Clinical Trials Directory

Trials / Completed

CompletedNCT06560320

Effect of Using Virtual Reality Goggles on Fear and Pain Level During Vaccination in Children

The Effect of Using Virtual Reality Goggles on Fear and Pain Level During Vaccination in Children: A Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Burdur Mehmet Akif Ersoy University · Academic / Other
Sex
All
Age
48 Months – 48 Months
Healthy volunteers
Accepted

Summary

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses reducing fear and pain during routine vaccination in children.

Detailed description

In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to examine the effect of distraction by using Virtual Reality Glasses in reducing fear and pain during routine vaccination in children. This study is a prospective, randomized and controlled trial. Children aged 48 months who required routine vaccination were divided into two groups; Virtual Reality Glasses and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's anxiety levels were also assessed using the Children's Fear Scale. The children's pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using Wong-Baker FACES. The study population consisted of the children's during routine vaccination in children aged 48 months. Sample of the study consisted of a total of 64 children who met the sample selection criteria and were selected via randomization method. Children were randomized into two groups: Virtual Reality Glasses group (n= 32) and Control group (n= 32). Data were collected using the Interview and Observation Form, Children's Fear Scale, and Wong-Baker FACES Pain Rating Scale.

Conditions

Interventions

TypeNameDescription
BEHAVIORALVirtual Reality GlassesVirtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the vaccination procedure.

Timeline

Start date
2024-04-01
Primary completion
2025-02-10
Completion
2025-03-15
First posted
2024-08-19
Last updated
2025-07-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06560320. Inclusion in this directory is not an endorsement.