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Clinical Trials/NCT06466551
NCT06466551
Completed
Not Applicable

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

Toros University1 site in 1 country75 target enrollmentJune 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Procedural
Sponsor
Toros University
Enrollment
75
Locations
1
Primary Endpoint
Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale
Status
Completed
Last Updated
8 months ago

Overview

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
June 15, 2024
End Date
April 1, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Didem Polat Kulcu

Assist. Prof. Dr.

Toros University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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).

Study Sites (1)

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