- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05275543
Robot Rehab: AAI With Robot During Inpatient Pediatric Rehab
Robot Rehab: Animal Assisted Interactions With a Robotic Baby Harp Seal During Inpatient Pediatric Rehabilitation
The purpose of this study is to:
Aim 1: Evaluate the feasibility [consent and refusal rates, attrition rates, length, and number of completed therapy sessions], and acceptability [interviews with children and guardians, overall patient and guardian satisfaction] during inpatient physical therapy (PT) and occupational therapy (OT) sessions. Hypothesis: Animal-assisted interaction (AAI) with Paro, a robotic baby harp seal, during pediatric inpatient PT/OT sessions will be feasible and acceptable.
Aim 2: Assess preliminary efficacy of AAI during PT/OT sessions with Paro on behavior (anxiety and affect) and motivation to participate in rehabilitation in hospitalized children. Hypothesis: Children who use Paro will demonstrate less anxiety, more positive affect, and greater motivation to participate in therapy than those who do not use Paro.
Aim 3: Test the stress, anxiety, and depression levels of parents/guardians of children who use Paro inpatient physical and occupational therapy sessions. Hypothesis: In addition, parents and guardians of children that use Paro will report less stress, anxiety, and depression compared to parents/guardians of children that do not use Paro.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Animal Assisted Interactions (AAIs) are interventions that intentionally incorporate animals as part of a therapeutic process to promote human health, learning, and well-being. In general, 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 observed, held, and petted, or more actively integrated into specific therapy activities such as brushing with different tools to encourage range of motion and fine motor coordination. AAIs also promote exercise through tandem walking with the animals. 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 hospitalized children has the potential to engage patients, family members, and healthcare staff in an innovative, holistic approach to recovery.
While additional research is warranted to further explore the potential impact of AAI on a variety of clinically meaningful patient outcomes, the highly technical, fast-paced hospital environment and the immunocompromised health statuses of many acutely ill hospitalized patients greatly limit the exploration of AAI in inpatient settings. A new frontier in animal robotics opens a vast array of opportunities to implement AAI in hospitalized populations. Robot animals may be just as effective as live animals and may provide even more flexibility and tailoring to meet the needs of diverse situations that arise in the hospital. In addition, the infection control risk that live animals pose to hospitalized patients may be significantly lessened.
For this study, the investigators plan to conduct a two-armed randomized controlled trial with repeated measures. Hospitalized pediatric patients will participate in semi-structured, prescriptive physical and occupational therapy sessions on the categories of: 1) speech; 2) balance and endurance; 3) memory; 4) self-esteem; 5) fine motor; 6) sensory stimulation. Intervention group subjects (n=30) will participate in 10-30 minute therapy sessions with Paro, a therapeutic robotic baby harp seal. Control group subjects (n=30) will participate in 10-30 minute therapy sessions without Paro.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Breanna D Hetland, PhD
- Phone Number: 402-559-5460
- Email: breanna.hetland@unmc.edu
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Children's Hosptial and Medical Center
-
Contact:
- Breanna D Hetland, PhD
- Phone Number: 309-231-4537
- Email: breanna.hetland@unmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 5-18
- admitted to any of the five inpatient units at Children's Hospital and Medical Center, Omaha, NE
- have an available parent or guardian
- have an active consult request for PT or OT
- awake, alert, able to follow commands
- not delirious
- able to understand English
- free from significant vision or hearing deficits
- able to verbalize.
Exclusion Criteria:
- Have a pacemaker
- have airborne, enteric, or enhanced contact precautions
- wounds without a covering dressing or a dressing that is visibly soiled
- known adverse psychological reactions to animals
- excessive secretions via nose or mouth
- report feeling nauseated
- shows signs of acute agitation (yelling, screaming, moaning, or is otherwise inconsolable).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical and Occupational Therapy with Paro Robot
10-30 minute semi-structured, prescriptive therapy sessions with Paro robot focused on the categories of 1) speech; 2) balance and endurance; 3) memory; 4) self-esteem; 5) fine motor; 6) sensory stimulation
|
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.
|
No Intervention: Physical and Occupational Therapy without Paro Robot
10-30 minute semi-structured, prescriptive therapy sessions without Paro robot focused on the categories of 1) speech; 2) balance and endurance; 3) memory; 4) self-esteem; 5) fine motor; 6) sensory stimulation
|
|
Experimental: Parents/Guardians of Hospitalized Children who use Paro Robot
Parents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with Paro Robot"
|
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.
|
No Intervention: Parents/Guardians of Hospitalized Children who do not use Paro Robot
Parents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with out Paro Robot"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain: Wrong-Baker FACES pain rating scale
Time Frame: Change from before therapy session to immediately after therapy session is completed
|
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
|
Anxiety: Children's Anxiety Meter-State (CAM-S)
Time Frame: Change from before therapy session to immediately after therapy session is completed.
|
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.
