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CompletedNCT04627909Updated May 6, 2021

Robot Therapy in Pediatric Emergency

An observational study in Child, Only, sponsored by University of L'Aquila. Completed at 1 site in Italy. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2021-05-06.

Sponsored by University of L'Aquila · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
109
Ages
3 Years to 10 Years
Sex
All
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Study 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.

02

Conditions studied

  • Child, Only

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03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 109 is below the median of 353 across 714 observational studies indexed under Emergencies.

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Lead sponsor

University of L'Aquila is the lead sponsor of 45 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children in pediatric emergency department

Inclusion criteria

  • children between the ages of 3 and 10 with white, green and yellow triage code

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
109 participants (actual)
Patient registry
No

Groups and cohorts

  • Group under Robot treatment

    Interaction with the Humanoid Robot for 15 minutes

    Other: Robot

  • Group involved with medical personnel

    Interaction with medical personnel for 15 minutes

    Other: Medical Personnel

  • Control group

    Exclusive interaction with the caregiver for 15 minutes

    Other: Caregiver

Interventions

  • OtherRobot

    The patient interacts with a robot

  • OtherMedical Personnel

    The patient interacts with medical personnel

  • OtherCaregiver

    The patient interacts with the caregiver

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: The surveys have been made after a 15-minute interaction with the robot or mother or medical staff.

07

Study locations

1 site
  • University of L'Aquila
    L'Aquila, 67100, Italy
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04627909
Lead sponsor
University of L'Aquila
Responsible party
Clara Balsano (Ordinary professor, University of L'Aquila) — Principal investigator
First posted
Nov 13, 2020
Start date
Jul 1, 2019
Primary completion
Feb 28, 2020
Completion
Feb 28, 2020
Last update
May 6, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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