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Clinical Trials/NCT04627909
NCT04627909
Completed
Not Applicable

Emotional Support of a Social Robot at the Pediatric Emergency Department: a Randomized Clinical Trial

University of L'Aquila1 site in 1 country109 target enrollmentJuly 1, 2019
ConditionsChild, Only

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child, Only
Sponsor
University of L'Aquila
Enrollment
109
Locations
1
Primary Endpoint
Salivary cortisol level
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
February 28, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Clara Balsano

Ordinary professor

University of L'Aquila

Eligibility Criteria

Inclusion Criteria

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

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Psychological tests(The surveys have been made after a 15-minute interaction with the robot or mother or medical staff.)

Study Sites (1)

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