The Effect of Virtual Reality Goggles and Stress Ball Used During Intravenous Catheterization on Pain and Fear in Children

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466551
• Other study ID #: Toros
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Toros University
• Contact: Didem POLAT KÜLCÜ
• Phone: 05066018023
• Email: didem.kulcu[@]toros.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children aged 6-12 years,
• Between April 20, 2024 and October 20, 2024, children admitted to Mersin Toros State Hospital Pediatrics Departments,
• Children scheduled for intravenous catheterization,
• Those who signed the informed consent form (child and parent),
• Children without mental and developmental retardation,
• They are children who can speak and communicate in Turkish.

Exclusion Criteria:

• Children under 6 years old and over 12 years old,
• Children hospitalized between April 20, 2024 - October 20, 2024 in clinics other than Mersin Toros State Hospital Pediatrics Service,
• Children for whom intravenous catheterization is not planned,
• Those who did not sign the informed consent form (child and parent),
• Children with mental and developmental retardation,
• They are children who cannot speak Turkish and cannot communicate.

Related Conditions & MeSH terms

• Anxiety
• Pain Management
• Pain, Procedural

Intervention

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.

Locations

Country	Name	City	State
Turkey	Toros Üniversty	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Toros University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)
Primary	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).	Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)