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Trial registered on ANZCTR


Registration number
ACTRN12622000401752
Ethics application status
Approved
Date submitted
21/02/2022
Date registered
9/03/2022
Date last updated
23/03/2023
Date data sharing statement initially provided
9/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability of augmented reality for children diagnosed with cystic fibrosis experiencing procedural anxiety: An exploration of perspectives
Scientific title
Exploration of perspectives from parents/guardians of children with cystic fibrosis and health professionals on the acceptability and usability of augmented reality technology embedded into print media to educate families of children with cystic fibrosis experiencing procedural anxiety with induced sputum collection via suction.
Secondary ID [1] 305658 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 324122 0
Procedural Anxiety 324123 0
Condition category
Condition code
Respiratory 321601 321601 0 0
Other respiratory disorders / diseases
Mental Health 322565 322565 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The prototype that will be created consists of a postcard embedded with augmented reality (AR) technology to educate parents and guardians about procedural anxiety and induced sputum collection. Parents and guardians of children diagnosed with cystic fibrosis (CF), along with health professionals, will be invited to complete a questionnaire and interview pre and post-interaction with prototype intervention regarding their thoughts and perspectives on the acceptability and usability for prospective clinical use. These interviews will be a single sessions lasting 45-60 minutes and will be conducted in the location of choice for the participant, including teleconference/zoom or in-person at The Women’s and Children’s Hospital (WCH), depending on current health recommendations during the global pandemic to research teams. This study is an iterative co-design; where-in every five interviews, a review of participant feedback will drive design and content changes, therefore allowing participants’ perspectives to facilitate changes that are likely to be influential. The prototype contains written material and a 1-2 minute animation that provides parents and guardians further information. The addition of an interactive platform for children with CF will be included as parents may choose to use this as one of their strategies to facilitate distraction clinically for their children through a balloon pop mini-game. The Zapper app will be used to scan one of two codes on the postcard to access both of the interactive augmented reality materials.
Intervention code [1] 322789 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330366 0
Examination of domains for acceptability of an augmented reality intervention for children diagnosed with CF. The examination will occur through the use of both a Likert scale questionnaire and a semi-moderator guided one-on-one interview taking approximately 45-60minutes in a single session to complete both data collection options.
Timepoint [1] 330366 0
Co-design - Immediate post single 2-minute intervention exploration.
Primary outcome [2] 330565 0
Examination of theoretical constructs for possible implementation of the intervention as examined by theoretical domains framework. The examination will occur through the use of both a Likert scale questionnaire and a semi-moderator guided one-on-one interview taking approximately 45-60minutes in a single session to complete both data collection options.
Timepoint [2] 330565 0
Co-design - Immediate post single 2-minute intervention exploration.
Primary outcome [3] 330566 0
Examination of intervention usability as examined by the System Usability Scale. The examination will occur through the use of both a Likert scale questionnaire and a semi-moderator guided one-on-one interview taking approximately 45-60minutes in a single session to complete both data collection options.
Timepoint [3] 330566 0
Co-design - Immediate post single 2-minute intervention exploration.
Secondary outcome [1] 406691 0
Nil
Timepoint [1] 406691 0
Nil

