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OpenTrials
Completed

NCT Number: NCT06313762

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pediatrics Signs and Symptoms Vaccination Virtual Reality

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catalan Institute of Health. Territorial Management of Central Catalonia.

Manresa, Barcelona, 08260, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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

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.

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.

    Time frame: Up to 24 months

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

Secondary outcomes

  1. 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.

    Time frame: Up to 24 months

    0: no anxiety, 1: mild anxiety, 2: moderate anxiety, 3: severe anxiety, 4: very severe anxiety

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

    Time frame: Up to 24 months

    Not at all satisfied, slightly satisfied, normal, satisfied, very satisfied.

  3. 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.

    Time frame: Up to 24 months

    Record of adverse effects: None, fall, seizures, loss of consciousness, blurred vision, dizziness, nausea, headache, others.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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