Understanding Endometriosis-related Symptoms and Their Relationship to Sleep
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Vrije Universiteit Brussel
- Enrollment
- 60
- Primary Endpoint
- Sleep quality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
Cyclic pain
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.
Intervention: ecological sampling method (Other)
Non-cyclical pain
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.
Intervention: ecological sampling method (Other)
Outcomes
Primary Outcomes
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).
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
- Night pain(From enrollment to the end of ESM at 8 weeks)
- Pain frequency(From enrollment to the end of ESM at 8 weeks)
- 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)
Investigators
Olivier Mairesse
Professor
Vrije Universiteit Brussel