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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-26

Study Completion Date

2022-11-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Virtual Reality for the Treatment of Pain in Pediatric Vaccination

NCT04096833

Virtual Reality Vaccination Pain +1 more

COMPLETED NA

Non-immersive Virtual Reality for Pediatric Pain Management

NCT03985930

Procedural Pain

COMPLETED NA

Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children

NCT05378581

Virtual Reality Children, Only Pain, Procedural +1 more

RECRUITING NA

Effect of Virtual Reality Distraction on Procedural Pain for Children and Adolescents in Onco-Hematology Unit.

NCT03888690

Procedural Pain Procedural Anxiety Virtual Reality

UNKNOWN NA

Virtual Reality and Peripheral Intravenous Catheter Insertion to Children (R3VP)

NCT05066061

Virtual Reality Catheterization, Peripheral Venous Children, Only +1 more

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Virtual Reality Pediatric ALL Pain, Procedural

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Virtual reality

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

Group Type ACTIVE_COMPARATOR

Virtual reality

Intervention Type BEHAVIORAL

In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual reality

In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes