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

NCT06466551 | Completed

• 1 other identifier: Toros
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Procedural; Anxiety; Pain Management

Keywords

distraction; fear; pain

Outcome Measures

Primary Outcomes (2)

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

  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

  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)

Study Arms (2)

Virtual Reality Goggles Group

EXPERIMENTAL

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

Stress Ball Group

EXPERIMENTAL

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

Interventions

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.

Stress Ball Group; Virtual Reality Goggles Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Toros University: lead

Study Sites (1)

Toros Üniversty

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders; Agnosia; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Didem Polat Külcü, Dr.

  Toros University, Faculty of Health Sciences, Department of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 20, 2024
• Study Start: June 15, 2024
• Primary Completion: December 20, 2024
• Study Completion: April 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

TU (1)