Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000186550
Ethics application status
Approved
Date submitted
19/01/2024
Date registered
27/02/2024
Date last updated
27/02/2024
Date data sharing statement initially provided
27/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A play-based investigation into children’s coping pre and post vaccination. A view from the child and parent’s perspectives (pilot).
Scientific title
A play-based investigation into children’s coping pre and post vaccination. A view from the child and parent’s perspectives (pilot).
Secondary ID [1] 311368 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 329264 0
PTSD 329265 0
Medical Trauma in children 329266 0
Acute Pain 329267 0
Paediatrics 332638 0
Condition category
Condition code
Public Health 326215 326215 0 0
Health promotion/education
Mental Health 326217 326217 0 0
Anxiety
Mental Health 326218 326218 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 326219 326219 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name- A play-based investigation into children’s coping pre and post vaccination. A view from the child and parent’s perspectives (pilot)

Why- to examine children’s coping responses before, during and after a routine vaccination procedure including a comparison of those having pre vaccination play therapy (experimental group) to those who have no pre vaccination play therapy (control group). The vaccination procedure may involve one or two injections at the time of vaccination (e.g. flu shot and 4yo vaccination) however this only occurs on the vaccination procedure visit.

What-
• Play Assessments (Pretend Play Enjoyment Developmental Checklist (PPEDC) https://www.learntoplayevents.com/product/pretend-play-enjoyment-developmental-checklist-ppe-dc-starter-package/
and 6PSM BASIC Ph assessment -https://www.lcps.org/cms/lib4/VA01000195/Centricity/Domain/8931/HOW%20CHILDREN%20COPE.pdf
• Play Therapy (Pre-Vaccination Play Therapy (experimental group only) and Post Vaccination Play Therapy) (individualised pre planned sessions facilitated by the researcher who is a registered play therapist)
• iPupilX data https://www.deakin.edu.au/research/impact-stories/monitoring-advertising-to-improve-childrens-health
(One vaccination session with iPupilX glasses on)
• Parent surveys https://researchsurveys.deakin.edu.au/jfe/form/SV_bd5hSsStScwo4aa

Parents participation involves bringing their child to the appointments, being with their child for the vaccination procedure and completing the two surveys. They are not instructed to do any type of play at home or given any information material to help with children's coping pre and post vaccination with their child.

Plain Language description of intervention:
Experimental:
1. Children in the experimental group will be required to participate in a play assessment session which is a minimum of 15minutes and a maximum of one hour. They will undertake two play based assessments (a drawing (6PSM- BASIC Ph) which has six parts where they are invited to draw a main character, a mission, what or who can help, who or what obstacle there is, how they cope and what happened next. They then engaged in an observed free play session (PPEDC) with some chosen toys to determine their pretend play level) they also practice wearing special glasses (iPupilX) (which will be kept on for the session and will record their eye movements) one-on-one with a play therapist.
2. They will then return for a pre vaccination play therapy session which will be individualised to their pretend play level and their coping style. It will go for a minimum of 30 minutes and a maximum of an hour. They will not wear the special glasses for this session.
3. They will then have their vaccination as usual, They will wear special glasses which monitor their eye movements.
4.Following their vaccination children will be invited back for a post vaccination play session which will go for a minimum of 30minutes and a maximum of one hour where the 6PSM BASIC Ph drawing assessment will be conducted again to measure their coping style (they will again wear the special glasses to track their eye movements) and then they will engage in child centred play therapy to have an opportunity to process any concerns from the vaccination procedure. They do not have a vaccination on this day.

Summary:

• 3 play sessions, over a 2-month period, for a minimum of 15minutes and upto one hour each sessions of one-on-one play therapy
• a routine vaccination procedure with eye tracking glasses on.
• 1 x parent survey before the vaccination procedure and 1 x parent survey after the vaccination procedure.

Location - Torquay Medical Health and Wellness Clinic

Play Therapy sessions will be digitally audio-visually recorded and conducted on a therapeutic protocol which will be based on the results of the play assessments and play level of each child.

To ensure fidelity all assessments will be blinded and scored by another member of the research team.
Intervention code [1] 325601 0
Prevention
Intervention code [2] 325602 0
Treatment: Other
Intervention code [3] 325603 0
Behaviour
Comparator / control treatment
Control:
1. Children in the control group will be required to participate in a play assessment session which is a minimum of 15 minutes and a maximum of one hour. They will undertake two play based assessments (a drawing which has six parts where they are invited to draw a main character, a mission, what or who can help, who or what obstacle there is, how they cope and what happened next. They then engaged in an observed free play session with some chosen toys to determine their pretend play level) they also practice wearing special glasses (which will be kept on for the session and will record their eye movements) one-on-one with a play therapist.
2.They will then have their vaccination as usual, however they will wear special glasses which monitor their eye movements. Children in the control group do not have the pre vaccination play therapy session.
3.Following their vaccination children will be invited back for a post vaccination play session which will go for a minimum of 30minutes and a maximum of one hour where the 6PSM BASIC Ph drawing assessment will be conducted again to measure their coping style (they will again wear the special glasses to track their eye movements) and then they will engage in child centred play therapy to have an opportunity to process any concerns from the vaccination procedure. They do not have the vaccination on this day.


