The Sleep-pain Relationship in Women with Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cyclic pain

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.

Group Type OTHER

ecological sampling method

Intervention Type OTHER

6-item diary, twice a day, over the course of 2 months.

Non-cyclical pain

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.

Group Type OTHER

ecological sampling method

Intervention Type OTHER

6-item diary, twice a day, over the course of 2 months.

Interventions

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ecological sampling method

6-item diary, twice a day, over the course of 2 months.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No