ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

vaping addiction

smoking addiction

Condition category

Condition code

Public Health

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]

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]

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]

These measures will be taken throughout the experiment; the outcome will be assessed once the data collection is complete

Primary outcome [2]

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]

These measures will be taken throughout the experiment; the outcome will be assessed once the data collection is complete.

Primary outcome [3]

Differences between the groups in skin conductance after exposure to cues, as measured by the Empatica E4 at four times per second.

Timepoint [3]

These measures will be taken throughout the experiment; the outcome will be assessed once the data collection is complete.

Secondary outcome [1]

[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]

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]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council (project number 18/738)

Address [1]

Level 3/110 Stanley Street, Grafton, Auckland 1010

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Health and Disability Ethics Committee (HDEC)

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

31/05/2021

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The current experiment aims to find out if people who smoke and/or vape automatically start craving for a vape when they see something that reminds them of vaping (a 'cue'). This something can obviously be a vape, or another person blowing out smoke, or an advertisement; but also a certain situation (such as a bar or a vape shop) in which they often vape. 
To test this, we have created three scenarios in virtual reality (VR): a bar, a park, and a vape shop. All of those have cues. We will compare how people who don't vape or smoke respond to these scenarios, with the response of people who do vape and/or smoke. Specifically, we will measure three types of body reactions that often occur when people start craving something: heart rate variability, pupil dilation, and skin conductance (basically if you start sweating a little). Also, we will straight up ask a couple of times during the VR session "how much would you like to vape right now?".
It is hypothesised that exposure to vaping cues will increase subjective craving and physiological indicators of craving in vapers and dual users, but not in non-users.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Simon Hoermann

Address

University of Canterbury,
School of Product Design,
West 314,
Engineering road,
Ilam, Christchurch
8041

Country

New Zealand

Phone

+64 33692457

Fax

simon.hoermann@canterbury.ac.nz

Contact person for public queries

Name

Simon Hoermann

Address

University of Canterbury,
School of Product Design,
West 314,
Engineering road,
Ilam, Christchurch
8041

Country

New Zealand

Phone

+64 33692457

Fax

simon.hoermann@canterbury.ac.nz

Contact person for scientific queries

Name

Simon Hoermann

Address

University of Canterbury,
School of Product Design,
West 314,
Engineering road,
Ilam, Christchurch
8041

Country

New Zealand

Phone

+64 33692457

Fax

simon.hoermann@canterbury.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Attachment
11044	Study protocol	381633-(Uploaded-27-04-2021-09-55-35)-Study-related document.docx
11045	Statistical analysis plan	381633-(Uploaded-27-04-2021-09-55-56)-Study-related document.docx
11046	Informed consent form	381633-(Uploaded-27-04-2021-09-56-40)-Study-related document.docx
11047	Analytic 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.

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