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Behavioral Intervention

Bubbles for Pain (BubblesRCT Trial)

N/A

Recruiting

Led By James Chen, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between entering procedure room (or clinician approaching) until first iv insertion attempt

Awards & highlights

BubblesRCT Trial Summary

"This trial is testing whether blowing bubbles or watching a video is better at helping young children feel less pain and discomfort when getting an IV inserted during medical imaging."

Who is the study for?

This trial is for children aged 2 to less than 6 years who need an IV inserted in the medical imaging department. It's designed to see if blowing bubbles helps distract from the discomfort of getting an IV better than watching a video.Check my eligibility

What is being tested?

The study compares two distraction methods during IV insertion: actively blowing bubbles versus passively watching a video. Children will be randomly assigned to one of these techniques to evaluate which is more effective at reducing pain and anxiety.See study design

What are the potential side effects?

There are no significant side effects expected from either bubble blowing or video watching as they are non-invasive, gentle distraction techniques used during medical procedures.

BubblesRCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at removal of topical anesthetic

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at removal of topical anesthetic

This trial's timeline: 3 weeks for screening, Varies for treatment, and at removal of topical anesthetic for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain after IV insertion

Pain before IV insertion

Pain during IV insertion

Secondary outcome measures

Anxiety after consent

Anxiety before IV insertion

BubblesRCT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BubblesExperimental Treatment1 Intervention

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

Group II: VideoActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,998 Total Patients Enrolled

16 Trials studying Pain

2,263 Patients Enrolled for Pain

James Chen, MDPrincipal InvestigatorProvincial Health Services Authority

1 Previous Clinical Trials

64 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research open to participants who are younger than 55 years old?

"Individuals aged above 24 months and below 60 months are eligible for recruitment into this clinical study."

Answered by AI

Is the current clinical trial open for enrollment?

"Indeed, information from clinicaltrials.gov shows that this particular medical investigation is actively seeking subjects. The trial was first listed on July 27th, 2023 and last revised on February 28th, 2024. It aims to enroll a total of 120 participants at one designated location."

Answered by AI

What is the upper limit for the total number of participants who can enroll in this clinical trial?

"Indeed, as per the details available on clinicaltrials.gov, this research initiative is actively seeking participants. The trial was first uploaded on July 27th, 2023 and underwent its last update on February 28th, 2024. A total of 120 individuals are sought across a single designated site for inclusion."

Answered by AI

Recent research and studies

Anesthesia & AnalgesiaJournal

Pediatric Distraction on Induction of Anesthesia with Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial

Jung, Michael J., Justin S. Libaw, Kevin Ma, Elizabeth L. Whitlock, John R. Feiner, and Jina L. Sinskey. 2020. “Pediatric Distraction on Induction of Anesthesia with Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000005004.

Nursing in Critical CareJournal

The COMFORT Behavioural Scale and the Modified FLACC Scale in Paediatric Intensive Care

Johansson, Monica, and Eva Kokinsky. 2009. “The COMFORT Behavioural Scale and the Modified FLACC Scale in Paediatric Intensive Care”. Nursing in Critical Care. Wiley. doi:10.1111/j.1478-5153.2009.00323.x.

clinicaltrials.govStudy

Bubble Blowing as an Effective Distraction During Pediatric IV Insertion

James Chen 2023. "Bubble Blowing as an Effective Distraction During Pediatric IV Insertion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05899452.