My name is Jo Burgin and I am a GP researcher at the University of Bristol.
I would like to invite you to participate in my research project ‘Facilitators and Barriers to Diagnosing and Treating Perimenopause in Primary Care Patients with Mental Health Presentations’ (IRAS 318483)
Before you decide to take part, it is important to understand why the research is being done and what your participation will involve. Please take the time to read through this information sheet and ask any questions you may have.
Aims
- To understand the awareness, perceptions and experiences of the perimenopause in patients aged 45-55 presenting with mental health symptoms
- To explore General Practitioners views on mental health presentations in the perimenopause and how this affects their consultations
We hope to use this information to improve diagnosis and treatment of mental health symptoms related to perimenopause.
Who is being asked to take part?
I am asking women aged 45-55 to participate in a phone or online interview to discuss their views and experiences of mental health symptoms in mid-life.
We want to speak to anyone who meets the following criteria:
- Women and people who will go through menopause
- Aged 45-55
- Has had a GP consultation about any mental health symptom in the last 6 months – this includes a wide range of symptoms such as stress, insomnia, anxiety, low mood, mood swings and depression.
There are a few reasons you may not be able to take part in the study. We are not able to include women who are:
- On Hormone Replacement Therapy (HRT) at the time of their mental health consultation
- Post-menopausal*
- Being seen by a hospital specialist for mental health issues
- Cannot speak enough English to answer the interview questions
*This is normally after 12 months without period. You can still take part if you do not have periods because of your contraception or a previous medical procedure.
Separately, we will also be asking GPs to tell us about their understanding of perimenopause and mental health.
Do I have to take part?
No. Participation is entirely voluntary and you can withdraw from the study at any time – you do not need to give a reason. If you decide to withdraw, you will be asked what you wish to happen to the data you have provided up to that point.
What does participation involve?
Participation involves an interview that will last for approximately 1 hour. The interview would take place either by phone or on Microsoft Teams or Zoom video conference software (online), at an agreed time. If the interview takes place online you will be able to choose whether you want your camera on or off.
The interview will be an informal discussion around your experience of mental health symptoms in the midlife. We will also ask about your understanding and experiences of the perimenopause.
After the interview you will be provided with a £25 Love to Shop voucher to thank you for your participation.
The interview will have 3 parts:
- Mental Health
This will involve an informal conversation about your recent and past mental health symptoms and what led you to seek advice from your GP.
- Your GP consultation
We will ask you about your recent experience seeking advice from your GP and if you felt this met your needs, or could have been improved.
- The perimenopause
We will ask if you have any knowledge or experience of the perimenopause and if you feel this may have affected your mental health symptoms
Will I be recorded?
Yes. We need a record of the interview in order to include your data in the study.
How will we use information about you?
We will need to use information from you for this research project.
This information will include your name and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.
We will keep all information about you safe and secure.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
What are your choices about how your information is used?
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.
Where can you find out more about how your information is used?
You can find out more about how we use your information:
- at http://www.bristol.ac.uk/secretary/data-protection/policy/research-participant-fair-processing-notice/
- by asking one of the research team
- by sending an email todata-protection@bristol.ac.uk , or
- by calling the University’s Data Protection Officer on (0117) 3941824.
Limits to confidentiality
Please note that confidentiality will be strictly adhered to unless there is any disclosure of harm or danger to yourself or others. In such cases the researcher would have a duty of care to inform authorities, such as the police or social services. We would always discuss this with you first.
What are the possible disadvantages and risks of taking part?
- The interview may cover potentially sensitive topics such as mental health symptoms, difficult life events and hormonal symptoms (if you wish to discuss these issues). You do not have to discuss anything that you find distressing.
- If you feel uncomfortable at any point, you can stop the interview and recording. If you prefer, you can take time out/ mute and re-start when you feel comfortable doing so.
- We will be discussing your healthcare experiences but individual medical advice cannot be offered. Please see further resources (below).
What are the possible benefits of taking part?
Your views and feedback will provide us with a better understanding of the particular mental health challenges for women in mid-life.
You will also be provided with a £25 Love to Shop voucher to thank you for your participation.
What if I have a complaint?
If you want to raise a complaint you can contact the researcher directly at jo.burgin@nhs.net.
If you remain unhappy and wish to complain formally you can do this by contacting The University of Bristol research governance team at research-governance@bristol.ac.uk stating the project title.
What will happen to the results of the research project?
We hope that the results will improve our understanding of how mental health can be affected by perimenopause. The results will be shared with other health staff through reports in medical and health journals, newsletters, and talking about the results at conferences.
Who is organising and funding the research?
This research is being organised by a GP Academic Clinical Fellow, Dr. Jo Burgin, under the supervision of the University of Bristol. No additional funding has been received to carry out this research.
Further resources
For medical queries and concerns we always recommend speaking to your GP. There are also some additional resources below:
Bristol Mental Health Service – NHS Self referral https://www.vitahealthgroup.co.uk/nhs-services/nhs-mental-health/bristol-north-somerset-and-south-gloucestershire/
Bristol based mental health charity https://www.womankindbristol.org.uk
NHS Information on menopause https://www.nhs.uk/conditions/menopause/symptoms/
Thank you for reading this information and considering taking part in this research. If there is anything that is unclear, or you would like more information, please email me at jo.burgin@nhs.net
If you would like to participate please Sign Up and fill out the Participant Contact Form on the project website
Or you can contact me directly at jo.burgin@nhs.net