NCT04993599

Brief Summary

This study is conducted for a mixed methods study. Subjects are 20 child patients and 20 their carers. First, Participants use and interact with a social robot. The robot is controlled by researcher with the wizard of oz. method. The interaction is video-recorded for the later analysis of the child's engagement through amount of his vocalization and sentences. After using social robot, a survey and an in-depth interview will be done. This study investigates the usability, satisfaction, emotion, and other dimensions of social robots of pediatric patients and carers and evaluate the degree of interaction with them with the recording data, survey and in-depth interview. This study is a basis for using social robots to pediatric patients in the hospital environments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 27, 2022

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 16, 2021

Last Update Submit

April 20, 2022

Conditions

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (3)

  • Duration and time of robot communication with the participants

    Assessment of how long the duration and time of the communication between the participants ans robot is.

    Through study completion, an average of 1 year

  • Number of conversations exchanged between the participant and the robot

    Assessment of the number of conversations exchanged between the participant and the robot

    Through study completion, an average of 1 year

  • The amount of the incidence of participants' vocalization when interacting with the robot

    Assessment of the incidence of participants' vocalization when interacting with the robot.

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • A qualitative study on user experience

    Through study completion, an average of 1 year

  • A quantitative study on the user experience

    Through study completion, an average of 1 year

Study Arms (2)

Pediatric patients

EXPERIMENTAL

\<Intervention\> The participants(Pediatric patients) mainly interact with the social robot which is controlled by the researcher behind the scene

Device: Social robot interaction

Carers

EXPERIMENTAL

\<Intervention\> The participants(Carers) interact with the social robot and watch how their child interact with the robot which is controlled by the researcher behind the scene

Device: Social robot interaction

Interventions

The participants interact with the social robot which is controlled by the researcher behind the scene (wizard of oz. method).

CarersPediatric patients

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients visiting Samsung Medical Center (Age 5\~12)
  • A person who voluntarily agrees to participate in the study
  • Patients who are able to agree with a consent

You may not qualify if:

  • Those who disagree with the study
  • Patients and carers who find it difficult to interact with the robot
  • \<Carers\>
  • Caregivers of the patient participant
  • Adults over 19 years of age
  • A person who voluntarily agrees to participate in the study
  • Those who disagree with the study
  • Patients and carers who find it difficult to interact with the robot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Centre

Seoul, 06351, South Korea

Location

Study Officials

  • Meong Hi Son

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2021

First Posted

August 6, 2021

Study Start

September 2, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

April 27, 2022

Record last verified: 2021-07

Locations