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

NCT06313762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-03-15

No results posted yet for this study

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

Conditions

  • Pain
  • Pediatrics
  • Vaccination
  • Virtual Reality

Interventions

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.

Sponsors & Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06313762 on ClinicalTrials.gov