Endometriosis
Conditions
Keywords
ESM, Endometriosis, Sleep, Cyclic pain, Chronic pelvic pain
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.
Interventions
OTHERecological sampling method
6-item diary, twice a day, over the course of 2 months.
Sponsors
Vrije Universiteit Brussel
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Menstrual cycle | 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 |
| Morning/ evening pain | 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) |
| Medication intake | 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 \_\_\_\_\_\_\_\_ |
Contacts
Primary ContactZosia Goossens
Outcome results
None listed