The child is instructed to indicate with a line how the child feels from from the bottom of the thermometer (not worried or nervous) to the top (very worried or nervous).
|
Change from before therapy session to immediately after therapy session is completed.
|
Intervention Acceptability
Time Frame: Within 1 week of study completion
|
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
|
Microbial Contamination Screening
Time Frame: Completed immediately after each individual session
|
The ATP Monitoring with SystemSURE Plus Process uses a process which monitors levels of ATP Bioluminescence The investigators will implement 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
|
Activity performance form
Time Frame: Immediately after each intervention therapy sesison
|
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
|
Physiologic variables
Time Frame: Change from before therapy session to immediately after therapy session is completed
|
Oxygen Saturation
|
Change from before therapy session to immediately after therapy session is completed
|
Opinion on Pets
Time Frame: Prior to the start of the first therapy session.
|
18-item instrument with seven-point Likert scale (1-strongly disagree to 7-strongly agreed) designed to measure the favorableness of attitudes toward pets.
Minimum Score = 18; Maximum score = 126.
The higher the score, the more favorable a patient feels towards pets.
|
Prior to the start of the first therapy session.
|
Parent/Guardian Stress
Time Frame: Change from the start of the first therapy session to the end of the final therapy session.
|
42-item instrument with a five-point Likert scale designed to measure stress in parents whose child has a chronic illness or requires prolonged medical monitoring.
It includes four domains or subscales.
Minimum Score = 42; Maximum Score = 210.
Higher scores indicate higher stress.
|
Change from the start of the first therapy session to the end of the final therapy session.
|
Parent/Guardian Anxiety and Depression
Time Frame: Change from the start of the first therapy session to the end of the final therapy session.
|
Parent/Guardian anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).
Two sub-scales (Anxiety & Depression) scored separately.
Minimum Score = 0; Maximum Score = 21.
Higher score = higher anxiety and/or depression
|
Change from the start of the first therapy session to the end of the final therapy session.
|
Mood/Affect
Time Frame: Change from the start of the first therapy session to the end of the final therapy session.
|
The PANAS-10 is a 10-item instrument that asks the child to rate adjectives of varying mood states according to how often the child feels joyful, cheerful, happy, lively, proud, miserable, mad, afraid, scared, and sad.
The item response uses a five-point Likert scale ranging from 1 ("very slightly or none at all") to 5 ("extremely").
Minimum score = 10; Maximum score = 50.
The higher the score, the better a child's mood/affect
|
Change from the start of the first therapy session to the end of the final therapy session.
|
Motivation to Participate in Therapy
Time Frame: Immediately after each therapy session.
|
19-item scale with a six-point smiley-face scale and two open-ended questions to measure motivation from a child's perspective.
It has six subscales (interest/enjoyment, competence, relatedness, autonomy, value/usefulness, and effort/importance).tems in each subscale are totaled and divided by the number of items to obtain an average score per subscale.
The total scores in each subscale are added to obtain and overall motivation score.
Higher scores within each subscale indicate a higher level of the concept in the subscale, whereas lower scores indicate the opposite.
Thus, the scores indicate differences in the quality and type of motivation for the child.
In addition, a higher total score indicates greater levels of motivation, overall.
|
Immediately after each therapy session.
|
Hospital Acquired Infections-Central Line Associated Blood Stream Infections (CLABSI)
Time Frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
|
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.
|
Hospital Acquired Infections-Catheter-Associated Urinary Tract Infections (CAUTI)
Time Frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
|
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.
|
Hospital Acquired Infections-Enteroviruses
Time Frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
|
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.
|
Hospital Acquired Infections-Influenza
Time Frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
|
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.
|
Hospital Acquired Infections-Multi-Drug Resistant Organisms
Time Frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
|
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.
|
Hospital Acquired Infections-Surgical-Site Infections (SSI)
Time Frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
|
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.
|
Hospital Acquired InfectionsVentilator-Associated Pneumonia (VAP)
Time Frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
|
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.
|
Sedation Exposure
Time Frame: 4 hours after each individual session
|
Sedative and analgesic medications 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
|
Physiologic variables-Respiratory Rate
Time Frame: Change from before therapy session to immediately after therapy session is completed
|
Respiratory Rate
|
Change from before therapy session to immediately after therapy session is completed
|
Physiologic variables-Blood Pressure
Time Frame: Change from before therapy session to immediately after therapy session is completed
|
Blood Pressure (systolic & diastolic)
|
Change from before therapy session to immediately after therapy session is completed
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Breanna D Hetland, PhD, University of Nebraska
Publications and helpful links
General Publications
- Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.
- Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- Streisand R, Braniecki S, Tercyak KP, Kazak AE. Childhood illness-related parenting stress: the pediatric inventory for parents. J Pediatr Psychol. 2001 Apr-May;26(3):155-62. doi: 10.1093/jpepsy/26.3.155.
- Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
- Fine AH. Handbook on Animal-Assisted Therapy: Theoretical Foundations and Guidelines for Practice. 4th ed. Burlington, MA: Academic Press; 2015
- Bailey T, Christenson G, Lust K. The role of an animal-assisted interaction (AAI) program as a means of reducing stress and anxiety within a college community. Oxford, UK: Inter-Disciplinary Press.
