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Trial registered on ANZCTR


Registration number
ACTRN12617000285358
Ethics application status
Approved
Date submitted
20/02/2017
Date registered
23/02/2017
Date last updated
6/08/2019
Date data sharing statement initially provided
6/08/2019
Date results provided
6/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the Management of paediatric procedural Pain Relief Obtained through Virtual Reality (IMPROVR)
Scientific title
To investigate the effect of using Virtual Reality distraction (using a computer simulation of an environment) on pain and distress in children aged 4 – 11 year olds during needle based procedures compared to standard care.
Secondary ID [1] 291233 0
None
Universal Trial Number (UTN)
Trial acronym
IMPROVR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain in children required to undergo needle-based procedures 302152 0
Anxiety in children required to undergo needle-based procedures 302153 0
Condition category
Condition code
Anaesthesiology 301765 301765 0 0
Pain management
Mental Health 301777 301777 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All procedures in this study will be conducted with standard care at clinician discretion in the control arm, with the addition of virtual reality to standard care at clinician discretion in the active arm.
Virtual reality digital content is played through a smartphone via software application. The smartphone is placed into the a Google Daydream headset which provides a stereoscopic display to create a 3D experience. The virtual reality experience will be provided as an adjunct to standard care (e.g. topical local anaesthetic) during the needle procedure. The content is an animated and immersive age-appropriate visualisation. The intervention will be delivered in both inpatient and outpatient (pathology collection centre) settings by the research team in conjunction with the proceduralists (doctors, nurses, phelbotomists).
Intervention code [1] 297233 0
Treatment: Devices
Comparator / control treatment
The comparator is standard care at clinician discretion. Standard care includes non-pharmacological procedural pain management (e.g. explaining the procedure to the child, distraction), pharmacologic management (e.g. topical local anaesthetic) and physical measures (e.g. positioning, restraints). In line with standard care topical local anaesthetic should be applied where possible (i.e. where not contraindicated or refused).
The investigators acknowledge standard care is variable, and will ensure this data is collected.
Control group
Active

Outcomes
Primary outcome [1] 301163 0
Between-group difference between mean pain scores from before to after needle procedure in the VR and standard care groups, as rated by patients using the FACES Pain Scale - Revised (FPS-R)
Timepoint [1] 301163 0
Immediately post-procedure
Secondary outcome [1] 331901 0
Impact on the ease of performing the procedure through the number of needle attempts required
Timepoint [1] 331901 0
The number of needle attempts will be recorded immediately post-procedure
Secondary outcome [2] 331944 0
Subjective assessment by the health practitioners involved in the procedure regarding the risk of needlestick injuries and patient’s cooperation during the procedure using a Likert scale
Timepoint [2] 331944 0
The proceduralist will report their subjective measures immediately post-procedure
Secondary outcome [3] 331945 0
Time required to prepare the patient and perform the procedure
Timepoint [3] 331945 0
The timing will be calculated as the total time from when the patient enters the procedure room until they exit the procedure room
Secondary outcome [4] 332008 0
Subjective anxiety scores from the child using a Visual Analogue Scale (VAS)
Timepoint [4] 332008 0
Anxiety scores will be measured immediately post-procedure
Secondary outcome [5] 332009 0
Anxiety scores of the child from the parent/guardian using a Visual Analogue Scale (VAS)
Timepoint [5] 332009 0
Anxiety scores will be measured immediately post-procedure
Secondary outcome [6] 332010 0
Satisfaction with the management of the procedure rated by the child using the Visual Analogue Scale (VAS)
Timepoint [6] 332010 0
Satisfaction scores will be measured immediately post-procedure
Secondary outcome [7] 332011 0
Safety and any adverse effects of VR through a questionnaire modified from the Child Simulator Sickness Questionnaire.
Adverse effects from previous studies are generally mild. The most frequent are motion sickness-like symptoms such as dizziness, nausea or eyestrain. The child and parent/guardian will be asked to notify the health practitioner if they experience any symptoms during or up to 1 hour post-procedure.
Timepoint [7] 332011 0
Monitoring for side effects will occur during the procedure and up to 1 hour post-procedure
Secondary outcome [8] 340909 0
Between-group difference between mean pain scores for the patient after needle procedure in the VR and standard care groups as rated by parents/guardians using the Visual Analogue Scale (VAS)
Timepoint [8] 340909 0
Immediately post-procedure
Secondary outcome [9] 340910 0
Between-group difference between mean pain scores for the patient after needle procedure in the VR and standard care groups as rated by healthcare practitioners using the Visual Analogue Scale (VAS)
Timepoint [9] 340910 0
Immediately post-procedure

Eligibility
Key inclusion criteria
1. Children between the age of 4 to 11 years inclusive
2. Require an peripheral IV cannula or venepuncture for clinical management of any indication
Minimum age
4 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significantly unwell or clinically deteriorating as judged by the Investigator or treating team
2. A significant disability or medical condition that is likely to interfere with the child’s ability to complete the entire protocol (e.g. visual issues, autism, known needle phobia)
3. Inability to complete consent or study instruments

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/04/2017
Actual
13/07/2017
Date of last participant enrolment
Anticipated
Actual
15/02/2018
Date of last data collection
Anticipated
Actual
15/02/2018
Sample size
Target
240
Accrual to date
Final
254
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295681 0
Hospital
Name [1] 295681 0
Monash Health
Country [1] 295681 0
Australia
Funding source category [2] 295692 0
Self funded/Unfunded
Name [2] 295692 0
Dr Paul Leong
Country [2] 295692 0
Australia
Funding source category [3] 299410 0
Government body
Name [3] 299410 0
Department of Industry, Innovation and Science
Country [3] 299410 0
Australia
Primary sponsor type
Other
Name
Smileyscope Pty Ltd
Address
Level 1, 333 Exhibition Street
Melbourne
3004
Country
Australia
Secondary sponsor category [1] 294528 0
None
Name [1] 294528 0
Monash Health
Address [1] 294528 0
246 Clayton Road
Clayton VIC 3168
Country [1] 294528 0
Australia
Other collaborator category [1] 279764 0
Hospital
Name [1] 279764 0
The Royal Children's Hospital
Address [1] 279764 0
52 Flemington Road, Parkville, VIC 3052
Country [1] 279764 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296995 0
Monash HREC-A
Ethics committee address [1] 296995 0
Ethics committee country [1] 296995 0
Australia
Date submitted for ethics approval [1] 296995 0
16/01/2017
Approval date [1] 296995 0
06/07/2017
Ethics approval number [1] 296995 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2108 2108 0 0
/AnzctrAttachments/372399-RES-17-0000-038A Revised HREC Review Only Final Approval Letter.pdf (Ethics approval)
Attachments [2] 2109 2109 0 0
/AnzctrAttachments/372399-RES-17-0000-038A SSA Authorisation Letter.pdf (Ethics approval)
Attachments [3] 2110 2110 0 0
/AnzctrAttachments/372399-RCH 37077A Governance Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 72654 0
Dr Erin Mills
Address 72654 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Country 72654 0
Australia
Phone 72654 0
+61 3 9594 2900
Fax 72654 0
Email 72654 0
[email protected]
Contact person for public queries
Name 72655 0
Evelyn Chan
Address 72655 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Country 72655 0
Australia
Phone 72655 0
+61 3 9594 2900
Fax 72655 0
Email 72655 0
[email protected]
Contact person for scientific queries
Name 72656 0
Evelyn Chan
Address 72656 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Country 72656 0
Australia
Phone 72656 0
+61 3 9594 2900
Fax 72656 0
Email 72656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.