PainNCT06313762
Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers.
A study testing Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet, Traditional Distractors and Triple Viral + Varicella Vaccine at 3 years of age in people with Pain and Pediatrics, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Pediatrics, Vaccination
- What is being tested?
- Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet, Traditional Distractors and Triple Viral + Varicella Vaccine at 3 years of age
- Type of treatment
- Vaccines, Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2022to 8 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Catalan Institute of Health. Territorial Management of Central Catalonia.
Manresa, Barcelona, 08260
About this study
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:
Read more
- To evaluate the reduction in pain during the administration of two vaccines in children aged 3 and 6 years.
- To evaluate the reduction in anxiety during and after the administration of two vaccines in children aged 3 and 6 years.
- Improve the satisfaction of parents or legal guardians after the administration of two vaccines in children aged 3 and 6 years.
- 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
Read the 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).
- Conditions
- Pain, Pediatrics, Vaccination, Virtual Reality
- Being tested
- Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet, Traditional Distractors, Triple Viral + Varicella Vaccine at 3 years of age, Hepatitis A + Diphtheria-Tetanus-Pertussis Vaccine at 6 years of age.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tabletDevice
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 DistractorsBehavioural
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 ageBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: 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 | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
0: no anxiety, 1: mild anxiety, 2: moderate anxiety, 3: severe anxiety, 4: very severe anxiety
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start18 Jan 2022
- Primary completion24 Jan 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mercedes de la Cruz Herrera, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313762
- Sponsor's protocol ID
- Codi CEIm: 21/132-P
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40334011
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers.
- ClinicalTrials.gov ID
- NCT06313762
- Acronym / sponsor ID
- Codi CEIm: 21/132-P
- Conditions
- Pain, Pediatrics, Vaccination, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the reduction in pain during the administration of two vaccines in children aged 3 and 6 years.
- To evaluate the reduction in anxiety during and after the administration of two vaccines in children aged 3 and 6 years.
- Improve the satisfaction of parents or legal guardians after the administration of two vaccines in children aged 3 and 6 years.
- 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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tabletThey will experience in first person the two and a half minute graphic adventure, called Leia\'s World, during the administration of the vaccines. | Device | Intervention Group |
| Traditional DistractorsThe 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. | Behavioural | Control Group |
| Triple Viral + Varicella Vaccine at 3 years of ageAdministration of vaccines in 3-year-old children, as appropriate according to the vaccination schedule | Biological | Control Group, Intervention Group |
| 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. | Biological | Control Group, Intervention Group |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 40334011De 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet, Traditional Distractors and Triple Viral + Varicella Vaccine at 3 years of age in people with Pain and Pediatrics, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06313762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.