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

NCT05075395 | Completed Results DMC FDA Device

• 1 other identifier: 0005-19-EP
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.Establish the feasibility and acceptability of a therapeutic robot, Paro, for critically ill patients admitted to the Pediatric Intensive Care Unit
2. 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. 3.Examine the therapeutic effect of Paro on patient psychological variables, physiological variables, and sedative and analgesic medication requirements.

Conditions

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

Keywords

Robot; Animal Assisted Interaction; Critical Care; Rehabilitation

Outcome Measures

Primary Outcomes (15)

• 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.

  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.

• 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." The range is 0 to 10 with 0 being no worry and 10 being the highest.

  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 recorded.

• Hospital Acquired Infections- Central Lines

  Rates of Central Line Associated Blood Stream Infections (CLABSI) will be collected from the electronic medical record.

  Chart review will be conducted staring the first day the participant is enrolled and continuing until 1 week after study completion. Participation varies for each participant between 1 and 7 sessions, depending on the length of ICU stay per participant.

• Hospital Acquired Infections- CAUTI

  Rates of Catheter-Associated Urinary Tract Infections (CAUTI) will be collected from the electronic medical record.

  Chart review will be conducted staring the first day the participant is enrolled and continuing until 1 week after study completion. Participation varies for each participant between 1 and 7 sessions, depending on the length of ICU stay per participant.

• Hospital Acquired Infections- Enteroviruses

  Rates of Enteroviruses will be collected from the electronic medical record.

  Chart review will be conducted staring the first day the participant is enrolled and continuing until 1 week after study completion. Participation varies for each participant between 1 and 7 sessions, depending on the length of ICU stay per participant.

• Hospital Acquired Infections- Influenza

  Rates Influenza will be collected from the electronic medical record.

  Chart review will be conducted staring the first day the participant is enrolled and continuing until 1 week after study completion. Participation varies for each participant between 1 and 7 sessions, depending on the length of ICU stay per participant.

• Hospital Acquired Infections - Multi-drug-resistant Organisms (MDR) Organisms

  Rates of Multi-Drug Resistant Organisms will be collected from the electronic medical record.

  Chart review will be conducted staring the first day the participant is enrolled and continuing until 1 week after study completion. Participation varies for each participant between 1 and 7 sessions, depending on the length of ICU stay per participant.

• Hospital Acquired Infections- Surgical Site

  Surgical-Site Infections (SSI) will be collected from the electronic medical record.

  Chart review will be conducted staring the first day the participant is enrolled and continuing until 1 week after study completion. Participation varies for each participant between 1 and 7 sessions, depending on the length of ICU stay per participant.

• Hospital Acquired Infections- VAP

  Rates of Ventilator-Associated Pneumonia (VAP) will be collected from the electronic medical record.

  Chart review will be conducted staring the first day the participant is enrolled and continuing until 1 week after study completion. Participation varies for each participant between 1 and 7 sessions, depending on the length of ICU stay per participant.

• Microbial Contamination Screening

  The Adenosine triphosphate (ATP) Monitoring with SystemSURE Plus Process uses a process which monitors levels of ATP Bioluminescence. We will implement an established cleaning protocol and then measure ATP after a 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 \[underneath\]. Relative Light Units were averaged across all regions to get one measure per participant. The amount of bioluminescence is measured by the luminometer and the result is given in units known as the relative light units. The ATP bioluminescence reaction is linear, the more ATP present means the more light will be present. The measure of ATP can therefore be determined indirectly by determining the measure of Rlu in living organisms and even organic materials.

  Screen was completed immediately after each individual session on the PARO and an average was reported

• Activity Performance Form

  The Activity Performance Form is an investigator developed measure that assesses the length of each therapy session (in minutes).

  Outcome measure data recorded within ten minutes after the therapy session has ended

• Physiologic Variables- Heart Rate

  Measure heart Rate before and after therapy session

  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 score was recorded.

• Physiologic Variables- Blood Pressure

  Measure blood pressure before and after each session.

  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 recorded.

• Physiologic Variables- Respiratory Rate

  Measure respiratory rate before and after each session.

  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 recorded.

• Physiologic Variables- Oxygen

  Measure oxygen saturation before and after each session.

  Baseline measures show data recorded within ten minutes prior to the therapy session, outcome measure shows data recorded within ten minutes after the therapy session and an average of the after therapy session scores was recorded.

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Device: PARO therapy seal

Interventions

PARO therapy seal 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.

Intervention

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Nebraska Medicine

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Critical Illness

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Breanna Hetland
• Organization: University of Nebraska Medical Center

breanna.hetland@unmc.edu

402-559-5460

Study Officials

• Breanna Hetland, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: October 12, 2021
• Study Start: July 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)