Social Robot Interaction on Fear and Pain Levels in Children

June 2, 2026 updated by: Remziye Semerci, Trakya University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34010
        • Koç University

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:

  • 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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: social robot
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.
Experimental: digital game
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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.
Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.

Collaborators and Investigators

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

Sponsor

Trakya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • REFERENCES Altman, I., & Taylor, D. A. (1973). Social penetration: The development of interpersonal relationships. Holt, Rinehart and Winston. Ball, J. W., Bindler, R. C., Cowen, K. J., & Shaw, N. M. (2017). Child health nursing: Partnering with children and families (3rd ed.). Pearson. Beran, T. N., Ramirez-Serrano, A., Vanderkooi, O. G., & Kuhn, S. (2013). Reducing children's pain and distress towards flu vaccinations: A novel and effective application of humanoid robotics. Vaccine, 31(25), 2772-2777. https://doi.org/10.1016/j.vaccine.2013.03.056 Birnie, K. A., Noel, M., Chambers, C. T., Uman, L. S., & Parker, J. A. (2018). Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database of Systematic Reviews, 10(10), CD005179. https://doi.org/10.1002/14651858.CD005179.pub4 Blount, R. L., Zempsky, W. T., Jaaniste, T., Evans, S., Cohen, L. L., Devine, K. A., & Inadomi, H. (2009). Management of pediatric pain and distress due to medical procedures. In M. C. Roberts & R. G. Steele (Eds.), Handbook of pediatric psychology (4th ed., pp. 171-188). Guilford Press. Boutron, I., Altman, D. G., Moher, D., Schulz, K. F., & Ravaud, P. (2017). CONSORT statement for randomized trials of nonpharmacologic treatments: A 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Annals of Internal Medicine, 167(1), 40-47. https://doi.org/10.7326/M17-0046 Campbell, K. A. (2022). The neurobiology of childhood trauma, from early physical pain onwards: As relevant as ever in today's fractured world. European Journal of Psychotraumatology, 13(2), Article 2131969. https://doi.org/10.1080/20008066.2022.2131969 Dawe, J., Sutherland, C., Barco, A., & Broadbent, E. (2019). Can social robots help children in healthcare contexts? A scoping review. BMJ Paediatrics Open, 3(1), Article e000371. https://doi.org/10.1136/bmjpo-2018-000371 Eijlers, R., Utens, E. M. W. J., Staals, L. M., de Nijs, P. F. A., Berghmans, J. M., Wijne

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)

December 21, 2025

Primary Completion (Actual)

December 21, 2025

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

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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