Social Robot Interaction on Fear and Pain Levels in Children

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.

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Key information

Conditions

Procedural Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Procedural Fear Signs and Symptoms

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University

Istanbul, 34010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

Wong-Baker Faces Pain Rating Scale

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

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
Children Fear Scale

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

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.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

The Effect of Social Robot Interaction on Fear and Pain Levels in Children During Venous Blood Sampling: A Randomized Controlled Study

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jun 8, 2026
Registry last updated: Jun 10, 2026

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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Completed