protocolSection identificationModule nctId: NCT06332560, orgStudyIdInfo id: NL86247.091.24, briefTitle: Pain in Endometriosis And the Relation to Lifestyle, acronym: PEARL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, collaborators name: ZonMw: The Netherlands Organisation for Health Research and Development, descriptionModule briefSummary: 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., conditionsModule conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: Anti-inflammatory diet (DI), interventions name: Cognitive behavioral therapy (CBT), outcomesModule primaryOutcomes measure: Change in Pain intensity assessed by the Numerical Rating Scale, primaryOutcomes measure: Change in inflammatory characteristics in menstruum, secondaryOutcomes measure: Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30, secondaryOutcomes measure: Change in general Quality of Life assessed by the Short Form 36, secondaryOutcomes measure: Change in the composition of vaginal and intestinal microbiome, secondaryOutcomes measure: Change in Objective stress assessed by measuring scalp hair cortisol levels, secondaryOutcomes measure: Adherence and anti-inflammatory status of the diet, otherOutcomes measure: Change in sleep quality assessed by the PSQI, otherOutcomes measure: Change in physical activity level assessed by the IPAQ-SF, otherOutcomes measure: Change in Subjective stress assessed by the Perceived Stress Scale, otherOutcomes measure: Changes in pain cognitions assessed by the Pain anxiety symptom scale, otherOutcomes measure: Changes in pain cognitions assessed by the pain catastrophizing Scale, otherOutcomes measure: Changes in Fatigue assessed by the checklist individual strength, otherOutcomes measure: Anti-inflammatory diet rating, eligibilityModule sex: FEMALE, minimumAge: 17 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboud University Medical Center, city: Nijmegen, country: Netherlands, contacts name: E Huijs, B, role: CONTACT, contacts name: A.W. Nap, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False