Animal Assisted Interactions With Animal Robot During PT/OT in the ICU (PARO)

Animal Assisted Interactions With an Animal Robot During Physical and Occupational Therapy Sessions in the Pediatric ICU: A Feasibility Study

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 ATP testing
3. Examine the therapeutic effect of Paro on patient psychological variables, physiological variables, and sedative and analgesic medication requirements.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Pediatric ALL; Occupational Therapy; Physical Therapy Modalities; Animal Assisted Therapy
• Intervention / Treatment: Device: PARO therapy seal

Detailed Description

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.

Large doses of sedative and analgesic medications are administered by nursing staff to help alleviate distressing symptoms. Overuse of sedative medications can cause a sequela 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 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Nebraska Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; The 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 PIs 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.

Device: PARO therapy seal; PARO, a baby harp seal, is an advanced interactive, therapeutic medical robot developed by AIST, a leading Japanese industrial automation pioneer. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability	Patient Satisfaction Measure: Investigator-developed Satisfaction Measure contains one item which asks the participants to rank their satisfaction with the intervention from 1-5 (not at all - very much)	Within 1 week of study completion
Hospital Acquired Infections	Rates of Central Line Associated Blood Stream Infections (CLABSI) will be collected from the electronic medical record.	Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Hospital Acquired Infections	Rates of Catheter-Associated Urinary Tract Infections (CAUTI) will be collected from the electronic medical record.	Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Hospital Acquired Infections	Rates of Enteroviruses will be collected from the electronic medical record.	Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Hospital Acquired Infections	Rates Influenza will be collected from the electronic medical record.	Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Hospital Acquired Infections	Rates of Multi-Drug Resistant Organisms will be collected from the electronic medical record.	Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Hospital Acquired Infections	Surgical-Site Infections (SSI) will be collected from the electronic medical record.	Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Hospital Acquired Infections	Rates of Ventilator-Associated Pneumonia (VAP) will be collected from the electronic medical record.	Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Sedation Exposure	Sedative and analgesic medications will be will be abstracted from the electronic medical record (EMR) in order to calculate sedation intensity for 4 hours after each PT/OT session in which PARO was used	4 hours after each individual session
Activity performance form	The Activity Performance Form is an investigator developed measure that assesses the length of each therapy session (in minutes), the time to the patient's first out of bed movement, as well as the number and types of range of motion exercises performed (Passive, Active assist, and Active)	Immediately after each intervention therapy sesison
Pain: Wrong-Baker FACES pain rating scale	The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain.	Change from before therapy session to immediately after therapy session is completed.
Anxiety: Children's Anxiety Meter-State (CAM-S)	The CAM scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the very bottom down here. If you are a little bit worried or nervous, the feelings might come up just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line showing how much worry or nervousness you feel."	Change from before therapy session to immediately after therapy session is completed.
Sedation Exposure	Sedative and analgesic medications will be will be abstracted from the electronic medical record (EMR) in order to calculate sedation frequency for 4 hours after each PT/OT session in which PARO was used	4 hours after each individual session
Microbial Contamination Screening	The ATP Monitoring with SystemSURE Plus Process uses a process which monitors levels of ATP Bioluminescence We will implement an established cleaning protocols and then measure ATP before the PT/OT session by swabbing PARO on the following areas: head, right flipper, left flipper, bottom [by on/off switch], top left back area, top right back area, stomach [underneath].	Completed immediately after each individual session
Physiologic variables	Heart Rate	]Change from before therapy session to immediately after therapy session is completed.
Physiologic variables	Blood Pressure	]Change from before therapy session to immediately after therapy session is completed.
Physiologic variables	Respiratory Rate	]Change from before therapy session to immediately after therapy session is completed.
Physiologic variables	Oxygen Saturation	]Change from before therapy session to immediately after therapy session is completed.

Collaborators and Investigators

• Sponsor: University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Robot; Critical Care; Animal Assisted Interaction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 005-19-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No