Robot Therapy in Pediatric Emergency

Child, Only Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627909
• Other study ID #: prot. N. 2666 06-25-2019
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Child, Only
• Emergencies

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.