Clinical trial NCT05902585: Virtual Reality in the Management of Pain in Pediatrics: a Multi-center Randomized Clinical Trial (RealPED)
Official title: Usefulness of Virtual Reality in the Management of Pain Associated With Venipuncture in Pediatrics: a Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Pediatric ALL
Pain, Procedural
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 83
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized in a 1:1 ratio to the intervention group (use of virtual reality during blood collection) and the control group (usual care). The randomization sequence is different for each participating center.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to test if the use of virtual reality glasses reduces the pain and anxiety that children feel when they perform a blood test.

Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate, and the children will be divided into two groups. In the control group, the analysis will be done in the usual way (for example, distracting with questions) and in the intervention group, the analysis will be done while the children use virtual reality.

The satisfaction of parents and nursing will also be analyzed.


Eligibility criteria: Inclusion Criteria:

* Children between 7 and 12 years old who attend participating centers for scheduled blood tests.
* Consent to participate by signing the informed consent.

Exclusion Criteria:

* Children younger than 7 years old.
* Children older than 12 years old.
* Children that don't sign the informed consent.
* Children with psychomotor and neurocognitive delay.
* Children with visual or hearing impairment.

Primary outcomes:
measure: Pain associated with venipuncture
timeFrame: 1 day: The day of the venipuncture
measure: Anxiety
timeFrame: 1 day: The day of the venipuncture
Secondary outcomes:
measure: Number of attempts for analytics
timeFrame: 1 day: The day of the venipuncture
measure: Time required for analysis
timeFrame: 1 day: The day of the venipuncture
measure: Difficulty level of the technique
timeFrame: 1 day: The day of the venipuncture
measure: Parents satisfaction
timeFrame: 1 day: The day of the venipuncture
measure: Nurse anxiety
timeFrame: 1 day: The day of the venipuncture
Other outcomes:
measure: Pacient age at the moment of venipuncture
timeFrame: Before venipuncture
measure: Pacient sex
timeFrame: Before venipuncture
measure: Venipuncture in the last 6 months
timeFrame: Before venipuncture
measure: Parental presence at the moment of venipuncture
timeFrame: 1 day: The day of the venipuncture
Locations:
city: Castelló
country: Spain
facility: Centre de Salut de Castelló
state: Valencia
city: Càrcer
country: Spain
facility: Centre de Salut de Carcer
state: Valencia
city: Ontinyent
country: Spain
facility: Hospital General de Onteniente
state: Valencia
city: Puebla Larga
country: Spain
facility: Centre de Salut de Pobla Llarga
state: Valencia
city: Xàtiva
country: Spain
facility: Centre de Salut de Xàtiva
state: Valencia
city: Xàtiva
country: Spain
facility: Hospital Lluís Alcanyís
state: Valencia
Study officials:
affiliation: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
name: Raquel Gil Piquer
role: PRINCIPAL_INVESTIGATOR
References: