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

Critical Illness Clinical Trial

— PARO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05075395
• Other study ID #: 005-19-EP
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Animal Assisted Therapy
• Critical Illness
• Occupational Therapy
• Pediatric ALL
• Physical Therapy Modalities

Intervention

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.

Locations

Country	Name	City	State
United States	Nebraska Medicine	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Physiologic variables	Heart Rate	]Change from before therapy session to immediately after therapy session is completed.
Primary	Physiologic variables	Blood Pressure	]Change from before therapy session to immediately after therapy session is completed.
Primary	Physiologic variables	Respiratory Rate	]Change from before therapy session to immediately after therapy session is completed.
Primary	Physiologic variables	Oxygen Saturation	]Change from before therapy session to immediately after therapy session is completed.