Clinical trial NCT03784976: Iyengar Yoga Therapy for Dysmenorrhea and Endometriosis
Official title: Iyengar Yoga for Treatment of Endometriosis and Secondary Dysmenorrhea: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Secondary Dysmenorrhea
Dysmenorrhea
Dysmenorrhea Secondary
Polycystic Ovary Syndrome
Endometriosis
Fibroid
Menstrual Pain
Menstrual Disorder
Menstrual Discomfort
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to look at the effectiveness of prescribing yoga classes to patients with dysmenorrhea (irregular or painful periods), or other menstrual disorders on patients' self reported pain and quality of life.

Patients will be recruited from primary care clinics around Illinois, including Carle Hospital. This is a randomized trial in which patients will first be randomized into the control or intervention group. Patients in the control group will undergo usual care and be surveyed at baseline, 3 months, 6 months and 9 months. Patients in the control group will be offered the 3 months of yoga therapy complimentary after completing the 9 month control. Control patients who choose to participate in the yoga therapy will be asked to also complete the surveys at the end of the 3 month yoga intervention. Patients in the intervention group will first undergo 3 months of regular care and then 3 months of biweekly yoga classes. Participants will complete surveys at baseline, 3 months (after of control care), 6 months (after 3 months of biweekly yoga classes), 9 months, and 12 months (after 6 months of observation and optional yoga practice).

Detailed description: Participants will contact the research team with the information on the flyer. Participants will be asked to come to the Iyengar Yoga Center (407 W Springfield Ave, Urbana, IL 61801) to receive more information. Participants will need to disclose their diagnosis to the research staff. If they are not aware of what their diagnosis is, they will need to contact their physician to get their official diagnosis. For example, a woman with dysmenorrhea may be diagnosed with poly cystic ovarian disease or endometriosis or idiopathic dysmenorrhea, or another reproductive disease; participants will need to know their specific diagnosis or find out their specific diagnosis and report it to the research staff. Participants can do this by calling their physicians. For participants that are unaware of their diagnosis, they may also request a copy of their medical records. These records may be shared with the research staff to help determine diagnosis. The research staff will not keep these medical records, but return them to the participants. Participants can then either consent on the first visit or choose to take time as much time as they need and return to the yoga center when they are ready to sign the consent form. Participants will complete the first round of surveys at the yoga center after they sign the consent form (20 minutes). Participants will receive an email or phone call from the study team to inform them of their randomization results.

A blind third party statistician will complete the randomization for all participants at the beginning of the study for all 90 participants and will email the study coordinator with the randomization results. Randomization will be done through a free online software called graphpad. (https://www.graphpad.com/quickcalcs/randomize1.cfm).

The study lasts 12 months for the intervention and 9 months for the control group with an optional 3 month yoga therapy session offered at the end: Once consented, participants will fill out baseline surveys, and then undergo 3 months of usual care (no intervention), the same baseline surveys will be filled out again, then participants will get biweekly free yoga therapy classes for 3 months, and surveys will again be completed at the end of the intervention. Patients will then have a 6 month follow up and will fill out the surveys one last time. Recruitment will occur on a rolling basis so patients may join the study at anytime and not have to wait for a batched group.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for the proposed study is any menstruating female with dysmenorrhea, endometriosis, or any menstrual disorder. (Ages 12-65)

Exclusion Criteria:

* The exclusion criteria any one who has not reached menarche (age of menstruation) or who has reached menopause (no longer menstruates). This age range of exclusion is roughly defined as anyone younger than 12 and older than 65. Pregnant individuals are not eligible to participate in this study.

Primary outcomes:
measure: NIH PROMIS Pain Interference Survey
timeFrame: baseline, 3 months, 6 months, 9 months, 12 months
measure: NIH PROMIS Pain Intensity Survey
timeFrame: baseline, 3 months, 6 months, 9 months, 12 months
measure: NIH PROMIS Fatigue Survey
timeFrame: baseline, 3 months, 6 months, 9 months, 12 months
measure: NIH PROMIS Physical Function Survey
timeFrame: baseline, 3 months, 6 months, 9 months, 12 months
measure: NIH PROMIS Global Health Scale
timeFrame: baseline, 3 months, 6 months, 9 months, 12 months
measure: Self-Reported Home Practice survey
timeFrame: baseline, 3 months, 6 months, 9 months, 12 months
measure: Menstrual Distress Questionnaire
timeFrame: baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Iyengar Yoga Center
state: Illinois
Study officials:
References: