Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001215910
Ethics application status
Approved
Date submitted
16/10/2020
Date registered
16/11/2020
Date last updated
16/11/2020
Date data sharing statement initially provided
16/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of wearing face masks on cognitive functioning
Scientific title
The effect of wearing face masks on cognitive functioning in younger adults
Secondary ID [1] 302535 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 319404 0
Condition category
Condition code
Neurological 317372 317372 0 0
Studies of the normal brain and nervous system
Mental Health 317373 317373 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will come into the laboratory in the Department of Psychology for two visits (each ~60 min) separated by 1 week. Participants will be asked to wear a PPE mask (Safe Plus anti-fog, earloop type, manufactured by BH medical products Co., Ltd.) for one of the visits for at least 8 hours during the day until completion of cognitive tests. Prior to their first visit, they will be randomly assigned a session order. Participants will perform different computer-based cognitive tests including (Pro keypress, Anti keypress, Pro/Anti keypress, Simon task, Forward spatial span, Backward spatial span, Two-back task and Flanker task) and visual analogue mood scale (VAMS).
Intervention code [1] 318821 0
Other interventions
Comparator / control treatment
All aspects of the control session are identical to the mask wearing session, except that participants are not required to wear the mask during the day of participation and during cognitive testing.
Control group
Active

Outcomes
Primary outcome [1] 325411 0
For Anti, Simon and Flanker tasks, median Reaction Times (RTs) (for
correct responses only) were used as a measure of inhibitory control.

References:
White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4),
539–549. https://doi.org/10.1037/pas0000503.

White, N., Flannery, L., McClintock, A., & Machado, L. (2019).
Repeated computerized cognitive testing: performance shifts and
test-retest reliability in healthy older adults. Journal of Clinical
and Experimental Neuropsychology, 41(2), 179–191. https://doi.
org/10.1080/13803395.2018.1526888
Timepoint [1] 325411 0
Assessed at two time points (i.e., mask wearing and control sessions), one week apart.
Primary outcome [2] 325412 0
For the Forward and Backward Spatial and Digit
tasks, maximum spans (i.e., the longest sequence length at which at least one sequence was recalled correctly), and total scores (i.e., the product of the maximum span and the total number of sequences recalled correctly were measured variables.

Reference
Kessels, R. P., van Zandvoort, M. J., Postma, A., Kappelle, L. J., & de
Haan, E. H. (2000). The Corsi block-tapping task: standardization
and normative data. Applied Neuropsychology, 7(4), 252–258.
https://doi.org/10.1207/S15324826AN0704_8.
Timepoint [2] 325412 0
Assessed at two time points (i.e., mask wearing and control sessions) one week apart.
Primary outcome [3] 325414 0
Switching ability (assessed via Pro/Anti task). Computerized reaction times (ms) are used as outcomes.

Timepoint [3] 325414 0
Assessed at two time points (i.e., mask wearing, and control) each one week apart.
Secondary outcome [1] 387854 0
Mood state (energetic) will be assessed using the Visual Analogue Mood Scales (VAMS).
The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [1] 387854 0
Assessed at two time points (i.e., mask wearing, and control ), each one week apart.
Secondary outcome [2] 387855 0
Mood state (sad) will be assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [2] 387855 0
Assessed at two time points (i.e., mask wearing, and control) each one week apart
Secondary outcome [3] 387856 0
Mood state (tense) will be assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [3] 387856 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [4] 387857 0
Mood state (happy) will be assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [4] 387857 0
Assessed at two time points (i..e, mask wearing, and control), each one week apart.
Secondary outcome [5] 387858 0
Mood state (tired) will be assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [5] 387858 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.
Secondary outcome [6] 387859 0
Mood state (calm) will be assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [6] 387859 0
Assessed at two time points (i.e., mask wearing, and control), each one week apart.

Eligibility
Key inclusion criteria
• Aged 18-35 years .
• Normal or corrected-to-normal vision.
• Comfortable wearing a face mask for at least 8 hours.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Chronic Obstructive Pulmonary Disease (COPD) based on self report

Study design
Purpose of the study
Diagnosis
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
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
We will use paired sample t tests to determine whether wearing face masks affect cognitive performance. Dropouts will be replaced to ensure a fully counterbalanced design with session order. If any missing data is deemed not missing at random, care will be taken to characterize it relative to other data.
The sensitivity power analysis using G*Power (Faul, 2007) indicated that with a sample size of 50 participants, alpha level of 0.05, and a desired power of 80% power, we will be able to detect a small to medium effect of wearing a face mask on cognitive functions (Cohen's d = 0.4).
Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G* Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39(2), 175-191. doi:10.3758/BF03193146

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/07/2020
Date of last participant enrolment
Anticipated
Actual
19/10/2020
Date of last data collection
Anticipated
Actual
27/10/2020
Sample size
Target
50
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 23061 0
New Zealand
State/province [1] 23061 0
OTAGO

Funding & Sponsors
Funding source category [1] 306972 0
University
Name [1] 306972 0
University of Otago
Country [1] 306972 0
New Zealand
Primary sponsor type
Individual
Name
Liana Machado
Address
Department of Psychology
University of Otago
362 Leith Street,
Dunedin 9016.
PO Box 56,
Dunedin 9054,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 307532 0
Individual
Name [1] 307532 0
Neda Nasrollahi
Address [1] 307532 0
Department of Psychology
University of Otago
362 Leith Street,
Dunedin 9016.
PO Box 56,
Dunedin 9054,
New Zealand
Country [1] 307532 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307104 0
University of Otago Human Ethics Committee
Ethics committee address [1] 307104 0
Ethics committee country [1] 307104 0
New Zealand
Date submitted for ethics approval [1] 307104 0
Approval date [1] 307104 0
02/07/2020
Ethics approval number [1] 307104 0

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

Contacts
Principal investigator
Name 106046 0
A/Prof Liana Machado
Address 106046 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 106046 0
New Zealand
Phone 106046 0
+64 3 479 7622
Fax 106046 0
Email 106046 0
[email protected]
Contact person for public queries
Name 106047 0
Neda Nasrollahi
Address 106047 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 106047 0
New Zealand
Phone 106047 0
+64 3 479 7622
Fax 106047 0
Email 106047 0
[email protected]
Contact person for scientific queries
Name 106048 0
Neda Nasrollahi
Address 106048 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 106048 0
New Zealand
Phone 106048 0
+64 3 479 7622
Fax 106048 0
Email 106048 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?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Data will be made available to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data will be available from the principal investigator upon request.

[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.