Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313762
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-02-22
Brief Title:
Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official Title:
Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 questions 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 PRR1-10219635910
The main questions 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 PRR1-10219635910
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 403
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 403
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None