The Sleep-pain Relationship in Women with Endometriosis (ENDO)

Vrije Universiteit Brussel

Status: Not yet enrolling

Conditions: Endometriosis

Treatments: Other: ecological sampling method

Study type: Interventional

Funder types: Other

Identifiers

NCT06834737

2526_ENDO

Details and patient eligibility

About

The goal of this study is to examine the sleep-pain relationship in women diagnosed with endometriosis, by monitoring different symptoms of endometriosis and sleep through an experience sample method study (ESM).The main question it aims to answer is:

How does sleep impact cyclic and chronic pain and vice versa in women with endometriosis?

Participants will be asked to fill in a 6-item diary (twice a day) over the course of 2 months.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult premenopausal women with a laparoscopic and histopathological diagnosis of endometriosis, without a history of hysterectomy, experiencing cyclic or chronic pelvic pain for 3 months or longer, with pain intensity of at least 3 out of 10 over the past 3 months, experiencing non-restorative sleep (defined as a subjective feeling of being unrefreshed up-on awakening) for 3 months or longer, in the absence of elevated risk for intrinsic sleep disorders (such as sleep apnea or restless leg syndrome), and having sufficient knowledge of either French, Dutch, or English

Exclusion criteria

• Participants younger than 18 years old, without laparoscopic and histopathological diagnosis of endometriosis, participants with a hysterectomy or pain intensity lower than 3/10, with restorative sleep or sleep apnea and restless leg syndrome, shift work and insufficient knowledge of either French, Dutch or English.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cyclic pain

Other group

Description:

Women eligible for the study are adult, non-(post)menopausal individuals who have received a laparoscopic and histopathological diagnosis of en-dometriosis. They have been experiencing cyclic pain (before, during, and/or after menstruation or monthly flare-ups without menstruation) for at least two months. Participants do not expect to undergo gynecologic or other surgical procedures for en-dometriosis during the study period and are not pregnant or breastfeeding. They must have no external factors interfering with their sleep for three or more nights per week, such as work, noise, or caregiving responsibilities. intervention: 6 item diary twice a day over the course of 2 months.

Treatment:

Other: ecological sampling method

Non-cyclical pain

Other group

Description:

Women eligible for the study are adult, non-(post)menopausal individuals who have received a laparoscopic and histopathological diagnosis of en-dometriosis. They have been experiencing non-cyclic pain for at least six months. Participants do not expect to undergo gynecologic or other surgical procedures for en-dometriosis during the study period and are not pregnant or breastfeeding. They must have no external factors interfering with their sleep for three or more nights per week, such as work, noise, or caregiving responsibilities. intervention: 6 item diary twice a day over the course of 2 months.

Treatment:

Other: ecological sampling method