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OpenTrials
Completed

NCT Number: NCT06466551

Effect of Virtual Reality Goggles and Stress Ball Use on Pain and Fear During IV Catheterization in Children

Although distraction methods such as virtual reality glasses, watching videos, watching cartoons, etc. have been reported to reduce pain in the literature, studies on which method is more effective in reducing pain are limited. Considering the developmental period characteristics, virtual reality glasses and stress ball squeezing may be effective in the 6-12 age group during painful intervention. However, no study has been found in the literature on which technique is more effective (9-23). Therefore, investigating the effects of virtual reality goggles and stress ball squeezing on pain and fear in children aged 6-12 years as a distraction method during intravenous catheterization may enable nurses to determine the technique with high clinical usefulness in pain management.

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Key information

Conditions

Pain, Procedural Agnosia Anxiety Anxiety Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toros Üniversty

Mersin, Turkey (Türkiye)

About this study

Provide a brief summary of the study, including the purpose, objectives, and brief methodology.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 6-12 years
  • Admitted to the pediatric unit of the hospital between June 20, 2024, and April 20, 2025
  • Scheduled to undergo intravenous catheterization
  • Having parental consent through a signed informed consent form
  • Absence of mental or developmental retardation

Exclusion criteria

  • Children for whom the first attempt at intravenous catheterization was unsuccessful

Treatment and study plan

intravenous catheterization

Other

This randomized experimental study was planned to examine the effect of virtual reality goggles and squeezing a stress ball as a distraction method during intravenous catheter application on pain and fear in children aged 6-12 years.

Primary outcomes

  1. Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale

    Time frame: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)

    Pain scores will be measured using the Wong-Baker FACES Pain Rating Scale. Scores will be recorded before, during, and after intravenous catheterization. Pain will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Pain will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).

  2. Change in Fear Scores Assessed by the Children's Fear Scale

    Time frame: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)

    Fear levels will be assessed using the Children's Fear Scale. Scores will be recorded before, during, and after intravenous catheterization. Fear will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Fear will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).

Sponsors and collaborators

Lead sponsor

Toros University

Other

Registry information

Official study title

The Effect of Virtual Reality Goggles and Stress Ball Used During Intravenous Catheterization on Pain and Fear in Children: A Randomized Experimental Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 20, 2024
Registry last updated
Aug 13, 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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