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Trial registered on ANZCTR


Registration number
ACTRN12619000270112
Ethics application status
Approved
Date submitted
19/02/2019
Date registered
21/02/2019
Date last updated
3/02/2020
Date data sharing statement initially provided
21/02/2019
Date results information initially provided
3/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimising Immunisation Pain of Childhood vaccines: The MIPY Study
Scientific title
An open label randomised controlled trial of Coolsense® versus Buzzy® with wings
versus standard care for Minimising Immunisation Pain of childhood vaccines in Younger children: The MIPY Study.
Secondary ID [1] 297416 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The MIPY Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain Management 311583 0
Condition category
Condition code
Anaesthesiology 310213 310213 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention devices to be used in the study will be the Coolsense® device and Buzzy® device. Coolsense® is fully registered with the Therapeutics Goods Administration (2013) and is a reusable, non-invasive hand-held device that immediately cools and numbs the skin
at the site of injection. Buzzy® is a vibrating handheld device used to help block sharp pain and provide distraction when giving injections to children. A frozen cooling pad (wings) is placed behind Buzzy® before the device is placed on the child's arm.

Participants will be randomised into one of three arms: Arm 1. Coolsense®, Arm 2. Buzzy® (with cooling pads) and Arm 3. Standard Care (distraction using Bubbles). If the participant is randomised to Arm 1., then the Coolsense® device will be placed on the child's arm at the site of injection for a count of 10 seconds. As soon as the device is removed (after the 10 seconds), the immunisation will be given. If the participant is randomised to Arm 2., then the Buzzy® device will be placed on the child/adolescent's arm at the site of injection for a count of 30 seconds. After 30 seconds the device is left on and lifted up the arm and the immunisation given immediately (below the Buzzy device).

The interventions (Buzzy®, Coolsense® or standard care) are used for the first injection only during the episode of care. The Immunisation Nurse will administer the intervention the participant has been randomised into.
Intervention code [1] 313661 0
Treatment: Devices
Comparator / control treatment
Standard Care for children during immunisation will be distraction using bubbles.
Control group
Active

Outcomes
Primary outcome [1] 319095 0
Child self-report of pain using Wong Baker Faces Scale immediately following completion of their first injection
Timepoint [1] 319095 0
Immediately post immunisation procedure
Secondary outcome [1] 366966 0
Parent/Guardian report of their child's pain using the Visual Analogue Scale (VAS) following completion of their child's FIRST injection.
Timepoint [1] 366966 0
Immediately post immunisation procedure
Secondary outcome [2] 367108 0
Nurse immuniser report of pain using the VAS following completion of injection.
Timepoint [2] 367108 0
Immediately post procedure
Secondary outcome [3] 367109 0
Parent/guardians perception of effectiveness of randomised device/standard care. Worded as: “What effect did the device have on your child?” No effect/less painful/more painful? OR if only Standard care used, “What effect did distraction with bubbles have on your child?” No effect/less painful/more painful?
Timepoint [3] 367109 0
Immediately post procedure.
Secondary outcome [4] 367110 0
Parent/guardians perception of usefulness of randomised device/standard care. Worded as “Would you consider the use of this device for your child next time or recommend it to others?” (Yes/No/Uncertain). OR “Would you consider the use of the bubbles for distraction for your child next time and/or recommend it to others?” (Yes/No/Uncertain).
Timepoint [4] 367110 0
Immediately post procedure
Secondary outcome [5] 367111 0
Parent/guardians assessment of their child’s level of fear/anxiety pre-procedure (during consent) and then post-procedure using the Children Fear Scale (CFS). The CFS is a tool used to measure fear in children undergoing painful medical procedures
Timepoint [5] 367111 0
Immediately post procedure
Secondary outcome [6] 367112 0
Investigator rating (Immunisation nurse) compliance score. This will be based on the child’s compliance with the device or distraction tool (bubbles). They are assessed as 1) Fully compliant, 2) Somewhat compliant or 3) Not compliant
Timepoint [6] 367112 0
Immediately post procedure
Secondary outcome [7] 367118 0
Investigator (Immunisation Nurse) assessment of child’s level of anxiety (fear) pre procedure and then post procedure based on the Children Fear Scale (CFS).
Timepoint [7] 367118 0
Immediately post procedure.

