RecruitingACTRN12618001363279

The use of a virtual reality headset for 4 year old immunisations to reduce pain and distress.

Virtual Reality for Immunisation Pain: A Randomised Controlled Clinical Trial in General Practice.

Sponsor

Dr Kirrily Ellerton

Enrollment

100 participants

Start Date

Jul 4, 2019

Study Type

Interventional

Conditions

Immunisation pain

Summary

Our study aims to determine the effectiveness of the use of virtual reality to reduce the pain and distress associated with childhood vaccination in the general practice setting. The hypothesis relating to our primary aim is that virtual reality content delivered through a headset will reduce pain and distress associated with childhood vaccination compared to the use of standard techniques used in the primary care setting.

Eligibility

Sex: Both males and femalesMin Age: 42 MonthssMax Age: 5 Yearss

Plain Language Summary

Simplified for easier understanding

Getting vaccinations can be a frightening experience for young children, and the pain and distress from needles can create lasting anxiety around medical procedures. This study is exploring whether virtual reality (VR) — where a child wears a headset and is immersed in a fun, engaging visual world — can distract young children effectively enough to reduce the pain and fear they feel during their 4-year-old immunisations. Children attending their general practice for the standard 4-year-old vaccination schedule will either use a VR headset during the injection or receive the usual care and comfort techniques their doctor normally uses. Parents, the children themselves, and researchers will measure how much distress and pain the child experiences. You may be eligible if your child is attending their general practice for their 4-year-old immunisations and their doctor believes they can participate in the study without problems. Children with significant medical conditions that might affect their ability to take part, or whose parents cannot provide informed consent, would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Virtual reality (VR) headset for 4 year old immunisations. Intervention will be delivered by General Practice Nurse Immunisers with a minimum of 5 years experience in vaccination of children.

Virtual reality (VR) headset for 4 year old immunisations. Intervention will be delivered by General Practice Nurse Immunisers with a minimum of 5 years experience in vaccination of children. Face-to-face intervention for individual patients receiving their 4 year old immunisation (once off intervention). The trial will take place in an urban General Practice (private clinic). Participants will be randomised to either standard care or the intervention - Virtual reality headset. Participants and their parents/guardians in the intervention group will be shown the VR headset. The device and its function will be explained by the practice nurse. The nurse immuniser will fit the device over the child's head / eyes and activate the software program. The software program is an animated short video. The video is an interactive underwater adventure that begins with relaxation and progresses to marina scenes. The child interacts with the environment (ie. virtual fish) through gaze-based tracking. The device will be worn for up to 1-2 minutes during which time the vaccination will be given.

Locations(1)

VIC, Australia

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ACTRN12618001363279