Effect of Augmented Reality on Pain, Anxiety, and Fear in Children During Blood Collection

April 14, 2025 updated by: Emine Zahide Özdemir, Dokuz Eylul University

Effect of Augmented Reality on Pain, Anxiety and Fear During Blood Collection in Children: Randomized Controlled Study

In recent years, technological advances have enabled the development of innovative intervention methods in healthcare. This study aims to examine the effect of augmented reality (AR) technology on pain, anxiety and fear in children during pediatric blood collection procedures. The study is based on a randomized controlled design. Participants were randomized into two groups, the group receiving AR intervention and the control group receiving standard care. Pain, anxiety and fear levels will be assessed with pre and post intervention measurements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

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
      • İzmir, Turkey, 35340
        • Emine Zahide Özdemir

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:

  • Both parent and child voluntarily agree to participate in the study
  • No language barrier

Exclusion Criteria:

  • Parents or children who refused to participate in the study
  • Problems with looking at the screen

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group, intervention group

This group will receive the standard blood collection procedure without any augmented reality video intervention. Pain, anxiety, and fear levels will be assessed using standardized scales after the procedure.

This group will receive the augmented reality video intervention during the blood collection procedure. The intervention consists of children watching AR videos designed to distract and comfort them during the blood draw. Pain, anxiety, and fear levels will be measured using standardized scales immediately after the procedure.
Behavioral: Augmented Reality Video Intervention
This intervention involves a video intervention using augmented reality (AR) technology to reduce the pain, anxiety and fear children experience during the blood collection process. During the intervention, children watch AR videos to distract and relax them from the blood collection process. These videos are equipped with a variety of entertaining and engaging content and aim to reduce children's psychological stress.
No Intervention: Control group
This group will receive the standard blood collection procedure without any augmented reality video intervention. Pain, anxiety, and fear levels will be assessed using standardized scales after the procedure.
Experimental: intervention group
This group will receive the augmented reality video intervention during the blood collection procedure. The intervention consists of children watching AR videos designed to distract and comfort them during the blood draw. Pain, anxiety, and fear levels will be measured using standardized scales immediately after the procedure.
Behavioral: Augmented Reality Video Intervention
This intervention involves a video intervention using augmented reality (AR) technology to reduce the pain, anxiety and fear children experience during the blood collection process. During the intervention, children watch AR videos to distract and relax them from the blood collection process. These videos are equipped with a variety of entertaining and engaging content and aim to reduce children's psychological stress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level
Time Frame: Five minutes before and 5 minutes after blood collection
Children's pain levels will be measured using a standardized pain scale, such as the Wong-Baker Pain Rating Scale, immediately after the blood collection procedure.The scale can be scored from a minimum of 0 to a maximum of 10. As the score increases, pain increases.
Five minutes before and 5 minutes after blood collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear Level
Time Frame: Five minutes before and 5 minutes after blood collection

Children's fear levels will be evaluated using a fear assessment tool, such as the Children's Fear Scale, before and after the blood collection procedure.

The scale can be scored from a minimum of 0 to a maximum of 4. As the score increases, fear increases.
Five minutes before and 5 minutes after blood collection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Level
Time Frame: Five minutes before and 5 minutes after blood collection
Children's anxiety levels will be assessed using the State-Trait Anxiety Inventory for Children before, during, and after the blood collection procedure.The scale can be scored from a minimum of 1 to a maximum of 10. As the score increases, Anxiety increases.
Five minutes before and 5 minutes after blood collection

Collaborators and Investigators

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

Sponsor

Dokuz Eylul University

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)

March 30, 2024

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

September 2, 2024

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DokuzEU-2024

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

product manufactured in and exported from the U.S.

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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