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

NCT ID: NCT06560320

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-03-15

Brief 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

Fear of Pain; Fear; Virtual Reality; Pain; Vaccination; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Glasses Group

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.

Group Type: EXPERIMENTAL

Virtual Reality Glasses

Intervention Type: BEHAVIORAL

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 the vaccination procedure.

Control group

In this group, children received routine vaccination procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Glasses

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 the vaccination procedure.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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,

• Minimum Eligible Age: 48 Months
• Maximum Eligible Age: 48 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Burdur Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Selda Ateş Beşirik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selda Ateş Beşirik

Role: PRINCIPAL_INVESTIGATOR

Burdur Mehmet Akif Ersoy University

Locations

Burdur Bucak

Burdur, Bucak, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GO 2024/176

Identifier Type: -

Identifier Source: org_study_id