The Sleep-pain Relationship in Women with Endometriosis

NCT06834737 | Not Yet Recruiting DMC

• 1 other identifier: 2526_ENDO
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometriosis

Keywords

ESM; Endometriosis; Sleep; Cyclic pain; Chronic pelvic pain

Outcome Measures

Primary Outcomes (2)

• Sleep quality

  Morning assessment: Irrespective of how much you slept, how good was the quality of your sleep? (0= not at all, 7= very good).

  From enrollment to the end of ESM at 8 weeks

• Pain intensity

  Evening assessment: How much pain did you experience today? (0= none, 7= very much)

  From enrollment to the end of ESM at 8 weeks

Secondary Outcomes (7)

• Mood

  From enrollment to the end of ESM at 8 weeks

• Stress

  From enrollment to the end of ESM at 8 weeks

• Sleep duration + sleep regulariy

  From enrollment to the end of ESM at 8 weeks

• Fatigue

  From enrollment to the end of ESM at 8 weeks

• Cognitive performance

  From enrollment to the end of ESM at 8 weeks

Other Outcomes (3)

• Menstrual cycle

  From enrollment to the end of ESM at 8 weeks

• Morning/ evening pain

  From enrollment to the end of ESM at 8 weeks

• Medication intake

  From enrollment to the end of ESM at 8 weeks

Study Arms (2)

Cyclic pain

OTHER

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.

Other: ecological sampling method

Non-cyclical pain

OTHER

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.

Other: ecological sampling method

Interventions

ecological sampling method OTHER

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

Cyclic pain; Non-cyclical pain

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Related Publications (4)

• Nunes FR, Ferreira JM, Bahamondes L. Pain threshold and sleep quality in women with endometriosis. Eur J Pain. 2015 Jan;19(1):15-20. doi: 10.1002/ejp.514. Epub 2014 Apr 14.

  PMID: 24733758 BACKGROUND

• Arion K, Orr NL, Noga H, Allaire C, Williams C, Bedaiwy MA, Yong PJ. A Quantitative Analysis of Sleep Quality in Women with Endometriosis. J Womens Health (Larchmt). 2020 Sep;29(9):1209-1215. doi: 10.1089/jwh.2019.8008. Epub 2020 Mar 13.

  PMID: 32176592 BACKGROUND

• Chaichian S, Mehdizadehkashi A, Haghgoo A, Ajdary M, Derakhshan R, Rokhgireh S, Sarhadi S, Nikfar B. Sleep disorders in patients with endometriosis; a cross-sectional study. BMC Womens Health. 2024 Jun 14;24(1):340. doi: 10.1186/s12905-024-03185-x.

  PMID: 38877485 BACKGROUND

• Sumbodo CD, Tyson K, Mooney S, Lamont J, McMahon M, Holdsworth-Carson SJ. The relationship between sleep disturbances and endometriosis: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2024 Feb;293:1-8. doi: 10.1016/j.ejogrb.2023.12.010. Epub 2023 Dec 9.

  PMID: 38091847 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zosia Goossens

CONTACT

02 629 25 26; zosia.goossens@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share