- Bailey T. Animal-assisted interactions (AAI): a creative modality to support youth with depression. In: Brooke SL, Myers CE, eds. The Use of the Creative Therapies in Treating Depression. Springfield, IL: Charles C. Thomas; 2015:269.
- Burres S, Edwards NE, Beck AM, Richards E. Incorporating Pets into Acute Inpatient Rehabilitation: A Case Study. Rehabil Nurs. 2016 Nov;41(6):336-341. doi: 10.1002/rnj.260. Epub 2016 Mar 9.
- Hetland B, Bailey T, Prince-Paul M. Animal Assisted Interactions to Alleviate Psychological Symptoms in Patients on Mechanical Ventilation. J Hosp Palliat Nurs. 2017 Dec;19(6):516-523.
- Templer D.I., Arikawa H. (2011) The Pet Attitude Scale. In: Blazina C., Boyraz G., Shen-Miller D. (eds) The Psychology of the Human-Animal Bond. Springer, New York, NY. https://doi.org/10.1007/978-14419-9761-6_20
- Ebesutani C, Regan J, Smith A, Reise S, Higa-McMillan C, Chorpita BF. The 10-item positive and negative affect schedule for children, child and parent shortened versions: Application of item response theory for more efficient assessment. J of Psychopathol. Behav. Assess. 2012; 34(2), 191-203.
- Tatla SK, Jarus T, Virji-Babul N, Holsti L. The development of the Pediatric Motivation Scale for rehabilitation. Can J Occup Ther. 2015 Apr;82(2):93-105. doi: 10.1177/0008417414556884.
- Tracy MF, Chlan L, Savik K, Skaar DJ, Weinert C. A Novel Research Method for Determining Sedative Exposure in Critically Ill Patients. Nurs Res. 2019 Jan/Feb;68(1):73-79. doi: 10.1097/NNR.0000000000000322.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0010-22-EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric ALL
-
Samsung Medical CenterMinistry of Health, Republic of KoreaRecruitingRelapsed Pediatric AML | Refractory Pediatric AML | Relapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
-
University of BirminghamCompletedCancer | Pediatric ALL | Pediatric Solid Tumor | Pediatric AMLUnited Kingdom, Australia, Netherlands
-
National Institute of Allergy and Infectious Diseases...Clinical Trials in Organ Transplantation in ChildrenCompletedPediatric Heart Transplantation | Pediatric Heart Transplant Recipients | Pediatric Cardiac TransplantationUnited States
-
University Hospital, Strasbourg, FranceTerminatedPediatric Lung Ultrasound | Pediatric Chest Radiography | Pediatric Lung DiagnosisFrance
-
TC Erciyes UniversityCompletedPediatric Cancer | Pediatric Brain Tumor | Pediatric Solid TumorTurkey
-
National Institute of Allergy and Infectious Diseases...National Heart, Lung, and Blood Institute (NHLBI)TerminatedPediatric Heart Transplantation | Pediatric Heart Transplant RecipientsUnited States, Canada
-
University of CalgaryCanadian Institutes of Health Research (CIHR); Alberta Children's Hospital; Stollery... and other collaboratorsNot yet recruitingPediatric Cancer | Pediatric Hematology
-
Children's Healthcare of AtlantaEmory UniversityCompletedPediatric Preoperative Anxiety, Pediatric CopingUnited States
-
Hospital Moinhos de VentoNot yet recruitingAdolescent | Telemedicine | Critical Care | Pediatric | Intensive Care Units, Pediatric
-
Samsung Medical CenterMinistry of Health, Republic of KoreaNot yet recruitingRelapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
Clinical Trials on Paro Robot
-
Istituto Nazionale di Ricovero e Cura per AnzianiRecruitingAlzheimer Disease | Older AdultsItaly
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Centre Hospitalier le MansCentre Hospitalier de Chateau du Loir; Centre Hospitalier de Saint Calais; Centre...RecruitingStress | Burnout, Professional | AnxietyFrance
-
Instituto de Mayores y Servicios Sociales (IMSERSO)Asturhealth SL; Servicio de Evaluación y Planificación del Servicio Canario...CompletedNeurocognitive Disorders | Dementia | Mild Cognitive ImpairmentSpain
-
Assistance Publique - Hôpitaux de ParisThe Paul Bennetot FoundationCompletedModerate to Severe DementiaFrance
-
University of NebraskaCompletedCritical Illness | Pediatric ALL | Occupational Therapy | Physical Therapy Modalities | Animal Assisted TherapyUnited States
-
Centre Hospitalier Departemental VendeeTerminated
-
University of PennsylvaniaEnrolling by invitationDelirium | DementiaUnited States
-
Children's Hospital Los AngelesUniversity of Southern CaliforniaCompleted
-
The Third Xiangya Hospital of Central South UniversityCompleted