Bubble Blowing As an Effective Distraction During Pediatric IV Insertion
NCT ID: NCT05899452
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2023-07-27
2024-07-24
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Bubbles
Patient will receive bubble distraction method prior to and during the placement of their IV cannula
Bubble blowing (active)
Bubble blowing as a method of active distraction during painful procedure (insertion of an IV cannula)
Video
Patient will receive video distraction on an tablet computer prior to and during the placement of their IV cannula
Video distraction (passive)
Video on a tablet computer as a method of passive distraction during painful procedure (insertion of an IV cannula)
Interventions
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Bubble blowing (active)
Bubble blowing as a method of active distraction during painful procedure (insertion of an IV cannula)
Video distraction (passive)
Video on a tablet computer as a method of passive distraction during painful procedure (insertion of an IV cannula)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
2 Years
5 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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James Chen
Principal Investigator
Principal Investigators
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James Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Provincial Health Services Authority
Locations
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BC Children's Hospital
Vancouver, British Columbia, Canada
Countries
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References
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Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.
Longobardi C, Prino LE, Fabris MA, Settanni M. Soap bubbles as a distraction technique in the management of pain, anxiety, and fear in children at the paediatric emergency room: A pilot study. Child Care Health Dev. 2019 Mar;45(2):300-305. doi: 10.1111/cch.12633. Epub 2018 Dec 12.
Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.
Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children. Paediatr Anaesth. 2010 Apr;20(4):318-22. doi: 10.1111/j.1460-9592.2010.03263.x. Epub 2010 Feb 23.
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.
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.
Krauss BS, Calligaris L, Green SM, Barbi E. Current concepts in management of pain in children in the emergency department. Lancet. 2016 Jan 2;387(10013):83-92. doi: 10.1016/S0140-6736(14)61686-X. Epub 2015 Jun 18.
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.
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.
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.
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.
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.
Ugucu G, Akdeniz Uysal D, Guzel Polat O, Artuvan Z, Polat Kulcu D, Aksu D, Gulgun Altintas M, Cetin H, Orekici Temel G. Effects of cartoon watching and bubble-blowing during venipuncture on pain, fear, and anxiety in children aged 6-8 years: A randomized experimental study. J Pediatr Nurs. 2022 Jul-Aug;65:e107-e114. doi: 10.1016/j.pedn.2022.03.016. Epub 2022 Apr 8.
Bellieni CV, Cordelli DM, Raffaelli M, Ricci B, Morgese G, Buonocore G. Analgesic effect of watching TV during venipuncture. Arch Dis Child. 2006 Dec;91(12):1015-7. doi: 10.1136/adc.2006.097246. Epub 2006 Aug 18.
Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
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.
West N, Christopher N, Stratton K, Gorges M, Brown Z. Reducing preoperative anxiety with Child Life preparation prior to intravenous induction of anesthesia: A randomized controlled trial. Paediatr Anaesth. 2020 Feb;30(2):168-180. doi: 10.1111/pan.13802. Epub 2020 Jan 8.
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.
Related Links
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Pediatric Anesthesia Research Team website
Other Identifiers
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H22-01928a
Identifier Type: -
Identifier Source: org_study_id