Robot Therapy in Pediatric Emergency
Emotional Support of a Social Robot at the Pediatric Emergency Department: a Randomized Clinical Trial
1 other identifier
observational
109
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedFirst Submitted
Initial submission to the registry
November 3, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedMay 6, 2021
May 1, 2021
8 months
November 3, 2020
May 3, 2021
Conditions
Outcome Measures
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.
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 surveys have been made after a 15-minute interaction with the robot or mother or medical staff.
Study Arms (3)
Group under Robot treatment
Interaction with the Humanoid Robot for 15 minutes
Group involved with medical personnel
Interaction with medical personnel for 15 minutes
Control group
Exclusive interaction with the caregiver for 15 minutes
Interventions
The patient interacts with medical personnel
Eligibility Criteria
Children in pediatric emergency department
You may qualify if:
- children between the ages of 3 and 10 with white, green and yellow triage code
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of L'Aquila
L’Aquila, 67100, Italy
Related Publications (1)
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.
PMID: 34854814DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ordinary professor
Study Record Dates
First Submitted
November 3, 2020
First Posted
November 13, 2020
Study Start
July 1, 2019
Primary Completion
February 28, 2020
Study Completion
February 28, 2020
Last Updated
May 6, 2021
Record last verified: 2021-05