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Completed

NCT Number: NCT03985930

Non-immersive Virtual Reality for Pediatric Pain Management

This is a multicenter, randomized, clinical trial comparing treatment as usual to distraction with video projection or virtual reality in the management of pediatric (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Universitaria Sanitas

Bogotá, Bogota D.C., 111321, Colombia

About this study

Background: Recent studies have shown that the use of virtual reality (VR) may be useful to provide distraction that attenuates pain in minimally invasive procedures in preschool children.

Aim: To assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 to 5 years undergoing painful injection procedures in an outpatient setting.

Method: This clinical trial will recruit patients under 6 years of age treated at participating medical centers in whom a painful procedure like vaccination, venipuncture or administration of intramuscular medication will be performed. The experimental group will consist of two subgroups which, in addition to treatment as usual, will be distracted using virtual reality content delivered through goggles. The control group will receive treatment as usual. The LLANTO pain scale will be used to measure different characteristics of pain. This scale has been validated in Colombia, and will be filled by two health professionals (one of which will perform the painful procedure.) and the parents.

Expected results: To show that virtual reality or projector distraction are effective distraction tools in pain management for children subjected to painful procedures of venipuncture, intramuscular medication administration, and vaccination.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients subjected to procedures of venipuncture, intramuscular injections, or vaccination at participating medical centers.

Exclusion criteria

  • Fever (Axillary temperature greater than 38°C).
  • Systemic Inflammatory Response Syndrome or Sepsis.
  • Pulmonary disease.
  • Neurological deficit of any kind.
  • Susspected or confirmed metabolic disease.
  • Undernutrition or obesity as defined by deviations from the mean of local values.

Treatment and study plan

Distraction with virtual reality

Device

Distraction content delivered through virtual reality goggles

Treatment as Usual

Other

Treatment as Usual

Primary outcomes

  1. LLANTO Pain level: LLANTO pain scale

    Time frame: Immediately after procedure

    Overall pain assessment using the LLANTO pain scale (Mild: 0-3, Moderate 4-6, Intense 7-10) For more information about LLANTO scale, please visit DOI: 10.1016/j.anpedi.2010.08.005

Secondary outcomes

  1. LLANTO Crying

    Time frame: Immediately after procedure

    Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2).

  2. LLANTO Attitude

    Time frame: Immediately after procedure

    Subcomponent of the LLANTO scale scored as at ease or sleeping (0), restless (1), or agressive (2).

  3. LLANTO Breathing

    Time frame: Immediately after procedure

    Subcomponent of the LLANTO scale scored normal (0), tachypneic (1), or irregular (2).

  4. LLANTO Facial expression

    Time frame: Immediately after procedure

    Subcomponent of the LLANTO scale scored content or sleeping (0), unsmiling (1), or unhappy (2).

  5. LLANTO Postural muscle tone

    Time frame: Immediately after procedure

    Subcomponent of the LLANTO scale scored as relaxed (0), indifferent (1), or contracted (2).

  6. Interrater reliability of the LLANTO scale

    Time frame: During the statistical analysis stage

    Between parents, nurse and physician

Sponsors and collaborators

Lead sponsor

Claudia Aristizábal

Other

Collaborators

  • Sanitas University

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2019
Registry last updated
Apr 3, 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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