Recruiting

Iyengar Yoga

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT03784976

Conditions

Secondary Dysmenorrhea

Dysmenorrhea

Dysmenorrhea Secondary

Polycystic Ovary Syndrome

Endometriosis

Eligibility Criteria

Sex: Female

Age: 12 - 65

Healthy Volunteers: Not accepted

Interventions

Iyengar Yoga Therapy

Study Details

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).

Conditions

Secondary Dysmenorrhea

Dysmenorrhea

Dysmenorrhea Secondary

Polycystic Ovary Syndrome

Endometriosis

Study ID

NCT03784976

Start date

Jul 3, 2018

Status verified date

Dec, 2018

Completion date

Jul 2, 2021

Anticipated

Primary completion date

Jul 2, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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), and 12 months (after 6 months of observation and optional yoga practice).

no intervention: Control

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

Interventions

Iyengar Yoga Therapy

2 weekly yoga class (1.25 hours each)

Primary outcome measure

  • NIH PROMIS Pain Interference Survey [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]
  • NIH PROMIS Pain Intensity Survey [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]
  • NIH PROMIS Fatigue Survey [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]
  • NIH PROMIS Physical Function Survey [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]
  • NIH PROMIS Global Health Scale [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]
  • Self-Reported Home Practice survey [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]
  • Menstrual Distress Questionnaire [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]

Central Contacts and Locations

Locations

Iyengar Yoga Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Gwen Derk, PhD

805-797-9496gderk2@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Dec 24, 2018

Last verified

Dec, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2018-12-24.