Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers.
NCT ID: NCT06313762
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2022-01-18
2024-02-08
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention Group
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.
Triple Viral + Varicella Vaccine at 3 years of age
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.
Administration of vaccines in 6-year-old children, as appropriate according to the vaccination schedule.
Control Group
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.
Triple Viral + Varicella Vaccine at 3 years of age
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.
Administration of vaccines in 6-year-old children, as appropriate according to the vaccination schedule.
Interventions
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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.
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.
Triple Viral + Varicella Vaccine at 3 years of age
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.
Administration of vaccines in 6-year-old children, as appropriate according to the vaccination schedule.
Eligibility Criteria
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Inclusion Criteria
1. the triple viral+varicella vaccine at 3 years of age.
2. the hepatitis A+diphtheria-tetanus-pertussis vaccine at age 6.
Exclusion Criteria
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.
3 Years
6 Years
ALL
Yes
Sponsors
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Mercedes de la Cruz Herrera
Principal Investigator
Locations
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Catalan Institute of Health. Territorial Management of Central Catalonia.
Manresa, Barcelona, Spain
Countries
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References
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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.
Study Documents
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Document Type: Study Protocol
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
View DocumentRelated Links
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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.
Other Identifiers
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Codi CEIm: 21/132-P
Identifier Type: -
Identifier Source: org_study_id
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