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Out Of This World: Virtual Reality Meditation for Migraine Management.

Investigating the feasibility, usability and preliminary effectiveness of home-based virtual reality (VR) meditation for the management of migraine in adults.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001063606
Enrollment
12
Registered
2023-10-04
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

The University of South Australia
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026