﬀective non- 
pharmacological interventions that decrease psychological distress, but do not alter level of alertness 
during acute critical illness. Established evidence supports the use of a variety of non-pharmacological 
approaches that can be easily applied as adjuncts to sedative and analgesic medications in order to 
reduce dependence on these medications. Animal assisted interactions (AAI) are a promising integrative 
approach that can be used as an adjunct to sedative and analgesic medications in order to improve 
psychological symptoms and promote comfort, relaxation, and positive mood in critically ill patients. 
AAI to Alleviate Symptoms in the ICU: AAI are interventions that intentionally incorporate animals as 
part of a therapeutic process to promote human health, learning, and well-being. Domestic and farm 
animals such as dogs, cats, birds, equines, guinea pigs, rabbits, llamas, sheep, goats, and pigs are 
predominantly featured in AAI programs. Animals can be simply observed, touched, held, and petted, or 
more actively integrated into speciﬁc therapy activities such as brushing with diﬀerent tools to exercise 
range of motion and ﬁne motor coordination and tandem walking with the animal to encourage 
exercise. Recent literature indicates that AAI can improve reality orientation and attention span, 
eliminate the sense of isolation, reduce stress and anxiety, enhance communication, promote positive 
social interactions, and enhance overall quality of life. The use of AAI in the ICU has the potential to 
engage patients, family members, and healthcare staﬀ in an innovative, holistic approach to symptom 
management. 
Beneﬁts of Robotic Animals for AAI in the ICU: While additional research is warranted to further explore 
the potential impact of AAI on a variety of clinically meaningful patient outcomes, the highly technical, 
fast-paced ICU environment and the severely immunocompromised health statuses of ICU patients 
greatly limits the exploration of AAI in the ICU. A new frontier in animal robotics opens a vast array of 
opportunities to implement AAI in the critically ill population. Robot animals may be just as eﬀective as 
live animals and may provide even more ﬂexibility and tailoring in order to meet the needs of diverse 

situation that arise in the ICU. In addition, the infection control risk that live animals pose to critically ill 
patients may be signiﬁcantly lessened. 
 
 
Methods 
At the patient’s ﬁrst physical/occupational (PT/OT) appointment, the PT/OT provider will assess whether 
eligibility criteria are met. If so, the study will be presented to the patient and their parent or guardian. 
If the patient is interested in participating, the PI or PI’s research assistant (RA) will obtain written 
informed consent. Pretest data collection is next, followed by the therapy session with PARO. The PI or 
RA will remain in the room during therapy session to record ﬁeld notes. After completion of the therapy 
session, the PI or RA will begin post-test data collection. The participant will remain in the study for up 
to 7 PT/OT sessions or until discharge from the PICU. 
The Patient Demographic Form will be administered to all participants prior to the initial PT/OT session 
with PARO. Data speciﬁc to the PARO intervention (Psychological and Physiological Variables, Activity 
Performance), will be collected via a face-to-face interview within 30 minutes prior to and within 30 
minutes after each PT/OT session with PARO. ATP testing will occur prior to each new subject 
enrollment to ensure participant safety. Semi-structured interviews will be conducted with the 
participant and an intervention satisfaction measure will be administered after the protocol is complete 
(either after 7 PT/OT sessions with PARO or at ICU discharge). 
 
Only one participant will be enrolled at a time. Participants & therapists will be required to practice hand 
hygiene before and after use of PARO. During the protocol, PARO will be kept in a hard plastic pet carrier 
which is brought to the participant’s room for the PT/OT sessions. A sheet or towel will be placed under 
PARO anytime it is placed on a bed, table, chair, etc. to avoid direct contact with surfaces in the room. 
Once the PT/OT session is done, the PARO is returned to the PI’s oﬃce in the carrier. The PARO is 
removed from the carrier, which is cleaned with a PDI Super Sani-Cloth wipe. The PARO is then cleaned 
per the Daily Cleaning Protocol. This entails moving a Rapid Razor-UV™ cordless handheld sanitizer over 
the entire PARO surface, pausing over each area for 20 to 30 seconds. The PARO is returned to the 
carrier after cleaning. 
Prior to a new enrollment or if the PARO is visibly soiled, it will be deep cleaned per the Deep Cleaning 
Protocol. This involves spraying the PARO’s fur with Dapple cleaner and wiping with a towel, avoiding 
the area around eyes and nose. Next the fur is wiped with a PDI Super Sani-Cloth and left to dry. Lastly, 
the fur is brushed with a brush sprayed with Clorox bleach and allowed to dry again. Cleanliness is 
tested by swabbing 14 locations on the PARO which are checked with the ATP monitoring system with 
SystemSURE Plus Process. All test results must be below the established RLU threshold of 30. If any of 
the areas tested do not meet the threshold, the entire PARO will be cleaned again. Once all areas tested 
fall below the 30 RLU threshold, the PARO is placed in its carrier. 

 
 
 
 
 
 
 
 
 
 
 
Statistical Analysis Plan 
Sample Size 
 
Prior studies of PAROTM in other non-ICU settings have shown moderate to large eﬀect sizes. A sample in 
the range of 20-25 is adequate for single-group eﬃcacy studies when population eﬀect sizes are likely to 
be moderate or larger. Since we are unsure of the exact expected eﬀect size in the ICU, we have 
increased our sample size to 30. 
 
Analysis 
All data collected will be entered directly into REDCap and exported into SPSS 24 for data analysis. For 
Aim 1, establishing the feasibility and acceptability of PAROTM for critically ill patients admitted to the 
PICU, feasibility will be calculated by comparing total consent and refusal rates, attrition rates, and the 
number of full therapy sessions completed. Refusal and attrition rates will be evaluated using point 
estimates and conﬁdence intervals. Intervention acceptability will be assessed by summarizing scores 
from the Patient Satisfaction Measure. Descriptive statistics will be used to summarize individual scores, 
including mean, standard deviation, range, median, and interquartile range. A content analysis on the 
results from the semi-structured interviews will be conducted. 
For Aim 2, exploring safety considerations related to infection control [participant hospital-acquired 
infection (HAI) rates, screening for the presence of microbial contamination with real-time ATP testing], 
any hospital acquired infection obtained while in the PICU will be tracked. The ATP scores after each 
deep cleaning session will be plotted for graphical trends. 
For Aim 3, examining the therapeutic eﬀect of PARO on patient psychological variables (pain, 
anxiety) physiological variables (heart rate, blood pressure, respiratory rate, oxygen saturation), and 
sedative and analgesic medication requirements will be recorded pre- and post-test. These scores will be 
summarized using descriptive statistics and the distributions of psychological and physical variables will 
be assessed for normality. Therapeutic eﬀects for normally distributed variables will be assessed with 
paired samples t-tests to assess changes as a result of PARO. Wilcoxon signed rank tests will be used for 
variables found to be non-normal.