Bubble Blowing As an Effective Method for Distraction During Pediatric IV Insertion: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Pain after IV insertion
Study Overview
Brief Summary
Insertion of an IV cannula is a standard but potentially painful procedure. Distraction techniques are among the strategies used to alleviate this discomfort. The investigators are conducting a randomized controlled trial to assess whether bubble blowing is more effective than video distraction during IV insertions in young children in the medical imaging suite.
Detailed Description
Purpose:
To assess the effectiveness of two distraction techniques used to reduce the perceived pain of pediatric IV insertions, comparing bubble blowing versus watching videos.
Hypotheses:
- Blowing bubbles will reduce perceived pain during IV insertions more than video watching in two- to five-year-olds.
- Bubble-blowing will reduce child anxiety with IV insertion more than video watching.
Justification:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
Cannot blind participants due to the nature of the intervention
Eligibility Criteria
- Ages
- 2 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children between the ages of two to five years (i.e. ≥ two years to < six years) requiring an IV in the medical imaging department.
Exclusion Criteria
- •Children with existing vascular access (do not have an IV placed)
- •Families who chose not to have topical anesthetic placed on their child's hands (will have a different amount of pain with the procedure than children who have had topical anesthetic)
- •Children receiving anxiolytic premedication (will have reduced anxiety associated with the procedure)
- •Children planned to undergo mask induction of anesthesia before IV placement (will not be awake to experience distraction method during IV insertion procedure)
- •Children who had inadequate time for the local anesthetic cream/gel to take effect (pain will be experienced differently, and the effect of the local anesthetic will be more variable)
Arms & Interventions
Bubbles
Patient will receive bubble distraction method prior to and during the placement of their IV cannula
Intervention: Bubble blowing (active) (Behavioral)
Video
Patient will receive video distraction on an tablet computer prior to and during the placement of their IV cannula
Intervention: Video distraction (passive) (Behavioral)
Outcomes
Primary Outcomes
Pain after IV insertion
Time Frame: once the IV insertion procedure is complete
Observed pain score after IV insertion at timepoint 3 (once the IV insertion procedure is complete) as measured by FLACC scale
Pain before IV insertion
Time Frame: at removal of topical anesthetic
Observed pain score before IV insertion at timepoint 1 (removal of topical anesthetic), assessed using Face, Legs, Activity, Cry, Consolability (FLACC) scale (observer pain rating assessed on 5 dimensions with total scores ranging from 0 indicating no pain to 10 indicating highest pain).
Pain during IV insertion
Time Frame: at the moment of skin penetration
Observed pain score during IV insertion at timepoint 2 (the moment of skin penetration) as measured by FLACC scale
Secondary Outcomes
- Anxiety after consent(up to 5 minutes in waiting room immediately after consent)
- Anxiety before IV insertion(between entering procedure room (or clinician approaching) until first IV insertion attempt)
Investigators
James Chen
Principal Investigator
University of British Columbia