NCT06313762

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Accepted

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

Detailed description

The participants will be selected from a patient diary register. Both the sequence and the allocation of participants to the interventions will be generated by using the RandomizedR computer system. Due to the nature of the study, it will not be possible to mask patients or health care professionals. Therefore, the trial will be open or unblinded. However, a blind evaluation by third parties will be carried out, as the person in charge of data analysis will not be involved with the intervention. To detect a 1-point difference between the two groups on the pain level scale, a sample of 150 boys and girls in each group is required, assuming an SD of 3 points, an α risk of 5%, a power of 80%, and an estimated loss to follow-up rate of 5%. The data will be obtained through Microsoft Forms (anapplication included in Office 365 \[Microsoft Corporation\] that allows one to create customized questionnaires, surveys, and records) and analyzed with R software (version 4.0.3).

Conditions

• Pain
• Pediatrics
• Vaccination
• Virtual Reality

Interventions

Type	Name	Description
DEVICE	Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet	They will experience in first person the two and a half minute graphic adventure, called Leia\'s World, during the administration of the vaccines.
BEHAVIORAL	Traditional Distractors	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, during the administration of the vaccines.
BIOLOGICAL	Triple Viral + Varicella Vaccine at 3 years of age	Administration of vaccines in 3-year-old children, as appropriate according to the vaccination schedule
BIOLOGICAL	Hepatitis A + Diphtheria-Tetanus-Pertussis Vaccine at 6 years of age.	Administration of vaccines in 6-year-old children, as appropriate according to the vaccination schedule.

Timeline

• Start date: 2022-01-18
• Primary completion: 2024-01-24
• Completion: 2024-02-08
• First posted: 2024-03-15
• Last updated: 2024-03-15

Locations

1 site across 1 country: Spain