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Social Robot Interaction on Fear and Pain Levels in Children

NCT07632625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-06-10

No results posted yet for this study

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 Pain
  • Procedural Fear

Interventions

OTHER

Social Robot

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.

OTHER

Digital Game

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.

Sponsors & Collaborators

  • Trakya University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-21
Primary Completion
2025-12-21
Completion
2026-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07632625 on ClinicalTrials.gov