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Completed

NCT Number: NCT06575816

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

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.

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Key information

Conditions

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

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emine Zahide Özdemir

Izmir, İzmir, 35340, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Augmented Reality Video Intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Apr 17, 2025

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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