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Trial registered on ANZCTR
Registration number
ACTRN12616000808448
Ethics application status
Approved
Date submitted
25/05/2016
Date registered
21/06/2016
Date last updated
23/05/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of eye gaze direction on mood and cognition
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Scientific title
The effect of eye gaze direction (forward or down) on mood and cognition in healthy volunteers
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Secondary ID [1]
289302
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mood
298890
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Cognition
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Condition category
Condition code
Mental Health
298971
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0
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Studies of normal psychology, cognitive function and behaviour
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Eye
298994
298994
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0
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Normal eye development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants who complete the study will be asked to come to the lab for one hour.
Participants will be told a cover story about the study and the researcher will attach electrooculogram (EOG) electrodes to the participant’s face to measure eye gaze direction, Participants will be asked to complete baseline questionnaires including demographics, mood and power. They will receive instructions about the position they are to
maintain for the duration of the study (i.e. either gazing forward or gazing downward.
A calibration process will be carried out within the first minute of the looking period. Then will complete two tasks - one with the head down and one with the head up.
They will be presented with the first task; watching a short silent, black and
white film for one minute, and then describe and give their opinion on the film for
five minutes. Their descriptions will later be transcribed by the researcher and
analysed using a Linguistic Inquiry Word Count [LIWC] analysis programme. After the
story, participants will complete VAS reports on positive, negative, overall mood and
comfort, AVI, and the questionnaire on power. Participants will be allowed to return
to their natural posture for five minutes while receiving instructions about the second
part of the study. For the second part of the study, participants will resume gazing
either forward or downward and adopt the head position they have not yet
experienced. They will then do the second task and repeat the measures. Once both
parts of the study have been completed, the researcher will disconnect and remove
the electrodes from the participant’s face. They will be thanked for their participation
and will be free to leave. The calibration will be performed while the head is in the first position. It will be repeated for the second task. The angles of the eyes is determined by placing the screen either at eye height when sitting normally or near the ground so the participant has to look down. Head angle is determined by asking the person to rest their head on a ball placed under the chin - a big ball for head up (12.5 cm diameter ) and a small ball (7cm diameter) for head down. The participant will be supervised by the researcher to ensure the instructions are adhered to.
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Intervention code [1]
294860
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Treatment: Other
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Comparator / control treatment
One group looks forward and the other group looks down. Forward eye gaze and forward head position will act as the control.
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Control group
Active
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Outcomes
Primary outcome [1]
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Mood, assessed with The Affect Valuation Index (AVI).
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Assessment method [1]
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Timepoint [1]
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Baseline, after the first speech, and after second speech.
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Secondary outcome [1]
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Eye movements will be tracked using an
electrooculogram (EOG) to assess whether there are differences in patterns of eye
movement depending on gaze direction.
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Assessment method [1]
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Timepoint [1]
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During watching film and speech period one, and during watching film and speech period two.
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Secondary outcome [2]
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Total word count, and use of singular personal pronouns, assessed by using Linguistic Inquiry Word Count [LIWC] analysis of the speeches.
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Assessment method [2]
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Timepoint [2]
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Speech period one and speech period two.
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Secondary outcome [3]
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Visual analogue scale (VAS) measuring current positive mood
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Assessment method [3]
324135
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Timepoint [3]
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Baseline, after the first speech, and after second speech.
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Secondary outcome [4]
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Visual analog scale of negative mood
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Assessment method [4]
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Timepoint [4]
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Baseline and after each speech
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Secondary outcome [5]
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overall mood assessed by visual analog scale
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Assessment method [5]
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Timepoint [5]
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baseline and after each speech
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Secondary outcome [6]
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feelings of power assessed by using four items adapted from Cuddy, Wilmuth, and Carney (2012). Participants rate how “dominant”, “in control”, “powerful”, and “confident” they felt from “not at all” to “extremely”.
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Assessment method [6]
324216
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Timepoint [6]
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baseline and after each task
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Eligibility
Key inclusion criteria
Able to understand and speak English,
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Participants will be excluded if they are under 16 years of age, if they are not fluent
in English or if they have severely impaired vision.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
The study will have a mixed 2 by 2 experimental design. In the proposed study, 72 participants will be randomised to two groups (eye gaze forward or down) and then they will do two similar visually-based socially-situated tasks under two different conditions (head
tilt forward, and head tilt down). The order of the tasks will be counterbalanced.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Repeated measure ANOVA with between subjects factor of eye gaze direction will be used and within subjects head position factor.
D’Souza (2014) found an effect size of partial eta squared = .05, of eye gaze direction on high arousal positive affect. G power indicates that to find a similar effect, using power of .80, alpha of .05, and a repeated measures between factors ANOVA analysis, 72 participants would be required overall.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
30/05/2016
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Date of last participant enrolment
Anticipated
9/08/2016
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Actual
30/05/2016
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Date of last data collection
Anticipated
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Actual
2/08/2016
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Sample size
Target
72
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Accrual to date
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Final
90
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of auckland
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Address [1]
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The University of Auckland,
Private Bag 92019, Auckland 1142.
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
The University of Auckland,
Private Bag 92019, Auckland 1142.
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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none
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Address [1]
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none
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Country [1]
292515
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Auckland Human Participants Ethics Committee,
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Ethics committee address [1]
295121
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Office of the Vice Chancellor, Research Office,
Alfred Nathan House, The University of Auckland,
Private Bag 92019, Auckland 1142.
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Ethics committee country [1]
295121
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New Zealand
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Date submitted for ethics approval [1]
295121
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15/04/2016
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Approval date [1]
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06/05/2016
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Ethics approval number [1]
295121
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017249
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Summary
Brief summary
The study aims to investigate whether eye gaze direction (looking forward or
downward) can affect emotion and cognition independently of head tilt. The investigators hypothesise that looking down will result in lower high arousal positive affect and that looking down will result in lower feelings of power, lower overall mood, reduced peripheral eye gaze, fewer words spoken, and more singular personal pronouns than gazing forward, independent of head tilt.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Elizabeth Broadbent
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Address
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Department of Psychological Medicine,
University of Auckland
Private Bag 92019, Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 3737599 Ext. 86756
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Elizabeth Broadbent
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Address
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Department of Psychological Medicine,
University of Auckland
Private Bag 92019, Auckland 1142
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Country
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New Zealand
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Phone
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+ 64 9 3737599 Ext. 86756
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Elizabeth Broadbent
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Address
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Department of Psychological Medicine,
University of Auckland
Private Bag 92019, Auckland 1142
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Country
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New Zealand
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Phone
66180
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+ 64 9 3737599 Ext. 86756
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Fax
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Email
66180
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[email protected]
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No information has been provided regarding IPD availability
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.
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