Actively Recruiting
Understanding the Role of Adolescent Dysmenorrhoea as a Risk Factor for the Transition to Chronic Pain: Clinical Cohort Study
Led by University of Oxford · Updated on 2024-06-14
132
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
U
University of Exeter
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand whether changes seen in adult women with period pain also occur in adolescent girls within the first few years of having periods. It focuses on how quickly these changes happen and how period pain might contribute to other chronic pain types. This observational clinical cohort study explores these questions to help inform clinical practice and potentially develop prevention strategies. Participants are divided into two groups based on their reported period pain intensity: those with pain rated 4 or higher out of 10 and those with pain rated 3 or lower out of 10, with no other chronic pain conditions. No treatments are given during the study. Data collection occurs during specific menstrual cycle phases (days 1-3 and days 10-12) and includes questionnaires, nerve function tests, stress response assessments, brain imaging, and bladder sensitivity evaluations. During the study, participants complete detailed questionnaires and undergo tests such as Quantitative Sensory Testing, heart rate monitoring, bladder sensitivity measurement, salivary cortisol profiling, and brain scans. These assessments occur at specified menstrual phases to measure pain sensitivity, stress response, and brain function. The study helps researchers understand the progression of changes related to period pain and its link to chronic pain development over time.
CONDITIONS
Brief Title
Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or parent/guardian can give informed consent for the study
- Female or assigned female at birth
- Aged between 11 and 20 years
- Has had at least 6 periods per year since first menstruation
- During the study, within 12-15, 36-39, or 60-63 months since first menstruation
- Reports either period pain of 4 or higher out of 10 or no period pain with 3 or lower out of 10
- Not currently using or previously used hormonal contraceptives
- Reasonably fluent in English
You will not qualify if you...
- Has or had chronic pain conditions other than dysmenorrhoea, including migraines
- Is pregnant or breastfeeding
- Has had a previous cancer diagnosis
- Has any contraindications to MRI scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Two menstrual cycles covering days 1-3 (menstrual phase) and days 10-12 (follicular phase)
Participants complete detailed questionnaires and undergo tests measuring nerve function, stress response, bladder sensitivity, heart rate, pain sensitivity, and brain imaging during specific phases of the menstrual cycle.
2 visits per menstrual cycle (days 1-3 and days 10-12), totaling approximately 4 visits
Duration - Up to 63 months since first menstruation
Participants are observed over time to track changes related to period pain and potential development of chronic pain.
Follow-up visits scheduled depending on individual timing within 12-15, 36-39, or 60-63 months since first menstruation
Trial Site Locations
Total: 1 location
1
University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
K
Katy Vincent, MRCOG, DPhil
L
Lydia Coxon, DPhil
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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