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OpenTrials
Completed

NCT Number: NCT04627909

Robot Therapy in Pediatric Emergency

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.

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Key information

Conditions

Child, Only

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of L'Aquila

L’Aquila, 67100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robot

Other

The patient interacts with a robot

Medical Personnel

Other

The patient interacts with medical personnel

Caregiver

Other

The patient interacts with the caregiver

Primary outcomes

  1. 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

  1. Psychological tests

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

    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

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2020
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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