Clinical trial NCT05899452: Bubble Blowing As an Effective Distraction During Pediatric IV Insertion
Official title: Bubble Blowing As an Effective Method for Distraction During Pediatric IV Insertion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Distraction
Bubbles
IV cannula insertion
Pediatric
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive bubble distraction while another group will receive video distraction.
Primary purpose: SUPPORTIVE_CARE

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:

1. Blowing bubbles will reduce perceived pain during IV insertions more than video watching in two- to five-year-olds.
2. Bubble-blowing will reduce child anxiety with IV insertion more than video watching.

Justification:

This study investigates whether bubble blowing is more effective in increasing patient comfort and reducing patient anxiety during IV insertions than the current standard practice. Managing patient comfort is essential because perioperative anxiety and pain lead to adverse outcomes, including prolonged induction of anesthesia, increased pain, increased incidence of postoperative delirium, and new onset negative behavioural changes.

Objectives:

* Primary Objective: To determine if bubble blowing reduces perceived pain during IV insertions more effectively than video watching in two- to five-year-old children.
* Secondary objectives: a) To compare child pain scores between bubble-blowing and video-watching groups; b) To quantify the rate of distress-free IV starts, as determined by the number of children with no worse than mildly uncomfortable.

Research Design:

This trial is designed as a randomized, controlled, superiority trial (RCT) involving children having an IV inserted in the medical imaging department; it aims to compare the effectiveness of distraction by bubble blowing versus video watching. Study participants will be randomized to either a bubble-blowing distraction group (Bubbles RCT intervention) or an iPad video-watching distraction group (Bubbles RCT control). A researcher not otherwise involved in the study will create a randomization schedule in blocks of four participants, and each participant's allocation will be concealed in envelopes. Participants and those conducting study procedures will be blinded to study allocation during recruitment. Next, the envelope will be opened, allocating the child to the control or experimental group to allow the pre-anesthetic consultation to explain what will happen and set family expectations.

Data collection procedures:

1. The research assistant (RA) will observe the child and their family and record a baseline modified Yale Preoperative Anxiety - Short Form (mYPAS-SF) score as soon as possible after consent is given.
2. Each participant will be randomized to bubble blowing group (Bubbles RCT intervention) or an iPad video-watching group (Bubbles RCT control). In both cases, the IV insertion will only occur after the topical anesthetic on the child's hands has had adequate time to take effect.
3. The Bubbles RCT control group will undergo the standard procedure for IV insertions in the medical imaging department but will utilize video distraction during IV insertions. Similarly, the Bubbles RCT intervention group will undergo the standard procedure for IV insertions in the medical imaging department but will utilize bubble-blowing distraction during IV insertion:

   1. The selected form of distraction (iPad video or Bubble blowing) will be active before the IV insertion procedure starts.
   2. The child will have their topical anesthetic removed and the IV placed quickly.
   3. The mYPAS-SF will be scored again by the RA observer as the patient enters the induction space or the clinician enters the patient's MRI anesthetic care unit (MRI-ACU) room. Pain will be assessed by the same observer using the Face Legs Activity Cry Consolability (FLACC) scale; this will be recorded twice during the IV insertion procedure (immediately before IV insertion and at the moment of skin penetration) and once more immediately after the IV insertion attempt is complete. The Bubbles RCT study ends at this point.
   4. If the IV insertion is unsuccessful on the first attempt, the provider will have discretion on how to proceed with the IV placement, including starting a second IV cannulation attempt after the final FLACC score is obtained or switching their induction of anesthesia modality.

Statistical Analysis: Participant demographics and characteristics will be tabulated and reported in a de-identified manner to protect participant privacy using descriptive statistics. Differences in FLACC pain scores between the two groups will be determined via a Wilcoxon rank sum test, as the investigators do not expect the data to be normally distributed. A linear regression model, controlling for age, sex, and baseline FLACC score, will be used to evaluate the superiority of the bubble-blowing technique. Similar analyses will be conducted for the mYPAS-SF scores.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain before IV insertion
timeFrame: at removal of topical anesthetic
measure: Pain during IV insertion
timeFrame: at the moment of skin penetration
measure: Pain after IV insertion
timeFrame: once the IV insertion procedure is complete
Secondary outcomes:
measure: Anxiety after consent
timeFrame: up to 5 minutes in waiting room immediately after consent
measure: Anxiety before IV insertion
timeFrame: between entering procedure room (or clinician approaching) until first IV insertion attempt
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: Provincial Health Services Authority
name: James Chen, MD
role: PRINCIPAL_INVESTIGATOR
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