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

August 7, 2025 updated by: Didem Polat Kulcu, Toros University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

75

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
      • Mersin, Turkey
        • Toros Üniversty

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 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

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
Experimental: Virtual Reality Goggles Group
Children in this group watched cartoons using virtual reality goggles starting 3 minutes before intravenous catheterization. Pain and fear were assessed before, during, and after the procedure.
Other: intravenous catheterization
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.
Experimental: Stress Ball Group
Children in this group used a stress ball as a distraction method starting 3 minutes before intravenous catheterization. Pain and fear were assessed before, during, and after the procedure.
Other: intravenous catheterization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)
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).
Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)

Collaborators and Investigators

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

Sponsor

Toros University

Investigators

  • Principal Investigator: Didem Polat Külcü, Dr., Toros University, Faculty of Health Sciences, Department of Nursing

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)

June 15, 2024

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Toros

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be shared for secondary research purposes upon reasonable request.

IPD Sharing Time Frame

IPD will be available within 6 months after publication of the main study results and will be accessible for up to 3 years.

IPD Sharing Access Criteria

Researchers must submit a methodologically sound proposal approved by an ethics committee. Data will be shared through secure, password-protected file transfer after signing a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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.

Subscribe