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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ecological sampling method | Other | 6-item diary, twice a day, over the course of 2 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mood | Evening assessment: How good was your mood overall today? (0= No good mood at all, 7= very good) | From enrollment to the end of ESM at 8 weeks |
| Stress | Evening assessment: How much stress did you experience today? (0= none, 7= very much) |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual cycle | Evening assessment: Have you menstruated today or experienced menstrual-like symptoms (e.g., spotting/intermittent bleeding,...)?
| From enrollment to the end of ESM at 8 weeks |
| Morning/ evening pain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zosia Goossens | Contact | 02 629 25 26 | zosia.goossens@vub.be |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24733758 | Background | 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. | |
| 32176592 | 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. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| From enrollment to the end of ESM at 8 weeks |
| Sleep duration + sleep regulariy | Morning assessment:
Sleep duration will be calculated based on Q1,Q2,Q3. Sleep regularity will be calculated based on Q1, Q2. | From enrollment to the end of ESM at 8 weeks |
| Fatigue | Evening assessment: How fatigued were you today? (0= Not at all, 7= very fatigued) | From enrollment to the end of ESM at 8 weeks |
| Cognitive performance | Evening assessment: How well do you think you performed cognitively today? (0= Not at all, 7= very good) | From enrollment to the end of ESM at 8 weeks |
| Night pain | Morning assessment: How much pain did you experience last night? (0= none, 7= very much) | From enrollment to the end of ESM at 8 weeks |
| Pain frequency | Evening assessment: How often did you experience pain today? (0 = not at all, 7 = continuous) | 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)
| From enrollment to the end of ESM at 8 weeks |
| Medication intake | Did you take any medication or other substances today? If so, please specify the medication and dosage (example: '1g dafalgan')
| From enrollment to the end of ESM at 8 weeks |
| 38877485 | 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. |
| 38091847 | 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. |
| D000091662 | Genital Diseases |