PediatricsNCT04993599
Evaluation of Social Robot Usability for Pediatric Patients and Carers
A study testing Social robot interaction in people with Pediatrics, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is conducted for a mixed methods study. Subjects are 20 child patients and 20 their carers. First, Participants use and interact with a social robot. The robot is controlled by researcher with the wizard of oz. method. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatrics
- What is being tested?
- Social robot interaction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Sep 2021to 31 Jan 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients visiting Samsung Medical Center (Age 5~12)
- A person who voluntarily agrees to participate in the study
- Patients who are able to agree with a consent
- Caregivers of the patient participant
- Adults over 19 years of age
- A person who voluntarily agrees to participate in the study
Who cannot join
- Those who disagree with the study
- Patients and carers who find it difficult to interact with the robot
- <Carers>
- Those who disagree with the study
- Patients and carers who find it difficult to interact with the robot
Trial locations and contacts
1 site in 1 country.
About this study
This study is conducted for a mixed methods study. Subjects are 20 child patients and 20 their carers. First, Participants use and interact with a social robot. The robot is controlled by researcher with the wizard of oz. method. The interaction is video-recorded for the later analysis of the child's engagement through amount of his vocalization and sentences. After using social robot, a survey and an in-depth interview will be done.
This study investigates the usability, satisfaction, emotion, and other dimensions of social robots of pediatric patients and carers and evaluate the degree of interaction with them with the recording data, survey and in-depth interview. This study is a basis for using social robots to pediatric patients in the hospital environments.
Read the detailed description
This study is conducted for a mixed methods study. Subjects are 20 child patients and 20 their carers. First, Participants use and interact with a social robot. The robot is controlled by researcher with the wizard of oz. method. And another researcher observes the participants-robot interaction. The interaction is video-recorded for the later analysis of the child's engagement through amount of his vocalization and sentences. After using social robot, a survey and an in-depth interview will be done.
This study investigates the usability, satisfaction, emotion, and other dimensions of social robots of pediatric patients and carers and evaluate the degree of interaction with them with the recording data, survey and in-depth interview. This study is a basis for using social robots to pediatric patients in the hospital environments.
- Conditions
- Pediatrics
- Being tested
- Social robot interaction
- Keywords
- Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social robot interactionDevice
The participants interact with the social robot which is controlled by the researcher behind the scene (wizard of oz. method).
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients | Experimental | <Intervention> The participants(Pediatric patients) mainly interact with the social robot which is controlled by the researcher behind the scene Receives: Device: Social robot interaction |
| Carers | Experimental | <Intervention> The participants(Carers) interact with the social robot and watch how their child interact with the robot which is controlled by the researcher behind the scene Receives: Device: Social robot interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration and time of robot communication with the participants
Assessment of how long the duration and time of the communication between the participants ans robot is.
Measured: Through study completion, an average of 1 year
Number of conversations exchanged between the participant and the robot
Assessment of the number of conversations exchanged between the participant and the robot
Measured: Through study completion, an average of 1 year
The amount of the incidence of participants' vocalization when interacting with the robot
Assessment of the incidence of participants' vocalization when interacting with the robot.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
A qualitative study on user experience
A qualitative study on user experience using a in-depth interview
Measured: Through study completion, an average of 1 year
A quantitative study on the user experience
A quantitative study on the user experience using User Experience Questionnaire. The items have the form of a semantic differential, i.e. each item is represented by two terms with opposite meanings. The items are scaled from -3 to +3. Thus, -3 represents the most negative answer, 0 a neutral answer, and +3 the most positive answer.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start2 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meong Hi Son, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993599
- Sponsor's protocol ID
- 2021-05-085-006
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Social Robot Usability for Pediatric Patients and Carers
- ClinicalTrials.gov ID
- NCT04993599
- Acronym / sponsor ID
- 2021-05-085-006
- Conditions
- Pediatrics
- Keywords
- Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 6 Aug 2021 (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.
This study is conducted for a mixed methods study. Subjects are 20 child patients and 20 their carers. First, Participants use and interact with a social robot. The robot is controlled by researcher with the wizard of oz. method. The interaction is video-recorded for the later analysis of the child's engagement through amount of his vocalization and sentences. After using social robot, a survey and an in-depth interview will be done.
This study investigates the usability, satisfaction, emotion, and other dimensions of social robots of pediatric patients and carers and evaluate the degree of interaction with them with the recording data, survey and in-depth interview. This study is a basis for using social robots to pediatric patients in the hospital environments.
Detailed description
This study is conducted for a mixed methods study. Subjects are 20 child patients and 20 their carers. First, Participants use and interact with a social robot. The robot is controlled by researcher with the wizard of oz. method. And another researcher observes the participants-robot interaction. The interaction is video-recorded for the later analysis of the child's engagement through amount of his vocalization and sentences. After using social robot, a survey and an in-depth interview will be done.
This study investigates the usability, satisfaction, emotion, and other dimensions of social robots of pediatric patients and carers and evaluate the degree of interaction with them with the recording data, survey and in-depth interview. This study is a basis for using social robots to pediatric patients in the hospital environments.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients | Experimental | Device: Social robot interaction<Intervention> The participants(Pediatric patients) mainly interact with the social robot which is controlled by the researcher behind the scene |
| Carers | Experimental | Device: Social robot interaction<Intervention> The participants(Carers) interact with the social robot and watch how their child interact with the robot which is controlled by the researcher behind the scene |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients visiting Samsung Medical Center (Age 5~12)
- A person who voluntarily agrees to participate in the study
- Patients who are able to agree with a consent
- Caregivers of the patient participant
- Adults over 19 years of age
Key exclusion criteria (5 listed)
- Those who disagree with the study
- Patients and carers who find it difficult to interact with the robot
- <Carers>
- Those who disagree with the study
- Patients and carers who find it difficult to interact with the robot
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 |
|---|---|---|
| Social robot interactionThe participants interact with the social robot which is controlled by the researcher behind the scene (wizard of oz. method). | Device | Carers, Pediatric patients |
Primary outcome
Duration and time of robot communication with the participants
Time frame: Through study completion, an average of 1 year
Assessment of how long the duration and time of the communication between the participants ans robot is.
Number of conversations exchanged between the participant and the robot
Time frame: Through study completion, an average of 1 year
Assessment of the number of conversations exchanged between the participant and the robot
The amount of the incidence of participants' vocalization when interacting with the robot
Time frame: Through study completion, an average of 1 year
Assessment of the incidence of participants' vocalization when interacting with the robot.
2 secondary outcomes
A qualitative study on user experience
Time frame: Through study completion, an average of 1 year
A quantitative study on the user experience
Time frame: Through study completion, an average of 1 year
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 27 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Pediatrics
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
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.
Meong Hi Son principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social robot interaction in people with Pediatrics, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 5 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 27 Apr 2022. 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 South Korea. 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?
Duration and time of robot communication with the participants (time frame: Through study completion, an average of 1 year). The study lists 3 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 27 Apr 2022.