Yoga for endometriosis related pai
- Conditions
- Endometriosis
- Registration Number
- NL-OMON22833
- Lead Sponsor
- Maxima Medical Center.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 64
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Premenopausal women = 18 years old.
•Diagnosed with endometriosis (by physical examination, imaging techniques or laparos-copy).
•Patients who report one of the endometriosis related pain symptoms dysmenorrhoea, abdominal/pelvic pain or dyspareunia; on average, at least 1 day per week in the last 3 months, with a minimum average pain score on the numeric rating scale of 4.
•Ability to understand and speak the Dutch language.
•Owning a smartphone.
•Ability to understand how to utilize the Experience Sampling Method [ESM] tool.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Change of hormonal medication during the past one month.
(for example for endometriosis treatment or fertility treatment).
•Surgery planned during the study period.
•Already performing yoga or mindfulness during the past 3 months.
•Any organic explanation for chronic pelvic pain besides endometriosis.
•Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain reduction on the numeric rating scale [NRS] after 8 weeks.<br>A significant reduction in pain score is defined as a mean difference between groups of at least 1.4 points measured on the NRS.
- Secondary Outcome Measures
Name Time Method •Quality of life, measured by the Endometriosis Health Profile [EHP-30] (after 8 weeks)<br>•Pain Catastrophizing, measured by the Pain Catastrophizing Scale [PCS] (after 8 weeks)<br>•Affective Symptoms, measured by the Generalized anxiety disorder [GAD-7] and patient health questionnaire [PHQ-9] (after 8 weeks)<br><br>Outcomes will be assessed by ESM at baseline and after intervention (8 weeks) and results will be compared to the results of the above mentioned validated retrospective questionnaires, measured at 8 weeks.<br><br>•Pain reduction on the numeric rating scale [NRS] after 4 and 12 weeks. Pain reduction on NRS is assessed by end of week pain score.<br>•Use of analgesics, measured by the BPI questionnaire.<br>•Reduction of dysmenorrhoea on NRS (if applicable) <br>•Reduction of dyspareunia on NRS (if applicable)<br>•The differences in pain reduction on NRS assessed by ESM compared to end of day pain scores [BPI] and end of week pain scores on the NRS.