Non-immersive Virtual Reality for Pediatric Pain Management
1 other identifier
interventional
122
1 country
1
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 (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedApril 3, 2023
March 1, 2023
1 year
June 11, 2019
March 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LLANTO Pain level: LLANTO pain scale
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
Immediately after procedure
Secondary Outcomes (6)
LLANTO Crying
Immediately after procedure
LLANTO Attitude
Immediately after procedure
LLANTO Breathing
Immediately after procedure
LLANTO Facial expression
Immediately after procedure
LLANTO Postural muscle tone
Immediately after procedure
- +1 more secondary outcomes
Study Arms (2)
Distraction Group
EXPERIMENTALChildren between the ages of 3 and 5 years will be distracted using virtual reality content delivered through goggles.
Treatment as Usual
ACTIVE COMPARATORChildren randomized to this group will receive the usual medical care.
Interventions
Distraction content delivered through virtual reality goggles
Eligibility Criteria
You may qualify if:
- Patients subjected to procedures of venipuncture, intramuscular injections, or vaccination at participating medical centers.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Claudia Aristizáballead
- Sanitas Universitycollaborator
Study Sites (1)
Fundación Universitaria Sanitas
Bogotá, Bogota D.C., 111321, Colombia
Related Publications (1)
Camacho-Cruz J, Palacios-Ariza MA, Orrego-Celestino L, Valbuena-Velandia N, Paez-Castellanos L, Bolanos JM, Pradilla I. Effectiveness of non-immersive virtual reality in the management of procedure-related pain in preschool children: a randomized clinical trial. Eur J Pediatr. 2023 Sep;182(9):4103-4112. doi: 10.1007/s00431-023-05070-5. Epub 2023 Jul 5.
PMID: 37407711DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jhon H Camacho Cruz, M.D.
Fundación Universitaria Sanitas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Coordinadora Unidad de Investigación
Study Record Dates
First Submitted
June 11, 2019
First Posted
June 14, 2019
Study Start
November 1, 2020
Primary Completion
November 1, 2021
Study Completion
December 1, 2021
Last Updated
April 3, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share