Summary:
Control group:
• 2 play sessions, over a 2 month period, for a minimum of 15 minutes up to one hour each sessions of one-on-one play therapy
• a routine vaccination procedure with eye tracking glasses on.
• 1 x parent survey before the vaccination procedure and 1 x parent survey after the vaccination procedure.
Control group
Active

Outcomes
Primary outcome [1] 334106 0
Fear response (data collected through iPupilX footage of eye and numerical coding of pupil diameter which is measured to determine dilation response at time of injection).
Timepoint [1] 334106 0
Difference in pupil response at baseline compared to time of vaccination.
Primary outcome [2] 334127 0
Ability to cope (6 part story making assessment analysed through BASIC Ph instrument which determines dominant coping style e.g. belief, affect, social, imagination, cognitive, physiological as analysed through the story narrative).
Timepoint [2] 334127 0
Pre play assessment compared to post vaccination play assessment
Secondary outcome [1] 419433 0
Parents perspectives (survey designed specifically for this study) See link: https://researchsurveys.deakin.edu.au/jfe/form/SV_6Kh1Op5OG1osG2i
Timepoint [1] 419433 0
Post vaccination (survey)

Eligibility
Key inclusion criteria
Inclusion criteria includes children aged 3 years old to 6 years old requiring a
vaccination procedure.
• Those who are able to attend the Torquay Medical Health and Wellness Clinic for all
allocated play therapy sessions as well as their vaccination procedure.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with a play level less than 24 months as scored on the PPE-DC (Pretend Play
Enjoyment Developmental Checklist) as they will not have the play ability to take
part.
• Children who have been required to have repeated injections or have a known
needle phobia or significant aversion to needles will be excluded as it will skew
results.
• Children who’ve experienced adverse childhood experiences (ACES) will be excluded
as it will not be ethical to engage in psychotherapy with them for only 3 or 4
sessions.
• Children who have vision impairment or are not able to wear iPupilX glasses as data
will not be able to be obtained.
• Children who have recently had a COVID-19 vaccination, those with a needle phobia
or needle related medical procedures will be excluded due to them having more
experience with injections than a normative sample.
• Children with a chronic or life limiting illness will also be excluded due to their
increased medical experience including needle related medical procedures.

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)
Allocation concealment in sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a table of random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/07/2023
Date of last participant enrolment
Anticipated
22/06/2024
Actual
Date of last data collection
Anticipated
22/08/2024
Actual
Sample size
Target
50
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313352 0
University
Name [1] 313352 0
Deakin University
Country [1] 313352 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Locked bag 20001GeelongVic 3220
Country
Australia
Secondary sponsor category [1] 315158 0
None
Name [1] 315158 0
Address [1] 315158 0
Country [1] 315158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314511 0
The Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 314511 0
Locked bag 20001, Geelong, Vic, 3220
Ethics committee country [1] 314511 0
Australia
Date submitted for ethics approval [1] 314511 0
20/04/2023
Approval date [1] 314511 0
27/06/2023
Ethics approval number [1] 314511 0
2023-129

Summary
Brief summary
This RCT experimental design with mixed methods aims to investigate a play-based intervention before, during and after a vaccination procedure. Play based modalities may be useful to prepare children for vaccinations to reduce fear responses and improve coping through age-appropriate health education initiatives. Parents will also be invited to assess their child’s coping before and after the vaccination.
Play assessments will be utilised to assess children’s play ability and coping resources. These assessments will then inform the pre-vaccination play therapy intervention.
This research is the first of its kind that uses eye tracking technology and play therapy methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125142 0
Dr Judi Parson
Address 125142 0
School of Health and Social Development, Waterfront Campus. Deakin University, Locked Bag 20001, Geelong, Vic, 3220
Country 125142 0
Australia
Phone 125142 0
+61 3 522 78985
Fax 125142 0
Email 125142 0
judi.parson@deakin.edu.au
Contact person for public queries
Name 125143 0
Ms Belinda Dean
Address 125143 0
School of Health and Social Development, Waterfront Campus. Deakin University, Locked Bag 20001, Geelong, Vic, 3220
Country 125143 0
Australia
Phone 125143 0
+61 0352479569
Fax 125143 0
Email 125143 0
bjmc@deakin.edu.au
Contact person for scientific queries
Name 125144 0
Dr Judi Parson
Address 125144 0
School of Health and Social Development, Waterfront Campus. Deakin University, Locked Bag 20001, Geelong, Vic, 3220
Country 125144 0
Australia
Phone 125144 0
+61 3 522 78985
Fax 125144 0
Email 125144 0
judi.parson@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individualised data will not be available to protect participant confidentiality. Only aggregate data will be available.

Personal information will be anonymised and coded to ensure privacy of all the participants throughout data protection. The coded data can be re-coded if required.


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.