Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence (ENDETECT)
This non-interventional study aims to assess the impact of an endometriosis diagnosis obtained through a salivary test (Ziwig Endotest®) on pain-related cognitions, quality of life, mood, and treatment adherence, comparingthese outcomes with those of individuals who underwent the same salivary test but received a negative result and were therefore not diagnosed with endometriosis.
Participation in this study will contribute to advancing research in the field of endometriosis diagnosis and multidisciplinary management by expanding current knowledge of diagnostic protocols and their impact on pain, quality of life, treatment adherence, and potential psychiatric comorbidities. The investigators hope to enhance understanding of endometriosis and pelvic pain symptomatology in order to develop new therapeutic strategies, including psychological interventions or integrated psychological care, that better address the needs and specific characteristics of patients whether or not they receive a diagnosis of endometriosis.
研究概览
地位
条件
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Celine CLAIRET-LESPINASSE
- 电话号码：+33 3204441145
- 邮箱：celine.clairet@chu-lille.fr
研究联系人备份
- 姓名：DRS. Promotion
- 电话号码：+33 3204441145
- 邮箱：drs.promotion@chu-lille.fr
学习地点
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Lille、法国
- CHU de Lille
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接触：
- Celine CLAIRET-LESPINASSE
- 电话号码：+33320444145
- 邮箱：celine.clairet@chu-lille.fr
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接触：
- Chrydtele RUBOD DIT GUILLET, Pr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients referred for suspected endometriosis, with negative imaging findings and for whom an endotest has been indicated.
描述
Inclusion Criteria:
- Patients eligible for an endotest as part of the innovation package at Jeanne de Flandre Hospital
- Patients between 18 to 43 years old
- Understand and can communicate in French
- Having received medical images that do not allow the diagnosis of endometriosis
- Presenting with symptoms suggestive of endometriosis
- Giving oral non-opposition to participe in the study
- Beneficiary of health insurance coverage
- Having normal visual and auditory acuity or corrected to normal levels
Exclusion Criteria:
- Minors, adults under guardianship, under judicial protection, and persons deprived of liberty
- Refusal to participate after receiving clear and fair information about the study
- Sensory, visual or auditory inability to participate in the study
- Personal history of neurological disorders or current neurological disorder
- Consumtion of toxic substances other than tobacco and alcohol.
- Personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, or trauma- and stress-related disorders
- Use of psychotropic medications
- Pregnant or breastfeeding women
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_ONLY
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in pain catastrophizing 1 month after being informed of the results of the saliva test among patients diagnosed with endometriosis and among patients not diagnosed with endometriosis.
大体时间：1 month + 3 weeks
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Change in the Pain Catastrophizing Scale score between baseline and 1 month after the announcement of the salivary test results. Use : Questionnaire Pain Catastrophizing scale-13 items divided into three dimensions: "rumination," "magnification," and "helplessness"-scored on a scale of 0 to 4-maximum total score of 52 points. |
1 month + 3 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes 1 month after the consultation during which the results of the salivary test for pain catastrophizing were announced, based on the diagnosis of endometriosis.
大体时间：6 months + 3 weeks
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Change from baseline to 1 month after the announcement of the salivary test results in the Pain Catastrophizing Scale score. Use : Questionnaire Pain Catastrophizing scale-13 items divided into three dimensions: "rumination," "magnification," and "helplessness"-scored on a scale of 0 to 4-maximum total score of 52 points. |
6 months + 3 weeks
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Changes at 1 month and 6 months after the consultation during which the saliva test results were announced, based on whether endometriosis was diagnosed: • Quality of life • Anxiety and depressive symptoms • Treatment adherence
大体时间：6 months + 3 weeks
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Change from baseline to 1 month after the results were announced, and from baseline to 6 months after the results were announced. Use:
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6 months + 3 weeks
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Changes at 6 months following the consultation during which the results of the salivary test for pain catastrophizing were reported, based on the diagnosis of endometriosis.
大体时间：6 months + 3 weeks
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To compare the change in pain catastrophizing at 6 months following the consultation disclosing the salivary test results, between patients diagnosed with endometriosis and those not diagnosed with endometriosis. Use : Questionnaire Pain Catastrophizing scale-13 items divided into three dimensions: "rumination," "magnification," and "helplessness"-scored on a scale of 0 to 4-maximum total score of 52 points. |
6 months + 3 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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