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Yoga for endometriosis related pain

Yoga for endometriosis related pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22833
Enrollment
64
Registered
2019-10-24
Start date
2019-12-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Interventions

Yoga sessions scheduled for 75 minutes once a week during 8 weeks vs no intervention (control).

Sponsors

Maxima Medical Center.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Pain reduction on the numeric rating scale [NRS] after 8 weeks. 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

MeasureTime frame
• Quality of life, measured by the Endometriosis Health Profile [EHP-30] (after 8 weeks) • Pain Catastrophizing, measured by the Pain Catastrophizing Scale [PCS] (after 8 weeks) • Affective Symptoms, measured by the Generalized anxiety disorder [GAD-7] and patient health questionnaire [PHQ-9] (after 8 weeks) 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. • 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. • Use of analgesics, measured by the BPI questionnaire. • Reduction of dysmenorrhoea on NRS (if applicable) • Reduction of dyspareunia on NRS (if applicable) • 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.

Contacts

Public ContactEsther van Barneveld

Maxima Medical Center

esther.van.barneveld@mumc.nl043-3874038

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)