Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001063606p
Ethics application status
Submitted, not yet approved
Date submitted
13/09/2023
Date registered
4/10/2023
Date last updated
4/10/2023
Date data sharing statement initially provided
4/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Out Of This World: Virtual Reality Meditation for Migraine Management.
Scientific title
Investigating the feasibility, usability and preliminary effectiveness of home-based virtual reality (VR) meditation for the management of migraine in adults.
Secondary ID [1] 310595 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 331471 0
Condition category
Condition code
Neurological 328199 328199 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multiple baseline, replicated Single Case Experimental Design using an ABA (A-baseline, B-treatment, A-follow-up) procedure. A N=1 design comprising 12 participants will involve serial observations before, during and post intervention. Participants will attend an initial 1-hour session at City East Campus at The University of South Australia (UniSA) and informed consent to be obtained.
During the baseline phase, participants will be asked to record a daily symptom diary which will establish ‘usual’ symptoms. Following this, treatment will commence in the mid luteal phase of menstrual cycle 2.
The VR intervention will be delivered in their home using a Meta Quest ProTM VR HMD (Meta, Sunnyvale, CA). Tripp meditation software will be utilised, which has a wide range of material and a user friendly interface. Daily diary entries and menstrual cycle will be tracked on N1-Headache™ phone app, a clinically validated tool recommended by Migraine and Headache Australia (2023). ( This will also be utilised to establish baseline daily symptoms)
Participants will be instructed to use the VR meditation:1-As a prophylactic technique by employing VR at the first sign of stress or other personal migraine pre-cursers/indicators, and 2-During each migraine episode. The treatment will be withdrawn in mid luteal phase of menstrual cycle 3 and the daily symptom diary to continue throughout the follow-up phase. On completion participants will complete a closing session at UniSA which should take around 30 minutes.
During the initial meeting participants will be given a demonstration of the technology. They will have the chance to set the technology up themselves and ask any questions regarding use. They will also be provided with a written instructions for use. They will also be provided with a helpline number to call for troubleshooting advice throughout the intervention.
The meditation application we will use is called Tripp which will be preloaded onto the head mounted display. They will be guided through a meditation through visual and auditory cues via the app. The meditations will last no longer than 10 minutes each.
The intervention will be self administered by the participants in their home environment.
The overall duration of the study will be dependant on the individual participants menstrual cycle. It will run over 4 menstrual cycles. As part of the inclusion criteria we are looking for participants with a regular menstrual cycle of between 25-35 days. Therefore with a cycle of 35 days the overall study duration would be approximately 17 weeks.
Phase A (Base line period) will commence day 1 of menstrual cycle 1 until the mid luteal phase of menstrual cycle 2 ( day 18-23)
Phase B-( Intervention)will be introduced day 18-23 menstrual cycle 2 and will continue until the mid luteal phase of menstrual cycle 3
Phase A- (Follow up)- Intervention is removed at the mid luteal phase of menstrual cycle 3 and follow up phase will continue until mid luteal phase of menstrual cycle 4.

To check adherence to the VR intervention the primary researcher will make a weekly phone call to participants. We can also check device analytics to observe use. The participants will additionally be required to send a copy of the daily symptom diary to the research team weekly.
Intervention code [1] 327004 0
Treatment: Devices
Intervention code [2] 327005 0
Lifestyle
Intervention code [3] 327069 0
Behaviour
Comparator / control treatment
The participants will serve as their own control.
Control group
Active

Outcomes
Primary outcome [1] 336075 0
System usability
Measurement tool-System Usability Scale.
Timepoint [1] 336075 0
Study Completion
Completion would be at the mid luteal phase of menstrual cycle 4. We aim to complete outcome measure within 7 days of study completion.
Primary outcome [2] 336076 0
Adherence.
Measurement tool-Adherence self report questionnaire.
Usage logged automatically by head mounted display.
Timepoint [2] 336076 0
End of intervention phase ( within 7 days)
Secondary outcome [1] 426765 0
Self reported pain intensity using numerical pain rating scale.
Recorded via a daily symptom diary.
Timepoint [1] 426765 0
Daily.
Participants will be asked to record daily- ( will score zero if they are not experiencing pain on that day) They will be required to record this from day one of the study to study completion. ( mid luteal phase menstrual cycle 4)
Secondary outcome [2] 427090 0
Headache Frequency
Timepoint [2] 427090 0
Using the daily diary. They will record on a daily basis.
They will be required to complete the daily diary from day 1 of the study to study completion ( mid luteal phase of menstrual cycle 4)

