Virtual Reality in the Management of Pain in Pediatrics: a Multi-center Randomized Clinical Trial (RealPED) (RealPED)
June 9, 2023 updated by: Raquel Gil Piquer, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Usefulness of Virtual Reality in the Management of Pain Associated With Venipuncture in Pediatrics: a Multi-center Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Valencia
-
Castelló, Valencia, Spain, 46270
- Centre de Salut de Castelló
-
Càrcer, Valencia, Spain, 46294
- Centre de Salut de Carcer
-
Ontinyent, Valencia, Spain, 46870
- Hospital General de Onteniente
-
Puebla Larga, Valencia, Spain, 46670
- Centre de Salut de Pobla Llarga
-
Xàtiva, Valencia, Spain, 46800
- Hospital Lluis Alcanyis
-
Xàtiva, Valencia, Spain, 46800
- Centre de Salut de Xàtiva
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care
In this arm, the analysis will be done in the usual way (for example, distracting with questions).
|
|
|
Active Comparator: Virtual reality
In this arm, the analysis will be done while the children use 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain associated with venipuncture
Time Frame: 1 day: The day of the venipuncture
|
Visual analog scale: From 1 to 10. 1 implies minimal pain and 10 unbearable pain.
|
1 day: The day of the venipuncture
|
|
Anxiety
Time Frame: 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.
|
1 day: The day of the venipuncture
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of attempts for analytics
Time Frame: 1 day: The day of the venipuncture
|
1, 2, 3, 4, or 5
|
1 day: The day of the venipuncture
|
|
Time required for analysis
Time Frame: 1 day: The day of the venipuncture
|
Minutes
|
1 day: The day of the venipuncture
|
|
Difficulty level of the technique
Time Frame: 1 day: The day of the venipuncture
|
Easy, normal or difficult
|
1 day: The day of the venipuncture
|
|
Parents satisfaction
Time Frame: 1 day: The day of the venipuncture
|
1 = unsatisfied 10 = very satisfied
|
1 day: The day of the venipuncture
|
|
Nurse anxiety
Time Frame: 1 day: The day of the venipuncture
|
1 = totally calm 10 = very anxious
|
1 day: The day of the venipuncture
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pacient age at the moment of venipuncture
Time Frame: Before venipuncture
|
In years
|
Before venipuncture
|
|
Pacient sex
Time Frame: Before venipuncture
|
Male or female
|
Before venipuncture
|
|
Venipuncture in the last 6 months
Time Frame: Before venipuncture
|
Venipuncture in the last 6 months
|
Before venipuncture
|
|
Parental presence at the moment of venipuncture
Time Frame: 1 day: The day of the venipuncture
|
Yes or not
|
1 day: The day of the venipuncture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raquel Gil Piquer, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 26, 2022
Primary Completion (Actual)
November 2, 2022
Study Completion (Actual)
November 2, 2022
Study Registration Dates
First Submitted
May 15, 2023
First Submitted That Met QC Criteria
June 9, 2023
First Posted (Actual)
June 15, 2023
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 9, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 37/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.