Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001227583
Ethics application status
Approved
Date submitted
9/09/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
How does built environment scale affect cognitive performance and neurophysiological measures in healthy adults?
Scientific title
A counter-balanced within-subjects study examining built environment scale on cognitive performance and neurophysiological measures in healthy adults
Secondary ID [1] 311511 0
None
Universal Trial Number (UTN)
U1111-1306-9257
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive abilities (optimising working memory and facial emotion recognition performance) 333565 0
Condition category
Condition code
Public Health 330247 330247 0 0
Other public health
Neurological 331660 331660 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess how exposure to different physical room sizes affect cognitive performance and neurophysiological measures across an adult population. The aim is to better understand how the dimensions of interior rooms affect participants by constructing physical spaces, to replicate previously computer-modelled rooms which participants had been exposed to through a virtual reality study. Please note the 'rooms' constructed will not be fully enclosed (no back wall, enabling direct observation of the participant) and no ceiling (for safety). This physical configuration will match the Cave Automatic Virtual Environment setup of the previous study.

Our 'intervention' or 'condition' in this study is an 'enlarged' room with two side walls (4.5m length by 3.6m height) and a participant front-facing wall 3.6m length by 3.6m height). The walls will be constructed using structural pine, and finished with medium density fiberboard (MDF), painted white. The room consists of the three walls, a door-frame positioned in the center of the participant facing wall (height cue), and a wooden chair positioned in the right-hand corner of the room. A desk and chair will be positioned in the center of the constructed space for participants to complete cognitive tasks.

Each participant will be exposed to both the control and enlarged room (order randomized), where they will complete a social orientated task (facial emotion recognition) and executive functioning (working memory) task. They will be in each room for approximately 30-minutes, with a 5-minute wash-out period between where they will be invited to stand up, and take a short assisted walk with the researcher to the second room before being re-seated. Adherence during the computerised tasks will be monitored through the supervising researcher who will be observing the participant (standing outside of the room facing the participants back).
Intervention code [1] 328422 0
Treatment: Other
Comparator / control treatment
Our ‘control’ will be a room with two side walls (3m length by 2.4m height) and a participant front-facing wall (2.4m length by 2.4m height). The room consists of the three walls, a door-frame positioned in the center of the participant facing wall (height cue), and a wooden chair positioned in the right-hand corner of the room. A desk and chair will be positioned in the center of the constructed space for participants to complete cognitive tasks.
Control group
Active

Outcomes
Primary outcome [1] 337995 0
Change in reaction time (behavioural indicator of performance).
Timepoint [1] 337995 0
The reaction times will be captured over a set of trials that take place during exposure to each of the two rooms (control and condition/intervention).
Primary outcome [2] 339510 0
Change in accuracy (% of correct to incorrect responses) as a measure of behavioral performance.
Timepoint [2] 339510 0
A % rate will be created to understand how many trials were correct out of the total number of trials presented during exposure to each of the two rooms (control and condition/intervention).
Secondary outcome [1] 434065 0
Change in neurophysiological activity (brain activity recorded through electroencephalography or 'EEG').
Timepoint [1] 434065 0
We will collect a continuous recording which will be time stamped to indicate the room (control or condition) and the task (probe, retention, stimuli).
Secondary outcome [2] 440253 0
Change in autonomic activity (heart rate variability or 'HRV').
Timepoint [2] 440253 0
We will collect a continuous recording which will be marked with the room (control or condition).
Secondary outcome [3] 440254 0
Change in autonomic activity (skin conductance response of 'SCR').
Timepoint [3] 440254 0
We will collect a continuous recording which will be marked with the room (control or condition).

Eligibility
Key inclusion criteria
- Aged between 18 to 40 years
- Normal or corrected to normal vision.
- Able to read and understand English proficiently.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Based on self-report, no prior diagnosis and/or undergoing treatment for, a psychiatric (other than depression or anxiety), neurological or neurodevelopmental condition, particularly excluding those undertaking pharmacological treatment.
- No prior training in built environment design as this has been shown to effect results.

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Group size has been selected through an analysis of variance (ANOVA) repeated measures, within measures for planning data collection design and power. We have used a small to moderate effect size (f-value) of 0.25 with 1 group and 2 measures, with a correlation amongst repeated measures of 0.5 and non-sphericity correction of 1. This results in a sample size of n = 54 with an actual power of 0.95.

To analyse results, a linear mixed model will be used to enable the inclusion of participants who may have missing data and enable the participant to be entered as a random effect. Specifically, we will be looking at the difference in participants results between the room conditions (control to enlarged). We will also examine undertake exploratory analyses to understand participant socio-demographic, personality, and mood disorder factors on their results between the room conditions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 42391 0
5072 - Magill
Recruitment postcode(s) [2] 43154 0
5000 - Adelaide
Recruitment postcode(s) [3] 43155 0
5095 - Mawson Lakes

Funding & Sponsors
Funding source category [1] 316309 0
University
Name [1] 316309 0
UniSA Justice & Society, University of South Australia
Country [1] 316309 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 318493 0
None
Name [1] 318493 0
Address [1] 318493 0
Country [1] 318493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314658 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 314658 0
Ethics committee country [1] 314658 0
Australia
Date submitted for ethics approval [1] 314658 0
16/04/2024
Approval date [1] 314658 0
12/09/2024
Ethics approval number [1] 314658 0
206104

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

Contacts
Principal investigator
Name 132314 0
Dr Isabella Bower
Address 132314 0
UniSA Justice & Society, University of South Australia, St. Bernards Rd, Magill, SA 5072
Country 132314 0
Australia
Phone 132314 0
+61 08 8302 7445
Fax 132314 0
Email 132314 0
[email protected]
Contact person for public queries
Name 132315 0
Isabella Bower
Address 132315 0
UniSA Justice & Society, University of South Australia, St. Bernards Rd, Magill, SA 5072
Country 132315 0
Australia
Phone 132315 0
+61 08 8302 7445
Fax 132315 0
Email 132315 0
[email protected]
Contact person for scientific queries
Name 132316 0
Isabella Bower
Address 132316 0
UniSA Justice & Society, University of South Australia, St. Bernards Rd, Magill, SA 5072
Country 132316 0
Australia
Phone 132316 0
+61 08 8302 7445
Fax 132316 0
Email 132316 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?
Individual de-identified participant data underlying published results only.
When will data be available (start and end dates)?
From publication of the study findings (anticipated late 2025 to early 2026) with no end date imposed.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data will be made available on Open Science Framework (www.osf.io). The Principle Investigator can also be contacted ([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.