Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000748617
Ethics application status
Approved
Date submitted
14/06/2023
Date registered
10/07/2023
Date last updated
1/08/2024
Date data sharing statement initially provided
10/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient education for jaw reconstruction using virtual reality
Scientific title
Virtual reality patient education for adults undergoing jaw reconstruction for head and neck cancer: a feasibility study
Secondary ID [1] 309894 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distress 330371 0
Anxiety 330372 0
Condition category
Condition code
Cancer 327214 327214 0 0
Head and neck
Mental Health 327311 327311 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Virtual Reality (VR) Intervention:

This will take no longer than 1 hour and will attempt to be coordinated on the same day as another attendance at Chris O'Brien Lifehouse (COBLH). That is, the intervention will only be delivered once. The participants will first be orientated to the technology and VR headset at the commencement of the practical session by a moderator (Investigators TM, DS, AS, or RV) with experience with the hardware and software. Comfort features such as adjusting straps or incorporating the participants personal glasses will be demonstrated to ensure comfort during the practical component.

There are two components to the practical module of the VR education experience. Participants will undertake a learning/training module designed to orientate themselves to the hand controls as well as moving safely within the designated space. This module is designed to replicate the controls and movements required during the education session. Functions will include ‘grabbing’ objects, repositioning objects and moving within the virtual world.

The second component is the education experience. It involves the participant sitting in a chair and ‘walking’ within the virtual world and interacting with a number of different stations. Each station has a computer generated hologram that will provide pre-produced educational material as well as the ability for the participant to interact with objects at the station. At the commencement, the participant will be able to control the amount of and level of information basic information given initially and the option to ‘learn more’ with the delivery of additional content. The participants will be able to choose which and how many stations they elect to interact with, with the order of these stations predetermined as it follows the patients experiences each during their treatment.

A screen capture (recording of the screen) will be performed and assessed following completion of the activity allowing accurate recording of timing as well as capturing technical issues and accurate documentation. An audio recording of the session will also be performed for recording of the think-aloud component of the session. This will undergo quantitative data analysis to identify themes as well as representative quotes across each participants experience.

CONTENT SUMMARY OF VR EDUCATION/STATIONS:

(NOTE: this has been taken from script)
Station 1 has some 3D models of the skull and face, which you might like to pick up and look at them from different perspectives to understand the anatomy of the face.

Station 2 shows the main steps of reconstructive surgery of the jaw bones.

Station 3 tells you about a process called Virtual Surgical Planning (VSP for short). Surgeons and engineers use VSP to accurately plan your surgery on a computer-generated model – this allows them to tailor the surgical plan to a person’s unique anatomy.

Station 4 is all about dental rehabilitation, which is an important part of the process for many patients to be able to regain important functions after surgery.

Station 5 provides you with information about how 3D printing is used to make important surgical tools in our Lab such as cutting guides, which are used during surgery.

Station 6 gives you an opportunity to see inside the operating theatre, much like the one where you’ll be having your surgery. You will see the layout of the operating theatre and see some of the team who will be there on the day.
Intervention code [1] 326332 0
Behaviour
Comparator / control treatment
No control group.
Only pre and post

This is a pre and post study design where participants will be compared to their baseline states of distress and anxiety with respect to their jaw reconstruction surgery,
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335172 0
Feasibility

Method/tools of assessing Feasibility:
- Proportion of eligible patients correctly identified for the study assessed by audit of study records
- Proportion of eligible patients who agree to be enrolled assessed by audit of study records
- Time taken to complete the VR education assessed by audit of study records
- Retention rates of participants in the study and reasons for withdrawal assessed by audit of study records
Each of these measures will be used to assess feasibility as a composite outcome
Timepoint [1] 335172 0
'Upon conclusion of the study'.
Primary outcome [2] 335242 0
Acceptability

