Animal Assisted Interactions With Animal Robot in the Intensive Care Unit (ICU)

NCT ID: NCT05075395

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-06-30

Brief 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.

Detailed Description

Admission to the Pediatric Intensive Care Unit (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.

Conditions

Acute Lymphoblastic Leukemia (ALL); Critical Illness; Physical Therapy Modalities; Occupational Therapy; Animal Assisted Therapy

Keywords

Robot; Animal Assisted Interaction; Critical Care; Rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

PARO therapy seal

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Breanna Hetland, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Nebraska Medicine

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0005-19-EP

Identifier Type: -

Identifier Source: org_study_id