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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05075395
Other study ID # 005-19-EP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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