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

Primary Purpose

Virtual Reality, Pediatric ALL, Pain, Procedural

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Virtual Reality

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Centre de Salut de Castelló
  • Centre de Salut de Carcer
  • Hospital General de Onteniente
  • Centre de Salut de Pobla Llarga
  • Centre de Salut de Xàtiva
  • Hospital Lluís Alcanyís

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual care

Virtual reality

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2023
Last Updated
June 9, 2023
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
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1. Study Identification

Unique Protocol Identification Number
NCT05902585
Brief Title
Virtual Reality in the Management of Pain in Pediatrics: a Multi-center Randomized Clinical Trial (RealPED)
Acronym
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2022 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Pediatric ALL, Pain, Procedural

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
In this arm, the analysis will be done in the usual way (for example, distracting with questions).
Arm Title
Virtual reality
Arm Type
Active Comparator
Arm Description
In this arm, the analysis will be done while the children use virtual reality.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality
Intervention Description
In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture.
Primary Outcome Measure Information:
Title
Pain associated with venipuncture
Description
Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain.
Time Frame
1 day: The day of the venipuncture
Title
Anxiety
Description
Groningen distress scale: From 1 to 5. 1 implies a non-anxious patient and 5 a very anxious patient.
Time Frame
1 day: The day of the venipuncture
Secondary Outcome Measure Information:
Title
Number of attempts for analytics
Description
1, 2, 3, 4, or 5
Time Frame
1 day: The day of the venipuncture
Title
Time required for analysis
Description
Minutes
Time Frame
1 day: The day of the venipuncture
Title
Difficulty level of the technique
Description
Easy, normal or difficult
Time Frame
1 day: The day of the venipuncture
Title
Parents satisfaction
Description
1 = unsatisfied 10 = very satisfied
Time Frame
1 day: The day of the venipuncture
Title
Nurse anxiety
Description
1 = totally calm 10 = very anxious
Time Frame
1 day: The day of the venipuncture
Other Pre-specified Outcome Measures:
Title
Pacient age at the moment of venipuncture
Description
In years
Time Frame
Before venipuncture
Title
Pacient sex
Description
Male or female
Time Frame
Before venipuncture
Title
Venipuncture in the last 6 months
Description
Venipuncture in the last 6 months
Time Frame
Before venipuncture
Title
Parental presence at the moment of venipuncture
Description
Yes or not
Time Frame
1 day: The day of the venipuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Gil Piquer
Organizational Affiliation
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Salut de Castelló
City
Castelló
State/Province
Valencia
ZIP/Postal Code
46270
Country
Spain
Facility Name
Centre de Salut de Carcer
City
Càrcer
State/Province
Valencia
ZIP/Postal Code
46294
Country
Spain
Facility Name
Hospital General de Onteniente
City
Ontinyent
State/Province
Valencia
ZIP/Postal Code
46870
Country
Spain
Facility Name
Centre de Salut de Pobla Llarga
City
Puebla Larga
State/Province
Valencia
ZIP/Postal Code
46670
Country
Spain
Facility Name
Centre de Salut de Xàtiva
City
Xàtiva
State/Province
Valencia
ZIP/Postal Code
46800
Country
Spain
Facility Name
Hospital Lluís Alcanyís
City
Xàtiva
State/Province
Valencia
ZIP/Postal Code
46800
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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