Procedural Pain Clinical Trial
Official title:
Non-immersive Virtual Reality for Pediatric Pain Management
Verified date | March 2023 |
Source | Sanitas University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 122 |
Est. completion date | December 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 5 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Colombia | Fundación Universitaria Sanitas | Bogotá | Bogotá D.C. |
Lead Sponsor | Collaborator |
---|---|
Claudia Aristizábal | Sanitas University |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | LLANTO Crying | Subcomponent of the LLANTO scale scored as not crying (0), crying but consolable (1), or insconsolable crying (2). | Immediately after procedure | |
Secondary | LLANTO Attitude | Subcomponent of the LLANTO scale scored as at ease or sleeping (0), restless (1), or agressive (2). | Immediately after procedure | |
Secondary | LLANTO Breathing | Subcomponent of the LLANTO scale scored normal (0), tachypneic (1), or irregular (2). | Immediately after procedure | |
Secondary | LLANTO Facial expression | Subcomponent of the LLANTO scale scored content or sleeping (0), unsmiling (1), or unhappy (2). | Immediately after procedure | |
Secondary | LLANTO Postural muscle tone | Subcomponent of the LLANTO scale scored as relaxed (0), indifferent (1), or contracted (2). | Immediately after procedure | |
Secondary | Interrater reliability of the LLANTO scale | Between parents, nurse and physician | During the statistical analysis stage |
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