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

NCT06575816 | Completed

• 1 other identifier: DokuzEU-2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Fear; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain Level

  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 Outcomes (1)

• Fear Level

  Five minutes before and 5 minutes after blood collection

Other Outcomes (1)

• Anxiety Level

  Five minutes before and 5 minutes after blood collection

Study Arms (3)

Control group, intervention group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

intervention group

EXPERIMENTAL

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

Interventions

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.

Control group, intervention group; intervention group

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Emine Zahide Özdemir

Izmir, İzmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor, PhD

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 28, 2024
• Study Start: March 30, 2024
• Primary Completion: August 30, 2024
• Study Completion: September 2, 2024
• Last Updated: April 17, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)