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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
Scientific title
The effect of eye gaze direction (forward or down) on mood and cognition in healthy volunteers
Secondary ID [1] 289302 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mood 298890 0
Cognition 298891 0
Condition category
Condition code
Mental Health 298971 298971 0 0
Studies of normal psychology, cognitive function and behaviour
Eye 298994 298994 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 294860 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 298436 0
Mood, assessed with The Affect Valuation Index (AVI).
Timepoint [1] 298436 0
Baseline, after the first speech, and after second speech.
Secondary outcome [1] 324127 0
Eye movements will be tracked using an
electrooculogram (EOG) to assess whether there are differences in patterns of eye
movement depending on gaze direction.
Timepoint [1] 324127 0
During watching film and speech period one, and during watching film and speech period two.
Secondary outcome [2] 324128 0
Total word count, and use of singular personal pronouns, assessed by using Linguistic Inquiry Word Count [LIWC] analysis of the speeches.
Timepoint [2] 324128 0
Speech period one and speech period two.
Secondary outcome [3] 324135 0
Visual analogue scale (VAS) measuring current positive mood
Timepoint [3] 324135 0
Baseline, after the first speech, and after second speech.
Secondary outcome [4] 324214 0
Visual analog scale of negative mood
Timepoint [4] 324214 0
Baseline and after each speech
Secondary outcome [5] 324215 0
overall mood assessed by visual analog scale
Timepoint [5] 324215 0
baseline and after each speech
Secondary outcome [6] 324216 0
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”.
Timepoint [6] 324216 0
baseline and after each task

Eligibility
Key inclusion criteria
Able to understand and speak English,
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/05/2016
Date of last participant enrolment
Anticipated
9/08/2016
Actual
30/05/2016
Date of last data collection
Anticipated
Actual
2/08/2016
Sample size
Target
72
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 7905 0
New Zealand
State/province [1] 7905 0
Auckland

Funding & Sponsors
Funding source category [1] 293681 0
University
Name [1] 293681 0
University of auckland
Country [1] 293681 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland,
Private Bag 92019, Auckland 1142.
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292515 0
None
Name [1] 292515 0
none
Address [1] 292515 0
none
Country [1] 292515 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295121 0
The University of Auckland Human Participants Ethics Committee,
Ethics committee address [1] 295121 0
Ethics committee country [1] 295121 0
New Zealand
Date submitted for ethics approval [1] 295121 0
15/04/2016
Approval date [1] 295121 0
06/05/2016
Ethics approval number [1] 295121 0
017249

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

Contacts
Principal investigator
Name 66178 0
A/Prof Elizabeth Broadbent
Address 66178 0
Department of Psychological Medicine,
University of Auckland
Private Bag 92019, Auckland 1142
Country 66178 0
New Zealand
Phone 66178 0
+64 9 3737599 Ext. 86756
Fax 66178 0
Email 66178 0
[email protected]
Contact person for public queries
Name 66179 0
Elizabeth Broadbent
Address 66179 0
Department of Psychological Medicine,
University of Auckland
Private Bag 92019, Auckland 1142
Country 66179 0
New Zealand
Phone 66179 0
+ 64 9 3737599 Ext. 86756
Fax 66179 0
Email 66179 0
[email protected]
Contact person for scientific queries
Name 66180 0
Elizabeth Broadbent
Address 66180 0
Department of Psychological Medicine,
University of Auckland
Private Bag 92019, Auckland 1142
Country 66180 0
New Zealand
Phone 66180 0
+ 64 9 3737599 Ext. 86756
Fax 66180 0
Email 66180 0
[email protected]

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

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Documents added automatically
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