Pure Global AI
NCT06332560Not yet recruiting

Pain in Endometriosis And the Relation to Lifestyle

Pain in Endometriosis And the Relation to Lifestyle: Effectiveness of a Dietary Intervention and Cognitive Behavioral Therapy in Endometriosis-associated Pain
Radboud University Medical CenterClinicalTrials.govbehavioral
Verified
Study focus
Disease/Condition
Endometriosis
Drug/Device/Intervention
Anti-inflammatory diet (DI)
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Radboud University Medical Center
Location
Nijmegen, Netherlands
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
May 01, 2027
Enrollment
170 participants
Primary outcome

Change in Pain intensity assessed by the Numerical Rating Scale,Change in inflammatory characteristics in menstruum

Summary

The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet
 intervention on health related quality of life and pain symptoms in women with endometriosis.
 And whether the addition of CBT enhancing this effect. The secondary objective is to
 investigate the effect of an anti-inflammatory diet on inflammatory characteristics in serum
 and menstruum samples as well as the effect on the gut and vaginal microbiome.
 
 Participants will be randomized between standard care (control group), standard care and an
 anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral
 therapy.
 
 Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines for
 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be
 available. cognitive behavioral therapy will be administered in a total of seven individual
 sessions led by a psychotherapist. The content of these sessions will be psycho-education
 regarding pain mechanisms and diet.

ICD-10 classifications
EndometriosisOther endometriosisEndometriosis, unspecifiedEndometriosis of uterusEndometriosis of ovary
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06332560
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06332560 through Pure Global AI's free database. This phase not specified trial is sponsored by Radboud University Medical Center and is currently Not yet recruiting. The study focuses on Endometriosis. Target enrollment is 170 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.