Pain in Endometriosis And the Relation to Lifestyle

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to understand how an anti-inflammatory diet and cognitive behavioral therapy (CBT) can help reduce pain and improve the quality of life for women with endometriosis and adenomyosis. The study will compare three different groups: one group will receive standard care, another will follow the anti-inflammatory diet along with standard care, and the third group will participate in CBT alongside the diet and standard care. Over 12 weeks, participants will get personalized meal plans from a dietician and attend individual sessions with a therapist to learn about managing pain and diet.

To be eligible for this study, women must be between 17 and 50 years old, premenopausal, and have a body mass index (BMI) between 18 and 30. They should also be willing to follow the diet and participate in CBT. Participants will need to collect menstrual samples and may need to take breaks from hormonal birth control during the study. It's important to note that those with certain health conditions, severe mental disorders, or who are pregnant cannot take part in this trial. This study offers an opportunity to explore new ways to manage endometriosis pain, and participants will receive support and resources throughout the process.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age from 17 years
• • Premenopausal status
• • Body Mass Index (BMI) 18-30 kg/m2
• • Ability to understand the explanation about the diet intervention (DI) and CBT
• • Willing to follow the DI
• • Willing to continue their use of food supplements
• • Willing to undergo CBT
• • Willing to collect menstrual effluent, and therefore willing to have two stop weeks from hormonal contraception (if applicable) during the study period.
• Exclusion Criteria:
• • Recurrent miscarriages (\> 2)
• • Eating disorder
• • Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome or another chronic inflammatory disease
• • Self-reported celiac disease
• • Vegan diet
• • Smoking
• • Use of immunosuppressive or psychotropic medication
• • Score on FFQ \> 120
• • Diagnosed with severe mental disorder currently requiring treatment by psychiatrist
• • NRS average score below 4 during the last month
• • Participation in another intervention study
• • Unable to speak Dutch or to understand the intervention
• • Need for surgery during the participation in the study
• • Serious pain (NRS \> 4) from other origin than endometriosis
• • Pregnant
• • Scalp hair shorter than 4 cm