Pain in Endometriosis And the Relation to Lifestyle: Effectiveness of a Dietary Intervention and Cognitive Behavioral Therapy in Endometriosis-associated Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Change in Pain intensity assessed by the Numerical Rating Scale
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet and cognitive behavioral therapy (CBT) on pain symptoms, health related quality of life and the effect on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome in women with endometriosis. In addition, we want to investigate the differences in stress (measured by hair cortisol levels), inflammatory markers in peripheral blood, menstrual effluent, and the vaginal and intestinal microbiome between persons without and with endometriosis. Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet intervention, or standard care, an anti-inflammatory diet intervention and CBT or CBT alone. Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines or CBT or a combination of both interventions 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of endometriosis via ultrasound, MRI or surgery*
- •NRS pain score > 4*
- •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.
排除标准
- •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
- •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
- •Scalp hair shorter than 4 cm
- •Only applicable to patients with endometriosis
结局指标
主要结局
Change in Pain intensity assessed by the Numerical Rating Scale
时间窗: 3 months
The Numerical Rating Scale (NRS) ranges from 0 (no pain) to 10 (unbearable pain), and is the most commonly used subjective measure to assess pain intensity. Patients will score there estimated average pain intensity and there highest pain intensity of the previous 7 days. Minimum value: 0 Maximum value: 10 Higher score indicates a higher level of pain intensity.
Change in Pain intensity assessed by the Numerical Rating Scale
时间窗: 3 months
The Numerical Rating Scale (NRS) ranges from 0 (no pain) to 10 (unbearable pain), and is the most commonly used subjective measure to assess pain intensity. Patients will score there estimated average pain intensity and there highest pain intensity of the previous 7 days. Minimum value: 0 Maximum value: 10 Higher score indicates a higher level of pain intensity.
次要结局
- Change in the composition of vaginal and intestinal microbiome(3 months)
- Adherence and anti-inflammatory status of the diet(3 months)
- Change in health related quality of life assessed by the Endometriosis Health Profile 30(3 months)
- Change in inflammatory characteristics in menstruum(3 months)
- Change in general quality of llife assessed by the Short Form 36(3 months)
- Change in inflammatory charecteristics in peripheral blood(3 months)
- Change in soluble factors in plasma(3 months)
- Change in the composition of vaginal and intestinal microbiome(3 months)
- Change in objective stress assessed by measuring scalp hair cortisol levels(3 months)
- Adherence and anti-inflammatory status of the diet(3 months)