Pain in endometriosis and the relation to Lifestyle (PEARL). Effectiveness of a dietary intervention and cognitive behavioral therapy in endometriosis-associated pai

Phase 4

• Conditions: dysmenorrhoe; Endometriosis; 10033283

• Registration Number: NL-OMON56879
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 180

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are the change in HRQoL (as measured by the<br /><br>Endometriosis Health Profile (EHP)-30 and Short Form (SF)-36, as well as a<br /><br>general rating) and pain symptoms (as measured by a Numerical Rating Scale<br /><br>(NRS)).</p><br>