Chronic pain during menopause
| ISRCTN | ISRCTN10701827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10701827 |
| IRAS number | 311041 |
| Secondary identifying numbers | IRAS 311041 |
- 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
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
| Study design | Medical anthropological study using interviews (semi-structured and go-along) and participant observation |
|---|---|
| Primary study design | Observational |
| Secondary study design | Ethnographic study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request 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 hypothesis | 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 |
| Condition | 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 | 1. Participant experiences measured using a semi-structured interview and life map at week 1 2. Participant experiences measured using a semi-structured interview at week 2 3. Participant experiences of activities and pain measured using a go-along interview at week 3 |
| Secondary outcome measures | 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. |
| Overall study start date | 01/09/2021 |
| Overall study end 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 number of participants | 10 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/12/2022 |
| Recruitment end date | 01/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
25 Cleveland Street
London
W1T 4AJ
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Sponsor information
University/education
Gower St
London
WC1E 6BT
England
United Kingdom
| uclh.randd@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- ESRC
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | This study’s participants are patients of a clinical pain management service, and as such a report will be disseminated to the clinical team in the form of a final report at the conclusion of the research. Results will inform part of Catherine Borra’s PhD, funded by the Economic and Social Research Council (ESRC) and Biological and Biotechnology Research Council (BBSRC), and will be included in her final thesis. Results will be communicated to the wider research community by: 1. Publications in peer-reviewed journals 2. Presentations at scientific meetings and conferences Funders will be acknowledged within the publications and other final reports of the study. Results will be communicated to participants who have expressed this wish in their ICF, in the form of a condensed report written in layman’s terms, and making the final scientific publication accessible to them upon request. The resulting publications and/or abstracts will be emailed to the JRO. Further dissemination will be done through patient support networks, and charities and will be circulated to general media – as part of the education of the general public which was identified as a priority in the PPI activities. PPI members also identified the need for sharing findings with primary care health professionals– this will be done by disseminating results in a condensed report form to relevant professional bodies. In all cases participants will remain anonymous. The primary author of any reports and studies utilising the primary data will be Catherine Borra (CB) – who will also be listed as the last author in any secondary publications using this data. All study team members who make a substantive contribution to reading and writing the final report will be granted authorship on the final study report. Substantive contributions will be defined by satisfying the following points, in line with the International Committee of Medical Journal Editors guidelines: 1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND 2. Drafting the work or revising it critically for important intellectual content; AND 3. Final approval of the version to be published; AND 4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
| 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. |
Editorial Notes
12/08/2022: Trial's existence confirmed by University College London.
