Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000511831p
Ethics application status
Not yet submitted
Date submitted
17/03/2021
Date registered
3/05/2021
Date last updated
3/05/2021
Date data sharing statement initially provided
3/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Smokers', vapers', and non-users' reactions to vaping cues presented in virtual reality
Scientific title
Smokers', vapers', and non-users' reactivity to vaping cues in virtual reality
Secondary ID [1] 303720 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vaping addiction 321146 0
smoking addiction 321147 0
Condition category
Condition code
Public Health 318951 318951 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experiment will be a single, individual, in-person session at the Human Interface Technology Laboratory of the University of Canterbury, during which participants' responses to exposure to vaping cues will be recorded.
Three environments have been developed in virtual reality (VR): a bar, a park, and a vape shop. All environments contain multiple vaping cues: for example, poster advertisements, avatars vaping, and televisions showing various vaping tricks (where the vapour is exhaled in a specific form). Participants will be exposed to each of those environments, in randomised order, and with a distraction scene in between each environment. Each of the environments takes approximately 4 minutes; the distraction scenes take 2 minutes each; and the introduction scene, which does not contain any cues but is presented at the very start of the trial so participants can familiarise themselves with virtual reality, takes 4 minutes. Thus in total, exposure will take 22 minutes (introduction, 4 times distraction, 3 cue exposure environments). During exposure to the environments, heart rate variability (HRV), skin conductance (SC), and pupil dilation will be measured 4 times/second; subjective craving will be assessed in VR every 50 seconds; and eye tracking will register whether participants are looking at a vaping cue 4 times/second as well.
HRV and SC will be measured with the Empatica E4 wristband; pupil dilation and eye tracking through the Vive Pro VR headset; and for subjective craving participants indicate how much they crave a vape on a scale of 1 (not at all) to 100 (extremely much).
Since the only way of non-adherence for the participant would be to close their eyes and refuse to look at the environments, eye tracking will be used to check if participants paid any attention (however passive).
Intervention code [1] 320030 0
Behaviour
Comparator / control treatment
The control group will be the non-users (who neither smoke nor vape), as cue reactivity would only be expected in people with addiction (to vapes, with the possibility that smoking addiction may generalise to vaping cues due to the visual similarities). The participant will privately indicate their smoking and vaping status in the opening survey, thus leading the experiment to be single blinded for the experimenter (i.e. the participant knows what group they're in, but the experimenter doesn't). The control group will go through the experimental procedure like everyone else.
Control group
Active

Outcomes
Primary outcome [1] 326877 0
Differences between the groups in heart rate variability after exposure to cues, as measured by the Emaptica E4 wristband at 4 times per second.
Timepoint [1] 326877 0
These measures will be taken throughout the experiment; the outcome will be assessed once the data collection is complete
Primary outcome [2] 326878 0
Differences between the groups in subjective measures (self-reported craving) after exposure to cues. Craving will be measured during the VR session by asking participants to indicate how much they crave a vape, on a scale from 0 to 100.
Timepoint [2] 326878 0
These measures will be taken throughout the experiment; the outcome will be assessed once the data collection is complete.
Primary outcome [3] 327323 0
Differences between the groups in skin conductance after exposure to cues, as measured by the Empatica E4 at four times per second.
Timepoint [3] 327323 0
These measures will be taken throughout the experiment; the outcome will be assessed once the data collection is complete.
Secondary outcome [1] 392944 0
[This is a fourth primary outcome]
Differences between the groups in pupil dilation after cue exposure, as measured through the VR headset's eye tracking.
Timepoint [1] 392944 0
These measures will be taken throughout the experiment; the outcome will be assessed once the data collection is complete.

Eligibility
Key inclusion criteria
Participants are 18 years or older; are not pregnant; and are able to provide consent. The take-in survey will apply sampling quotas to ensure that similar amounts of smokers, vapers, dual users, and non-users will be recruited.
If participants display signs of cybersickness during the experiment, they will be asked to stop.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Being underage; pregnancy; cybersickness during experiment; did not adhere to the 1 hour or abstinence from cigarettes and vapes prior to the experiment (self-reported; rescheduling is possible)

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
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Based on an effect size f of .38 (which holds the middle between the benchmark for an average effect size, i.e. .25, and the large effect size reported by the literature on reactivity to smoking cues , i.e. .52), an alpha error probability of .05 and an assumed power of .95, G*Power estimated a required sample size of 60 participants in total. A conventional rule of thumb in research is a minimum of 20 people per condition however, so to avoid any issues with reviewers we aim to recruit at least 20 exclusive vapers, 20 exclusive smokers, 20 dual users, and 20 non-users.
For the main outcomes of interest, four multilevel models are proposed, where the outcomes of interest (skin conductance, pupil dilation, heart rate variability, and subjective cravings) are predicted by three fixed effects (smoking status, vaping status, and VR scenario), and including a random slope for VR scenario and a random effect for participants.
Finally, correlations between the physiological (heart rate variability, skin conductance, pupil dilation) and the subjective measures; thus validating the current operationalisation of 'craving'.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/06/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 23544 0
New Zealand
State/province [1] 23544 0
Canterbury

Funding & Sponsors
Funding source category [1] 308129 0
Government body
Name [1] 308129 0
Health Research Council (project number 18/738)
Country [1] 308129 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Simon Hoermann, University of Canterbury, School of product design, West 314, Engineering Road, Ilam, Christchurch 8041
Country
New Zealand
Secondary sponsor category [1] 308888 0
None
Name [1] 308888 0
Address [1] 308888 0
Country [1] 308888 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 308116 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 308116 0
Ethics committee country [1] 308116 0
New Zealand
Date submitted for ethics approval [1] 308116 0
31/05/2021
Approval date [1] 308116 0
Ethics approval number [1] 308116 0

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

Contacts
Principal investigator
Name 109590 0
Prof Simon Hoermann
Address 109590 0
University of Canterbury,
School of Product Design,
West 314,
Engineering road,
Ilam, Christchurch
8041
Country 109590 0
New Zealand
Phone 109590 0
+64 33692457
Fax 109590 0
Email 109590 0
[email protected]
Contact person for public queries
Name 109591 0
Simon Hoermann
Address 109591 0
University of Canterbury,
School of Product Design,
West 314,
Engineering road,
Ilam, Christchurch
8041
Country 109591 0
New Zealand
Phone 109591 0
+64 33692457
Fax 109591 0
Email 109591 0
[email protected]
Contact person for scientific queries
Name 109592 0
Simon Hoermann
Address 109592 0
University of Canterbury,
School of Product Design,
West 314,
Engineering road,
Ilam, Christchurch
8041
Country 109592 0
New Zealand
Phone 109592 0
+64 33692457
Fax 109592 0
Email 109592 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
While data will be recorded anonymously, to protect the participants' privacy we will not share raw data. Aggregated data will be reported in the planned experiment paper.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11044Study protocol    381633-(Uploaded-27-04-2021-09-55-35)-Study-related document.docx
11045Statistical analysis plan    381633-(Uploaded-27-04-2021-09-55-56)-Study-related document.docx
11046Informed consent form    381633-(Uploaded-27-04-2021-09-56-40)-Study-related document.docx
11047Analytic code    381633-(Uploaded-17-03-2021-12-11-36)-Study-related document.docx



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.