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

Virtual Reality 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05902585
• Other study ID #: 37/2021
• Status: Completed
• Phase: N/A
• Start date: February 26, 2022
• Est. completion date: November 2, 2022

Study information

• Verified date: June 2023
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Procedural
• Pediatric ALL
• Virtual Reality

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Centre de Salut de Carcer	Càrcer	Valencia
Spain	Centre de Salut de Castelló	Castelló	Valencia
Spain	Hospital General de Onteniente	Ontinyent	Valencia
Spain	Centre de Salut de Pobla Llarga	Puebla Larga	Valencia
Spain	Centre de Salut de Xàtiva	Xàtiva	Valencia
Spain	Hospital Lluís Alcanyís	Xàtiva	Valencia

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pacient age at the moment of venipuncture	In years	Before venipuncture
Other	Pacient sex	Male or female	Before venipuncture
Other	Venipuncture in the last 6 months	Venipuncture in the last 6 months	Before venipuncture
Other	Parental presence at the moment of venipuncture	Yes or not	1 day: The day of the venipuncture
Primary	Pain associated with venipuncture	Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain.	1 day: The day of the venipuncture
Primary	Anxiety	Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient.	1 day: The day of the venipuncture
Secondary	Number of attempts for analytics	1, 2, 3, 4, or 5	1 day: The day of the venipuncture
Secondary	Time required for analysis	Minutes	1 day: The day of the venipuncture
Secondary	Difficulty level of the technique	Easy, normal or difficult	1 day: The day of the venipuncture
Secondary	Parents satisfaction	1 = unsatisfied 10 = very satisfied	1 day: The day of the venipuncture
Secondary	Nurse anxiety	1 = totally calm 10 = very anxious	1 day: The day of the venipuncture