Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 22, 2021
Open Peer Review Period: Dec 22, 2021 - Feb 16, 2022
Date Accepted: Jan 17, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Single-centre study on the use of virtual reality in the reduction of pain after the administration of vaccines in children aged 3 to 6 years in primary care centres in Central Catalonia: randomized clinical trial
ABSTRACT
Background:
Pain and anxiety caused by vaccination and other medical procedures in childhood can cause discomfort for both the patient and their parents. Virtual reality (VR) is a technology capable of entertaining and distracting the user. Among its many applications, we find the improvement of pain management and the reduction of anxiety in patients undergoing medical interventions.
Objective:
Reduction of pain and anxiety after the administration of two vaccines in children aged 3 to 6 years.
Methods:
Randomized, parallel, controlled clinical trial with two assigned groups. The intervention group will wear virtual reality goggles during the administration of two vaccines, while the control group will receive standard primary care centre care for the procedure. Randomization will be carried out using the "RandomizedR" computer system, a randomization tool of the R Studio program. This is an open or unblinded trial, both the subject and the investigator will know the assigned treatment group. Due to the nature of the VR intervention, it is impossible to blind patients, caregivers or observers. However, a blind third party assessment will be carried out. The study population focuses on children aged 3 to 6 years, included in the patient registry and cared for in the primary care centre of the region of Central Catalonia, who will receive the following vaccines during the well child check-up: triple viral + varicella at 3 years of age and hepatitis A + Diphtheria-Tetanus-Pertussis at 6 years of age.
Results:
The study is scheduled to begin in January 2022 and is scheduled to end in January 2023 when the statistical analysis will begin.
Conclusions:
Virtual reality can be a useful tool in paediatric procedures that generate pain and anxiety. Clinical Trial: The clinical trial has been approved by the IDIAP Jordi Gol i Guirna ethics committee with code 4R21/061.
Citation
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Copyright
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