Iyengar Yoga Therapy for Dysmenorrhea and Endometriosis

NCT03784976 | Unknown

• 1 other identifier: 18257
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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; Fibroid; Menstrual Pain; Menstrual Disorder; Menstrual Discomfort

Outcome Measures

Primary Outcomes (7)

• NIH PROMIS Pain Interference Survey

  This survey is a 4 question short form. The PROMIS(r) Pain Interference instruments (adult and child) measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.

  baseline, 3 months, 6 months, 9 months, 12 months

• NIH PROMIS Pain Intensity Survey

  This survey is a 3 question short form. The PROMIS Pain Intensity instrument assesses how much a person hurts.

  baseline, 3 months, 6 months, 9 months, 12 months

• NIH PROMIS Fatigue Survey

  This survey is a 4 question short form. The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles.

  baseline, 3 months, 6 months, 9 months, 12 months

• NIH PROMIS Physical Function Survey

  This survey is a 4 question short form. Physical Function measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands.

  baseline, 3 months, 6 months, 9 months, 12 months

• NIH PROMIS Global Health Scale

  This survey is a 7 question short form. The PROMIS Global Health measures assess an individual's physical, mental, and social health.

  baseline, 3 months, 6 months, 9 months, 12 months

• Self-Reported Home Practice survey

  This survey is a 10 question survey about participants home yoga practice.

  baseline, 3 months, 6 months, 9 months, 12 months

• Menstrual Distress Questionnaire

  The Menstrual Distress Questionnaire (MDQ) is a standard method for measuring cyclical perimenstrual symptoms. It is used to help clinicians and researchers make systematic, empirical evaluations of a woman's symptoms, of treatments, and of etiological theories. The MDQ is a 46-item self-report inventory for use in the assessment and treatment of premenstrual and menstrual symptoms.

  baseline, 3 months, 6 months, 9 months, 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Other: Iyengar Yoga Therapy

Control

NO INTERVENTION

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 OTHER

2 weekly yoga class (1.25 hours each)

Also known as: Iyengar Yoga

Intervention

Eligibility Criteria

• Age: 12 Years - 65 Years
• Gender Eligibility Details: Must menstruate or be of menstruating age
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

Iyengar Yoga Center

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea; Polycystic Ovary Syndrome; Endometriosis; Leiomyoma; Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: December 24, 2018
• Study Start: July 3, 2018
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)