Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899452
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-05-16
Brief Title:
Bubble Blowing as an Effective Distraction During Pediatric IV Insertion
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Bubble Blowing as an Effective Method for Distraction During Pediatric IV Insertion a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BubblesRCT
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
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 participants 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 childs 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 patients 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
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 participants 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 childs 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None