Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The Physical Therapy/Occupational Therapy (PT/OT) provider will assess whether the patient meets eligibility criteria. If the patient is eligible to participate, they will then introduce the study to the patient and their parent or guardian. If the patient is interested in participating, the PI or PI's research assistant (RA) will seek written informed consent. After informed consent is obtained, the PI or RA will begin pretest data collection. Then, the PT/OT provider will begin the therapy session with Paro. The PI or RA will remain in the room during therapy session to record field notes. When the therapy session is complete, the PI or RA will begin posttest data collection. The patient will remain in the study for up to 7 PT/OT sessions or until they are discharged from the PICU. The PT/OT providers will coordinate all subsequent therapy sessions with the PI/RA while the patient remains on the study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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." The range is 0 to 10 with 0 being no worry and 10 being the highest. | 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. |
| Hospital Acquired Infections- Central Lines | Rates of Central Line Associated Blood Stream Infections (CLABSI) will be collected from the electronic medical record. | 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. |
| Hospital Acquired Infections- CAUTI | Rates of Catheter-Associated Urinary Tract Infections (CAUTI) will be collected from the electronic medical record. | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Breanna Hetland, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nebraska Medicine | Omaha | Nebraska | 68105 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
pediatric Intensive Care Unite (PICU) patients from a single tertiary medical center
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The Physical Therapy/Occupational Therapy (PT/OT) provider will assess whether the patient meets eligibility criteria. If the patient is eligible to participate, they will then introduce the study to the patient and their parent or guardian. If the patient is interested in participating, the PI or PIs research assistant (RA) will seek written informed consent. After informed consent is obtained, the PI or RA will begin pretest data collection. Then, the PT/OT provider will begin the therapy session with Paro. The PI or RA will remain in the room during therapy session to record field notes. When the therapy session is complete, the PI or RA will begin post-test data collection. The patient will remain in the study for up to 7 PT/OT sessions or until they are discharged from the Pediatric Intensive Care Unite (PICU). The PT/OT providers will coordinate all subsequent therapy sessions with the PI/RA while the patient remains on the study protocol. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The PT/OT provider will assess whether the patient meets eligibility criteria. If the patient is eligible to participate, they will then introduce the study to the patient and their parent or guardian. If the patient is interested in participating, the PI or PIs research assistant (RA) will seek written informed consent. After informed consent is obtained, the PI or RA will begin pretest data collection. Then, the PT/OT provider will begin the therapy session with Paro. The PI or RA will remain in the room during therapy session to record field notes. When the therapy session is complete, the PI or RA will begin posttest data collection. The patient will remain in the study for up to 7 PT/OT sessions or until they are discharged from the PICU. The PT/OT providers will coordinate all subsequent therapy sessions with the PI/RA while the patient remains on the study protocol. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
Adverse event data was recorded for up to 7 sessions or discharge from the Pediatric ICU, whichever comes first; for an average of 2.5 sessions.
We did not use a different definition of adverse event from the ClinicalTrials.gov definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | The PT/OT provider will assess whether the patient meets eligibility criteria. If the patient is eligible to participate, they will then introduce the study to the patient and their parent or guardian. If the patient is interested in participating, the PI or PIs research assistant (RA) will seek written informed consent. After informed consent is obtained, the PI or RA will begin pretest data collection. Then, the PT/OT provider will begin the therapy session with Paro. The PI or RA will remain in the room during therapy session to record field notes. When the therapy session is complete, the PI or RA will begin posttest data collection. The patient will remain in the study for up to 7 PT/OT sessions or until they are discharged from the PICU. The PT/OT providers will coordinate all subsequent therapy sessions with the PI/RA while the patient remains on the study protocol. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Breanna Hetland | University of Nebraska Medical Center | 402-559-5460 | breanna.hetland@unmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Oct 30, 2024 | Prot_SAP_006.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2023 | Sep 12, 2024 | ICF_005.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Hospital Acquired Infections- Enteroviruses | Rates of Enteroviruses will be collected from the electronic medical record. | 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. |
| Hospital Acquired Infections- Influenza | Rates Influenza will be collected from the electronic medical record. | 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. |
| Hospital Acquired Infections - Multi-drug-resistant Organisms (MDR) Organisms | Rates of Multi-Drug Resistant Organisms will be collected from the electronic medical record. | 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. |
