Virtual Reality in the Management of Pain in Pediatrics: a Multi-center Randomized Clinical Trial (RealPED)

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Status: Completed

Conditions: Pediatric ALL; Virtual Reality; Pain, Procedural

Treatments: Behavioral: Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05902585

37/2021

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Usual care

No Intervention group

Description:

In this arm, the analysis will be done in the usual way (for example, distracting with questions).

Virtual reality

Active Comparator group

Description:

In this arm, the analysis will be done while the children use virtual reality.

Treatment:

Behavioral: Virtual reality