Acute Lymphoblastic Leukemia (ALL)PARONCT05075395
Animal Assisted Interactions With Animal Robot in the Intensive Care Unit (ICU)
A study testing PARO therapy seal in people with Acute Lymphoblastic Leukemia (ALL) and Critical Illness, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to: 1. Establish the feasibility and acceptability of a therapeutic robot, Paro, for critically ill patients admitted to the Pediatric Intensive Care Unit 2. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL), Critical Illness, Physical Therapy Modalities
- What is being tested?
- PARO therapy seal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Animal Assisted Interactions With an Animal Robot During Physical and Occupational Therapy Sessions in the Pediatric ICU: A Feasibility Study
The purpose of this study is to:
- Establish the feasibility and acceptability of a therapeutic robot, Paro, for critically ill patients admitted to the Pediatric Intensive Care Unit
- 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
- Examine the therapeutic effect of Paro on patient psychological variables, physiological variables, and sedative and analgesic medication requirements.
Read the detailed description
Admission to the Pediatric Intensive Care Unit (PICU) can be an extremely upsetting experience for children of all ages. In addition to physical symptoms such as pain, thirst and fatigue, patients in the PICU also experience a multitude of psychological symptoms. Symptoms like anxiety, spells of terror, social isolation, disturbed sleeping patterns, restlessness, fear, confusion and loss of control are exacerbated in the PICU because patients often have limited mobility, decreased capacity to communicate, and rely on healthcare providers for survival.
Large doses of sedative and analgesic medications are administered by nursing staff to help alleviate distressing symptoms. Overuse of sedative medications can cause a sequela of adverse effects, and therefore, recent recommendations call for reducing sedative use as much as possible. To minimize the overwhelming symptom burden of acute critical illness and promote lasting psychological well-being during recovery, it is imperative to identify effective non-pharmacological interventions that decrease psychological distress, but do not alter level of alertness during acute critical illness. Established evidence supports the use of a variety of non-pharmacological approaches that can be easily applied as adjuncts to sedative and analgesic medications in order to reduce dependence on these medications. Animal assisted interactions (AAI) are a promising integrative approach that can be used as an adjunct to sedative and analgesic medications in order to improve psychological symptoms and promote comfort, relaxation, and positive mood in critically ill patients.
AAI are interventions that intentionally incorporate animals as part of a therapeutic process to promote human health, learning, and well-being. Domestic and farm animals such as dogs, cats, birds, equines, guinea pigs, rabbits, llamas, sheep, goats, and pigs are predominantly featured in AAI programs. Animals can be simply observed, touched, held, and petted, or more actively integrated into specific therapy activities such as brushing with different tools to exercise range of motion and fine motor coordination and tandem walking with the animal to encourage exercise. Recent literature indicates that AAI can improve reality orientation and attention span, eliminate the sense of isolation, reduce stress and anxiety, enhance communication, promote positive social interactions, and enhance overall quality of life. The use of AAI in the ICU has the potential to engage patients, family members, and healthcare staff in an innovative, holistic approach to symptom management.
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Critical Illness, Physical Therapy Modalities, Occupational Therapy, Animal Assisted Therapy
- Being tested
- PARO therapy seal
- Keywords
- Robot, Animal Assisted Interaction, Critical Care, Rehabilitation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARO therapy sealDevice
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 |
|---|---|---|
| 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. Receives: Device: PARO therapy seal |
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: 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.
Measured: 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.
Measured: 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.
Measured: 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- Enteroviruses
Rates of Enteroviruses will be collected from the electronic medical record.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Jul 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lymphoblastic Leukemia (ALL)Studies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Breanna Hetland, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075395
- Sponsor's protocol ID
- 0005-19-EP
- Acronym
- PARO
- Status last verified
- Nov 2024
- First submitted
- 16 Jul 2021
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal Assisted Interactions With an Animal Robot During Physical and Occupational Therapy Sessions in the Pediatric ICU: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05075395
- Acronym / sponsor ID
- PARO / 0005-19-EP
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Critical Illness, Physical Therapy Modalities, Occupational Therapy, Animal Assisted Therapy
- Keywords
- Robot, Animal Assisted Interaction, Critical Care, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Posted 16 Dec 2024
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:
- Establish the feasibility and acceptability of a therapeutic robot, Paro, for critically ill patients admitted to the Pediatric Intensive Care Unit
- 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
- Examine the therapeutic effect of Paro on patient psychological variables, physiological variables, and sedative and analgesic medication requirements.
Detailed description
Admission to the Pediatric Intensive Care Unit (PICU) can be an extremely upsetting experience for children of all ages. In addition to physical symptoms such as pain, thirst and fatigue, patients in the PICU also experience a multitude of psychological symptoms. Symptoms like anxiety, spells of terror, social isolation, disturbed sleeping patterns, restlessness, fear, confusion and loss of control are exacerbated in the PICU because patients often have limited mobility, decreased capacity to communicate, and rely on healthcare providers for survival.
Large doses of sedative and analgesic medications are administered by nursing staff to help alleviate distressing symptoms. Overuse of sedative medications can cause a sequela of adverse effects, and therefore, recent recommendations call for reducing sedative use as much as possible. To minimize the overwhelming symptom burden of acute critical illness and promote lasting psychological well-being during recovery, it is imperative to identify effective non-pharmacological interventions that decrease psychological distress, but do not alter level of alertness during acute critical illness. Established evidence supports the use of a variety of non-pharmacological approaches that can be easily applied as adjuncts to sedative and analgesic medications in order to reduce dependence on these medications. Animal assisted interactions (AAI) are a promising integrative approach that can be used as an adjunct to sedative and analgesic medications in order to improve psychological symptoms and promote comfort, relaxation, and positive mood in critically ill patients.
AAI are interventions that intentionally incorporate animals as part of a therapeutic process to promote human health, learning, and well-being. Domestic and farm animals such as dogs, cats, birds, equines, guinea pigs, rabbits, llamas, sheep, goats, and pigs are predominantly featured in AAI programs. Animals can be simply observed, touched, held, and petted, or more actively integrated into specific therapy activities such as brushing with different tools to exercise range of motion and fine motor coordination and tandem walking with the animal to encourage exercise. Recent literature indicates that AAI can improve reality orientation and attention span, eliminate the sense of isolation, reduce stress and anxiety, enhance communication, promote positive social interactions, and enhance overall quality of life. The use of AAI in the ICU has the potential to engage patients, family members, and healthcare staff in an innovative, holistic approach to symptom management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: PARO therapy sealThe 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
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 therapy sealPARO, 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 | Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 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 therapy seal in people with Acute Lymphoblastic Leukemia (ALL) and Critical Illness, 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 8 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 16 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 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 study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.