drugset / Trial / NCT06313762

Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers.

NCT06313762

RandomizedParallel-groupOpen-labelHealth-services research

Summary

The objective of this randomized, multicenter, open-label, parallel, controlled clinical trial is to evaluate pain reduction during the administration of two vaccines in children aged 3 and 6 years through virtual reality. The main question\[s\] it aims to answer are: 1. To evaluate the reduction in pain during the administration of two vaccines in children aged 3 and 6 years. 2. To evaluate the reduction in anxiety during and after the administration of two vaccines in children aged 3 and 6 years. 3. Improve the satisfaction of parents or legal guardians after the administration of two vaccines in children aged 3 and 6 years. 4. Evaluate the Safety of the use of virtual reality glasses in children aged 3 and 6 years during the administration of vaccines. The study population will include children aged 3 and 6 years who are included in the patient registry and are being seen in a primary care center of the Catalan Institute of Health in Central Catalonia. The clinical trial has two assigned groups: a control group and an intervention group. The intervention group will use the Pico G2 VR goggles (Pico Interactive Inc) during the administration of the two vaccines, together with an Android AOYODKG tablet, which will be connected to the goggles as a controller. The control group participants will receive traditional distractors, such as being held by the parent or guardian who accompanies them to the appointment, receiving stickers at the end of the appointment, or receiving rewards that the parent or guardian has prepared from home. International Registered Report Identifier (IRRID): PRR1-10.2196/35910

Timeline

Start
2022-01-18
Primary completion
2024-01-24
Completion
2024-02-08

Drugs

EvaluationDrugModalityDoseRoute
Background Diphtheria-Tetanus-Pertussis Vaccine Unknown
Background Hepatitis A Vaccine
Background Triple Viral Unknown
Background Varicella vaccine Vaccine

Indications

No indication recorded.