Bubble Blowing As an Effective Distraction During Pediatric IV Insertion (BubblesRCT)

December 17, 2024 updated by: James Chen, University of British Columbia

Bubble Blowing As an Effective Method for Distraction During Pediatric IV Insertion: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bubbles
Patient will receive bubble distraction method prior to and during the placement of their IV cannula
Behavioral: Bubble blowing (active)
Bubble blowing as a method of active distraction during painful procedure (insertion of an IV cannula)
Active Comparator: Video
Patient will receive video distraction on an tablet computer prior to and during the placement of their IV cannula
Behavioral: Video distraction (passive)
Video on a tablet computer as a method of passive distraction during painful procedure (insertion of an IV cannula)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at removal of topical anesthetic
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
at the moment of skin penetration
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
once the IV insertion procedure is complete

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety after consent
Time Frame: up to 5 minutes in waiting room immediately after consent
Observed anxiety in waiting room as assessed using modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF, observer anxiety rating, assessed on 4 dimensions with total scores ranging from 22.9 indicating minimal anxiety, to 100 indicating maximal anxiety)
up to 5 minutes in waiting room immediately after consent
Anxiety before IV insertion
Time Frame: between entering procedure room (or clinician approaching) until first IV insertion attempt
Observed anxiety immediately before IV insertion procedure as assessed using mYPAS-SF
between entering procedure room (or clinician approaching) until first IV insertion attempt

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: James Chen, MD, Provincial Health Services Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Actual)

July 24, 2024

Study Completion (Actual)

July 24, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H22-01928a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results will be presented at scientific conferences and published in peer-reviewed anesthesia journals. Once data collection is complete, a de-identified version of the data may be made available to other researchers. This is stated explicitly in the consent form, and participants are notified during the consent process that their de-identified data may be released to others for research purposes.

IPD Sharing Time Frame

Once data collection is complete, de-identified data will be deposited in the University of British Columbia (UBC)'s Dataverse Repository. The study teams will keep research data for five years post-publication, as outlined in the UBC study data retention guidelines, after which it will be destroyed.

IPD Sharing Access Criteria

Details have yet to be determined.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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