Child, OnlyNCT04627909
Robot Therapy in Pediatric Emergency
An observational study of Child, Only, run by University of L'Aquila at 1 site in Italy.
Trial summary
The investigators are evaluating if the use of humanoid robots is an optimal distraction strategy in order to produce positive emotional states and facilitate the diagnosis and to reduce treatment time in pediatric age in emergency situations. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Child, Only
- What is being tested?
- Robot, Medical Personnel and Caregiver
- How many people
- 109 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2019to 28 Feb 2020
- Phase
- Observational
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children in pediatric emergency department
Who may be able to join
- children between the ages of 3 and 10 with white, green and yellow triage code
Who cannot join
- Red triage code
- inadequate knowledge of the Italian language,
- yellow triage code in case of: headache for recent trauma with visual impairment; headache with neck rigidity or vomiting; indifference to the environment; dyspnea and increased respiratory work; intoxication by inhalation of toxic substances; significant trauma to the head with altered state of consciousness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotional Support of a Social Robot at the Pediatric Emergency Department: a Randomized Clinical Trial
The investigators are evaluating if the use of humanoid robots is an optimal distraction strategy in order to produce positive emotional states and facilitate the diagnosis and to reduce treatment time in pediatric age in emergency situations.
- Conditions
- Child, Only
- Being tested
- Robot, Medical Personnel, Caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RobotOther
The patient interacts with a robot
Medical PersonnelOther
The patient interacts with medical personnel
CaregiverOther
The patient interacts with the caregiver
| Study group | Role | What they receive |
|---|---|---|
| Group under Robot treatment | Interaction with the Humanoid Robot for 15 minutes Receives: Other: Robot | |
| Group involved with medical personnel | Interaction with medical personnel for 15 minutes Receives: Other: Medical Personnel | |
| Control group | Exclusive interaction with the caregiver for 15 minutes Receives: Other: Caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol level
The children's salivary cortisol production was measured over time to obtain a clear picture of the trend of the children's stress level before the emergency medical procedures.
Measured: The surveys have been made when children arrived, after their assigned 15-minutes interaction, and twenty minutes before medical physical examination.
Secondary outcomes (1)
Psychological tests
The secondary endpoint was to explore whether and how psychological characteristics of the children, such as temperament and understanding of emotions, affected their emotional responses
Measured: The surveys have been made after a 15-minute interaction with the robot or mother or medical staff.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Jul 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Balsano, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627909
- Sponsor's protocol ID
- prot. N. 2666 06-25-2019
- Status last verified
- May 2021
- First submitted
- 3 Nov 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rossi S, Santini SJ, Di Genova D, Maggi G, Verrotti A, Farello G, Romualdi R, Alisi A, Tozzi AE, Balsano C. Using the Social Robot NAO for Emotional Support to Children at a Pediatric Emergency Department: Randomized Clinical Trial. J Med Internet Res. 2022 Jan 13;24(1):e29656. doi: 10.2196/29656.
PubMed 34854814
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Support of a Social Robot at the Pediatric Emergency Department: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04627909
- Acronym / sponsor ID
- prot. N. 2666 06-25-2019
- Conditions
- Child, Only
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 13 Nov 2020 (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 investigators are evaluating if the use of humanoid robots is an optimal distraction strategy in order to produce positive emotional states and facilitate the diagnosis and to reduce treatment time in pediatric age in emergency situations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group under Robot treatment | – | Other: RobotInteraction with the Humanoid Robot for 15 minutes |
| Group involved with medical personnel | – | Other: Medical PersonnelInteraction with medical personnel for 15 minutes |
| Control group | – | Other: CaregiverExclusive interaction with the caregiver for 15 minutes |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children in pediatric emergency department
Key inclusion criteria (1 listed)
- children between the ages of 3 and 10 with white, green and yellow triage code
Key exclusion criteria (3 listed)
- Red triage code
- inadequate knowledge of the Italian language,
- yellow triage code in case of: headache for recent trauma with visual impairment; headache with neck rigidity or vomiting; indifference to the environment; dyspnea and increased respiratory work; intoxication by inhalation of toxic substances; significant trauma to the head with altered state of consciousness.
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 |
|---|---|---|
| RobotThe patient interacts with a robot | Other | Group under Robot treatment |
| Medical PersonnelThe patient interacts with medical personnel | Other | Group involved with medical personnel |
| CaregiverThe patient interacts with the caregiver | Other | Control group |
Primary outcome
Salivary cortisol level
Time frame: The surveys have been made when children arrived, after their assigned 15-minutes interaction, and twenty minutes before medical physical examination.
The children's salivary cortisol production was measured over time to obtain a clear picture of the trend of the children's stress level before the emergency medical procedures.
1 secondary outcome
Psychological tests
Time frame: The surveys have been made after a 15-minute interaction with the robot or mother or medical staff.
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 6 May 2021.
- Derived from this study: PubMed 34854814Rossi S, Santini SJ, Di Genova D, Maggi G, Verrotti A, Farello G, Romualdi R, Alisi A, Tozzi AE, Balsano C. Using the Social Robot NAO for Emotional Support to Children at a Pediatric Emergency Department: Randomized Clinical Trial. J Med Internet Res. 2022 Jan 13;24(1):e29656. doi: 10.2196/29656.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child, Only, run by University of L'Aquila at 1 site in Italy.
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 1 inclusion and 3 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 6 May 2021. 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 Italy. 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?
Salivary cortisol level (time frame: The surveys have been made when children arrived, after their assigned 15-minutes interaction, and twenty minutes before medical physical examination.). 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 NCT04627909, which also lists 1 linked publication.
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 6 May 2021.