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NCT Number: NCT06834737

The Sleep-pain Relationship in Women with Endometriosis

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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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ecological sampling method

Other

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

Primary outcomes

  1. Sleep quality

    Time frame: 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).

  2. Pain intensity

    Time frame: 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 outcomes

  1. Mood

    Time frame: 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)

  2. Stress

    Time frame: From enrollment to the end of ESM at 8 weeks

    Evening assessment:

    How much stress did you experience today? (0= none, 7= very much)

  3. Sleep duration + sleep regulariy

    Time frame: From enrollment to the end of ESM at 8 weeks

    Morning assessment:

    • What time did you go to bed last night?
    • What time did you wake up this morning?
    • 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.

  4. Fatigue

    Time frame: From enrollment to the end of ESM at 8 weeks

    Evening assessment:

    How fatigued were you today? (0= Not at all, 7= very fatigued)

  5. Cognitive performance

    Time frame: 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)

  6. Night pain

    Time frame: 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)

  7. Pain frequency

    Time frame: 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)

Other outcomes

  1. Menstrual cycle

    Time frame: From enrollment to the end of ESM at 8 weeks

    Evening assessment: Have you menstruated today or experienced menstrual-like symptoms (e.g., spotting/intermittent bleeding,...)?

    • Yes
    • No
    • Not applicable

  2. Morning/ evening pain

    Time frame: From enrollment to the end of ESM at 8 weeks

    Morning and evening assessment:

    How much pain do you experience right now? (0= none, 7= very much)

  3. Medication intake

    Time frame: From enrollment to the end of ESM at 8 weeks

    Did you take any medication or other substances today? If so, please specify the medication and dosage (example: '1g dafalgan')

    • No
    • Yes, sleep medication ______
    • Yes, pain medication _______
    • Yes, sedatives ________
    • Yes, other ________

Study contacts

Contact information is provided by the study sponsor or research team.

Zosia Goossens

CONTACT

[email protected]

02 629 25 26

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

Understanding Endometriosis-related Symptoms and Their Relationship to Sleep

Acronym: ENDO

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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