Pediatric ALLNCT05275543
Robot Rehab: AAI With Robot During Inpatient Pediatric Rehab
A study testing Paro Robot in people with Pediatric ALL and Child, Hospitalized, run by University of Nebraska at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Pediatric ALL, Child, Hospitalized, Physical Therapy Modalities
- What is being tested?
- Paro Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 3 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- able to understand English
- free from significant vision or hearing deficits
- able to verbalize.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hosptial and Medical Center
Omaha, Nebraska, 68114
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pediatric ALL, Child, Hospitalized, Physical Therapy Modalities, Occupational Therapy, Animal Assisted Therapy
- Being tested
- Paro Robot
- Keywords
- Robot, Animal Assisted Interaction, Hosptilization, Rehabiliation, Pediatric
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paro RobotDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical and Occupational Therapy with Paro Robot | Experimental | 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 Receives: Device: Paro Robot |
| Physical and Occupational Therapy without Paro Robot | No intervention | 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 |
| Parents/Guardians of Hospitalized Children who use Paro Robot | Experimental | Parents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with Paro Robot" Receives: Device: Paro Robot |
| Parents/Guardians of Hospitalized Children who do not use Paro Robot | No intervention | Parents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with out Paro Robot" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from before therapy session to immediately after therapy session is completed
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. 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).
Measured: Change from before therapy session to immediately after therapy session is completed.
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)
Measured: Within 1 week of study completion
Hospital Acquired Infections-Central Line Associated Blood Stream Infections (CLABSI)
Rates of Central Line Associated Blood Stream Infections (CLABSI) will be collected from the electronic medical record.
Measured: 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)
Rates of Catheter-Associated Urinary Tract Infections (CAUTI) will be collected from the electronic medical record.
Measured: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Hospital Acquired Infections-Enteroviruses
Rates of Enteroviruses will be collected from the electronic medical record.
Measured: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Hospital Acquired Infections-Influenza
Rates Influenza will be collected from the electronic medical record.
Measured: 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
Rates of Multi-Drug Resistant Organisms will be collected from the electronic medical record.
Measured: 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)
Surgical-Site Infections (SSI) will be collected from the electronic medical record.
Measured: 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)
Rates of Ventilator-Associated Pneumonia (VAP) will be collected from the electronic medical record.
Measured: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
Sedation Exposure
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.
Measured: 4 hours after each individual session
Microbial Contamination Screening
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].
Measured: Completed immediately after each individual session
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)
Measured: Immediately after each intervention therapy sesison
Physiologic variables-Blood Pressure
Blood Pressure (systolic \& diastolic)
Measured: Change from before therapy session to immediately after therapy session is completed
Physiologic variables-Respiratory Rate
Respiratory Rate
Measured: Change from before therapy session to immediately after therapy session is completed
Physiologic variables
Oxygen Saturation
Measured: Change from before therapy session to immediately after therapy session is completed
Opinion on Pets
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.
Measured: Prior to the start of the first therapy session.
Parent/Guardian Stress
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.
Measured: Change from the start of the first therapy session to the end of the final therapy session.
Parent/Guardian Anxiety and Depression
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
Measured: Change from the start of the first therapy session to the end of the final therapy session.
Mood/Affect
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
Measured: Change from the start of the first therapy session to the end of the final therapy session.
Motivation to Participate in Therapy
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.
Measured: Immediately after each therapy session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Apr 2022
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with Repeated Measures
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Breanna D Hetland, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275543
- Sponsor's protocol ID
- 0010-22-EP
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26956570Hetland 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.
PubMed 29276432Templer 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
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.
PubMed 11259517Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
PubMed 12914662Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
PubMed 3344163Ersig 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.
PubMed 24094126Ebesutani 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.
PubMed 26281433Tracy 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.
PubMed 30540694
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot Rehab: Animal Assisted Interactions With a Robotic Baby Harp Seal During Inpatient Pediatric Rehabilitation
- ClinicalTrials.gov ID
- NCT05275543
- Acronym / sponsor ID
- 0010-22-EP
- Conditions
- Pediatric ALL, Child, Hospitalized, Physical Therapy Modalities, Occupational Therapy, Animal Assisted Therapy
- Keywords
- Robot, Animal Assisted Interaction, Hosptilization, Rehabiliation, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized Controlled Trial with Repeated Measures
| Arm | Type | Receives |
|---|---|---|
| Physical and Occupational Therapy with Paro Robot | Experimental | Device: Paro Robot10-30 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 |
| Physical and Occupational Therapy without Paro Robot | No intervention | –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 |
| Parents/Guardians of Hospitalized Children who use Paro Robot | Experimental | Device: Paro RobotParents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with Paro Robot" |
| Parents/Guardians of Hospitalized Children who do not use Paro Robot | No intervention | –Parents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with out Paro Robot" |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paro RobotDevice: 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. | Device | Parents/Guardians of Hospitalized Children who use Paro Robot, Physical and Occupational Therapy with Paro Robot |
Primary outcome
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.
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).
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)
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.
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.
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.
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.
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.
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.
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.
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.
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].
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)
Physiologic variables-Blood Pressure
Time frame: Change from before therapy session to immediately after therapy session is completed
Blood Pressure (systolic \& diastolic)
Physiologic variables-Respiratory Rate
Time frame: Change from before therapy session to immediately after therapy session is completed
Respiratory Rate
Physiologic variables
Time frame: Change from before therapy session to immediately after therapy session is completed
Oxygen Saturation
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.
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.
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- BackgroundFine AH. Handbook on Animal-Assisted Therapy: Theoretical Foundations and Guidelines for Practice. 4th ed. Burlington, MA: Academic Press; 2015
- BackgroundBailey 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.
- BackgroundBailey 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.
- Background: PubMed 26956570Burres 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.
- Background: PubMed 29276432Hetland 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.
- BackgroundTempler 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
- Background: PubMed 11259517Streisand 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.
- Background: PubMed 12914662Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- Background: PubMed 3344163Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
- Background: PubMed 24094126Ersig 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.
- BackgroundEbesutani 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.
- Background: PubMed 26281433Tatla 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.
- Individual participant dataSharing planned: No
Related trials for Pediatric ALL
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Not yet recruitingObservational study
Multimodal Mechanical, Tissue, Architectural, and Histological Evaluation of the Bone and Sutures of the Parietal Bone in an Infant With Craniosynostosis.
Craniostenosis
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Breanna D Hetland, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paro Robot in people with Pediatric ALL and Child, Hospitalized, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: Wrong-Baker FACES pain rating scale (time frame: Change from before therapy session to immediately after therapy session is completed). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05275543, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.