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

Not Applicable

Completed

• Conditions: Pediatric ALL; Virtual Reality; Pain, Procedural
• Interventions: Behavioral: Virtual reality

• Registration Number: NCT05902585
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-26
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Study First Submitted: 2023-05-15
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-09
• Last Update Submitted: 2023-06-09
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality	Virtual reality	In this arm, the analysis will be done while the children use virtual reality.

Primary Outcome Measures

Name	Time	Method
Anxiety	1 day: The day of the venipuncture	Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient.
Pain associated with venipuncture	1 day: The day of the venipuncture	Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain.

Secondary Outcome Measures

Name	Time	Method
Time required for analysis	1 day: The day of the venipuncture	Minutes
Difficulty level of the technique	1 day: The day of the venipuncture	Easy, normal or difficult
Parents satisfaction	1 day: The day of the venipuncture	1 = unsatisfied 10 = very satisfied
Number of attempts for analytics	1 day: The day of the venipuncture	1, 2, 3, 4, or 5
Nurse anxiety	1 day: The day of the venipuncture	1 = totally calm 10 = very anxious

Trial Locations

Locations (6)

Centre de Salut de Castelló; 🇪🇸 Castelló, Valencia, Spain

Hospital General de Onteniente; 🇪🇸 Ontinyent, Valencia, Spain

Hospital Lluís Alcanyís; 🇪🇸 Xàtiva, Valencia, Spain

Centre de Salut de Xàtiva; 🇪🇸 Xàtiva, Valencia, Spain

Centre de Salut de Pobla Llarga; 🇪🇸 Puebla Larga, Valencia, Spain

Centre de Salut de Carcer; 🇪🇸 Càrcer, Valencia, Spain