PainBubblesRCTNCT05899452
Bubble Blowing As an Effective Distraction During Pediatric IV Insertion
A study testing Bubble blowing (active) and Video distraction (passive) in people with Pain and Anxiety, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- What is being tested?
- Bubble blowing (active) and Video distraction (passive)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jul 2023to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of two to five years (i.e. ≥ two years to < six years) requiring an IV in the medical imaging department.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
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:
- 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.
- 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.
- 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:
- The selected form of distraction (iPad video or Bubble blowing) will be active before the IV insertion procedure starts.
- The child will have their topical anesthetic removed and the IV placed quickly.
- 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.
- 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.
- Being tested
- Bubble blowing (active), Video distraction (passive)
- Keywords
- Distraction, Bubbles, IV cannula insertion, Pediatric
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble blowing (active)Behavioural
Bubble blowing as a method of active distraction during painful procedure (insertion of an IV cannula)
Video distraction (passive)Behavioural
Video on a tablet computer as a method of passive distraction during painful procedure (insertion of an IV cannula)
| Study group | Role | What they receive |
|---|---|---|
| Bubbles | Experimental | Patient will receive bubble distraction method prior to and during the placement of their IV cannula Receives: 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 Receives: Behavioral: Video distraction (passive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: once the IV insertion procedure is complete
Secondary outcomes (2)
Anxiety 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)
Measured: up to 5 minutes in waiting room immediately after consent
Anxiety before IV insertion
Observed anxiety immediately before IV insertion procedure as assessed using mYPAS-SF
Measured: between entering procedure room (or clinician approaching) until first IV insertion attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start27 Jul 2023
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive bubble distraction while another group will receive video distraction.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Chen, University of British Columbia
- Investigators
- James Chen, MD, Principal investigator, Provincial Health Services Authority British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899452
- Sponsor's protocol ID
- H22-01928a
- Acronym
- BubblesRCT
- Status last verified
- Dec 2024
- First submitted
- 16 May 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33456927Longobardi 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.
PubMed 30466144Chieng 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.
PubMed 23865442Fortier 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.
PubMed 20199609Vieco-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.
PubMed 34903293Jung 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.
PubMed 32618627Krauss 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.
PubMed 26095580Al-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.
PubMed 27080806Bahrololoomi 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.
PubMed 35082960Sridhar 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.
PubMed 30887592Lilik 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.
PubMed 29166202Kucuk 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.
PubMed 30711327Ugucu 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.
PubMed 35410736Bellieni 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.
PubMed 16920758Bergomi 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.
PubMed 29728296
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bubble Blowing As an Effective Method for Distraction During Pediatric IV Insertion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05899452
- Acronym / sponsor ID
- BubblesRCT / H22-01928a
- Keywords
- Distraction, Bubbles, IV cannula insertion, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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:
- 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.
- 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.
- 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:
- The selected form of distraction (iPad video or Bubble blowing) will be active before the IV insertion procedure starts.
- The child will have their topical anesthetic removed and the IV placed quickly.
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will receive bubble distraction while another group will receive video distraction.
| Arm | Type | Receives |
|---|---|---|
| Bubbles | Experimental | Behavioral: Bubble blowing (active)Patient will receive bubble distraction method prior to and during the placement of their IV cannula |
| Video | Active comparator | Behavioral: Video distraction (passive)Patient will receive video distraction on an tablet computer prior to and during the placement of their IV cannula |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of two to five years (i.e. ≥ two years to < six years) requiring an IV in the medical imaging department.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bubble blowing (active)Bubble blowing as a method of active distraction during painful procedure (insertion of an IV cannula) | Behavioural | Bubbles |
| Video distraction (passive)Video on a tablet computer as a method of passive distraction during painful procedure (insertion of an IV cannula) | Behavioural | Video |
Primary outcome
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
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
2 secondary outcomes
Anxiety after consent
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 33456927Agbayani 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.
- Background: PubMed 30466144Longobardi 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.
- Background: PubMed 23865442Chieng 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.
- Background: PubMed 20199609Fortier 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.
- Background: PubMed 34903293Vieco-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.
- Background: PubMed 32618627Jung 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.
- Background: PubMed 26095580Krauss 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.
- Background: PubMed 27080806Al-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.
- Background: PubMed 35082960Bahrololoomi 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.
- Background: PubMed 30887592Sridhar 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.
- Background: PubMed 29166202Lilik 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.
- Background: PubMed 30711327Kucuk 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.
- Pediatric Anesthesia Research Team websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Chen, MD principal investigator
Provincial Health Services Authority British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bubble blowing (active) and Video distraction (passive) in people with Pain and Anxiety, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain before IV insertion (time frame: at removal of topical anesthetic). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05899452, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.