Child's Interaction With a Social Robot During Dressing

NCT07549191 | Completed

• 1 other identifier: OMU-KAEK-2025-188
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distraction Methods; Distraction; Fear Anxiety; Fear; Wound Care; Children Pain Management

Outcome Measures

Primary Outcomes (2)

• Children's Fear during wound care

  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

  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

Study Arms (2)

Not robot

NO INTERVENTION

The control group consists of 30 child patients aged 5-10 years.

Robot

EXPERIMENTAL

The intervention group consists of 30 child patients aged 5-10 years.

Device: Social Robot

Interventions

Social Robot DEVICE

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.

Robot

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Çorum Osmancık Esentepe neighbourhood destan street no 8

Çorum, Osmancık, 19500, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Student

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 24, 2026
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)