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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04627909
Other study ID # prot. N. 2666 06-25-2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date February 28, 2020

Study information

Verified date May 2021
Source University of L'Aquila
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date February 28, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group 3 Years to 10 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Robot
The patient interacts with a robot
Medical Personnel
The patient interacts with medical personnel
Caregiver
The patient interacts with the caregiver

Locations

Country Name City State
Italy University of L'Aquila L'Aquila

Sponsors (1)

Lead Sponsor Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 The surveys have been made after a 15-minute interaction with the robot or mother or medical staff.
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