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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)

28 de outubro de 2026 atualizado por: University Hospital, Lille

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Endometriose

Tipo de estudo

Observacional

Inscrição (Estimado)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Celine CLAIRET-LESPINASSE
Número de telefone: +33 3204441145
E-mail: celine.clairet@chu-lille.fr

Estude backup de contato

Nome: DRS. Promotion
Número de telefone: +33 3204441145
E-mail: drs.promotion@chu-lille.fr

Locais de estudo

França
- - Lille, França
    - CHU de Lille
    - Contato:
      
      Celine CLAIRET-LESPINASSE
      
      Número de telefone: +33320444145
      
      E-mail: celine.clairet@chu-lille.fr
    - Contato:
      
      Chrydtele RUBOD DIT GUILLET, Pr

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 43 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients referred for suspected endometriosis, with negative imaging findings and for whom an endotest has been indicated.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: CASE_ONLY
Perspectivas de Tempo: PROSPECTIVE

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
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. Prazo: 1 month + 3 weeks	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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
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. Prazo: 6 months + 3 weeks	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
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 Prazo: 6 months + 3 weeks	Change from baseline to 1 month after the results were announced, and from baseline to 6 months after the results were announced. Use: Endometriosis Health Profile-30 questionnaire (Quality-of-life score specific to women with endometriosis) - divided into several themes: general (focusing particularly on pain and psychological impacts), work, children, sexual relations, healthcare providers, treatment, and difficulties conceiving - 53 items rated on a scale of 1 to 5, World Health Organization Quality of Life (Quality of life score in the domains of "physical health," "psychological well-being," "social relationships," and "environment") - 26 items rated on a 5-point scale with a maximum total score of 130, Hospital Anxiety and Depression Scale questionnaire (Anxiety and depression score) - a two-part score consisting of 7 items each, rated on a 21-point scale, Medication Adherence Report Scale (Therapeutic compliance) - 10 items - score out of 10.	6 months + 3 weeks
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. Prazo: 6 months + 3 weeks	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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Lille

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

1 de junho de 2028

Conclusão do estudo (Estimado)

1 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

14 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de outubro de 2026

Primeira postagem (Real)

4 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)