protocolSection identificationModule nctId: NCT06313762, orgStudyIdInfo id: Codi CEIm: 21/132-P, briefTitle: Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-18, primaryCompletionDateStruct date: 2024-01-24, completionDateStruct date: 2024-02-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Pain, conditions: Pediatrics, conditions: Vaccination, conditions: Virtual Reality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: Pico G2 Virtual Reality Glasses (Pico Interactive Inc), together with an Android AOYODKG tablet, interventions name: Traditional Distractors, interventions name: Triple Viral + Varicella Vaccine at 3 years of age, interventions name: Hepatitis A + Diphtheria-Tetanus-Pertussis Vaccine at 6 years of age., outcomesModule primaryOutcomes measure: Evaluation of pain perception during the administration of two vaccines in children aged 3 and 6 years, through the Wong-Baker Pain Scale., secondaryOutcomes measure: 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., secondaryOutcomes measure: Degree of satisfaction of parents/legal guardians of minors after the administration of two vaccines, using the CSAT scale., secondaryOutcomes measure: 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., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Catalan Institute of Health. Territorial Management of Central Catalonia., city: Manresa, state: Barcelona, zip: 08260, country: Spain, geoPoint lat: 41.72815, lon: 1.82399, hasResults: False