Eligibility
Key inclusion criteria
-Meet ICHD criteria for chronic OR episodic migraine
-Sufficient upper limb and neck mobility to install head mounted display (HMD) and navigate software.
-Smart phone access.
-Fluent English.
-Pre-menopausal females, aged 18-45 with a regular menstrual cycle of 25-35 days.
-Must have headache as a main symptom.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
-Hearing/vision difficulties sufficient to impair VR experience.
-Epilepsy or claustrophobia.
-Severe psychiatric co- morbidities.
-Significant change in treatment in 3 months preceding study.
-Self-reported susceptibility to motion sickness

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single Case Experimental Design
A multiple baseline, replicated Single Case Experimental Design (SCED) using an ABA (A-baseline, B-treatment, A-follow-up) procedure. A N=1 design comprising 4 participants will involve serial observations before, during and post intervention. Key strengths of this design include improved statistical power because more data points are collected, providing better indications of the stability of outcome variables and a more reliable estimates of symptoms within and across phases.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314809 0
University
Name [1] 314809 0
The University of South Australia
Country [1] 314809 0
Australia
Primary sponsor type
University
Name
The University of South Australia
Address
GPO Box 2471 Adelaide South Australia 5001
Country
Australia
Secondary sponsor category [1] 316796 0
None
Name [1] 316796 0
Address [1] 316796 0
Country [1] 316796 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313815 0
UniSA Human Research Ethics Committee
Ethics committee address [1] 313815 0
Human Research Ethics Committee. The University of South Australia. GPO Box 2471 Adelaide. 5001
Ethics committee country [1] 313815 0
Australia
Date submitted for ethics approval [1] 313815 0
11/09/2023
Approval date [1] 313815 0
Ethics approval number [1] 313815 0

Summary
Brief summary
This study will seek to explore potential benefits of meditation delivered via a virtual reality (VR) headset to people living with chronic or episodic migraine. It will also seek to identify avenues and challenges for further research in this area.
A multiple baseline, replicated Single Case Experimental Design using an ABA (A-baseline, B-treatment, A-follow-up) procedure. A N=1 design comprising 12 participants will involve serial observations before, during and post intervention.
Trial website
Trial related presentations / publications
Public notes
Safety considerations include cybersickness (Sevinc & Berkman, 2020), with symptoms such as nausea, vomiting, disorientation and postural instability (Ramaseri Chandra et al., 2022). Susceptibility to cybersickness will be assessed with a trial of the VR at the initial meeting. Participants will be exposed to low visual simulation environments without quickly changing images or rapid acceleration/deceleration to reduce visual/vestibular conflict (Saredakis et al., 2020). Studies have also shown that nausea and disorientation may increase when VR exposure is >10minutes per session (Saredakis et al., 2020). This study will utilise short meditations of <10 minutes and participants will be encouraged to only use the VR technology when seated. With the use of a high quality VR device and careful selection of content, research shows that risk can be reduced and easily managed (Saredakis et al., 2020). It is recognised that the pressure of the strap and the weight of the HMD might also present a barrier. To help mitigate this, deluxe straps have been purchased to improve comfort. Furthermore, ‘Pro’ Meta Quest range will be used, which is lighter weight and more balanced on the head.

Contacts
Principal investigator
Name 129430 0
Mrs Laura Bell
Address 129430 0
The University of South Australia. City East Campus. Corner of North Terrace and Frome Road. Adelaide.5000
Country 129430 0
Australia
Phone 129430 0
+61 8 830 21265
Fax 129430 0
Email 129430 0
[email protected]
Contact person for public queries
Name 129431 0
Mrs Laura Bell
Address 129431 0
The University of South Australia. City East Campus. Corner of North Terrace and Frome Road. Adelaide.5000
Country 129431 0
Australia
Phone 129431 0
+61 8 830 21265
Fax 129431 0
Email 129431 0
[email protected]
Contact person for scientific queries
Name 129432 0
Mrs Laura Bell
Address 129432 0
The University of South Australia. City East Campus. Corner of North Terrace and Frome Road. Adelaide.5000
Country 129432 0
Australia
Phone 129432 0
+61 8 830 21265
Fax 129432 0
Email 129432 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


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.