Eligibility
Key inclusion criteria
All children aged 3.5 to 9 years of age inclusive presenting with their parents/guardians to the Royal Children’s Hospital Immunisation Service Drop-in Centre for immunisations.
Minimum age
3 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be excluded if:
1. Child with needle phobia (defined by:fear of medical needle procedure and/or recent prior failure to vaccinate due to fear/distress of the procedure).
2. Child with Haemophilia or other bleeding disorders that require deep subcutaneous injections rather than intramuscular.
3. Child with damage to the skin at the site of injection E.G. Overlying Eczema
4. Child with developmental/behavioural disorders that may prevent them from being able to complete the Wong Baker Faces scale.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be enrolled and randomised on the day of the vaccination via Redcap. Randomisation will be to Coolsense®, Buzzy® with wings or Standard care with an allocation ratio of 1:1:1. Randomisation will be in randomly permuted blocks of variable length. An independent statistician in the Clinical Epidemiology and Biostatistics Unit(CEBU) at the Murdoch Children’s Research Institute (MCRI) will provide the randomisation schedules to the Immunisation Clinic.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be in randomly permuted blocks of variable length via Redcap Software Version 6013.3©2016 Vanderbuilt University.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size has been calculated at 492 participants who will be randomly allocated in a 1:1:1 ratio to Coolsense® (n=164), Buzzy® with wings (n=164) and standard care (n=164). This ensures sufficient power to support both primary outcomes. Since the study aims to assess two primary endpoints (1a. and 1.b), generalised Bonferroni-adjustment of p-values and confidence interval limits will be applied in order to warrant a global type I error probability of 5%.

For the primary objective (Coolsense® versus standard care) and based on the results from a previous pilot RCT, we have powered this trial to be able to detect a difference child/adolescent reported VAS of 2.85 points between Coolsense® and standard care (equivalent to a 25% reduction from pain. in standard care - mean = 3.8) We have based our sample size estimate on a SD of 2.7. To detect a mean difference in VAS score of 2.85 point post immunisation procedure with a two-sided significance level of 2.5% and power of 80% with equal allocation to these two arms would require 155 patients in each arm.
For the primary objective (Buzzy® with wings versus standard care) and based on the results of our previous pilot RCT, we have powered this trial to be able to detect a difference child/adolescent reported VAS of 2.85 points between Buzzy® with wings and standard care (equivalent to a 25% reduction from pain in standard care - mean = 3.8). We have based our sample size estimate on a SD of 2.7. To detect a mean difference in VAS score of 2.85 point post immunisation procedure with a two-sided significance level of 2.5% and power of 80% with equal allocation to these two arms would require 155 patients in each arm.
Allowing for 5% loss to follow up, we will recruit 164 participants to each arm, therefore 492 in total.

The intention-to-treat (ITT) population will be used in the analyses. Participants will be compared according to the group to which they were randomly allocated, regardless compliance to the device used, crossover to other groups or withdrawal from the study. This approach preserves the prognostic balance in the study arms achieved by randomisation.

The baseline and demographic characteristics of participants, as well as all the primary and secondary outcomes will be presented for each arm using the mean, standard deviation (or medians and inter-quartile ranges for non-normal data) for continuous data and proportions for categorical data.

Primary outcome
Comparisons between Coolsense® and standard care, and Buzzy® with wings and standard care regarding the primary outcome (post procedure child/adolescent VAS score) will be made using linear regression models with adjustment for the stratification variable (10-17 years inclusive) used in the randomization, with presentation of mean differences and the corresponding 97.5% confidence intervals (CIs).