| Hospital Acquired Infections- Surgical Site | Surgical-Site Infections (SSI) will be collected from the electronic medical record. | 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. |
| Hospital Acquired Infections- VAP | Rates of Ventilator-Associated Pneumonia (VAP) will be collected from the electronic medical record. | 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. |
| Microbial Contamination Screening | 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. | Screen was completed immediately after each individual session on the PARO and an average was reported |
| Activity Performance Form | The Activity Performance Form is an investigator developed measure that assesses the length of each therapy session (in minutes). | Outcome measure data recorded within ten minutes after the therapy session has ended |
| Physiologic Variables- Heart Rate | Measure heart Rate before and after therapy session | 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. |
| Physiologic Variables- Blood Pressure | Measure blood pressure before and after each session. | 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. |
| Physiologic Variables- Respiratory Rate | Measure respiratory rate before and after each session. | 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. |
| Physiologic Variables- Oxygen | Measure oxygen saturation before and after each session. | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pain: Wrong-Baker FACES Pain Rating Scale | Two participants did not complete the baseline measure for pain score | Mean | Standard Deviation | Scores on a scale |
|
| Children's Anxiety Meter-State (CAM-S) | State anxiety is anxiety at this moment in time. The measure is a vertical analog for child self-report of state. 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 bottom part of the thermometer. If you are a little bit worried or nervous, the feelings come up in the thermometer just a little bit. If you are very, very worried or nervous, the feelings go all the way to the top. The range is 0 to 10, 10 being the highest. | 3 participants did not complete the baseline score for anxiety | Mean | Standard Deviation | units on a scale |
|
| Physiologic Variables- Heart Rate | Mean | Full Range | beats per minute |
|
| Physiologic Variables- Blood Pressure | Mean | Full Range | Millimeters of mercury (mm Hg) |
|
| Physiologic Variables- Respiratory Rate | Mean | Full Range | breaths per minute |
|
| Physiologic Variables- Oxygen | Mean | Full Range | percentage of blood oxygen saturated |
|
|
|
| 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." The range is 0 to 10 with 0 being no worry and 10 being the highest. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
|
|
| Primary | Hospital Acquired Infections- Central Lines | Rates of Central Line Associated Blood Stream Infections (CLABSI) will be collected from the electronic medical record. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Hospital Acquired Infections- CAUTI | Rates of Catheter-Associated Urinary Tract Infections (CAUTI) will be collected from the electronic medical record. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Hospital Acquired Infections- Enteroviruses | Rates of Enteroviruses will be collected from the electronic medical record. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Hospital Acquired Infections- Influenza | Rates Influenza will be collected from the electronic medical record. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Hospital Acquired Infections - Multi-drug-resistant Organisms (MDR) Organisms | Rates of Multi-Drug Resistant Organisms will be collected from the electronic medical record. | Intervention Group | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Hospital Acquired Infections- Surgical Site | Surgical-Site Infections (SSI) will be collected from the electronic medical record. | Intervention Group | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Hospital Acquired Infections- VAP | Rates of Ventilator-Associated Pneumonia (VAP) will be collected from the electronic medical record. | Intervention Group | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Microbial Contamination Screening | 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. | Intervention Group | Posted | Mean | Standard Deviation | Relative Light Units (RLU) | Screen was completed immediately after each individual session on the PARO and an average was reported |
|
|
|
| Primary | Activity Performance Form | The Activity Performance Form is an investigator developed measure that assesses the length of each therapy session (in minutes). | Posted | Mean | Standard Deviation | Minutes per session | Outcome measure data recorded within ten minutes after the therapy session has ended |
|
|
|
| Primary | Physiologic Variables- Heart Rate | Measure heart Rate before and after therapy session | Posted | Mean | Full Range | beats per minute | 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. |
|
|
|
| Primary | Physiologic Variables- Blood Pressure | Measure blood pressure before and after each session. | Posted | Mean | Full Range | millimeters of mercury (mmHg) | 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. |
|
|
|
| Primary | Physiologic Variables- Respiratory Rate | Measure respiratory rate before and after each session. | Posted | Mean | Full Range | breaths per minute | 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. |
|
|
|
| Primary | Physiologic Variables- Oxygen | Measure oxygen saturation before and after each session. | Posted | Mean | Full Range | percent of blood cells saturated | 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. |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
Not provided
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|