Eligibility
Key inclusion criteria
Parents/guardians:
- Parent/guardian of at least one child diagnosed with CF that has undergone induced sputum collection via suction in the past 5 years.
- Primary caregiver of that child for over 12 months
Health Professionals:
- Experienced work with induced sputum collection via suction with child CF patients
- Medical staff member (interns, medical students, and physicians), respiratory physiotherapist, psychologist or nursing staff.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- All participants must be able to speak and interpret spoken English, have nothing impeding their ability to interact with the content and no intellectual or cognitive impairment. Therefore, informed consent can be acquired.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
18/04/2022
Actual
18/04/2022
Date of last participant enrolment
Anticipated
23/05/2022
Actual
23/05/2022
Date of last data collection
Anticipated
30/06/2022
Actual
19/09/2022
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21656 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 36700 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 310017 0
University
Name [1] 310017 0
The University of South Australia
Country [1] 310017 0
Australia
Primary sponsor type
University
Name
The University of South Australia
Address
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 312088 0
None
Name [1] 312088 0
Address [1] 312088 0
Country [1] 312088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309724 0
Women's and Children's Hospital Network Human Research Ethics Committee (HREC)
Ethics committee address [1] 309724 0
72 King William Rd, North Adelaide SA 5006
Ethics committee country [1] 309724 0
Australia
Date submitted for ethics approval [1] 309724 0
27/10/2021
Approval date [1] 309724 0
21/02/2022
Ethics approval number [1] 309724 0
HRE00377
Ethics committee name [2] 310399 0
UniSA Human Research Ethics Committee
Ethics committee address [2] 310399 0
GPO Box 2471, Adelaide SA, 5001
Ethics committee country [2] 310399 0
Australia
Date submitted for ethics approval [2] 310399 0
23/02/2022
Approval date [2] 310399 0
Ethics approval number [2] 310399 0

Summary
Brief summary
The purpose of this study is to identify if AR technology is a practical approach within this clinical setting, Considering both the acceptability of this resource along with participant usability. The team is trying to identify if it is an age-appropriate tool to reduce procedural anxiety through education and self-management. The study will be done using one-on-one interviews accompanied by a short questionnaire that has been developed using the Theoretical Framework of Acceptability (TFA), the Theoretical Domains Framework (TDF) and the System Usability Scale (SUS).

Currently, there are minimal resources for this cohort within the cystic fibrosis community experiencing procedural anxiety. The topic of procedural anxiety may cause emotional distress in participants. Should this be bought to the attention of the researcher through observation within the interviews or a participant coming forward, they will be offered the support systems that are in place for this study.

A deductive thematic analysis of the semi-structured moderator guide responses accompanied by a comparison of mean and standard deviation from the questionnaire which will be used only for hypothesis generation, reporting and comparison of results. A narrative synthesis will be used to gather results and collate multiple forms of data allowing comparison of the different data collection methods. For the purpose of the research honours project, data will only be analysed through the TFA and the SUS. The TDF responses will be used for a separate paper associated with this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115174 0
Mrs Heather Lovelock
Address 115174 0
South Australian Health & Medical Research Institute (SAHMRI), Level 8 | Office 8.313
GPO Box 2471, Adelaide SA 5001
Country 115174 0
Australia
Phone 115174 0
+61 417272977
Fax 115174 0
Email 115174 0
[email protected]
Contact person for public queries
Name 115175 0
Kristin Carson-Chahhoud
Address 115175 0
Translational Medicine and Technology Group
Australian Centre for Precision Health
University of South Australia Cancer Research Institute (UniSA CRI)
South Australian Health & Medical Research Institute (SAHMRI), Level 8
GPO Box 2471, Adelaide SA 5001
Country 115175 0
Australia
Phone 115175 0
+61 8 8302 0453
Fax 115175 0
Email 115175 0
[email protected]
Contact person for scientific queries
Name 115176 0
Kristin Carson-Chahhoud
Address 115176 0
Translational Medicine and Technology Group
Australian Centre for Precision Health
University of South Australia Cancer Research Institute (UniSA CRI)
South Australian Health & Medical Research Institute (SAHMRI), Level 8
GPO Box 2471, Adelaide SA 5001
Country 115176 0
Australia
Phone 115176 0
+61 8 8302 0453
Fax 115176 0
Email 115176 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified transcripts
When will data be available (start and end dates)?
Start: 9 May 2022
End: 22 Aug 22
Available to whom?
This data will be available to participants and by others upon request within reason.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Through contact with one of the primary investigators, who will determine if the request is within reason.
Contact either Heather or Kristin:
[email protected]
[email protected]


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.