Instrument to assess Acceptability:
The Theoretical Framework of Acceptability (TFA) questionnaire is a 7-item generic tool that can be used to assess the acceptability of an intervention across seven constructs – affective attitude, burden, perceived effectiveness, opportunity costs, ethicality, intervention coherence, and self-efficacy. The TFA questionnaire is theory based and has demonstrated good content validity in pre-validation work. The optional 8th item of the TFA has been included in the questionnaire.
Timepoint [2] 335242 0
Post VR (Immediately after VR session)
Secondary outcome [1] 422972 0
Anxiety

State Trait Anxiety Inventory (STAI) will be used to assess state as well as trait anxiety.
Timepoint [1] 422972 0
Pre-intervention/Pre-VR
Post-intervention/Post-VR (Immediately following VR session)
Pre-discharge/Post operative follow-up
Secondary outcome [2] 423389 0
Distress

Distress Thermometer will be used to assess distress levels as well as assessing its sources.
Timepoint [2] 423389 0
Pre-intervention/Pre-VR
Post-intervention/Post-VR (Immediately following VR session)
Pre-discharge/Post operative follow-up
Secondary outcome [3] 423623 0
Understandability

Instrument used to assess Understandability:
This is an investigator designed questionnaire which consists 4 sub-scales related to the understandability VR Educational content, word choice in the content, organization of the content, and finally layout and design of the material.
Timepoint [3] 423623 0
Post-intervention/Post-VR (Immediately following VR session)

Eligibility
Key inclusion criteria
• Patients aged 18 years or older
• Scheduled to undergo reconstruction of the mandible for any head and neck pathology (malignant or benign)
• Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with a history of claustrophobia, hearing or visual impairments, or any balance disorders
• Patients unable to wear a VR-headset (for example due to pain, discomfort, or craniofacial deformities)
• Patients who require use of an interpreter for medical consultations

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative data
Analysis of quantitative survey data will be performed using appropriate statistical tests using statistical software programs (SPSS or SAS). Categorical data will be analysed using Chi-square (or Fisher’s exact) test statistics, as appropriate. Continuous data will be analysed using t-tests or Mann-Whitney U-tests, depending on the distribution of the data. For inferential statistics, statistical significance will be taken at P<0.05.

Qualitative data
Transcripts of recordings from the VR education sessions will be transcribed using Otter AI Transcription Software and checked for accuracy by at least two study team members. Interview transcripts will be analysed using NVivo software. Qualitative data (interview recordings) will be analysed thematically to perceptions of the VR education platform, opportunities for improvements, and aspects of acceptability and feasibility of integrating this form of education into routine practice. Participants will also be offered to review the transcripts before data analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
23/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24917 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 24918 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 40569 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314078 0
Hospital
Name [1] 314078 0
Chris O'Brien Lifehouse
Country [1] 314078 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Chris O’Brien Lifehouse, 119-143 Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 315988 0
None
Name [1] 315988 0
Address [1] 315988 0
Country [1] 315988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313217 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313217 0
Ethics committee country [1] 313217 0
Australia
Date submitted for ethics approval [1] 313217 0
16/06/2023
Approval date [1] 313217 0
18/07/2023
Ethics approval number [1] 313217 0
X23-0222 & 2023/ETH01244

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127378 0
Dr Rebecca Venchiarutti
Address 127378 0
Chris O’Brien Lifehouse, 119-143 Missenden Road, Camperdown NSW 2050
Country 127378 0
Australia
Phone 127378 0
+61 285140866
Fax 127378 0
Email 127378 0
[email protected]
Contact person for public queries
Name 127379 0
Rebecca Venchiarutti
Address 127379 0
Chris O’Brien Lifehouse, 119-143 Missenden Road, Camperdown NSW 2050
Country 127379 0
Australia
Phone 127379 0
+61 285140866
Fax 127379 0
Email 127379 0
[email protected]
Contact person for scientific queries
Name 127380 0
Rebecca Venchiarutti
Address 127380 0
Chris O’Brien Lifehouse, 119-143 Missenden Road, Camperdown NSW 2050
Country 127380 0
Australia
Phone 127380 0
+61 285140866
Fax 127380 0
Email 127380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregate data will be available from the authors, on request.


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.