The Sleep-pain Relationship in Women with Endometriosis

Not Applicable

Not yet recruiting

• Conditions: Endometriosis

• Registration Number: NCT06834737
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Study Start: 2025-03
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sleep quality	From enrollment to the end of ESM at 8 weeks	Morning assessment: Irrespective of how much you slept, how good was the quality of your sleep? (0= not at all, 7= very good).
Pain intensity	From enrollment to the end of ESM at 8 weeks	Evening assessment: How much pain did you experience today? (0= none, 7= very much)

Secondary Outcome Measures

Name	Time	Method
Mood	From enrollment to the end of ESM at 8 weeks	Evening assessment: How good was your mood overall today? (0= No good mood at all, 7= very good)
Stress	From enrollment to the end of ESM at 8 weeks	Evening assessment: How much stress did you experience today? (0= none, 7= very much)
Sleep duration + sleep regulariy	From enrollment to the end of ESM at 8 weeks	Morning assessment: 1. What time did you go to bed last night?; 2. What time did you wake up this morning?; 3. For how long were you awake during the night?; Sleep duration will be calculated based on Q1,Q2,Q3. Sleep regularity will be calculated based on Q1, Q2.
Fatigue	From enrollment to the end of ESM at 8 weeks	Evening assessment: How fatigued were you today? (0= Not at all, 7= very fatigued)
Cognitive performance	From enrollment to the end of ESM at 8 weeks	Evening assessment: How well do you think you performed cognitively today? (0= Not at all, 7= very good)
Night pain	From enrollment to the end of ESM at 8 weeks	Morning assessment: How much pain did you experience last night? (0= none, 7= very much)
Pain frequency	From enrollment to the end of ESM at 8 weeks	Evening assessment: How often did you experience pain today? (0 = not at all, 7 = continuous)