Clinical trial NCT03681730: Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization
Official title: A Pragmatic Randomized Controlled Trial of Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intravenous Catheterization
Keywords: Virtual Reality
Pain
Anxiety
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children often need an intravenous catheter placement for delivery of fluids and medications, a procedure associated with pain and anxiety. In the Emergency Department topical anesthetics are frequently used.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to topical anaesthetics during IV placement procedure. Investigators will measure pain, anxiety and satisfaction, amount of analgesics used and the level of success in placing the IV and compare between the two groups.


Eligibility criteria: Inclusion Criteria:

* Children age 6 - \<17
* The managing physician determines a need for an intravenous catheterization (IV) procedure
* Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

* Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, others)
* Triage Category 1 (resuscitation)
* Facial features or injury prohibiting wearing the VR goggles

Primary outcomes:
measure: Pain using the Faces Pain Scale - Revised.
timeFrame: Pain is reported by children immediately following completion of the IV start
Secondary outcomes:
measure: Anxiety using the Venham Situational Anxiety Score
timeFrame: Anxiety is reported by children immediately following completion of the IV start
measure: Patient Satisfaction determined by Global Rating Scale
timeFrame: Satisfaction questions are reported by children immediately following completion of the IV start
measure: Patient Satisfaction determined qualitatively by an open ended question
timeFrame: Satisfaction questions are reported by children immediately following completion of the IV start
measure: Parent Satisfaction determined qualitatively by an open ended question
timeFrame: Satisfaction question is reported by parents immediately following completion of the IV start
measure: Medication Dose
timeFrame: These will be recorded during the procedure and immediately following the procedure using the patient chart and nursing notes
measure: Number of IV Trials Until Success
timeFrame: This number will be collected during the procedure
measure: Timing
timeFrame: Documented immediately after patient and family given discharge paperwork
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ran D Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldman RD, Behboudi A. Virtual reality for intravenous placement in the emergency department-a randomized controlled trial. Eur J Pediatr. 2021 Mar;180(3):725-731. doi: 10.1007/s00431-020-03771-9. Epub 2020 Aug 10.