Clinical trial NCT05075395: Animal Assisted Interactions With Animal Robot in the Intensive Care Unit (ICU)
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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia (ALL)
Critical Illness
Physical Therapy Modalities
Occupational Therapy
Animal Assisted Therapy
Keywords: Robot
Animal Assisted Interaction
Critical Care
Rehabilitation
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 19
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain: Wrong-Baker FACES Pain Rating Scale
timeFrame: 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.
measure: Anxiety: Children's Anxiety Meter-State (CAM-S)
timeFrame: 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.
measure: Hospital Acquired Infections- Central Lines
timeFrame: 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.
measure: Hospital Acquired Infections- CAUTI
timeFrame: 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.
measure: Hospital Acquired Infections- Enteroviruses
timeFrame: 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.
measure: Hospital Acquired Infections- Influenza
timeFrame: 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.
measure: Hospital Acquired Infections - Multi-drug-resistant Organisms (MDR) Organisms
timeFrame: 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.
measure: Hospital Acquired Infections- Surgical Site
timeFrame: 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.
measure: Hospital Acquired Infections- VAP
timeFrame: 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.
measure: Microbial Contamination Screening
timeFrame: Screen was completed immediately after each individual session on the PARO and an average was reported
measure: Activity Performance Form
timeFrame: Outcome measure data recorded within ten minutes after the therapy session has ended
measure: Physiologic Variables- Heart Rate
timeFrame: 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.
measure: Physiologic Variables- Blood Pressure
timeFrame: 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.
measure: Physiologic Variables- Respiratory Rate
timeFrame: 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.
measure: Physiologic Variables- Oxygen
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Medicine
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Breanna Hetland, PhD
role: PRINCIPAL_INVESTIGATOR
References: