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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

Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 14, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
LLANTO Pain level: LLANTO pain scale [ Time Frame: Immediately after procedure ]
Overall pain assessment using the LLANTO pain scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • LLANTO Crying [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored as not crying, crying but consolable, or insconsolable crying.
  • LLANTO Attitude [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored as at ease or sleeping, restless, or agressive.
  • LLANTO Breathing [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored normal, tachypneic, or irregular.
  • LLANTO Facial expression [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored content or sleeping, unsmiling, or unhappy.
  • LLANTO Postural muscle tone [ Time Frame: Immediately after procedure ]
    Subcomponent of the LLANTO scale scored as relaxed, indifferent, or contracted.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-immersive Virtual Reality for Pediatric Pain Management
Official Title  ICMJE Uso de Realidad Virtual No Inmersiva Para el Manejo Del Dolor en Pediatría
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Procedural Pain
Intervention  ICMJE Other: Distraction with virtual reality or video projection
Distraction content delivered through virtual reality goggles or video projection.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Distraction with virtual reality or video projection
  • Active Comparator: Treatment as Usual
    Children randomized to this group will receive the usual medical care.
    Intervention: Other: Distraction with virtual reality or video projection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03985930
Other Study ID Numbers  ICMJE VRPedPain
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Claudia Aristizábal, Sanitas University
Study Sponsor  ICMJE Claudia Aristizábal
Collaborators  ICMJE
  • Clínica Colsanitas
  • Fundación Universitaria Sanitas
Investigators  ICMJE
Principal Investigator: Jhon H Camacho Cruz, M.D. Fundación Universitaria Sanitas
PRS Account Sanitas University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP