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Non-immersive Virtual Reality for Pediatric Pain Management

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ClinicalTrials.gov Identifier: NCT03985930
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
Clínica Colsanitas
Fundación Universitaria Sanitas
Information provided by (Responsible Party):
Claudia Aristizábal, Sanitas University

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

Condition or disease Intervention/treatment Phase
Procedural Pain Other: Distraction with virtual reality or video projection Not Applicable

Detailed Description:

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: Assess the effect on pain of distraction with virtual reality or video projections during procedures of venipuncture, administration of intramuscular medication and vaccination to children under 6 years of age.

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 either video projections or virtual reality. Children in the experimental group between 12 months and 3 years of age will be distracted using video projections, and those between 3 and 6 years of age 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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uso de Realidad Virtual No Inmersiva Para el Manejo Del Dolor en Pediatría
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: Distraction Group
Children between the ages of 3 and 6 years will be distracted using virtual reality content delivered through goggles. Since exposure to video screens has been previously discouraged by various scientific and professional medical organizations in children under 3 years of age, these children will be distracted using video projections of the same content.
Other: Distraction with virtual reality or video projection
Distraction content delivered through virtual reality goggles or video projection.

Active Comparator: Treatment as Usual
Children randomized to this group will receive the usual medical care.
Other: Distraction with virtual reality or video projection
Distraction content delivered through virtual reality goggles or video projection.




Primary Outcome Measures :
  1. LLANTO Pain level: LLANTO pain scale [ Time Frame: Immediately after procedure ]
    Overall pain assessment using the LLANTO pain scale


Secondary Outcome Measures :
  1. LLANTO Crying [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored as not crying, crying but consolable, or insconsolable crying.

  2. LLANTO Attitude [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored as at ease or sleeping, restless, or agressive.

  3. LLANTO Breathing [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored normal, tachypneic, or irregular.

  4. LLANTO Facial expression [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored content or sleeping, unsmiling, or unhappy.

  5. LLANTO Postural muscle tone [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored as relaxed, indifferent, or contracted.



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985930


Contacts
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Contact: María A Palacios-Ariza, M.D. M.Sc. +57 312 450 5802 mapalaciosar@unisanitas.edu.co
Contact: Luisa M Orrego Celestino, M.D. +57 316 406 7188 luisamariaorrego@hotmail.com

Locations
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Colombia
Fundación Universitaria Sanitas Not yet recruiting
Bogotá, Bogotá D.C., Colombia, 111321
Contact: María A Palacios-Ariza, M.D. M.Sc.    +57 312 450 5802    mapalaciosar@unisanitas.edu.co   
Sponsors and Collaborators
Claudia Aristizábal
Clínica Colsanitas
Fundación Universitaria Sanitas
Investigators
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Principal Investigator: Jhon H Camacho Cruz, M.D. Fundación Universitaria Sanitas

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Responsible Party: Claudia Aristizábal, Coordinadora Unidad de Investigación, Sanitas University
ClinicalTrials.gov Identifier: NCT03985930     History of Changes
Other Study ID Numbers: VRPedPain
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claudia Aristizábal, Sanitas University:
Infant
Child
Virtual Reality
Procedural Pain
Additional relevant MeSH terms:
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Pain, Procedural
Pain
Neurologic Manifestations
Signs and Symptoms