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

Primary Purpose

Pediatric ALL, Critical Illness, Physical Therapy Modalities

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PARO therapy seal
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric ALL focused on measuring Robot, Animal Assisted Interaction, Critical Care, Rehabilitation

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nebraska Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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."
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)
Hospital Acquired Infections
Rates of Central Line Associated Blood Stream Infections (CLABSI) will be collected from the electronic medical record.
Hospital Acquired Infections
Rates of Catheter-Associated Urinary Tract Infections (CAUTI) will be collected from the electronic medical record.
Hospital Acquired Infections
Rates of Enteroviruses will be collected from the electronic medical record.
Hospital Acquired Infections
Rates Influenza will be collected from the electronic medical record.
Hospital Acquired Infections
Rates of Multi-Drug Resistant Organisms will be collected from the electronic medical record.
Hospital Acquired Infections
Surgical-Site Infections (SSI) will be collected from the electronic medical record.
Hospital Acquired Infections
Rates of Ventilator-Associated Pneumonia (VAP) will be collected from the electronic medical record.
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
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
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].
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)
Physiologic variables
Heart Rate
Physiologic variables
Blood Pressure
Physiologic variables
Respiratory Rate
Physiologic variables
Oxygen Saturation

Secondary Outcome Measures

Full Information

First Posted
July 16, 2021
Last Updated
November 1, 2022
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT05075395
Brief Title
Animal Assisted Interactions With Animal Robot During PT/OT in the ICU
Acronym
PARO
Official Title
Animal Assisted Interactions With an Animal Robot During Physical and Occupational Therapy Sessions in the Pediatric ICU: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to: Establish the feasibility and acceptability of a therapeutic robot, Paro, for critically ill patients admitted to the Pediatric Intensive Care Unit 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 Examine the therapeutic effect of Paro on patient psychological variables, physiological variables, and sedative and analgesic medication requirements.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric ALL, Critical Illness, Physical Therapy Modalities, Occupational Therapy, Animal Assisted Therapy
Keywords
Robot, Animal Assisted Interaction, Critical Care, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PARO therapy seal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain: Wrong-Baker FACES pain rating scale
Description
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.
Time Frame
Change from before therapy session to immediately after therapy session is completed.
Title
Anxiety: Children's Anxiety Meter-State (CAM-S)
Description
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."
Time Frame
Change from before therapy session to immediately after therapy session is completed.
Title
Intervention Acceptability
Description
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)
Time Frame
Within 1 week of study completion
Title
Hospital Acquired Infections
Description
Rates of Central Line Associated Blood Stream Infections (CLABSI) will be collected from the electronic medical record.
Time Frame
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Title
Hospital Acquired Infections
Description
Rates of Catheter-Associated Urinary Tract Infections (CAUTI) will be collected from the electronic medical record.
Time Frame
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Title
Hospital Acquired Infections
Description
Rates of Enteroviruses will be collected from the electronic medical record.
Time Frame
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Title
Hospital Acquired Infections
Description
Rates Influenza will be collected from the electronic medical record.
Time Frame
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Title
Hospital Acquired Infections
Description
Rates of Multi-Drug Resistant Organisms will be collected from the electronic medical record.
Time Frame
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Title
Hospital Acquired Infections
Description
Surgical-Site Infections (SSI) will be collected from the electronic medical record.
Time Frame
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Title
Hospital Acquired Infections
Description
Rates of Ventilator-Associated Pneumonia (VAP) will be collected from the electronic medical record.
Time Frame
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Title
Sedation Exposure
Description
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
Time Frame
4 hours after each individual session
Title
Sedation Exposure
Description
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
Time Frame
4 hours after each individual session
Title
Microbial Contamination Screening
Description
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].
Time Frame
Completed immediately after each individual session
Title
Activity performance form
Description
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)
Time Frame
Immediately after each intervention therapy sesison
Title
Physiologic variables
Description
Heart Rate
Time Frame
]Change from before therapy session to immediately after therapy session is completed.
Title
Physiologic variables
Description
Blood Pressure
Time Frame
]Change from before therapy session to immediately after therapy session is completed.
Title
Physiologic variables
Description
Respiratory Rate
Time Frame
]Change from before therapy session to immediately after therapy session is completed.
Title
Physiologic variables
Description
Oxygen Saturation
Time Frame
]Change from before therapy session to immediately after therapy session is completed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nebraska Medicine
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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