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Completed

NCT Number: NCT05075395

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia (ALL) Animal Assisted Therapy Critical Illness Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Occupational Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Therapy Modalities Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nebraska Medicine

Omaha, Nebraska, 68105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain: Wrong-Baker FACES Pain Rating Scale

    Time frame: 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.

    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.

  2. Anxiety: Children's Anxiety Meter-State (CAM-S)

    Time frame: 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.

    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.

  3. Hospital Acquired Infections- Central Lines

    Time frame: 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.

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

  4. Hospital Acquired Infections- CAUTI

    Time frame: 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.

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

  5. Hospital Acquired Infections- Enteroviruses

    Time frame: 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.

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

  6. Hospital Acquired Infections- Influenza

    Time frame: 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.

    Rates Influenza will be collected from the electronic medical record.

  7. Hospital Acquired Infections - Multi-drug-resistant Organisms (MDR) Organisms

    Time frame: 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.

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

  8. Hospital Acquired Infections- Surgical Site

    Time frame: 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.

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

  9. Hospital Acquired Infections- VAP

    Time frame: 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.

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

  10. Microbial Contamination Screening

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

    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.

  11. Activity Performance Form

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

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

  12. Physiologic Variables- Heart Rate

    Time frame: 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 heart Rate before and after therapy session

  13. Physiologic Variables- Blood Pressure

    Time frame: 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 blood pressure before and after each session.

  14. Physiologic Variables- Respiratory Rate

    Time frame: 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 respiratory rate before and after each session.

  15. Physiologic Variables- Oxygen

    Time frame: 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.

    Measure oxygen saturation before and after each session.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Acronym: PARO

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2021
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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