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

B

Burdur Mehmet Akif Ersoy University

Status

Completed

Conditions

Fear
Vaccination
Fear of Pain
Children
Pain
Virtual Reality

Treatments

Behavioral: Virtual Reality Glasses

Study type

Interventional

Funder types

Other

Identifiers

NCT06560320
GO 2024/176

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

48 to 48 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children the ages of 48 months,
  • Volunteering of the child and parent to participate in the study,
  • Healthy children,
  • Vaccination should be done by the same nurse,

Exclusion criteria

  • The child has any acute or chronic disease,
  • The child has a mental disability, vision, speech or communication problems,
  • The parent has hearing, vision or verbal communication difficulties,
  • The child used analgesics in the last 6 hours,
  • Infection, disruption of skin integrity and rash in the area where the application will be made,
  • Exclusion criteria were that the parent or child wanted to leave the study at any point.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Virtual Reality Glasses Group
Experimental group
Description:
Virtual 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 vaccination procedure.
Treatment:
Behavioral: Virtual Reality Glasses
Control group
No Intervention group
Description:
In this group, children received routine vaccination procedure.

Trial contacts and locations

1

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Central trial contact

Selda Ateş Beşirik, PhD.

Data sourced from clinicaltrials.gov

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