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Completed

NCT Number: NCT05902585

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

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.

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Key information

Conditions

Virtual Reality Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Salut de Castelló, Castellon, Valencia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Number of attempts for analytics

    Time frame: 1 day: The day of the venipuncture

    1, 2, 3, 4, or 5

  2. Time required for analysis

    Time frame: 1 day: The day of the venipuncture

    Minutes

  3. Difficulty level of the technique

    Time frame: 1 day: The day of the venipuncture

    Easy, normal or difficult

  4. Parents satisfaction

    Time frame: 1 day: The day of the venipuncture

    1 = unsatisfied 10 = very satisfied

  5. Nurse anxiety

    Time frame: 1 day: The day of the venipuncture

    1 = totally calm 10 = very anxious

Other outcomes

  1. Pacient age at the moment of venipuncture

    Time frame: Before venipuncture

    In years

  2. Pacient sex

    Time frame: Before venipuncture

    Male or female

  3. Venipuncture in the last 6 months

    Time frame: Before venipuncture

    Venipuncture in the last 6 months

  4. Parental presence at the moment of venipuncture

    Time frame: 1 day: The day of the venipuncture

    Yes or not

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: RealPED

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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