About the Study
Here are all the details you'll need to know about the additional Medi Daith Survey you can complete alongside your piercing.
Study Title: Effectiveness of Daith Ear Piercing in the Treatment of Migraine Headaches
Information Provided by Dr Chris Blatchley
Here's everything you need to know about the additional study you can be a part of when you have a Medi Daith piercing at Blue Banana. This study, conducted by the London Migraine Clinic, will measure any change in your migraine headaches immediately after and the year after your Medi Daith piercing.
Before you decide whether you would like to participate, it is important that you understand why the evaluation is being done and what it will involve. This information will describe the procedures and your rights as a study participant.
Why is this evaluation being performed?
The purpose of the study is to evaluate the effect of Daith piercing in the treatment of migraine headaches.
Do you have to take part in the study?
No, you do not have to take part in the study. Your participation is entirely voluntary.
If you do agree to participate, your piercer will be recording some additional information and will be asking you about any discomfort you have when looking at a series of patterns of stripes that the piercer will show you.* You will also be asked to complete short follow-up questionnaires regularly over the next 12 months (5 mins online or by phone).
You can also decide at any time in the future to stop participating for any reason, and without explanation.
What would taking part in the research involve?
The research involves receiving a Daith piercing by a piercer who has been trained to carry it out for this study. Before the piercing, your piercer will be identifying the point to be pierced with a specialist electrical meter. This involves running a probe over the skin of the ear; this is completely painless.
The piercer may also, with your permission, take photographs of your ear to record the position of the piercing for both clinical and research purposes. You will not be recognisable from these photos, and the photos will not be used for any other purpose without your specific consent. These are the extra steps that will happen during your Medi Daith piercing experience.
- During your appointment, the piercer will ask you a series of questions regarding your migraine headaches and any symptoms you may be experiencing.
- Before and immediately after the piercing your piercer will measure any discomfort you experience when looking at patterns of black and white lines. Many, but not all, migraine headache sufferers find it uncomfortable to look at patterns like these. You will only look at each pattern for a second or two, and you do not need to look at any patterns that are particularly unpleasant.*
- Your piercer may ask you to take part in an extra stage before piercing in which we use extremely fine needles to temporarily stimulate two separate points of the ear. Your participation in this step is entirely voluntary. The needles are so fine that they cause little or no pain during insertion. After each needle is inserted, they will again use the patterns to measure if the discomfort changes.
- After the treatment we will contact you regularly by email or phone with a short questionnaire to follow up on the effect of the piercing on your migraine headaches.
There are no immediate direct benefits to you but the information you provide will help others in the future. As a thank you, everyone who completes all the online follow-up questionnaires will be offered a money-off voucher at the end of the study, to be redeemed at Blue Banana.
What are the possible disadvantages and risks of taking part?
There is the small inconvenience of filling in the short follow-up questionnaires (online or by phone) over the next 12 months.
The temporary insertion of the fine needles carries a very small risk of infection. However, the needles are sterile and the skin is cleaned with surgical spirit. The same type of needles are routinely inserted into the ear as an acupuncture treatment without a problem.
* You should not look at these patterns if you know you have photosensitive epilepsy which can be triggered by flashing lights. The presence of this condition will be checked by the piercer during your procedure.
How will my information be kept confidential?
- Medical information collected online by London Migraine Clinic (LMC) before your piercing appointment will be stored directly on LMC secure servers. Blue Banana (BB) will not have any access to this information.
- Medical information collected by BB during the piercing appointment, as part of the research and piercing will be securely transferred to LMC servers.
- Separate information from the follow-up questionnaires collected online or by phone will be saved directly on LMC secure servers.
- All medical information will remain part of your medical record at LMC and will be stored securely. All data will be collected and processed with care to ensure confidentiality and compliance with applicable data privacy protection laws and regulations.
- Your personal data (name and contact details) collected as part of the research will only be known to staff at LMC and BB, and will not be shared with members of the study team outside LMC.
What will happen to my data?
All medical data collected by Blue Banana will be securely transferred to London Migraine Clinic and will remain part of your medical record at The London Migraine Clinic.
Your personal data such as name or contact details will not be passed to the external evaluation team, who will only have access to a password-protected spreadsheet that will include only anonymous medical data. The evaluation team will group your anonymous data with the anonymous data from others to understand how to improve the outcome of Daith piercing on migraine headaches and the grouped analysis will be published in medical journals.
Under no circumstances will personal data be published. The only circumstances under which your personal data will be shared is in the very unlikely event that this is required for regulatory reasons such as if there is a serious adverse event and an insurance claim is being made; this would be discussed with you beforehand.
What if something goes wrong?
All of the procedures are in routine use and do not normally give rise to any problems. Blue Banana is very experienced with Daith piercing and has insurance to cover this procedure. In the unlikely event that participation in this study was to cause any damage to your health, insurance cover has also been arranged through the London Migraine Clinic.