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

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

Study Overview

• Status: Completed
• Conditions: Pain; Virtual Reality; Pediatrics; Vaccination
• Intervention / Treatment: 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.; Behavioral: Traditional Distractors

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).

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 08260
      • Catalan Institute of Health. Territorial Management of Central Catalonia.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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:

1. the triple viral+varicella vaccine at 3 years of age.
2. the hepatitis A+diphtheria-tetanus-pertussis vaccine at age 6.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	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.; 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.
Active Comparator: Control Group	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0: no anxiety, 1: mild anxiety, 2: moderate anxiety, 3: severe anxiety, 4: very severe anxiety	Up to 24 months
Degree of satisfaction of parents/legal guardians of minors after the administration of two vaccines, using the CSAT scale.	Not at all satisfied, slightly satisfied, normal, satisfied, very satisfied.	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.	Record of adverse effects: None, fall, seizures, loss of consciousness, blurred vision, dizziness, nausea, headache, others.	Up to 24 months

Collaborators and Investigators

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

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): February 8, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: Codi CEIm: 21/132-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
   Information identifier: (IRRID): PRR1-10.2196/35910
   Information comments: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No