Bubble Blowing As an Effective Distraction During Pediatric IV Insertion

NCT05899452 | Completed

• 1 other identifier: H22-01928a
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

Distraction; Bubbles; IV cannula insertion; Pediatric

Outcome Measures

Primary Outcomes (3)

• Pain before IV insertion

  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

  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

  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 Outcomes (2)

• 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

Study Arms (2)

Bubbles

EXPERIMENTAL

Patient will receive bubble distraction method prior to and during the placement of their IV cannula

Behavioral: Bubble blowing (active)

Video

ACTIVE COMPARATOR

Patient will receive video distraction on an tablet computer prior to and during the placement of their IV cannula

Behavioral: Video distraction (passive)

Interventions

Bubble blowing (active) BEHAVIORAL

Bubble blowing as a method of active distraction during painful procedure (insertion of an IV cannula)

Bubbles

Video distraction (passive) BEHAVIORAL

Video on a tablet computer as a method of passive distraction during painful procedure (insertion of an IV cannula)

Video

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of two to five years (i.e. ≥ two years to \< six years) requiring an IV in the medical imaging department.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (19)

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• Vieco-Garcia A, Lopez-Picado A, Fuentes M, Francisco-Gonzalez L, Joyanes B, Soto C, Garcia de la Aldea A, Gonzalez-Perrino C, Aleo E. Comparison of different scales for the evaluation of anxiety and compliance with anesthetic induction in children undergoing scheduled major outpatient surgery. Perioper Med (Lond). 2021 Dec 14;10(1):58. doi: 10.1186/s13741-021-00228-x.

  PMID: 34903293 BACKGROUND

• Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.

  PMID: 32618627 BACKGROUND

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• Al-Yateem N, Brenner M, Shorrab AA, Docherty C. Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: a randomized controlled non-inferiority trial. Child Care Health Dev. 2016 Jul;42(4):572-81. doi: 10.1111/cch.12343. Epub 2016 Apr 14.

  PMID: 27080806 BACKGROUND

• Bahrololoomi Z, Sadeghiyeh T, Rezaei M, Maghsoudi N. The Effect of Breathing Exercise Using Bubble Blower on Anxiety and Pain during Inferior Alveolar Nerve Block in Children Aged 7 to 10 Years: A Crossover Randomized Clinical Trial. Pain Res Manag. 2022 Jan 17;2022:7817267. doi: 10.1155/2022/7817267. eCollection 2022.

  PMID: 35082960 BACKGROUND

• Sridhar S, Suprabha BS, Shenoy R, Shwetha KT, Rao A. Effect of a relaxation training exercise on behaviour, anxiety, and pain during buccal infiltration anaesthesia in children: Randomized clinical trial. Int J Paediatr Dent. 2019 Sep;29(5):596-602. doi: 10.1111/ipd.12497. Epub 2019 Apr 8.

  PMID: 30887592 BACKGROUND

• Lilik Lestari MP, Wanda D, Hayati H. The Effectiveness of Distraction (Cartoon-Patterned Clothes and Bubble-Blowing) on Pain and Anxiety in Preschool Children during Venipuncture in the Emergency Department. Compr Child Adolesc Nurs. 2017;40(sup1):22-28. doi: 10.1080/24694193.2017.1386967.

  PMID: 29166202 BACKGROUND

• Kucuk Alemdar D, Yaman Aktas Y. The Use of the Buzzy, Jet Lidokaine, Bubble-blowing and Aromatherapy for Reducing Pediatric Pain, Stress and Fear Associated with Phlebotomy. J Pediatr Nurs. 2019 Mar-Apr;45:e64-e72. doi: 10.1016/j.pedn.2019.01.010. Epub 2019 Jan 30.

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  PMID: 35410736 BACKGROUND

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  PMID: 29728296 BACKGROUND

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  PMID: 9220806 BACKGROUND

• Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350.

  PMID: 25010821 BACKGROUND

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  PMID: 31869478 BACKGROUND

• Postles M, West N, Moxham L, Ramji J, Palm J, Morrison C, Gorges M, Chen J. The Effectiveness of Bubble-Blowing as a Distraction Technique During Pediatric Intravenous Cannulation: A Randomized Controlled Trial. Paediatr Anaesth. 2025 Aug;35(8):635-642. doi: 10.1111/pan.15138. Epub 2025 Jun 9.

  PMID: 40488535 DERIVED

Related Links

• Pediatric Anesthesia Research Team website

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James Chen, MD

  Provincial Health Services Authority British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Cannot blind participants due to the nature of the intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One group will receive bubble distraction while another group will receive video distraction.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 12, 2023
• Study Start: July 27, 2023
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• Access Criteria: Details have yet to be determined.

Locations

CA (1)