Social Robot Interaction on Fear and Pain Levels in Children

NCT07632625 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness of social robot interaction and digital game-based distraction in reducing fear and pain during venous blood sampling in children aged 4-12 years with chronic diseases. The main questions it aims to answer are:

• Does social robot interaction reduce procedural fear and pain more effectively than standard care during venous blood sampling?
• Does social robot interaction provide greater emotional recovery after the procedure compared with digital game-based distraction and standard care? Researchers will compare a social robot intervention group, a digital game-based distraction group, and a standard care group to determine their effects on children's fear and pain levels before, during, and after venous blood sampling. Participants will:
• Be randomly assigned to one of three groups: social robot, digital game, or standard care.
• Complete fear and pain assessments 5 minutes before, during, and 5 minutes after the venous blood sampling procedure.
• Interact with a social robot or play a digital game before and during the procedure if assigned to one of the intervention groups.
• Receive routine clinical care if assigned to the standard care group. The study aims to provide evidence on the effectiveness of technology-based distraction methods for reducing procedural distress and improving the procedural experience of children undergoing venous blood sampling.

Conditions

Procedural Fear; Procedural Pain

Keywords

social robot; children; pain; anxiety; fear

Outcome Measures

Primary Outcomes (2)

• Wong-Baker Faces Pain Rating Scale

  Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six facial expressions scored from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity

  Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.

• Children Fear Scale

  Procedural fear was assessed using the Scary Scale, a self-report instrument designed for children aged 4-12 years. The scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear), with higher scores indicating greater fear levels.

  Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.

Study Arms (3)

Control Group

NO INTERVENTION

social robot

EXPERIMENTAL

Other: Social Robot

digital game

EXPERIMENTAL

Other: Digital Game

Interventions

Social Robot OTHER

Children interacted with an interactive social robot for approximately 5 minutes before venous blood sampling and throughout the procedure. The robot provided age-appropriate storytelling, songs, verbal communication, movement-based interaction, and visual stimulation to distract children and reduce procedural fear and pain.

social robot

Digital Game OTHER

Children received a digital game-based distraction intervention using the Bubble Rainbow application. Participants were allowed to familiarize themselves with the game for approximately 5 minutes before venous blood sampling. During the procedure, children continued playing the game on a tablet device while receiving support from their parents. The game included interactive activities such as bubble popping, color matching, and visual attention tasks designed to engage the child's attention and reduce procedural fear and pain.

digital game

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-12 years
• Clinical indication for venous blood sampling
• Ability to communicate in Turkish
• No cognitive disabilities
• No sensory disabilities
• Parent or legal guardian provides informed consent
• Child provides verbal assent

You may not qualify if:

• Requirement for emergency medical intervention
• Use of analgesic medication within 6 hours prior to the procedure
• Diagnosis of developmental delay
• Previous participation in a social robot-based intervention or study

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Koç University

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (2)

• Lakatos G, Gacsi M, Konok V, Bruder I, Bereczky B, Korondi P, Miklosi A. Emotion attribution to a non-humanoid robot in different social situations. PLoS One. 2014 Dec 31;9(12):e114207. doi: 10.1371/journal.pone.0114207. eCollection 2014.

  PMID: 25551218 RESULT

• Fox J, Gambino A. Relationship Development with Humanoid Social Robots: Applying Interpersonal Theories to Human-Robot Interaction. Cyberpsychol Behav Soc Netw. 2021 May;24(5):294-299. doi: 10.1089/cyber.2020.0181. Epub 2021 Jan 11.

  PMID: 33434097 RESULT

MeSH Terms

Conditions

Pain, Procedural; Pain; Anxiety Disorders

Interventions

Robotics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Automation; Technology; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: December 21, 2025
• Primary Completion: December 21, 2025
• Study Completion: April 30, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)