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Clinical Trials/NCT05902585
NCT05902585
Completed
N/A

Usefulness of Virtual Reality in the Management of Pain Associated With Venipuncture in Pediatrics: a Multi-center Randomized Clinical Trial

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana6 sites in 1 country83 target enrollmentFebruary 26, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Virtual Reality
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Enrollment
83
Locations
6
Primary Endpoint
Anxiety
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 26, 2022
End Date
November 2, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Responsible Party
Principal Investigator
Principal Investigator

Raquel Gil Piquer

Principal investigator

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

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Time required for analysis(1 day: The day of the venipuncture)
  • Difficulty level of the technique(1 day: The day of the venipuncture)
  • Parents satisfaction(1 day: The day of the venipuncture)
  • Number of attempts for analytics(1 day: The day of the venipuncture)
  • Nurse anxiety(1 day: The day of the venipuncture)

Study Sites (6)

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