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

NCT06313762 | Completed DMC

• 1 other identifier: Codi CEIm: 21/132-P
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 1.To evaluate the reduction in pain during the administration of two vaccines in children aged 3 and 6 years.
2. 2.To evaluate the reduction in anxiety during and after the administration of two vaccines in children aged 3 and 6 years.
3. 3.Improve the satisfaction of parents or legal guardians after the administration of two vaccines in children aged 3 and 6 years.
4. 4.Evaluate the Safety of the use of virtual reality glasses in children aged 3 and 6 years during the administration of vaccines.

Conditions

Pain; Pediatrics; Vaccination; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Evaluation of pain perception during the administration of two vaccines in children aged 3 and 6 years, through the Wong-Baker Pain Scale.

  O: no hurt, 2: hurts little bit, 4: hurts little more, 6: hurts even more, 8: hurts whole lot, 10: hurts worst

  Up to 24 months

Secondary Outcomes (3)

• Evaluation of anxiety during the administration of two vaccines in children aged 3 and 6 years, through heart rate and the Children's Fear Scale.

  Up to 24 months

• Degree of satisfaction of parents/legal guardians of minors after the administration of two vaccines, using the CSAT scale.

  Up to 24 months

• Number of patients who experienced adverse effects during the administration of vaccines and who used virtual reality glasses, through the registration of the effects presented.

  Up to 24 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Device: Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet; Biological: Triple Viral + Varicella Vaccine at 3 years of age; Biological: Hepatitis A + Diphtheria-Tetanus-Pertussis Vaccine at 6 years of age.

Control Group

ACTIVE COMPARATOR

Behavioral: Traditional Distractors; Biological: Triple Viral + Varicella Vaccine at 3 years of age; Biological: Hepatitis A + Diphtheria-Tetanus-Pertussis Vaccine at 6 years of age.

Interventions

Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet DEVICE

They will experience in first person the two and a half minute graphic adventure, called Leia\'s World, during the administration of the vaccines.

Intervention Group

Traditional Distractors BEHAVIORAL

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.

Control Group

Triple Viral + Varicella Vaccine at 3 years of age BIOLOGICAL

Administration of vaccines in 3-year-old children, as appropriate according to the vaccination schedule

Control Group; Intervention Group

Hepatitis A + Diphtheria-Tetanus-Pertussis Vaccine at 6 years of age. BIOLOGICAL

Administration of vaccines in 6-year-old children, as appropriate according to the vaccination schedule.

Control Group; Intervention Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The patients who will take part in the study will be those from the pediatric population (ie, those aged 3 and 6 years) in the register of patients from a primary care center of the Catalan Institute of Health in Central Catalonia who, according to the vaccination schedule, are due to receive 1 of the following 2 vaccinations:
• the triple viral+varicella vaccine at 3 years of age.
• the hepatitis A+diphtheria-tetanus-pertussis vaccine at age 6.

You may not qualify if:

• Patients who have already received 1 of the 2 vaccines to be administered.
• Patients and accompanying persons who do not understand and speak Catalan or Spanish.
• Patients with physical or mental illnesses, as well as those with blindness or deafness.
• Patients with a known history of epileptic episodes or severe motion sickness.
• Patients with autism spectrum disorder.
• patients with any infections, burns, or injuries to the face, head, or neck that may interfere with the placement of the VR device.
• the absence of legal guardians for signing the informed consent form.

Sponsors & Collaborators

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

Study Sites (1)

Catalan Institute of Health. Territorial Management of Central Catalonia.

Manresa, Barcelona, 08260, Spain

Location

Related Publications (1)

• De La Cruz Herrera M, Fuster-Casanovas A, Miro Catalina Q, Cigarrran Mensa M, Vilanova Guitart I, Aguera Sedeno A, Vidal-Alaball J, Grau Carrion S. Use of virtual reality in the reduction of pain after the administration of vaccines among children in primary care centers in Central Catalonia: Randomized clinical trial. PLoS One. 2025 May 7;20(5):e0322840. doi: 10.1371/journal.pone.0322840. eCollection 2025.

  PMID: 40334011 DERIVED

Related Links

• Protocol: Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers: Protocol for a Randomized Clinical Trial.

MeSH Terms

Conditions

Pain

Interventions

Aging; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena; Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 15, 2024
• Study Start: January 18, 2022
• Primary Completion: January 24, 2024
• Study Completion: February 8, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)