Chronic pain during menopause
| ISRCTN | ISRCTN10701827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10701827 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 311041 |
| Protocol serial number | IRAS 311041 |
| Sponsor | University College London |
| Funders | Economic and Social Research Council, Biotechnology and Biological Sciences Research Council |
- Submission date
- 11/08/2022
- Registration date
- 12/08/2022
- Last edited
- 12/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
This study aims to understand the experiences of women with chronic/persistent pain conditions during the perimenopause – the period preceding and immediately after the final menstrual period. The perimenopause is a sensitive period for women, characterized by both physical and social changes that may predispose them to pain.
Through the use of in-depth interviews and other qualitative activities, the study will expose the narratives by which women make sense of pain and gynaecological events throughout their life as well as their interpretation of the variety of symptoms experienced during the perimenopause – and how pain and perimenopause symptoms may overlap or interact.
Who can participate?
Women aged 45-69 years of peri-menopausal age with a chronic/persistent pain diagnosis at an NHS secondary care pain management service
What does the study involve?
The research activities will be:
1. A first semi-structured interview with a life mapping exercise conducted by the researcher at participants' homes
2. A second semi-structured interview conducted by the researcher at the participants' homes
3. A go-along interview conducted by the researcher at the participants' homes or communities, in which the participant carries out a daily-life activity (eg. shopping, cooking, etc)
What are the possible benefits and risks of participating?
While there is no direct benefit in participating in this study, participating in research can be rewarding as the participants contribute to the furthering of knowledge that might one day result in enhanced experiences for people with similar conditions. There are no direct risks in participating in this study, but taking part in interviews can sometimes be distressing so the researchers will take care to monitor participants' well-being. Participants also have the right to withdraw from the study at any point.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
September 2021 to June 2023
Who is funding the study?
1. Economic and Social Research Council (ESRC) (UK)
2. Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Who is the main contact?
Prof. Sahra Gibbon, s.gibbon@ucl.ac.uk.
Contact information
Scientific
UCL Social Research Institute
University College London
27 Woburn Square
London
WC1H 0AA
United Kingdom
 ORCID ID |
0000-0002-4325-2377 |
|---|---|
| Phone | +44 (0)7588398228 |
| catherine.borra.19@ucl.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Medical anthropological study using interviews (semi-structured and go-along) and participant observation |
| Secondary study design | Ethnographic study |
| Study type | Participant information sheet |
| Scientific title | The emergence of chronic pain during perimenopause: an ethnographic study of women attending a secondary care pain management service |
| Study objectives | This study will investigate the experiences of chronic pain in women during perimenopause, since there is an unequal distribution of chronic pain during adulthood between men and women. This study will investigate if and how the intersection of pain and menopause affect women. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic pain, menopause |
| Intervention | This study will collect data through three interviews - two semi-structured interviews with a life-mapping exercise, and one go-along interview - and participant observation. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Participant experiences measured using a semi-structured interview and life map at week 1 |
| Key secondary outcome measure(s) |
Participant experiences and contextual information measured using field notes from participant observation at weeks 1-3. A sub-sample of participants had measurements taken at additional monthly sessions over a period of 5 months. |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Upper age limit | 69 Years |
| Sex | Female |
| Target sample size at registration | 10 |
| Key inclusion criteria | 1. Cis-gender women (females at birth who self-identify as women) 2. Aged 45-69 years 3. Pain symptom onset age 40-55 years 4. Have had the final menstrual period (FMP) 5. English-speaking 6. Formal diagnosis of chronic pain (CP) 7. Able to understand the study processes |
| Key exclusion criteria | 1. Awaiting further investigations to confirm diagnosis 2. Significant comorbidities which may affect CP and perimenopause symptoms (e.g. cancer, diabetes, neuropathy) 3. Unable to comply with study processes 4. Lack of capacity to give consent |
| Date of first enrolment | 01/12/2022 |
| Date of final enrolment | 01/06/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
25 Cleveland Street
London
W1T 4AJ
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The data will not be made available since ethnographic data is context-specific. It will be held in the UCL Data Safe Haven for 10 years upon study completion. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/08/2022: Trial's existence confirmed by University College London.