Secondary outcomes
Comparisons between Coolsense® and Buzzy® with wings regarding the post procedure child/adolescent VAS score will be made using the same linear regression model specified for the primary outcome, with presentation of mean differences and the corresponding 95% CI.
Arms comparisons (Coolsense® versus standard care, Buzzy® with wings versus standard care, Coolsense® versus Buzzy® with wings) regarding continuous outcomes (post procedure nurse reported VAS scores, post procedure parent and nurse reported CFS score) will be made using the same linear regression model specified for the primary outcome, with presentation of mean differences and the corresponding 95% CI.
Arms comparisons (Coolsense® versus standard care, Buzzy® with wings versus standard care, Coolsense® versus Buzzy® with wings) regarding dichotomous outcomes (compliance to technique, technique effectiveness and usefulness) will be made using a binary regression model specified adjusted for e stratification variable used in the randomization, with presentation of mean differences and the corresponding 95% CI.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/11/2018
Date of last participant enrolment
Anticipated
31/07/2019
Actual
17/01/2020
Date of last data collection
Anticipated
31/07/2019
Actual
17/01/2020
Sample size
Target
492
Accrual to date
Final
492
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13193 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 25748 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 301983 0
Charities/Societies/Foundations
Name [1] 301983 0
The Royal Children's Hospital Foundation
Country [1] 301983 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Royal Childrens Hospital Foundation
Address
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 301762 0
None
Name [1] 301762 0
Address [1] 301762 0
Country [1] 301762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302662 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC).
Ethics committee address [1] 302662 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052
Ethics committee country [1] 302662 0
Australia
Date submitted for ethics approval [1] 302662 0
15/06/2018
Approval date [1] 302662 0
25/07/2018
Ethics approval number [1] 302662 0
38079A

Summary
Brief summary
The aim of the proposed study, 'Minimising Immunisatin Pain in Younger Children (MIPY) is to evaluate the efficacy of two novel devices, Coolsense® (cools and numbs the skin) and Buzzy® (vibration) with cooling pads (wings) versus standard care, and to minimise pain during immunisations in younger (aged 3.5 - 9 years inclusive) children (MIPY). Outcome measures will include 1. Child/adolescent self report of pain using the Wong Baker Faces pain rating scale, 2. Parent assessment of their child's fear/anxiety using the Child Fear Scale (CFS) (Pre and post procedure), 3. Nurse assessment of child's fear/anxiety using the CFS scale (Pre and post procedure) 4. Nurse report of observed pain using the VAS Scale, 5. Parent perception of usefulness of Intervention and Nurse observed compliance with intervention. We estimate it will take up to 6 months to recruit the required number of children for these studies based on 75% uptake of those that meet the inclusion criteria.

The study groups will be assigned randomly by a computer.

It is hoped 492 children will participate in this study, with 164 participants in each group.

Before each child has their vaccine, we will either apply Buzzy® (with the cooling pad) or the Coolsense®device, or use the standard distraction method (blowing bubbles).

Possible outcomes will be reduced pain and fear/anxiety scores and improved patient and family experience of vaccination.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90978 0
Dr Kirsten Perrett
Address 90978 0
Royal Children's Hospital
50 Flemington Rd
Parkville
VIC 3052
Country 90978 0
Australia
Phone 90978 0
+613 99366278
Fax 90978 0
Email 90978 0
kirsten.perrett@rch.org.au
Contact person for public queries
Name 90979 0
Mrs Narelle Jenkins
Address 90979 0
Royal Children's Hospital
50 Flemington Rd
Parkville
VIC 3052
Country 90979 0
Australia
Phone 90979 0
+613 9345 4899
Fax 90979 0
Email 90979 0
Narelle.Jenkins@rch.org.au
Contact person for scientific queries
Name 90980 0
Mrs Narelle Jenkins
Address 90980 0
Royal Children's Hospital
50 Flemington Rd
Parkville
VIC 3052
Country 90980 0
Australia
Phone 90980 0
+613 9345 4899
Fax 90980 0
Email 90980 0
Narelle.Jenkins@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.