Child's Interaction With a Social Robot During Dressing

April 17, 2026 updated by: Cihan KAZEL, Ondokuz Mayıs University

The Effect of a Child's Interaction With a Social Robot During Dressing on Fear and Pain

The aim of this randomized controlled trial, consisting of 30 experimental and 30 control groups, was to examine the effect of a child's interaction with a social robot during wound dressing on their fear and pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Osmancık
      • Çorum, Osmancık, Turkey (Türkiye), 19500
        • Çorum Osmancık Esentepe neighbourhood destan street no 8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  1. The children should be between 5 and 10 years old.
  2. The child must have come to the emergency room for initial wound dressing.
  3. The child and parent must be able to speak and understand Turkish.
  4. The children must not have received any analgesics in the last four hours.

Exclusion Criteria:

  1. The child does not apply for their first dressing change,
  2. The child is not between 5-10 years old,
  3. The child has a mental, visual, or hearing impairment,
  4. The child has received any analgesic within the last four hours,
  5. An analgesic-containing ointment has been applied before the dressing change.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Not robot
The control group consists of 30 child patients aged 5-10 years.
Experimental: Robot
The intervention group consists of 30 child patients aged 5-10 years.
Device: Social Robot
In the intervention group, the child interacts with the social robot through wound dressing, and fear and pain scales are completed by the child, parent, and researcher before and after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Fear during wound care
Time Frame: 3 months

In the intervention group, the child interacts with the social robot during wound dressing, and fear scales are completed by the child, parent, and researcher before and after the procedure.

''The Child Fear Scale'' is designed for children aged 5-10 years. This scale uses a 0-4 rating system, representing five different facial expressions ranging from a blank expression (0=no anxiety) to a frightened face (4=severe anxiety). 0 indicates no anxiety, 1 mild anxiety, 2 moderate anxiety, 3 anxiety, and 4 severe anxiety.
3 months
Children's Pain during wound care
Time Frame: 3 months

In the intervention group, the child interacts with a social robot during wound dressing, and pain scales are completed by the child, parent, and researcher before and after the procedure.

''The WongBaker Facial Pain Scale'' is used for children aged 3 to 18 years. It consists of six different facial expressions, starting with a smiling face and ending with a crying face. The pain level corresponding to the faces on the scale is explained to the child: "Face 0" indicates no pain and is very happy. "Face 2" has some pain. "Face 4" has some more pain. "Face 6" has more pain. "Face 8" has very much pain. "Face 10" has unbearable pain.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • OMU-KAEK-2025-188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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